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

Transcription

1 Translation from Latvian Approved by SAM on PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROFEN 200 mg film-coated tablets Ibuprofenum Read all of this leaflet carefully because it contains important information for you. - This medicine is available without prescription. However, you still need to take Ibuprofen 200 mg carefully to get the best results from it. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - You must consult a doctor if your symptoms worsen or do not improve after 3-10 days. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Ibuprofen is and what it is used for 2. Before you take Ibuprofen 3. How to take Ibuprofen 4. Possible side effects 5. How to store Ibuprofen 6. Further information 1. WHAT IBUPROFEN IS AND WHAT IT IS USED FOR Ibuprofen 200 mg film-coated tablets active substance ibuprofen is non-steroidal anti-inflammatory agent [NSAID] with analgesic, antiinflammatory and moderate antipyretic activity. Ibuprofen is used for a short period to decrease mild and moderate pain including menstrual pain, post operational pain, tooth ache, migraine, fever. 2. BEFORE YOU TAKE IBUPROFEN Do not take Ibuprofen -if you are allergic (hypersensitive) to ibuprofen, acetylsalycilic acid or any of the other non-steroidal antiinflammatory agents and any/or other ingredients of Ibuprofen, - if you have previously had bronchospasm, asthma attacks, as well swelling of the nasal mucosa and rash, - following previous intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs- unclarified blood-formation disturbances, - if you have current or previously had a gastrointestinal ulcers or bleeding, related to previous NSAIDs therapy (two or several proved ulcer or bleeding episodes), - if you suffer from severe heart failure, - if you suffer from severely impaired liver and/or kidney function, - if you have eye nerve disease, - if you have haematopoietic disorders, - if you are pregnant - if you take lithium preparations (medicines to treat psychic disorders) or cycloooxygenase-2-inhibitors (non-steroidal anti-inflammatory agents, ex. nimesulide, celecoxib). Take special care with Ibuprofen You should avoid using ibuprofen concomitantly with acetylsalycilic acid or other non-steroidal antiinflammatory drugs, as well as cycloooxygenase-2-inhibitors. 1

2 The adverse effects of the medicine can be diminished using the low effective dose, which is necessary to control the symptoms for the possible short period. Elderly The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation. Gastrointestinal bleeding, ulceration and perforation Gastrointestinal adverse effects (GI bleeding, ulceration or perforation) can occur not depending on duration of therapy. Occurrence of adverse effects may be informed anytime during treatment with or without warning symptoms, as well as adverse effects may appear in patients without a previous history of gastrointestinal disorders. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, if you previously had ulcer, particularly if complicated with bleeding or perforation, and in the elderly. These patients should start treatment on the lowest dose available. Please talk to your doctor as a combination therapy with protective agents could be considered. This also applies if you concomitantly take low dose acetylsalicylic acid, or other active substances likely to increase gastrointestinal risk, the doctor can prescribe you additionally gastro protectors, for example mizoprostol or proton pump inhibitor (ex. omeprazole) You should give your utmost attention to the above mentioned symptoms in the initial stages of treatment. Caution should be advised if you concomitantly use medicines which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (ex. warfarin), selective serotonin-reuptake inhibitors (medicine for treatment of depression) or anti-platelet agents such as acetylsalicylic acid. If some gastrointestinal disorders appear in a patient who is taking ibuprofen, the use of the medicine should be immediately interrupted and he should consult his doctor. Patients who had previously diagnosed GI disease (ulcerative colitis, Crohn's disease) should use ibuprofen with caution as the disease may be aggravated. Chronic heart failure, arterial hypertension. The use of this medicine may be associated with risk of heart attack (myocardial infarction) or decreased blood flow to the brain (stroke). If this medicine is used particularly at a high dose and in long-term treatment, the risk of aforementioned disorders is higher. Do not exceed the recommended dose or duration of treatment. Talk to your doctor before taking this medicine, if you are suffering from heart failure, have had a previous stroke or think that you may be at risk of these conditions (for example if you have high blood pressure, diabetes, or high cholesterol, or are a smoker). Bronchial asthma and narrow airway diseases may increase the risk of bronchospasm. Skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy. Stop taking ibuprofen and consult a doctor immediately at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Kidney and/or liver function impairment. If during treatment have kidney or liver problems (excessive fatigue, nausea, jaundice), or systemic reactions (eosinophilia), ibuprofen should be discontinued and you should consult your doctor immediately. Patients with haemopoesis and blood coagulation disorders and patients that use anticoagulants, ibuprofen should be used with caution. During treatment course the peripheral blood cell count should be monitored. If corticosteroids were used for a long-term period and ibuprofen was started to use, corticosteroids should be reduced gradually to avoid exacerbation of disease or adrenal insufficiency. Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 2

3 Ipuprofen is not allowed to use with other NSAIDs, lithium preparations. Using ibuprofen with antihypertensive agents (ACE inhibitors, beta-blockers), or diuretics (furosemide, thiazides) may reduce the medicine efficacy, increase blood potassium levels, and renal failure. Ibuprofen may increase anticoagulant activity, such as warfarin. Using ibuprofen concomitantly with antithrombotic agents and selective serotonin reuptake inhibitors (drugs for the treatment of depression) increases the risk of gastrointestinal bleeding. Corticosteroids, as well as moclobemide, pentoxifylline, ritonavir increase activity of ibuprofen, thus causing a rise in the stomach and gastrointestinal ulceration or bleeding. The medicine should be very cautiously administered with digitalis (digoxin) because ibuprofen may increase the concentration of digoxin in the blood, increase the medicine activity, strengthen heart insufficiency. Combination with a quinolone antibacterials (for example, nalidixic acid, norfloxacin) will increase the central nervous system (CNS) risk of side effects development. If ibuprofen is taken in combination with methotrexate, baclofen, cyclosporine, tacrolimus, zidovudine may increase the drug toxicity. Ibuprofen may increase the antiepileptic drug phenytoin performance and cause unwanted side effects. Taking Ibuprofen with food and drink Alcoholic beverages should be avoided during the therapy as it may increase the risk of gastrointestinal ulceration and bleeding. Pregnancy, breast-feeding and fertility Ask your doctor for advice before taking any medicine. Use during pregnancy is not allowed. During breast-feeding the medicine is allowed for a short use in case of pain and fever, consultation with a doctor is mandatory. Breast-feeding should be discontinued if continuous treatment or dose greater than 800 mg daily use. Driving and using machines The preparation does not affect the ability to drive a car and use machines. Do not drive or operate machinery if you experience headache, dizziness, drowsiness and other central nervous system disorders or visual disturbances as well if you have used alcoholic beverages at the same time. Important information about some of the ingredients of Ibuprofen If your doctor has told you that you have sugar intolerability, before using this medicine, consult your doctor. The tablet coating contains wheat flour. Medicines should not be used in patients with wheat allergy (different from celiac disease). The tablet coating contains colouring agent carmoisine E122, which may cause allergic reactions. 3. HOW TO TAKE IBUPROFEN Ibuprofen tablet should be swallowed whole with or after meals with a sufficient amount of water. The minimum effective dose should be used. Adults and children over 12 years of age 200 mg 3-4 times a day after meals. The dose may be increased, and 400 mg 3 times a day are used. The daily dose should not exceed 1200 mg. As soon as the therapeutic effect is achieved, the dose should be decreased till mg a day. Elderly The lowest effective dose should be used for the shortest possible duration in elderly patients who are more prone to side effects. Patients who have light or moderately serious kidney and liver disorders- decrease of the dose is not necessary. Without consulting a doctor adults should not take Ibuprofen 200 mg tablets to relieve pain longer than 10 days, not more than 3 days to relieve fever. Before using Ibuprofen 200 mg film-coated tablets for children of 6-12 years of age, you must consult your doctor! Children from 6-9 years of age (body weight kg) - dose is 200 mg 3 times a day. Children from years of age (body weight kg) - dose is 200 mg 3-4 times a day. 3

4 Ibuprofen 200 mg film-coated tablets should not be used in children under 6 years of age or children with body weight less than 20 kg, since the active substance dosage in a tablet is not suitable for this age group. If you feel that the medicine is too strong or too weak, consult with your doctor. If you take more Ibuprofen than you should If you take too many Ibuprofen tablets, contact a doctor or seek medical attention at the nearest hospital immediately. Overdose symptoms are nausea, vomiting, headache, drowsiness, decreased blood presure, tinnitus (ringing in the ears), bradycardia (slow heartbeat), kidney and liver function disorders, convulsion, breathing disorder and loss of consciousness. If you forget to take Ibuprofen If you forget to take a dose, take the next dose as usual. Do not take a double dose to make up for a forgotten dose. If you stop using Ibuprofen If you have no need for further continuation of this medicine, you can safely stop using Ibuprofen. 4. POSSIBLE SIDE EFFECTS Like all medicines, Ibuprofen can cause side effects, although not everybody gets them. Side effects mainly depend on the dose and treatment duration. Side effects may be minimised by using the lowest effective dose for the shortest possible duration. Classification of side effects frequency: Very common: 1 or more than 1 out of 10 patients Common: less than 1 in 10 but more than 1 in 100 patients Uncommon: less than 1 in 100 but more than 1 in 1,000 Rare: affects less than 1 in 1000, but more than 1 in 10,000 Very rare: affects less than 1 in 10,000 patients, including isolated reports. Cardiac disorders: use of Ibuprofen, particularly at high doses (2400 mg daily) and long term treatment may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke). It is reported about edema, hypertension, and heart failure. Blood and lymphatic system disorders: very rare decrease of red cells, platelets, red blood cells, which can be manifested in fever, sore throat, flu-like symptoms, nasal bleeding. Nervous system disorders: rare - headache, dizziness, nervousness, insomnia, somnolence. Eye disorders: rare vision disorders (color vision, a limited field of vision, visual impairment). Ear and labyrinth disorders: rare - ringing in the ears. Gastrointestinal disorders are the most common adverse effects. Peptic ulcers and bleeding are possible, especially in elderly patients. Reported side effects are nausea, vomiting, diarrhea, bloating, indigestion, constipation, abdominal pain, blood in the stool, vomiting with blood, ulcerative stomatitis, colitis or Crohn's disease exacerbation. Uncommon gastritis has been observed. Renal and urinary disorders: very rare - fluid retention and edema (more common in case of heart failure in elderly patients), blood in the urine, kidney problems, kidney failure. Skin and subcutaneous tissue disorders: rare - skin rash, itching, hives, skin sensitivity to sunlight. Very rare - bullous skin reactions (blistering), Stevens-Johnson syndrome and toxic epidermal necrolysis. Infections and infestations: aseptic meningitis symptoms are rarely seen, such as severe headache, nausea, vomiting, fever, neck stiffness or darkening of consciousness. Patients with pre-existing autoimmune disorders (systemic lupus erythematosus or mixed connective tissue disease) are at increased risk. Immune system disorders: rare - hypersensitivity reactions characterized by itching and rashes, asthma attacks. Very rare - face, neck, mouth, throat, respiratory tissues swelling. Liver and / or biliary disorders: very rare - liver dysfunction, jaundice, inflammation of the liver. Psychiatric disorders: very rare - depression. If you notice any side effects not listed in this package leaflet, or any of the side effects gets serious, please tell your doctor. 4

5 5. HOW TO STORE IBUPROFEN Do not store above 25 C. Protect from light and moisture. Keep out of the reach and sight of children. Do not use after the expiry date, which is stated on the package. The expiry date refers to the last date of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines. 6. FURTHER INFORMATION What Ibuprofen contains Active substance is ibuprofen (Ibuprofenum). Each film - coated tablet contains 200 mg of ibuprofen. The other ingredients are potato starch, magnesium stearate, sucrose, povidone, coloring agent carmoisine E122, magnesium hydroxycarbonate, coloring agent titanium dioxide 171, silica, wheat flour, carnauba wax. What Ibuprofen looks like and contents of the pack Tablets have pink coating, in the break of the tablet white or off-white tablet core is visible. 10 tablets in a blister. 1, 2 or 20 blisters (10, 20 or 200 film-coated tablets) and the package leaflet in a carton pack; 100 film-coated tablets in polypropylene jar. One jar (100 tablets) and the package leaflet in a carton pack; Marketing Authorisation Holder and Manufacturer Joint-Stock Company OLAINFARM Address: 5, Rupnicu St., Olaine, LV 2114 Country: Latvia Telephone: Telefax: olainfarm@olainfarm.lv This leaflet was last revised in Translation from Latvian according to the original document. Translation was carried by Larisa Želnina Senior Regulatory Affairs specialist Date: