SUMMARY OF THE PRODUCT CHARACTERISTICS

Size: px
Start display at page:

Download "SUMMARY OF THE PRODUCT CHARACTERISTICS"

Transcription

1 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT IBALGIN FAST 400 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg ibuprofen (as mg ibuprofen lysinate). For the full list of excipients, see section PHARMACEUTICAL FORM Film-coated tablet Product description: Light red-violet oblong biconvex film-coated tablet of size approx.19,1 x 9,1 mm. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications IBALGIN FAST is intended for symptomatic treatment of mild to moderate acute pain of various origin, such as headaches (including tension headache, and migraine headache), toothache, pain after dental extraction (including surgical removal of impacted teeth), pain of muscles and dysmenorrhea. IBALGIN FAST also shows antipyretic effect in feverish conditions. The product is designed for adults and adolescents from 40 kg bodyweight (12 years of age and above) Posology and method of administration For oral administration Adults and adolescents from 40 kg bodyweight (12 years of age and above) Initial dose is 400 mg of ibuprofen (one tablet of IBALGIN FAST corresponding to 684 mg of ibuprofen lysinate). If necessary, then, 400 mg of ibuprofen (1 tablet of IBALGIN FAST) can be taken every 6 hours as required. The interval between two doses should be at least 6 hours. Maximal daily dose for the dispensing without medical prescription is 1200 mg of ibuprofen (3 tablets of IBALGIN FAST) within 24 hours. If this product is required for more than 3 days in the case of migraine headaches or fever or for more than 4 days for the treatment of pain, or if the symptoms worsen the patient is advised to consult a doctor. Elderly In elderly patients the dosage is the same like in adults, but increased caution is necessary (see section 4.4)

2 Children under 40 kg bodyweight (under 12 years of age) The product IBALGIN FAST is contraindicated in children under 40 kg bodyweight (under 12 years of age) due to the strength of a single dose, see section 4.3. Patients with impaired hepatic or renal function No dose reduction is required in patients with mild to moderate impairment of renal or hepatic function, however increased caution is necessary (see section 4.4) The tablet may be taken with or without food. If taken with food or shortly after eating, the onset of action may be delayed. However taking it with food improves tolerability of the product and reduce probability of gastrointestinal problems. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4) Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with a history of hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with the intake of acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). In patients with cerebrovascular or other active bleeding. Disorders of haemocoagulation and haemopoiesis. Severe heart failure. Severe hepatic or renal failure. Severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake). Children under 40 kg bodyweight (under 12 years of age). Third trimester of pregnancy Special warnings and precautions for use Undesirable effects may be minimised by using the lowest effective dose for the shortest possible duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below). Gastrointestinal (GI) safety The use of IBALGIN FAST with concomitant NSAIDs including cyclooxygenase 2 selective inhibitors should be avoided. Elderly:

3 The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.8). Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose acetylsalicylic acid, or other active substances likely to increase gastrointestinal risk (see below and section 4.5). Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, or anticoagulants such as warfarin, SSRI or anti-platelet agents such as acetylsalicylic acid (see section 4.5). When GI bleeding or ulceration occurs in patients receiving IBALGIN FAST, the treatment should be withdrawn. NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn s disease) as these conditions may be exacerbated (see section 4.8) Cardiovascular and cerebrovascular effects Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose of ibuprofen (e.g mg daily) is associated with an increased risk of myocardial infarction. Increased attention is necessary during renal impairment (see section 4.2, 4.3 and 4.8) monitoring of renal functions is recommended in patients at risk, i.e. patients with cardiac and renal impairment, treated with diuretics or during dehydration of any etiology. during liver impairment (see section 4.2, 4.3 and 4.8) control of blood count and routine monitoring of kidney and liver functions is advisable in prolonged administration. It is suitable to discontinue the therapy with ibuprofen when deterioration of the liver functions occurs in connection with its administration. After discontinuation of the treatment the health state usually normalizes. Occasional monitoring of glycemia is also suitable.

4 directly after major surgery in congenital disorder of porphyrin metabolism (e.g. acute intermittent porphyria) in asthmatic patients in patients treated by coumarin anticoagulants. More frequent control of hemocoagulation parameters is suitable in patients using coumarin anticoagulants. systemic lupus erythematodes and mixed connective tissue disease (the risk of aseptic meningitis). Aseptic meningitis has been observed on rare occasions in patients on treatment with ibuprofen. Although it is more likely to occur in patients with systemic lupus erythematosus and connective tissue diseases, aseptic meningitis has been reported in patients with no underlying chronic disease if the vision problems, blurred vision, scotomata, malfunctions of colour perception appear, it is necessary to interrupt the treatment. in patients who suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders as an increased risk of allergic reactions exists for them. These may present as asthma attacks (so-called analgesic asthma), Quincke s oedema or urticaria. Severe acute hypersensitivity reactions (for example anaphylactic shock) are observed very rarely. At the first signs of hypersensitivity reaction after taking/administering IBALGIN FAST therapy must be stopped. Medically required measures, in line with the symptoms, must be initiated by a specialist. Skin reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. IBALGIN FAST must be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications. To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of IBALGIN FAST in case of varicella. Other notes: Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications. In general terms, the habitual intake of painkillers, particularly on combination of several pain-relieving active substances, may lead to permanent renal damage with the risk of renal failure (analgesic nephropathy). This risk may be increased under physical strain associated with loss of salt and dehydration. Therefore, it should be avoided.

5 Through concomitant consumption of alcohol, active substance-related undesirable effects, particularly those that concern the gastrointestinal tract or the central nervous system, may be increased on use of NSAIDs. Ibuprofen may mask the symptoms of an infection (fever, pain and swelling). Using cyclooxygenase inhibitors/ inhibitors of prostaglandin synthesis may have negative influence on female fertility due to effect on ovulation. This effect is reversible and relieves after discontinuation of the therapy. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of ibuprofen should be considered Interaction with other medicinal products and other forms of interaction The concomitant use of IBALGIN FAST with other NSAIDs including cyclooxygenase 2 specific inhibitors should be avoided. Ibuprofen (like other NSAIDs) must be used with particular caution with the following drugs: - Acetylsalicylic acid or other NSAIDs: increase in the risk of gastrointestinal ulcers and bleeding - Acetylsalicylic acid: experimental data suggest that ibuprofen may inhibit the effect of low dose acetylsalicylic acid (aspirin) on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1). - Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (See section 4.4) - Antihypertensive and diuretic agents: NSAIDs may reduce the effect of diuretics and other antihypertensive medicinal products. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the coadministration of an ACE inhibitor, betareceptor-blockers or angiotensin-ii antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal functions after initiation of concomitant therapy, and periodically thereafter. - Potassium sparing diuretics: The concomitant administration of ibuprofen and potassiumsparing diuretics may lead to hyperkalaemia (check of serum potassium is recommended). - Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (See section 4.4) - Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (See section 4.4) - Lithium, digoxin, phenytoin: the concomitant use of IBALGIN FAST with lithium, digoxin or phenytoin preparations may increase serum levels of these active substances. A check of serum-lithium, serum-digoxin, and serum-phenytoin levels is not as a rule required on correct use (maximum over 4 days).

6 - Methotrexate: the administration of IBALGIN FAST within 24 hours before or after administration of methotrexate may lead to elevated concentrations of methotrexate and an increase in its toxic effect. - Baclofen: there are clinical data indicating that NSAIDs may increase plasma level of this drug - Zidovudine: there is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receving concurrent treatment with zidovudine and ibuprofen. - Quinolone antibiotics: animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions. - Cyclosporin, tacrolimus: may increase the risk of nephrotoxicity on account of reduced synthesis of prostaglandins in the kidney. During combination treatment renal function must be closely monitored, especially in the elderly. - Sulphonylurea derivatives: clinical investigations have shown interactions between nonsteroidal anti-inflammatory drugs and antidiabetics (sulphonylureas). Although interactions between ibuprofen and sulphonylureas have not been described to date, a check of blood-glucose values is recommended as a precaution on concomitant intake. - Sulfinpyrazone, probenecid: Medicinal products that contain probenecid or sulfinpyrazone may delay the excretion of ibuprofen. - Aminoglycosides: since ibuprofen may decrease the clearance of aminoglycosides, their co-administration may increase the risk of nephrotoxicity and ototoxicity Fertility, pregnancy and lactation Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, ibuprofen should not be given unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of pregnancy, to:

7 - a possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses. - to an inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy (see section 4.3). Lactation Ibuprofen and its metabolites penetrate to the milk of breast-feeding mothers only at low concentrations. Due to the minimal amount in breast milk, the short elimination half-life and no records till now concerning a harmful influence on infants, ibuprofen may be used during breast-feeding for short-term treatment of pain or fever at the recomended dose. Safety after long-term use has not been established. Fertility: There is some evidence that drugs, which inhibit cyclo-oxygenase/prostaglandin synthesis, may cause impairment of female fertility by an effect on ovulation. This is revers ible on withdrawal of treatment (see section 4.4) Effects on ability to drive and use machines As central nervous undesirable effects such as tiredness, dizziness and visual disturbances may occur on use of IBALGIN FAST at higher dosage, the ability to react and the ability to take part actively in road traffic and to operate machines may be impaired in isolated cases. This applies to a greater extent in combination with alcohol Undesirable effects The following table summarises adverse drug reactions of ibuprofen divided into groups according to MedDRA terminology together with their frequency: very common ( 1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to < 1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). With the following adverse drug reactions, it must be accounted for that they are predominantly dose-dependent and vary interindividually. The most commonly observed adverse reactions are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4) have been reported following administration. Less frequently, gastritis has been observed. Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

8 Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high dose (2400 mg daily), and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). MedDRA system organ class Blood and lymphatic system disorders Immune disorders system Metabolism and nutrition disorders Frequency Very rare Uncommon Rare Very rare Very rare Undesirable effect blood formation disorders (anemia, leucopenia, trombocytopenia, pancytopenia, agranulocytosis) The first signs may be fever, sore throat, superficial wounds in the mouth, influenza-like complaints, severe lassitude, nosebleeds and skin bleeding. The blood count should be checked regularly in long-term therapy. hypersensitive reactions with skin rashes and itching, as well as asthma attacks (possibly with drop in blood pressure) The patient is to be instructed to inform a doctor at once and no longer to take IBALGIN FAST in this case. aseptic meningitis (especially in patients with systemic lupus erythematodes or mixed connective tisssue disease) severe general hypersensivity reactions (face, tongue and larynx oedema, dyspnoea, tachycardia, hypotension, life-threatening shock). If one of these symptoms occurs, which can happen even on the first use, the immediate assistance of a doctor is required. retention of sodium and fluids Psychiatric disorders Very rare depression, emotional lability, psychotic reactions Nervous system Uncommon vertigo, headache, sleeplessness, agitation, disorders irritability or tiredness Eye disorders Uncommon visual disturbances, Rare colour perception disorders, toxic amblyopia Ear and labyrinth Rare tinnitus disorders Cardiac disorders Rare cardiac failure Very rare palpitations, myocardial infarction Vascular disorders Very rare decrease of blood pressure, hypertension Respiratory, thoracic and medastinal disorders Very rare bronchospasm (predominantly in asthmatic patients), asthma exacerbation

9 Gastrointestinal disorders Very common Common Uncommon Very rare nausea, vomiting, heartburn, diarrhoea, constipation, flatulence abdominal pain and slight gastro-intestinal blood losses that may cause anaemia in exceptional cases. gastritis, gastrointestinal ulcers, potentially with bleeding (melena, hematemesis) and perforation, ulcerative stomatitis, exacerbation of Crohn s disease, exacerbation of colitis oesophagitis, pancreatitis, formation of intestinal diaphragm-like strictures. The patient is to be instructed to withdraw the medicinal product and to go to a doctor immediately if severe pain in the upper abdomen or melaena or haematemesis occurs. Hepatobiliary disorders Rare changes in hepatic functions (usually reversible) Skin and subcutaneous tissue disorders Renal and urinary disorders Very rare Uncommon Very rare Very rare hepatic damage, particularly in long-term therapy, hepatic failure, acute hepatitis Urticaria, pruritus alopecia, bullous reaction including Stevens-Johnson syndrome and toxic epidermal necrolysis, erythema multiforme. In exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection (see also "Infections and infestations"). cystitis, hematuria, renal function disorders incl. nephrotic syndrome or interstitial nephritis that may be accompanied by acute renal failure, papillary necrosis, especially in long-term use, increased serum urea concentrations and oedema. Renal function should therefore be checked regularly Overdose Ibuprofen overdose mainly causes gastrointestinal symptoms (nausea, vomiting, epigastric pain, gastrointestinal bleeding or, more rarely diarrhoea) and in more serious poisoning CNS disorders (headache, dizziness, agitation, somnolence, disorientation, convulsions or coma). Occasionally patients develop convulsions. In serious poisoning, metabolic acidosis may occur and the prothrombin time/inr may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics. There may furthermore be hypotension and respiratory depression. Treatment There is no specific antidote, treatment is supportive and symptomatic.

10 Therapy of acute overdose: to carry out gastric lavage as soon as possible with administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount and laxative or to evoke vomiting reflex. Management should be supportive and symptomatic and include control and adjustment of liquid and electrolyte balance, maintenance of respiratory and cardiovascular functions, diazepam or lorazepam can be administered in the case upon convulsions, plasma-expanders, eventually dopamine or norepinephrine during hypotension. Give bronchodilators for asthma. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmacodynamic properties Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids; propionic acid derivatives ATC code: M01AE01 Ibuprofen lysinate is the lysine salt of ibuprofen, propionic acid derivative NSAID. The therapeutic effects of ibuprofen lysinate result from its inhibitory effect on the enzyme cyclooxygenase, which results in inhibition of prostaglandin synthesis. In humans, ibuprofen reduces inflammatory-related pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits ADP- and collagen-induced platelet aggregation. Following oral administration, ibuprofen lysine dissociates to ibuprofen acid and lysine. Lysine has no recognised pharmacological activity. The pharmacological properties of ibuprofen lysine, therefore, are the same as those of ibuprofen acid. A clinical trial was performed in 350 volunteers with postoperative dental pain which demonstrated at least the same efficacy of IBALGIN FAST compared with ibuprofen acid tablets 400 mg and proved superiority over placebo for the treatment of moderate to severe pain. The first two primary endpoints of this study, superiority over placebo and non-inferiority with ibuprofen acid tablets, were demonstrated. For the third primary endpoint of this study, pain relieve at 45 minutes superiority to ibuprofen acid tablets could not be demonstrated. The pre-planned secondary analyses of time to onset of action (time to any relief, time to meaningful relief, time to pain half gone) did not show any significant differences between Nurofen and IBALGIN FAST The faster onset of action has been supported in post-hoc analyses only by secondary parameters pain relieve and pain intensity at 15 and 30 minutes. There were no differences in safety between IBALGIN FAST and ibuprofen acid tablets. However, the study was not powered to detect differences in safety. Experimental data suggest that ibuprofen may inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release acetylsalicylic acid dosing (81mg), a decreased effect of acetylsalicylic acid on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use Pharmacokinetic properties

11 Most pharmacokinetic data obtained following the administration of ibuprofen acid also apply to ibuprofen lysine. Ibuprofen is rapidly and well absorbed after oral administration. Peak plasma concentration after oral administration of ibuprofen acid is achieved already after 1-2 hours upon administration on empty stomach, when administered with meal after approximately 1-3 hours. However, ibuprofen is more rapidly absorbed from the gastrointestinal tract following the administration of IBALGIN FAST. In a pharmacokinetic study in healthy fasting volunteers IBALGIN FAST has confirmed a faster onset of peak plasma concentrations in comparison with of ibuprofen acid tablets 400 mg. The median difference in Tmax was 15 minutes. Peak plasma concentrations of 37 µg/ml were achieved 45 minutes after oral administration of IBALGIN FAST in comparison with 30 µg/ml within 60 minutes after administration of ibuprofen acid tablets 400 mg. The area under the curve of plasma concentration for both IBALGIN FAST and ibuprofen acid was similar. The elimination half-life of ibuprofen acid is approximately 2 hours. Ibuprofen is bound extensively to plasma proteins, but the binding is reversible. It is relatively quickly metabolized in the liver to two inactive metabolites and these, together with unchanged ibuprofen, are excreted by urine, either as such or as conjugates, minor part is excreted by bile into the faeces. Drug accumulation in the organism may occur in the case of decreased excretion. Ibup rofen excretion is finished 24 hours after the administration of the last dose. Presence of meal minimally alters its bioavailability. Ibuprofen passes through the placental barrier, it is excreted into the breast milk at amount lower than l µg/ml. No specific difference in pharmacokinetic profile is observed in the elderly Preclinical safety data The subchronic and chronic toxicity of ibuprofen in animal experiments was observed principally as lesions and ulcerations in the gastro-intestinal tract. In vitro and in vivo studies gave no clinically relevant evidence of a mutagenic potential of ibuprofen. In studies in rats and mice no evidence of carcinogenic effects of ibuprofen was found. Ibuprofen led to inhibition of ovulation in rabbits as well as disturbance of implantation in various animal species (rabbit, rat, mouse). Experimental studies have demonstrated that ibuprofen crosses the placenta. Following administration of maternally toxic doses, an increased incidence of malformations (e.g. ventricular septal defects) was observed in the progeny of rats. 6. PHARMACEUTICAL PARTICULARS 6.1. List of excipients Core: Silicified Microcrystalline cellulose (type Prosolv SMCC 90)

12 Croscarmellose Sodium Silica,colloidal anhydrous Hydroxypropylcellulose (type EF) Sodium stearyl fumarate Coating: Hypromellose 2910/3 Macrogol 6000 Talc Titanium dioxide (E171) Polysorbate 80 Simeticone emulsion SE 4 Erythrosine (E 127) 6.2. Incompatibilities Not applicable 6.3. Shelf life 2 years 6.4. Special precautions for storage Store below 30 C, in the original package in order to protect from moisture Nature and contents of the container The blister is formed of transparent three-ply plastic foil PVC/Aclar/PVC (thickness 127/76/127 µm) and of Aluminium foil (thickness 25 µm) one side is covered by thermocoating layer, second side is printed. Size of packing The size of packing is 6, 12, 18 or 24 film-coated tablets. It means from 1 to 4 blisters, each containing 6 film-coated tablets, in one folding box, together with patient information leaflet. Not all pack sizes may be marketed Special precautions for disposal No special requirements. 7. MARKETING AUTHORIZATION HOLDER Zentiva k.s., U kabelovny 130, , Prague 10, Dolní Měcholupy, Czech Republic [To be completed nationally]

13 8. MARKETING AUTHORIZATION NUMBER(S) 9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION 10. DATE OF REVISION OF THE TEXT Remark; Shaded text is to be deleted/replaced in national translations according to the prescription statut Rx/OTC, Product name and local administrative data (MAH). Rx OTC

14 LABELLING PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1. NAME OF THE MEDICINAL PRODUCT IBALGIN FAST 400 mg film-coated tablets Ibuprofen 2. STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 400 mg of ibuprofen equivalent to 684 mg of ibuprofen lysinate. 3. LIST OF EXCIPIENTS 4. PHARMACEUTICAL FORM AND CONTENTS 6 film-coated tablets 12 film-coated tablets 18 film-coated tablets 24 film-coated teblets 5. METHOD AND ROUTE OF ADMINISTRATION Oral use. Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXP:

15 9. SPECIAL STORAGE CONDITIONS Store below 30 C, in the original package in order to protect from moisture. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Return unusable medicinal product to the pharmacy. 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Zentiva k.s., Prague, Czech Republic [To be completed nationally] 12. MARKETING AUTHORISATION NUMBER(S) To be completed nationally 13. BATCH NUMBER Batch: 14. GENERAL CLASSIFICATION FOR SUPPLY Medicinal product not subject to medical prescription. [To be completed nationally] 15. INSTRUCTIONS ON USE [To be completed nationally] For OTC; IBALGIN FAST is used for the symptomatic treatment of mild to moderate acute pain including headaches, migraine headache, toothache, menstrual pain and pain of muscles. IBALGIN FAST is also used for the symptomatic treatment of fever. For adults and adolescents from 40 kg bodyweight (from 12 years of age); Initial dose is one tablet of IBALGIN FAST, then, 1 tablet of the product every 6 hours as required.

16 Do not exceed 3 tablets of IBALGIN FAST (or 1200 mg of ibuprofen) in 24 hours. [To be completed nationally] For Rx; IBALGIN FAST is used for the symptomatic treatment of mild to moderate acute pain and fever. For adults and adolescents from 40 kg bodyweight (from 12 years of age) 16. INFORMATION IN BRAILLE IBALGIN FAST ((kod EAN)) Remark; Shaded text is to be deleted/replaced in national translations according to the prescription statut Rx/OTC, Product name and local administrative data (MAH). Rx OTC

17 MINIMUM PARTICULARS TO APPEAR ON BLISTERS 1. NAME OF THE MEDICINAL PRODUCT IBALGIN FAST 400 mg film-coated tablets Ibuprofen 2. NAME OF THE MARKETING AUTHORISATION HOLDER logo Zentiva [To be completed nationally] 3. EXPIRY DATE expiry date 4. BATCH NUMBER batch number 5. OTHER Remark; Shaded text is to be deleted/replaced in national translations according to the prescription statut Rx/OTC, Product name and local administrative data (MAH).

18 Package leaflet Information for the patient IBALGIN FAST 400 mg film-coated tablets Ibuprofen [To be completed nationally] For OTC; Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. - You must talk to a doctor if you do not feel better or if you feel worse after 4 days for pain or 3 days for migraine headache or fever [To be completed nationally] For Rx; Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet: 1. What IBALGIN FAST is and what it is used for 2. What you need to know before you take IBALGIN FAST 3. How to take IBALGIN FAST 4. Possible side effects 5. How to store IBALGIN FAST 6. Contents of the pack and other information 1. What IBALGIN FAST is and what it is used for The active substance of the product - ibuprofen - belongs to a group of so called non-steroidal anti-inflammatory drugs (NSAID); medications that have pain relieving and fever relieving properties.

19 IBALGIN FAST contains ibuprofen in the form of ibuprofen lysinate, which break down easily in the body and the active substance is easily absorbed into the bloodstream and so gets to the site of pain quickly. IBALGIN FAST is intended for symptomatic treatment of mild to moderate acute pain of various origin, such as headaches (including tension headache, and migraine headache), toothache, pain after dental extraction (including surgical removal of impacted teeth), pain of muscles and menstrual pain. IBALGIN FAST also shows antipyretic effect in feverish conditions. The preparation can be used by adults and children from 40 kg bodyweight (12 years of age and above). 2. What you need to know before you take IBALGIN FAST Do not take IBALGIN FAST - if you are allergic to ibuprofen (active substance of the product IBALGIN FAST) or to any of the other ingredients of this medicine (listed in section 6) - if you are hypersensitive to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs manifested as shortness of breath, asthma, a runny nose, swelling or urticaria - if you have active or recurrent ulcer or bleeding to the stomach or duodenum or if you have ever had it repeatedly (i.e. at least twice) in the past - if you have ever had gastrointestinal bleeding or perforation, related to previous NSAIDs therapy - if you suffer from cerebrovascular or other active bleeding - if you suffer from disorder of blood formation or disorder of blood clotting - if you have severe heart, liver or kidney failure. - if you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) - if you are a women in the third trimester of pregnancy - for children under 40 kg bodyweight ( under 12 years of age) Warnings and precautions Talk to your doctor or pharmacist before taking this (or any other ibuprofen-containing) product - if you suffer from kidney or liver disorder - directly after major surgery - if you have hereditary blood formation disorder (acute intermittent porphyria) - if you suffer from bronchial asthma - if you concomitantly use drugs which could increase the risk of gastrotoxicity or bleeding (see below) - if you suffer from systemic lupus erythematodes (immunity system disorder) or mixed connective tissue disease (the risk of aseptic meningitis).

20 - if you suffer from inflammatory ulcerous disease of digestive tract such as Cro hn s disease or ulcerative colitis - if you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist - if you suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders an increased risk of allergic reactions exists. The allergic reactions may present as asthma attacks (so-called analgesic asthma), Quincke s oedema or urticaria - if you suffer from dehydration In prolonged administration of IBALGIN FAST regular checking of liver values, the kidney function, as well as the blood count, is required. Undesirable effects are minimised by using the minimum effective dose for the shortest period of time. The elderly are at increased risk of side effects. The use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors, increases risk of adverse reactions (see section Taking other medicines below) and should be avoided Treatment must be stopped and a doctor consulted when gastrointestinal bleeding or ulceration occurs during treatment with IBALGIN FAST. Gastrointestinal bleeding, ulceration or perforation can occur at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses, in patients with a history of ulcer and in the elderly. Some concomitant medications could increase the risk of gastrotoxicity or bleeding (other nonsteroidal antiinflammatory drugs, corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs), or anti-platelet agents such as acetylsalicylic acid). In patients with increased risk of gastrointestinal toxicity concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered. If you previously had gastrointestinal toxicity, particularly when elderly, you should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment to your doctor. Medicines such as IBALGIN FAST may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment [3 days in the case of migraine headaches or fever and 4 days for the treatment of pain]. Very rarely, serious skin reactions with redness and blistering, some of which were fatal, have been reported during NSAID therapy (exfoliative dermatitis, Stevens Johnson syndrome and toxic epidermal necrolysis/lyell's syndrome; see section 4). The risk of such reactions appears to be greatest early in the course of therapy, as these reactions occurred during the first month of treatment in the majority of cases. At the first signs of skin rash, mucous

21 membrane defects or any other signs of a hypersensitivity reaction, you should stop taking IBALGIN FAST and consult your doctor immediately In general the habitual use of (several sorts of) analgesics can lead to lasting severe kidney problems. This risk may be increased under physical strain associated with loss of salt and dehydration. Therefore it should be avoided. During chicken pox (varicella) it is advisable to avoid use of IBALGIN FAST. Prolonged use of any type of painkiller for headaches can make them worse. If you experience frequent or daily headaches despite (or because of) the regular use of headache medications consult your doctor before taking another painkiller. The treatment should be discontinued if medication overuse headache (MOH) is diagnosed. Ibuprofen may mask the symptoms of an infection (fever, pain and swelling). Other medicines and IBALGIN FAST Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. What should you avoid when you are taking this medicine? Some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic acid/aspirin, warfarin, ticlopidin), some medicines against high blood pressure (ACE-inhibitors e.g. captopril, betareceptor blocking medicines, angiotensin II antagonists), and even some other medicines may affect or be affected by the treatment of ibuprofen. Seek therefore always advice of a doctor before you use ibuprofen with other medicines. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell them if you are taking: - acetylsalicylic acid or other NSAIDs (anti-inflammatories and analgesics) and glucocorticoids (medicinal products containing cortisone or cortisone-like substances) since these medicine may increase the risk of gastrointestinal ulcers or bleeding, - selective serotonin reuptake inhibitors (SSRIs) (medicines used for depression) as these may increase the risk of gastrointestinal bleeding, - anti-platelet agents since this may increase the risk of bleeding, - acetylsalicylic acid (low dose) since the blood-thinning effect may be impaired, - medicines against high blood pressure and water tablets since ibuprofens may diminish the effects of these medicines and there could be a possible increased risk for the kidney, - potassium sparing diuretics since this may lead to hyperkalaemia, - quinolone antibiotics since the risk for convulsions may be increased,

22 - aminoglycosides (antibiotics) since ibuprofen may decrease the clearence of aminoglycosides, their co-administration may increase the risk of nephrotoxicity and ototoxicity, - sulphonylureas (antidiabetic drugs) since possible interactions with ibuprofen, - products containing lithium (a medicine for manic depressive illness and depression), digoxin (for heart insufficiency), medicines for thinning the blood (such as warfarin), phenytoin (for epilepsy) and methotrexate (a medicine for cancer or rheumatism) since ibuprofen may enhance the effects of these medicines, - sulfinpyrazone, probenecid (medicines for gout) since the excretion of ibuprofen may be delayed, - there are clinical data indicating that NSAIDs may increase the plasma level of baclofen, - cyclosporin, tacrolimus (immunosuppressive medicines) since kidney damage may occur, - zidovudine (a medicine for treating HIV/Aids) since the use of IBALGIN FAST may result in an increased risk of bleeding into a joint or a bleeding that leads to swelling in HIV (+) haemophiliacs. Taking IBALGIN FAST with food, drink and alcohol Coated tablets should be swallowed as a whole and followed with a sufficient amount of liquid. The tablet may be taken with or without food. If taken with food or shortly after eating, the onset of action may be delayed. However taking it with food improves tolerability of the product and reduce probability of gastrointestinal problems. Drinking of alcoholic beverages and smoking is not suitable during treatment. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking any medicine. Tell your doctor if you become pregnant during intake of Ibalgin Fast. The product must not be used by women in the third trimester of pregnancy. In the first and second trimester of pregnancy use the product only on recommendation of a physician. The short-term use of Ibalgin Fast during breast-feeding is possible when necessary, because ibuprofen penetrates into breast milk in small amounts only. An adverse impact on the breastfed child is not expected and has never been documented. In case of long-term use consult your doctor. The product belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the medicine. Driving and using machines The product may induce dizziness, tiredness and visual disturbances, thereby it may adversely affect activities requiring increased attention. Do not drive or use machines if this happen to you.

23 3. How to take IBALGIN FAST [To be completed nationally] For OTC; Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.. Check with your doctor or pharmacist if you are not sure. [To be completed nationally] For Rx; Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Adults and adolescents from 40 kg bodyweight (12 years of age and above) Initial dose is 1 tablet of IBALGIN FAST (400 mg of ibuprofen), then, 1 tablet of the product (400 mg ibuprofen) every 6 hours as required. Leave at least six hours between doses and do not exceed 3 tablets of IBALGIN FAST (1200 mg of ibuprofen) in 24 hours without medical advice. The product IBALGIN FAST must not be used in children under 40 kg bodyweight (under 12 years of age) due to the amount of active substance in one tablet. Elderly In elderly patients the dosage is the same like in adults, but increased caution is necessary (see section Take special care with IBALGIN FAST) Patients with impaired hepatic or renal function In patients with renal and hepatic insufficiency increased caution is necessary ( see section Take special care with IBALGIN FAST) Consult a doctor if this product is required for more than 3 days in the case of migraine headaches or fever or for more than 4 days for the treatment of pain, or if the symptoms worsen. Do not exceed the recommended dose or duration of treatment. If you take more IBALGIN FAST than you should Seek for a medical assistance immediately in case of overdose or an accidental ingestion of coated tablets by a child. Main signs of overdose are nausea, vomiting, stomach pain, bleeding from digestive tract (see also part 4 below), diarrhoea, headache, dizziness or drowsiness. Rarely may occur low blood pressure, reduced breathing and loss of consciousness. If you forget to take IBALGIN FAST

24 If you have forgotten to take your dose, do not take more than the usual recommended amount at your next dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Probability of occurrence of side effects is increasing in elderly patients, in patients with history of gastric or duodenal ulcer (mainly with bleeding or mucosa perforation), in patients long-term treated with products containing acetylsalicylic acid. Discontinue use of this product and seek for an immediate medical assistance at the first appearance any of hypersensitivity reaction such as skin rash, mucosal lesions, nettle-rash, a sudden occurrence of swelling around eyes, feeling of distress on the chest with difficult breathing or swallowing, further in epigastric pain or disorders of vision, or at bleeding from digestive tract (vomiting of blood or stools of black color). The side effect which may occur are listed below in groups according to the frequency: Very common (may affect more than 1 in 10 people): nausea, vomiting, heartburn, diarrhea, constipation, flatulence. Common (may affect up to 1 in 10 people): abdominal pain and slight blood losses in stomach and/or bowel that may cause anaemia in exceptional cases. Uncommon (may affect up to 1 in 100 people): headache, vertigo (dizziness), sleeplessness, agitation, irritability or tiredness, disturbances of vision, urticaria, itching, allergic reactions (such as skin rash and itching as well as asthma attacks), inflammation, ulceration or perforation of digestive tract mucous membrane (black stools and vomiting of blood), mouth inflammation, worsening of existing bowel disease (colitis or Crohn s disease). Rare (may affect up to 1 in 1,000 people): heart failure, aseptic meningitis (especially in patients with connective tissue disease or systemic lupus erythematodes), disturbance of colour perception, blurred vision, tinnitus, liver functions disorders (usually reversible). Very rare (may affect up to 1 in 10,000 people): difficulty in breathing (predominantly in patients with bronchial asthma), aggravation of asthma, an inflammation of the lining of the oesophagus (gullet or swallowing tube leading to the stomach), inflammation of the pancreas associated with severe upper abdominal pain radiating to the back and nausea and vomiting (pancreatitis), abnormal narrowing of the intestine, problems in the blood cell production (first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding), retention of fluid and/or sodium, psychotic reaction, depression, emotional lability, palpitation (rapid heart beating felt by patient), heart attack ("myocardial infarction"), decrease or increase of blood pressure, inflammation of urinary bladder, presence of blood in urine, kidney function disorder including oedema and cloudy urine

NEOFEN 60 mg suppository

NEOFEN 60 mg suppository PACKAGE LEAFLET: INFORMATION FOR THE USER NEOFEN 60 mg suppository IBUPROFEN This leaflet is a copy of the Summary of Product Characteristics and Patient Information Leaflet for a medicine, which outlines

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Diclofenac Orifarm, 11.6 mg/g gel. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 gram Diclofenac Orifarm gel contains 11.6 mg (1.16%)

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. EASOFEN MAX STRENGTH 400mg FILM-COATED TABLETS. Ibuprofen

PACKAGE LEAFLET: INFORMATION FOR THE USER. EASOFEN MAX STRENGTH 400mg FILM-COATED TABLETS. Ibuprofen PACKAGE LEAFLET: INFORMATION FOR THE USER EASOFEN MAX STRENGTH 400mg FILM-COATED TABLETS Ibuprofen Read all of this leaflet carefully before you start taking Easofen Max Strength Tablets because it contains

More information

CSP Nabumetone ES/H/PSUR/0014/001. January 2010

CSP Nabumetone ES/H/PSUR/0014/001. January 2010 CSP Nabumetone ES/H/PSUR/0014/001 January 2010 CLINICAL PARTICULARS 4.1 Therapeutic indications Nabumetone is indicated in the symptomatic treatment of a variety of musculoskeletal disorders requiring

More information

Elements for a Public Summary Overview of disease epidemiology

Elements for a Public Summary Overview of disease epidemiology VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Acute pain usually responds to medication and should settle in less than three months. Inadequate pain relief may lead to other

More information

Patient leaflet: Information for the user. Paracetamol Galpharm 500mg tablets paracetamol

Patient leaflet: Information for the user. Paracetamol Galpharm 500mg tablets paracetamol Patient leaflet: Information for the user Paracetamol Galpharm 500mg tablets paracetamol [For medicines available only on prescription:] Read all of this leaflet carefully before you start taking this

More information

Package leaflet: Information for the patient. Acetylsalicylic acid Bluefish 75 mg tablets Acetylsalicylic acid Bluefish 160 mg tablets

Package leaflet: Information for the patient. Acetylsalicylic acid Bluefish 75 mg tablets Acetylsalicylic acid Bluefish 160 mg tablets Package leaflet: Information for the patient Acetylsalicylic acid Bluefish 75 mg tablets Acetylsalicylic acid Bluefish 160 mg tablets Acetylsalicylic acid Read all of this leaflet carefully before you

More information

Package leaflet: Information for the patient. Melox 10 mg/ml solution for injection meloxicam

Package leaflet: Information for the patient. Melox 10 mg/ml solution for injection meloxicam Package leaflet: Information for the patient Melox 10 mg/ml solution for injection meloxicam Read all of this leaflet carefully before you start using this medicine because it contains important information

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Melfen 200 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg ibuprofen. Excipients:

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Comfora 595 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains: glucosamine sulphate

More information

DEXOMEN 25 mg film-coated tablets

DEXOMEN 25 mg film-coated tablets PACKAGE LEAFLET: INFORMATION FOR THE USER DEXOMEN 25 mg film-coated tablets DEXKETOPROFEN This leaflet is a copy of the Summary of Product Characteristics and Patient Information Leaflet for a medicine,

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. Flarin 200 mg Soft Capsules Ibuprofen

PACKAGE LEAFLET: INFORMATION FOR THE USER. Flarin 200 mg Soft Capsules Ibuprofen PACKAGE LEAFLET: INFORMATION FOR THE USER Flarin 200 mg Soft Capsules Ibuprofen Read all of this leaflet carefully before you start taking this product. This medicine is available without prescription.

More information

Read all of this leaflet carefully because it contains important information for you.

Read all of this leaflet carefully because it contains important information for you. Nurofen Plus Tablets Ibuprofen 200mg, Codeine Phosphate Hemihydrate 12.8mg ADVANCED DUAL ACTION FOR POWERFUL RELIEF Read all of this leaflet carefully because it contains important information for you.

More information

COMPOSITION: Each film-coated tablet contains 500mg mefenamic acid. Also includes sunset yellow E110. See leaflet for further information.

COMPOSITION: Each film-coated tablet contains 500mg mefenamic acid. Also includes sunset yellow E110. See leaflet for further information. Mefac 500mg Film-coated Tablets Mefenamic acid 100 Film-coated Tablets PA Holder: Rowa Pharmaceuticals Ltd., Bantry Co. Cork, Ireland PA 74/15/2 Marketed by: Rowex Ltd., Bantry, Co. Cork, Ireland COMPOSITION:

More information

Package leaflet: Information for the user. Fasdol Film-coated tablets 400 mg, 600 mg. (Ibuprofen)

Package leaflet: Information for the user. Fasdol Film-coated tablets 400 mg, 600 mg. (Ibuprofen) Package leaflet: Information for the user Fasdol Film-coated tablets 400 mg, 600 mg (Ibuprofen) Read this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read

More information

Package Leaflet: Information for the User. Read all of this leaflet carefully because it contains important information for you.

Package Leaflet: Information for the User. Read all of this leaflet carefully because it contains important information for you. ASPIRIN 300mg Effervescent Tablets Acetylsalicylic acid (Aspirin) Package Leaflet: Information for the User Read all of this leaflet carefully because it contains important information for you. This medicine

More information

Children Enteric coated tablet : 1-3 mg/kg per day in divided doses.

Children Enteric coated tablet : 1-3 mg/kg per day in divided doses. Ultrafen Tablet/SR Tablet/Suppository/Gel Description Ultrafen is a preparation of Diclofenac is a non-steroidal antiinflammatory agent with marked analgesic, anti-inflammatory and antipyretic properties.

More information

BRUFEN 400 mg Effervescent Granules

BRUFEN 400 mg Effervescent Granules PACKAGE LEAFLET: INFORMATION FOR THE USER BRUFEN 400 mg Effervescent Granules IBUPROFEN This leaflet is a copy of the Summary of Product Characteristics and Patient Information Leaflet for a medicine,

More information

Migraine Relief Film-coated Tablets ibuprofen lysine

Migraine Relief Film-coated Tablets ibuprofen lysine PACKAGE LEAFLET 1 Package leaflet: Information for the user Migraine Relief Film-coated Tablets ibuprofen lysine Read all of this leaflet carefully before you start taking this medicine because it contains

More information

SUMMARY OF PRODUCT CHARACTERISTICS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

SUMMARY OF PRODUCT CHARACTERISTICS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ibuprofen 200mg. Also contains lactose, sucrose

More information

PROFESSIONAL INFORMATION

PROFESSIONAL INFORMATION SCHEDULING STATUS: S1 PROPRIETARY NAME AND DOSAGE FORM: Aleve Tablets COMPOSITION: Each tablet contains naproxen sodium 220 mg (equivalent to 200 mg naproxen) CATEGORY AND CLASS: A / 2.7 Antipyretic or

More information

Etopan XL 600 mg tablets

Etopan XL 600 mg tablets Package leaflet: Information for the user Etopan XL 600 mg tablets etodolac Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep

More information

RABEPRAZOL 10mg and 20mg Gastro-resistant Tablets

RABEPRAZOL 10mg and 20mg Gastro-resistant Tablets PACKAGE LEAFLET: INFORMATION FOR THE USER RABEPRAZOL 10mg and 20mg Gastro-resistant Tablets RABEPRAZOLE This leaflet is a copy of the Summary of Product Characteristics and Patient Information Leaflet

More information

Patient Information Leaflet Lodine* SR Tablets 600mg (etodolac) 1. WHAT LODINE SR TABLETS ARE AND WHAT THEY ARE USED FOR

Patient Information Leaflet Lodine* SR Tablets 600mg (etodolac) 1. WHAT LODINE SR TABLETS ARE AND WHAT THEY ARE USED FOR Patient Information Leaflet Lodine* SR Tablets 600mg (etodolac) Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. Disprin Extra Strength 500mg Effervescent Tablets. ASPIRIN (acetylsalicylic acid)

PACKAGE LEAFLET: INFORMATION FOR THE USER. Disprin Extra Strength 500mg Effervescent Tablets. ASPIRIN (acetylsalicylic acid) PACKAGE LEAFLET: INFORMATION FOR THE USER Disprin Extra Strength 500mg Effervescent Tablets ASPIRIN (acetylsalicylic acid) Read all of this leaflet carefully before you start taking this medicine because

More information

Summary of Product Characteristics

Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Vitafen 100mg Film-coated Tablets Summary of Product Characteristics 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Aceclofenac 100mg. For a full list of

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Melfen 400 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg ibuprofen. For the

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fexofenadine Cipla 120 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 120 mg fexofenadine

More information

Translation from Latvian Approved by SAM on PACKAGE LEAFLET: INFORMATION FOR THE USER. IBUPROFEN 200 mg film-coated tablets Ibuprofenum

Translation from Latvian Approved by SAM on PACKAGE LEAFLET: INFORMATION FOR THE USER. IBUPROFEN 200 mg film-coated tablets Ibuprofenum Translation from Latvian Approved by SAM on 31-01-2013 PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN 200 mg film-coated tablets Ibuprofenum Read all of this leaflet carefully because it contains

More information

Please note that the information highlighted in grey colour is the additional information specific to the concerned dosage form.

Please note that the information highlighted in grey colour is the additional information specific to the concerned dosage form. Proposed Core Safety Profile for diclofenac systemic formulations, including solution for injection, sugar-coated tablets, prolonged release tablets, dispersible tablets, gastro-resistant tablets and suppositories

More information

1. WHAT IBUPROFEN GALPHARM MAX 400MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR.

1. WHAT IBUPROFEN GALPHARM MAX 400MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR. PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN GALPHARM MAX 400MG FILM-COATED TABLETS For adults and adolescents weighing from 40kg body weight (12 years and above) Read all of this leaflet carefully

More information

Package leaflet: Information for the user. Diklofenak T Actavis 25 mg mg film-coated tablets. diclofenac potassium

Package leaflet: Information for the user. Diklofenak T Actavis 25 mg mg film-coated tablets. diclofenac potassium PACKAGE LEAFLET Package leaflet: Information for the user Diklofenak T Actavis 25 mg mg film-coated tablets diclofenac potassium RX Read all of this leaflet carefully before you start taking this medicine

More information

PATIENT INFORMATION LEAFLET FENOPINE 200MG, 400MG, & 600MG FILM-COATED TABLETS Ibuprofen

PATIENT INFORMATION LEAFLET FENOPINE 200MG, 400MG, & 600MG FILM-COATED TABLETS Ibuprofen PATIENT INFORMATION LEAFLET FENOPINE 200MG, 400MG, & 600MG FILM-COATED TABLETS Ibuprofen Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read

More information

Package leaflet: Information for the user MELFEN 200mg FILM-COATED TABLETS MELFEN 400mg FILM-COATED TABLETS. Ibuprofen

Package leaflet: Information for the user MELFEN 200mg FILM-COATED TABLETS MELFEN 400mg FILM-COATED TABLETS. Ibuprofen Package leaflet: Information for the user MELFEN 200mg FILM-COATED TABLETS MELFEN 400mg FILM-COATED TABLETS Ibuprofen Read all of this leaflet carefully before you start taking this medicine because it

More information

Package leaflet: Information for the user

Package leaflet: Information for the user Package leaflet: Information for the user Irbesartan 75mg Film-coated Tablets Irbesartan 150mg Film-coated Tablets Irbesartan 300mg Film-coated Tablets irbesartan Read all of this leaflet carefully before

More information

Advil Liqui - gels 200 Capsules

Advil Liqui - gels 200 Capsules 1. NAME OF THE MEDICINAL PRODUCT Advil Liqui - gels 200 Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 200mg Ibuprofen For excipients, see 6.1 3. PHARMACEUTICAL FORM Capsules

More information

PRODUCT INFORMATION. Sudafed* Sinus + Anti-inflammatory Pain Relief Caplets

PRODUCT INFORMATION. Sudafed* Sinus + Anti-inflammatory Pain Relief Caplets PRODUCT INFORMATION Sudafed* Sinus + Anti-inflammatory Pain Relief Caplets Product description Sudafed* Sinus + Anti-inflammatory Pain Relief caplets contain pseudoephedrine hydrochloride 30 mg and ibuprofen

More information

PUBLIC SUMMARY OF RISK MANAGEMENT PLAN BURANA 40 MG/ML ORAL SUSPENSION DATE: , VERSION 1

PUBLIC SUMMARY OF RISK MANAGEMENT PLAN BURANA 40 MG/ML ORAL SUSPENSION DATE: , VERSION 1 PUBLIC SUMMARY OF RISK MANAGEMENT PLAN BURANA 40 MG/ML ORAL SUSPENSION DATE: 15-5-2015, VERSION 1 VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Musculoskeletal pain: Musculoskeletal

More information

SUMMARY OF PRODUCT CHARACTERISTICS. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains the following active ingredients:

SUMMARY OF PRODUCT CHARACTERISTICS. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains the following active ingredients: SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lacrofarm, powder for oral solution, sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains the following active ingredients:

More information

Package leaflet: Information for the user. Acetylsalicylic acid Krka 160 mg gastro-resistant tablets. acetylsalicylic acid

Package leaflet: Information for the user. Acetylsalicylic acid Krka 160 mg gastro-resistant tablets. acetylsalicylic acid Package leaflet: Information for the user Acetylsalicylic acid Krka 75 mg gastro-resistant tablets Acetylsalicylic acid Krka 100 mg gastro-resistant tablets Acetylsalicylic acid Krka 160 mg gastro-resistant

More information

Package leaflet: Information for the patient. / / 30 mg/5 ml syrup. Ambroxol hydrochloride

Package leaflet: Information for the patient. / / 30 mg/5 ml syrup. Ambroxol hydrochloride Package leaflet: Information for the patient / / 30 mg/5 ml syrup Ambroxol hydrochloride Read all of this leaflet carefully before you start taking this medicine because it contains important information

More information

Summary of Product Characteristics

Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Brupro 200mg Film-coated tablets Summary of Product Characteristics 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of ibuprofen. For the full list

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lacrofarm Junior, powder for oral solution, sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of contains the following active

More information

Irbenida H 150mg/12,5mg film-coated tablets

Irbenida H 150mg/12,5mg film-coated tablets PACKAGE LEAFLET: INFORMATION FOR THE USER Irbenida H 150mg/12,5mg film-coated tablets IRBESARTAN/HYDROCHLOROTHIAZIDE This leaflet is a copy of the Summary of Product Characteristics and Patient Information

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cyklonova 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tranexamic acid 500 mg. For the full list of excipients,

More information

RANTUDIL F 60mg capsules

RANTUDIL F 60mg capsules PACKAGE LEAFLET: INFORMATION FOR THE USER RANTUDIL F 60mg capsules ACEMETACIN This leaflet is a copy of the Summary of Product Characteristics and Patient Information Leaflet for a medicine, which outlines

More information

ASPIRIN mg tablet

ASPIRIN mg tablet PACKAGE LEAFLET: INFORMATION FOR THE USER ASPIRIN 500 500 mg tablet ACETYLSALICYLIC ACID This leaflet is a copy of the Summary of Product Characteristics and Patient Information Leaflet for a medicine,

More information

Advil* 200mg Tablets Ibuprofen

Advil* 200mg Tablets Ibuprofen Advil* 200mg Tablets Ibuprofen Please read this leaflet carefully before you start to take your tablets. If you have any questions or are not sure about anything, ask your doctor or pharmacist. What is

More information

Boots Fever and Pain Relief 6 Months Plus Ibuprofen 100 mg/5 ml Suspension

Boots Fever and Pain Relief 6 Months Plus Ibuprofen 100 mg/5 ml Suspension Information for the user Boots Fever and Pain Relief 6 Months Plus Ibuprofen 100 mg/5 ml Suspension Read all of this leaflet carefully because it contains important information for you. This medicine is

More information

Package leaflet: Information for the user. Cetiristad 10 mg film-coated tablets Cetirizine dihydrochloride

Package leaflet: Information for the user. Cetiristad 10 mg film-coated tablets Cetirizine dihydrochloride Package leaflet: Information for the user Cetiristad 10 mg film-coated tablets Cetirizine dihydrochloride Read all of this leaflet carefully before you start taking this medicine because it contains important

More information

PATIENT INFORMATION LEAFLET. Nu-Seals 75 aspirin (acetylsalicylic acid)

PATIENT INFORMATION LEAFLET. Nu-Seals 75 aspirin (acetylsalicylic acid) PATIENT INFORMATION LEAFLET Nu-Seals 75 aspirin (acetylsalicylic acid) Read all of this leaflet carefully before you start taking this medicine Keep this leaflet. You may need to read it again. If you

More information

DEXOMEN 25 mg granules for oral solution

DEXOMEN 25 mg granules for oral solution PACKAGE LEAFLET: INFORMATION FOR THE USER DEXOMEN 25 mg granules for oral solution DEXKETOPROFEN This leaflet is a copy of the Summary of Product Characteristics and Patient Information Leaflet for a medicine,

More information

Package leaflet: Information for the patient. Diclofenac T ratiopharm 50 mg film-coated tablets. Diclofenac potassium

Package leaflet: Information for the patient. Diclofenac T ratiopharm 50 mg film-coated tablets. Diclofenac potassium Package leaflet: Information for the patient Diclofenac T ratiopharm 50 mg film-coated tablets Diclofenac potassium Read all of this leaflet carefully before you start taking this medicine because it contains

More information

PACKAGE LEAFLET Package leaflet: Information for the user. Ranitidin Actavis 150 mg and 300 mg film-coated tablets. Ranitidine

PACKAGE LEAFLET Package leaflet: Information for the user. Ranitidin Actavis 150 mg and 300 mg film-coated tablets. Ranitidine PACKAGE LEAFLET Package leaflet: Information for the user Ranitidin Actavis 150 mg and 300 mg film-coated tablets Ranitidine Read all of this leaflet carefully, before you start taking this medicine because

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ibuprofen Bril 600 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg ibuprofen

More information

* Adults. NSAID associated peptic ulceration: - Acute treatment: 150 mg twice daily for 8 to 12 weeks, or 300mg nocte.

* Adults. NSAID associated peptic ulceration: - Acute treatment: 150 mg twice daily for 8 to 12 weeks, or 300mg nocte. Trade Name Aciloc 75 mg & 300 mg Film-coated tablets Generic Name Ranitidine Composition Each Aciloc 300 mg film-coated tablet contains: - Active ingredient: Ranitidine hydrochloride 336 mg equivalent

More information

Package leaflet: Information for the patient. Cetirizin Sandoz 10 mg film-coated tablets. cetirizine dihydrochloride

Package leaflet: Information for the patient. Cetirizin Sandoz 10 mg film-coated tablets. cetirizine dihydrochloride Package leaflet: Information for the patient Cetirizin Sandoz 10 mg film-coated tablets cetirizine dihydrochloride [For medicine available only on prescription:] Read all of this leaflet carefully before

More information

SUMMARY OF PRODUCT CHARACTERISTICS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

SUMMARY OF PRODUCT CHARACTERISTICS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fexofenadine hydrochloride 180 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 180mg

More information

Package Leaflet: Information for the user. Barcan 100 mg film-coated tablets Aceclofenac

Package Leaflet: Information for the user. Barcan 100 mg film-coated tablets Aceclofenac Package Leaflet: Information for the user Barcan 100 mg film-coated tablets Aceclofenac Read all of this leaflet carefully before you start taking this medicine because it contains important information

More information

SUMMARY OF PRODUCT CHARACTERISTICS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

SUMMARY OF PRODUCT CHARACTERISTICS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Telfast 120 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 120 mg of fexofenadine hydrochloride,

More information

SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen 400 mg Tablets BP Ibuprofen 400 mg Caplets Ibuprofen 400 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet

More information

Package leaflet: Information for the user. Ebateva 20 mg Orodispersible Tablets. Ebastine

Package leaflet: Information for the user. Ebateva 20 mg Orodispersible Tablets. Ebastine Package leaflet: Information for the user Ebateva 10 mg Orodispersible Tablets Ebateva 20 mg Orodispersible Tablets Ebastine Read all of this leaflet carefully before you start taking this medicine because

More information

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

2. QUALITATIVE AND QUANTITATIVE COMPOSITION SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen 200 mg Tablets Lloyds pharmacy Ibuprofen 200mg Caplets Ibuprofen 200 mg Caplets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen 200 mg Caplets Ibuprofen 200 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200mg of Ibuprofen.

More information

LEAFLET: INFORMATION FOR THE USER. Freshalgin 500th mg tablets Metamizole sodium (M etamizol sodium)

LEAFLET: INFORMATION FOR THE USER. Freshalgin 500th mg tablets Metamizole sodium (M etamizol sodium) LEAFLET: INFORMATION FOR THE USER Freshalgin 500th mg tablets Metamizole sodium (M etamizol sodium) Read this leaflet carefully before you start taking this medicine. This medicine is available without

More information

TEFIN 75 MG SUPPOSITORIES. Ibuprofen

TEFIN 75 MG SUPPOSITORIES. Ibuprofen TEFIN 75 MG SUPPOSITORIES Ibuprofen INFORMATION FOR THE USER FOR RECTAL ADMINSTRATION ONLY FOR INFANTS Age 8 months up to 3 years Contains Ibuprofen Read all of this leaflet carefully before taking Tefin

More information

Package Insert. Spasfree

Package Insert. Spasfree Package Insert Spasfree Product Summary 1. Name of the medicinal product Spasfree 2. Qualitative and quantitative composition Each film-coated tablet contains Aceclofenac 100 mg and drotaverine hydrochloride

More information

patient group direction

patient group direction NAPROXEN v01 1/10 NAPROXEN PGD Details Version 1.0 Legal category Staff grades Approved by POM Paramedic (Non-ECP) Nurse (Non-ECP) Emergency Care Practitioner (Paramedic) Emergency Care Practitioner (Nurse)

More information

Etoricoxib STADA 30 mg, 60 mg, 90 mg and 120 mg film-coated tablets , Version V1.2 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN

Etoricoxib STADA 30 mg, 60 mg, 90 mg and 120 mg film-coated tablets , Version V1.2 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN Etoricoxib STADA 30 mg, 60 mg, 90 mg and 120 mg film-coated tablets 23.5.2016, Version V1.2 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN VI.2 Elements for a Public Summary Etoricoxib STADA 30 mg film-coated

More information

Name Brufen Flu Tablets & Suspension Description For the relief of the symptoms of colds and flu. Active Ingredients:

Name Brufen Flu Tablets & Suspension Description For the relief of the symptoms of colds and flu. Active Ingredients: Name Brufen Flu Tablets & Suspension Description For the relief of the symptoms of colds and flu Active Ingredients: Brufen Flu each tablet (Film-coated) contains: Ibuprofen 200 mg Pseudoephedrine hydrochloride

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER Nicorandil 10 mg Tablets Nicorandil 20 mg Tablets nicorandil

PACKAGE LEAFLET: INFORMATION FOR THE USER Nicorandil 10 mg Tablets Nicorandil 20 mg Tablets nicorandil PACKAGE LEAFLET: INFORMATION FOR THE USER Nicorandil 10 mg Tablets Nicorandil 20 mg Tablets nicorandil Read all of this leaflet carefully before you start taking this medicine because it contains important

More information

NEW ZEALAND DATA SHEET ACUPAN TM. 3. PHARMACEUTICAL FORM White, round, biconvex, film-coated tablets (7 mm diameter) engraved APN on one face.

NEW ZEALAND DATA SHEET ACUPAN TM. 3. PHARMACEUTICAL FORM White, round, biconvex, film-coated tablets (7 mm diameter) engraved APN on one face. 1. PRODUCT NAME ACUPAN 30 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains nefopam hydrochloride 30 mg. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM

More information

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

2. QUALITATIVE AND QUANTITATIVE COMPOSITION Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT {To be completed nationally} 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mg tablets: each tablet contains 1 mg granisetron (as hydrochloride).

More information

Dexibuprofen Gebro Powder for oral suspension

Dexibuprofen Gebro Powder for oral suspension Page 1/12 Common Summary of Product Characteristics (SmPC) 1. Name of the medicinal product Dexibuprofen Gebro 200 mg powder for oral suspension Dexibuprofen Gebro 300 mg powder for oral suspension Dexibuprofen

More information

NALGESIN NALGESIN S 275 mg Film-coated tablets NALGESIN F 500 mg Film-coated tablets

NALGESIN NALGESIN S 275 mg Film-coated tablets NALGESIN F 500 mg Film-coated tablets PACKAGE LEAFLET: INFORMATION FOR THE USER NALGESIN NALGESIN S 275 mg Film-coated tablets NALGESIN F 500 mg Film-coated tablets NAPROXEN This leaflet is a copy of the Summary of Product Characteristics

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Flurbiprofen Sandoz sinaasappel suikervrij 8,75 mg, zuigtabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each lozenge contains 8.75

More information

RISK MANAGEMENT PLAN (RMP) PUBLIC SUMMARY ETORICOXIB ORION (ETORICOXIB) 30 MG, 60 MG, 90 MG & 120 MG FILM-COATED TABLET DATE: , VERSION 1.

RISK MANAGEMENT PLAN (RMP) PUBLIC SUMMARY ETORICOXIB ORION (ETORICOXIB) 30 MG, 60 MG, 90 MG & 120 MG FILM-COATED TABLET DATE: , VERSION 1. RISK MANAGEMENT PLAN (RMP) PUBLIC SUMMARY ETORICOXIB ORION (ETORICOXIB) 30 MG, 60 MG, 90 MG & 120 MG FILM-COATED TABLET DATE: 07-10-2016, VERSION 1.2 VI.2 Elements for a Public Summary Etoricoxib Orion

More information

2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Macrovic Junior powder for oral solution contains the following active ingredients:

2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Macrovic Junior powder for oral solution contains the following active ingredients: SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Macrovic Junior powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Macrovic Junior powder for oral solution

More information

1. WHAT OXCARBAZEPINE IS AND WHAT IT IS USED FOR

1. WHAT OXCARBAZEPINE IS AND WHAT IT IS USED FOR PACKAGE LEAFLET: INFORMATION FOR THE USER Oxcarbazepine 150/300/600 mg Film-Coated Tablets (Oxcarbazepine) Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You

More information

Summary of Product Characteristics

Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Strepsils Intensive 8.75mg Lozenges Summary of Product Characteristics 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient flurbiprofen 8.75 mg. Excipients: each

More information

Package leaflet: Information for the patient. Clarithromycin Kern Pharma 500 film-coated tablets Clarithromycin

Package leaflet: Information for the patient. Clarithromycin Kern Pharma 500 film-coated tablets Clarithromycin Package leaflet: Information for the patient Clarithromycin Kern Pharma 500 film-coated tablets Clarithromycin Read all of this leaflet carefully before you start taking this medicine because it contains

More information

XYZAL 5 MG FILM-COATED TABLET

XYZAL 5 MG FILM-COATED TABLET XYZAL 5 MG FILM-COATED TABLET Levocetirizine dihydrochloride Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However,

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ebateva 10 mg Orodispersible Tablets Ebateva 20 mg Orodispersible Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One orodispersible

More information

ASK LEK 100 mg Gastro-resistant tablets

ASK LEK 100 mg Gastro-resistant tablets PACKAGE LEAFLET: INFORMATION FOR THE USER ASK LEK 100 mg Gastro-resistant tablets ACETYLSALICYLIC ACID This leaflet is a copy of the Summary of Product Characteristics and Patient Information Leaflet for

More information

Package Leaflet: Information for the User

Package Leaflet: Information for the User Package Leaflet: Information for the User Tempocol Gastro-resistant soft capsules Peppermint Oil Read all of this leaflet carefully before you start using this medicine because it contains important information

More information

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM: Read this entire leaflet carefully before you start taking DYNAFLOC.

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM: Read this entire leaflet carefully before you start taking DYNAFLOC. SCHEDULING STATUS: S4 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM: DYNAFLOC 250 (tablets) DYNAFLOC 500 (tablets) DYNAFLOC 750 (tablets) Read this entire leaflet carefully before you start taking

More information

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

2 QUALITATIVE AND QUANTITATIVE COMPOSITION SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 80mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains 80mg Paracetamol For a full list of

More information

NEW ZEALAND DATA SHEET

NEW ZEALAND DATA SHEET IBUPROFEN (Arrowcare) Ibuprofen Tablets 200mg Presentation NEW ZEALAND DATA SHEET White, capsule shaped, coated tablets with no markings. Uses Actions Ibuprofen is a non-steroidal anti-inflammatory agent.

More information

Package leaflet: Information for the user. Rowalief 500 mg Film-coated tablets. paracetamol

Package leaflet: Information for the user. Rowalief 500 mg Film-coated tablets. paracetamol Package leaflet: Information for the user Rowalief 500 mg Film-coated tablets paracetamol Read all of this leaflet carefully before you start taking this medicine because it contains important information

More information

Package leaflet: Information for the patient. [To be completed nationally] 10 mg film-coated tablets Ebastine

Package leaflet: Information for the patient. [To be completed nationally] 10 mg film-coated tablets Ebastine Package leaflet: Information for the patient [To be completed nationally] 10 mg film-coated tablets Ebastine Read all of this leaflet carefully before you start taking this medicine because it contains

More information

SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TRANSISOFT 8.5 g powder for oral solution in sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 8.5 g of macrogol

More information

LACIPIL QUALITATIVE AND QUANTITATIVE COMPOSITION

LACIPIL QUALITATIVE AND QUANTITATIVE COMPOSITION LACIPIL lacidipine QUALITATIVE AND QUANTITATIVE COMPOSITION Lacidipine, 2 mg - round shaped white engraved on one face. Lacidipine, 4 mg - oval white with break line on both faces. Lacidipine, 6 mg - oval

More information

Package leaflet: Information for the patient. Felodipin AstraZeneca 10 mg prolonged-release tablets. felodipine

Package leaflet: Information for the patient. Felodipin AstraZeneca 10 mg prolonged-release tablets. felodipine Package leaflet: Information for the patient Felodipin AstraZeneca 2.5 mg prolonged-release tablets Felodipin AstraZeneca 5 mg prolonged-release tablets Felodipin AstraZeneca 10 mg prolonged-release tablets

More information

SUMMARY OF PRODUCT CHARACTERISTICS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

SUMMARY OF PRODUCT CHARACTERISTICS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ibuprofen 400mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ibuprofen 400mg Also contains lactose, sucrose

More information

Package leaflet: Information for the user. Cefixime ABR 100 mg/5 ml powder for oral suspension Cefixime

Package leaflet: Information for the user. Cefixime ABR 100 mg/5 ml powder for oral suspension Cefixime Package leaflet: Information for the user Cefixime ABR 100 mg/5 ml powder for oral suspension Cefixime Read all of this leaflet carefully before you start taking this medicine because it contains important

More information

0BCore Safety Profile. Pharmaceutical form(s)/strength: Losec MUPS tablets 10, 20 mg (OTC) NL/H/PSUR/0058/001 Date of FAR:

0BCore Safety Profile. Pharmaceutical form(s)/strength: Losec MUPS tablets 10, 20 mg (OTC) NL/H/PSUR/0058/001 Date of FAR: 0BCore Safety Profile Active substance: Omeprazole Pharmaceutical form(s)/strength: Losec MUPS tablets 10, 20 mg (OTC) P-RMS: NL/H/PSUR/0058/001 Date of FAR: 13.06.2013 4.2 Posology and method of administration

More information

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

2 QUALITATIVE AND QUANTITATIVE COMPOSITION SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Compound Macrogol 13.72 g powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Compound Macrogol 13.72 g

More information