MOMENT 200 mg film-coated tablets

Transcription

1 BEFORE USING, PLEASE READ ALL OF THIS PACKAGE LEAFLET CAREFULLY. This is a medicinal product for SELF MEDICATION which can be used to remedy minor, temporary conditions that are easily recognised and treatable without the need for a doctor. This product may therefore be purchased without a prescription but it must be used correctly to ensure its effectiveness and to reduce undesirable effects. For more information and advice, ask your pharmacist. Consult a doctor if the problem is not resolved after a short period of treatment. MOMENT 200 mg film-coated tablets Ibuprofen What it is Moment belongs to the analgesic anti-inflammatory group, that is the group of medicinal products designed to relieve pain and inflammation. What it is used for pain of various types and origins (headache, toothache, neuralgia, osteoarticular and muscular pain, menstrual pain). An adjunct treatment for the symptoms of fever and flu. When it should not be used Hypersensitivity to the active ingredient (ibuprofen), to acetylsalicylic acid, to other analgesics, antipyretics, non steroidal anti-inflammatory agents (NSAIDS) or to any of the product excipients listed in section 6.1. In children aged under 12 years old. Third trimester of pregnancy and when breastfeeding (see What to do if pregnant or breastfeeding ). Severe or active gastroduodenal ulcer or other gastric disease. History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic haemorrhage/ulcer (two or more distinct episodes of established ulceration or bleeding). Severe heart failure. Severe renal or hepatic impairment. Severe dehydration (caused by vomiting, diarrhoea or insufficient intake of liquids). Precautions for use The undesirable effects can be minimised if the lowest effective dose to control the symptoms is used for the shortest possible treatment time. Elderly: The elderly have an increased frequency of adverse drug reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal (see the section How to use this medicinal product ). In asthmatic patients, the product must be used with caution, after having consulted a doctor. Gastrointestinal haemorrhage, ulceration and perforation Use of Moment should be avoided together with NSAIDs, including selective COX-2 inhibitors, due to the increased risk of ulceration or bleeding (see Medications and foods which could alter the effect of the medicinal product ). Gastrointestinal bleeding, ulceration and perforation, which can even be fatal, have been reported with all NSAIDs and can happen at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcers, particularly where complicated by haemorrhage or perforation (see the section When it should not be used ), the risk of gastrointestinal bleeding, ulceration or perforation is higher with higher doses of NSAIDs. These patients should start their treatment on the lowest dose available. The concomitant use of protecting agents (misoprostol or proton pump inhibitors) should be considered in treating these patients as well as in treating patients taking low doses of aspirin or other medications which can increase gastrointestinal risk (see below and the section Medications and foods which could alter the effect of the medicinal product ). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. 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 Undesirable effects ). If gastrointestinal bleeding or ulceration occurs in patients receiving Moment, the treatment must be discontinued. Special attention should be paid to patients undergoing concomitant treatment with medications capable of increasing the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulant agents like warfarin, serotonin selective reuptake inhibitors or anti-platelet agents like aspirin (see the section Medications and foods which could alter the effect of the medicinal product ). Cardiovascular and cerebrovascular effects Caution 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. NSAIDs can reduce the effect of diuretics and other high-blood-pressure drugs (see Medications and foods which could alter the effect of the medicinal product ). Anti-inflammatory/painkiller medications such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, particularly when administered at high doses. Do not exceed the recommended dose or treatment time (3 days). Consult your doctor or pharmacist about your treatment before taking Moment if you have: - heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including mini-stroke or TIA transient ischaemic attack); - high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker. Dermatological effects 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 the section Undesirable effects ). Patients appear to be at the highest risk early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Moment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity and if visual disturbances or persistent signs of hepatic dysfunction are seen. Renal effects When starting treatment with ibuprofen, care must be taken in patients with considerable dehydration. Long-term use of ibuprofen, as with other NSAIDs, has led to pathological alterations of the kidneys. In general, habitual intake of painkillers, particularly a combination of several analgesic active substances, can

2 lead to permanent renal damage, with the risk of renal failure (analgesic nephropathy). Renal toxicity has been seen, through to kidney failure, in patients in whom renal prostaglandins play a compensatory role in maintaining renal perfusion. In adolescents suffering from dehydration, there is a risk of renal impairment. In the event of prolonged use, monitor kidney function, particularly in the presence of diffused lupus erythematosus. Respiratory disorders Ibuprofen must be taken with caution in patients with bronchial asthma, chronic rhinitis, nasal polyps, sinusitis or current or previous allergic diseases, because this may cause bronchospasm, urticaria and angioedema. The same applies to subjects who have experienced bronchospasm subsequent to the use of acetylsalicylic acid or other NSAIDs. Hypersensitivity reactions Analgesics, antipyretics and NSAIDs, may cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in persons not previously exposed to these types of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in people who have already had a similar reaction after taking other analgesics, antipyretics or, NSAIDs and in persons with bronchial hyperactivity (asthma), hay fever, nasal polyps or chronic obstructive respiratory diseases or previous episodes of angioedema (see When it should not be used and Undesirable Effects ). Hypersensitivity reactions can take the form of asthmatic attacks (referred to as analgesic asthma ), Quincke s oedema or urticaria. Severe hypersensitivity reactions (such as anaphylactic shock) have been observed rarely. At the first signs of hypersensitivity reaction after the administration of ibuprofen, treatment must be suspended. Impaired heart, kidney and liver function Special care must be taken in treating patients with impaired heart, kidney or liver function, as the use of NSAIDs can cause kidney function to deteriorate. Habitual simultaneous use of various painkillers can increase this risk further. Haematological effects Ibuprofen, like other NSAIDs, can inhibit blood platelet aggregation and has been shown to prolong bleeding time in healthy subjects. Therefore, patients with coagulation defects or in anticoagulant therapy must be observed closely. Aseptic meningitis On rare occasions, in patients treated with ibuprofen, symptoms of aseptic meningitis have been seen. Although it is more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been seen in patients who did not show chronic concomitant pathologies (see Undesirable effects ). As eye alterations have been seen in studies on animals with NSAIDs, in the event of prolonged treatments, regular ophthalmologic controls are recommended. Alcohol consumption should be avoided insofar as it can intensify the side effects of NSAIDs, particularly those involving the gastrointestinal tract or central nervous system. Ibuprofen can mask the signs or symptoms of infection (fever, pain and swelling). As with any medication inhibiting the synthesis of prostaglandins and cyclooxygenase, the use of Moment is not recommended in women planning pregnancy (see also What to do if pregnant or breastfeeding ). The administration of Moment should be discontinued in women with fertility disorders or who are undergoing investigations of infertility. Children and adolescents: Moment should not be used in children under 12 years of age. Medications and foods which could alter the effect of the medicinal product Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including non-prescription medicines. Moment may influence or be influenced by other medicines. For example: Acetylsalicylic acid, COX-2 inhibitors and other NSAIDs: these substances can cause the risk of adverse drug reactions involving the gastrointestinal tract to increase (see Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see Medicines which have an anticoagulant effect (substances used to thin the blood and avoid clots, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine, heparin, dicoumarol): NSAIDs may enhance the effects of anticoagulants (see In the event of concomitant treatment, monitoring of coagulation status is recommended. Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see Diuretics, medicines which reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol and angiotensin II receptor antagonists such as losartan): 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 co-administration of an ACE-inhibitor or angiotensin-ii antagonists and agents that inhibit the cyclooxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These forms of interaction should be considered in patients undergoing concomitant treatment with Moment and ACE-inhibitors or angiotensin-ii antagonists. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration given to monitoring renal function after starting concomitant therapy and during the periods thereafter. Phenytoin and lithium: the concomitant administration of ibuprofen and phenytoin or lithium preparations can determine a reduced elimination of these medicinal products with consequent increase in their plasma levels and the possibility of reaching a toxic threshold. Methotrexate: NSAIDs may inhibit the tubular secretion of methotrexate and certain metabolic interactions can occur with the consequent reduction of methotrexate clearance and increased risk of toxicity. Moclobemide: increases the effect of ibuprofen. Aminoglycosides: NSAIDs can reduce the excretion of aminoglycosides, increasing the toxicity. Cardiac glycosides: NSAIDs can exacerbate congestive heart failure, reduce the rate of glomerular filtration and increase plasma levels of cardiac glycosides. Monitoring of the serum glycosides level is recommended. Cholestyramine: reduction in the absorption of ibuprofen in the gastrointestinal tract. Ciclosporin: increased risk of kidney damage. Plant extracts: Ginkgo Biloba can increase the risk of bleeding in association with NSAIDs. Mifepristone: reduction of the effect of mifepristone. Quinolone antibiotics: increased risk of developing convulsions. Sulfonylureas: NSAIDs can increase the hypoglycaemia effect of sulphonylureas. Tacrolimus: the co-administration of NSAIDs and tacrolimus can bring about an increased risk of nephrotoxicity. Zidovudine: there is evidence of an increased risk of haemarthrosis and haematoma. Ritonavir: can cause an increase in plasma concentrations of NSAIDs. Probenecid: slows the excretion of ibuprofen, with possible increase in their plasma concentrations. CYP2C9 inhibitors: the concomitant administration of ibuprofen and CYP2C9 inhibitors can slow the elimination of ibuprofen (substrate of the CYP2C9), resulting in an increased exposure to ibuprofen. Alcohol, bisphosphonates and oxpentifylline (pentoxifylline): can increase the gastrointestinal side effects and the risk of bleeding and ulcer. Baclofen: high toxicity of baclofen.

3 There are also some other medicines which may influence or be influenced by treatment with Moment. Therefore, always consult your doctor or pharmacist before using Moment with other medicines. IMPORTANT INFORMATION As with any medication inhibiting the synthesis of prostaglandins and cyclooxygenase, the use of Moment is not recommended in women planning pregnancy. The administration of Moment should be discontinued in women with fertility disorders or who are undergoing investigations of infertility. During treatment with NSAIDs, including selective COX-2 inhibitors, gastrointestinal bleeding, ulceration and perforation have been reported, which can be fatal (see Medications and foods which could alter the effect of the medicinal product ). When it should be used only on medical advice Asthmatic patients (see Elderly patients (see Precautions for use and How to use this medicinal product ). Patients with a history of gastroduodenal ulcers or haemorrhage (see Patients with a history of hypertension and/or heart failure (see Patients undergoing coumarin anticoagulant-based therapies (warfarin, dicoumarol, etc.) (see Medications and foods which could alter the effect of the medicinal product ). Patients suffering from impaired liver function (see Precautions for use ). Patients with impaired kidney function (see Patients with systemic lupus erythematosus or mixed connective tissue disease (see Patients with gastrointestinal tract disorders (ulcerative colitis or Crohn s disease) (see In the event of severe skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (see Undesirable effects ). What to do during pregnancy and breastfeeding Always consult your doctor or pharmacist before taking any medicinal product. In pregnant and breastfeeding women, Moment should only be used on medical advice and concordant assessment of the individual risk/ benefit ratio. Consult your doctor if you suspect that you are pregnant or if you are planning on becoming pregnant. Pregnancy Inhibition of prostaglandin synthesis may adversely affect pregnancy and/ or embryonic/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 of cardiac malformation increased from less than 1% up to approximately 1.5%. The risk was deemed 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 embryofoetal lethality. In addition, increased incidence of various malformations, also of a cardiovascular nature, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, Moment should not be given unless absolutely necessary. If Moment 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 is 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 oligohydroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time and anti-aggregating effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, Moment is contraindicated during the third trimester of pregnancy. Breastfeeding Ibuprofen is excreted into the mother s milk, but at therapeutic doses, during short-term treatment, the risk of influence on the neonate would appear to be unlikely. If, on the other hand, treatment is longer-term, early weaning should be considered. NSAIDs must be avoided during breastfeeding. Fertility The use of ibuprofen can compromise female fertility and is not recommended in women planning pregnancy. This is reversible on withdrawal of treatment. Women who are having difficulty conceiving or undergoing infertility studies should consider stopping treatment with ibuprofen. Driving and using machines The medicinal product does not usually alter the ability to drive or use machinery. However, subjects performing activities that require vigilance should use it with caution if they notice drowsiness, vertigo or depression during the treatment. Important information about some of the excipients of Moment Moment contains: sucrose: if you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicinal product. HEALTH EDUCATION NOTES All of us may experience various types of pain, of varying origin, frequency and intensity, in our daily lives: headache, toothache, muscular and articular pain, menstrual pain. Headache (cephalea) is certainly one of the most common pains. There are three main types of primary headache (those not due to other diseases): migraine, so called because the pulsating pain only affects one side of the head; the most commonly experienced tension headache, affecting the whole head and the cluster headache, characterized by fits of shooting pain affecting an eye or one side of the face. In some cases, a headache may be a symptom of another disease (allergies, anaemia, myopia, poisoning, stomach troubles, cervical arthritis, sinusitis, constipation, head traumas). When suffering from headache, it is important that factors which may provoke it (irregular feeding habits, particular foods, smoking, alcohol, stress, over-intensive physical exertion, excessive exposure to sunlight, loud noises, heavy scents, etc.) be identified and prevented. In case of recurring fits of headache, it is, anyhow, advisable for you to consult your physician. Menstrual pain (dysmenorrhoea) is a very common ailment; in addition to pain there are altered moods (sadness, easy irritability), breast tension and feeling of generalized fatigue. Eliminating substances like coffee, salt or chocolate from your diet or reducing them in favour of food rich in vitamins like fruit, as well as taking hot infusions and camomile tea, may help reduce these effects. Menstrual pain, at times quite intense, can

4 be fought by using pain-relieving drugs that act to reduce the amount of prostaglandins, substances produced in the womb and considered largely responsible for this complaint. How to use this medicinal product How much Adults and adolescents over 12 years old: 1-2 tablets, two-three times daily. Warning: do not exceed the dose of 6 tablets a day without first consulting your doctor. Elderly patients should follow the minimum dosage indicated above. Undesirable effects can be minimised by using the lowest effective dose required to control symptoms and for the shortest time possible (see Renal impairment: in patients with minor or moderate renal impairment, the dosage must be kept as low as possible for the shortest time necessary to control the symptoms and kidney function must be monitored. Hepatic impairment: in patients with minor or moderate hepatic impairment, the dosage must be kept as low as possible for the shortest time necessary to control the symptoms and liver function must be monitored. Moment is contraindicated in patients with severe hepatic impairment (see When it should not be used ). When and for how long Moment can be taken on an empty stomach. Patients with gastric disorders should take this medicinal product on a full stomach. Consult a doctor if there are no clear signs of improvement after three days of treatment. Consult your doctor if symptoms present themselves repeatedly or if you note any recent change in their nature. Consult a doctor if use of the medicinal product is necessary in adolescents for more than 3 days or in case of worsening symptoms. How Swallow the tablet whole. What to do in the case of an excessive dose of the medicinal product Symptoms Most patients who have ingested significant quantities of ibuprofen show symptoms within 4-6 hours. The symptoms of overdose most commonly reported include: nausea, vomiting, abdominal pain, lethargy and drowsiness. The effects on the central nervous system (CNS) include headache, tinnitus, vertigo, convulsions and loss of consciousness. Rarely, nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnoea, diarrhoea and depression of the CNS and respiratory system have also been reported. Disorientation, a state of excitation, fainting and cardiovascular toxicity have been reported, including hypotension, bradycardia and tachycardia. In the event of significant overdose, acute renal failure and liver damage are possible. Treatment There is no specific antidote for ibuprofen overdose. In the event of overdose, symptomatic and supporting treatment is therefore recommended. In the case of accidental intake of an excessive dose of Moment, contact a doctor immediately or go to the nearest hospital. If you have any doubt whatsoever regarding the use of Moment, consult your doctor or pharmacist. Undesirable effects Like all medicines, Moment can cause side effects, although not everybody will experience them. The undesirable effects observed with ibuprofen are generally common to the other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and have been reported using the following convention: 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) Gastrointestinal disorders The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see the section Important information ). Gastrointestinal perforation with the use of ibuprofen has been observed rarely. The following effects have been reported after Moment has been administered: feeling of indigestion, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, epigastric pain, gastric pyrosis, abdominal pain, melaena, haematemesis, ulcerative stomatitis, Crohn s disease and colitis exacerbation (see the section Important information ). Uncommon: gastritis. Very rare: pancreatitis. Immune system disorders Following treatment with NSAIDs, the following undesirable effects have been reported: non-specific allergic reaction and anaphylaxis; uncommon: hypersensitivity reactions such as various types of rash, urticaria, itching, purpura, angioedema, exanthema, reactions involving the respiratory system, including bronchospasm, dyspnoea, or asthmatic attacks (sometimes with hypotension); rare: lupus erythematosus syndrome; very rare: severe hypersensitivity reactions. The symptoms may include: severe asthma, facial oedema, oedema in the tongue and larynx, oedema of the airways with bronchospasm, dyspnoea, tachycardia, anaphylaxis, exfoliative dermatitis and bullous reactions. Cardiac and vascular disorders 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) (see section Very rare: palpitations, congestive heart failure, myocardial infarction, acute pulmonary oedema, hypertension. Other adverse events for which no causal link has necessarily been established, include: Blood and lymphatic system disorders Rare: leukopenia, thrombocytopenia, neutropaenia, agranulocytosis, aplastic anaemia and haemolytic anaemia, inhibition of platelet aggregation. Psychiatric disorders Uncommon: insomnia, anxiety Rare: depression, state of confusion, hallucinations. Nervous system disorders Common: dizziness. Uncommon: paraesthesia, drowsiness. Rare: optic neuritis.

5 Infections and infestations Uncommon: rhinitis. Rare: aseptic meningitis. Rhinitis and aseptic meningitis have been observed particularly in patients with pre-existing autoimmune disorders, (such as systemic lupus erythematosus and mixed connectivitis) with symptoms of neck stiffness, headache, nausea, vomiting, fever or disorientation (see section The exacerbation of infection-related inflammations (e.g. development of necrotising fasciitis) has been described. Respiratory, thoracic and mediastinal disorders Uncommon: bronchospasm, dyspnoea, apnoea. Eye disorders Uncommon: visual disturbances. Rare: ocular alteration with consequent visual disturbances, toxic optic neuropathy. Ear and labyrinth disorders Uncommon: impaired hearing, tinnitus, vertigo. Hepatobiliary disorders Uncommon: abnormal liver function, hepatitis and jaundice. Very rare: hepatic impairment. Skin and subcutaneous tissue disorders Allergy-based forms of cutaneous rash (erythema, pruritus, urticaria) may occasionally develop. Uncommon: photosensitivity reactions. Very rare: blistering dermatitis including Stevens-Johnson syndrome, toxic epidermal necrolysis and multiform erythema. In exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection (see also Infections and infestations ). Renal and urinary disorders Uncommon: altered kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrosis syndrome and renal impairment. Rare: hyperazotaemia. It is important that the information on the medicinal product is always available; therefore always keep the package and the package leaflet together. Keep this medicine out of the sight and reach of children. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment. Composition Each tablet contains: active ingredient: ibuprofen 200 mg. Excipients: corn starch, sodium starch glycolate, povidone, colloidal anhydrous silica, talc, hydroxypropyl cellulose, gum arabic, sucrose, Macrogol 6000, light magnesium carbonate, titanium dioxide. What it looks like Moment 200 mg comes in the form of coated oral tablets. Each pack contains 6, 10, 12, 20, 24, 30, 32 or 36 tablets. The pack of 6 coated tablets includes a blister pack protection. Marketing Authorisation Holder Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Viale Amelia, Rome - Italy Manufacturer A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio, Ancona - Italy. Famar Italia S.p.A., Via Zambelletti, Baranzate di Bollate, Milan - Italy Review of the package leaflet by the Italian Medicines Agency (AIFA): April 2017 Use the QR Code on the box or go to to read the updated package leaflet and read the package leaflet in other languages. General disorders and administration site conditions Common: ill-being, fatigue. Rare: oedema. Investigations: Rare: increased transaminase, increased alkaline phosphatase, reduced haemoglobin, reduced haematocrit, prolonged bleeding time, reduced blood calcium, increased uric acid in blood. Following the indications provided in this package leaflet will reduce the risk of side effects. Reporting of side effects If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system on the website By reporting side effects you can help provide more information on the safety of this medicine. Shelf life and storage Shelf life: check the expiry date on the packaging. Do not use the medicine after the expiry date indicated on the packaging. The expiry date refers to the product in the original packaging, stored correctly _03