PACKAGE LEAFLET: INFORMATION FOR THE USER RIBOKSĪNS 200 mg film- coated tablets Inosinum Read all of this leaflet carefully because it contains important information for you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - The medicine is prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms of the disease are similar to yours. - 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 Riboksīns and what it is used for 2. Before you take Riboksīns 3. How to take Riboksīns 4. Possible side effects Riboksīns 5. How to store 6. Further information 1. WHAT RIBOKSĪNS IS AND WHAT IT IS USED FOR Active substance of the medicine RIBOKSĪNS 200 mg film- coated tablets inosine promotes metabolism in body tissues, mainly myocardium. Heart coronary diseases, cardiac infarction, stenocardia, myocarditis, cardiomyopathy, for the complex treatment of rheumatic heart diseases; for prevention of heart rhythm disorders that occur due to the use of cardiac glycosides; a complex treatment of liver diseases (hepatitis, liver cirrhosis, fatty liver dystrophy) caused by poisoning with drugs or alcohol. The complex therapy for prophylaxis of ischemia and mitigation of its effects, in particular in case of cerebral stroke, microcirculatory and pancreatic damage prevention in case of acute necrotizing pancreatitis. As an antioxidant and radio-protective agent during radiation therapy. 2. BEFORE YOU TAKE Riboksīns Do not take Riboksīns: - if you are hypersensitive (allergic) to inosine or any of the other ingredients of the medicine mentioned in section 6, - if you have hyperuricaemia (increased content of uric acid in plasma), - if you have acute gout. 1
Warning and precautions If you have had gout, taking Riboksīns a long time (especially in excess of recommended doses), gout may increase. If you have any swelling, redness and pain of the big toe or other joint, the use of the drug should be discontinued and you should consult with your doctor. Children under 18 years are not recommended to use the drug, because there is no information about the safety and efficacy for this age group. Other medicines and Riboksīns Tell your doctor if you are taking, have recently taken or might take other medicines. Inosine can be used in combination with other agents including anabolic agents (agents, which reinforce the need and recycle nutrients, protein synthesis and muscle growth). During complex therapy with antiarrhythmics, antianginal agents and agents with inotropic activity inosine increases the efficacy of these medicines. Inosine reduces cardiac glycoside toxicity. Riboksīns with food, drink and alcohol Alcohol should not be used during treatment. When used concomitantly with alcohol, inosine effect decreases and heart problems are possible. Pregnancy and breast-feeding If you are pregnant or breast-feeding, if you think that you can get pregnant or planning a pregnancy, before using this drug, consult your doctor. Data regarding inosine toxicity during pregnancy and lactation are not available. Its use is allowed only after careful risk/benefit ratio evaluation. Driving and using machines The medicine does not affect the ability to drive a car and using machines. Important information about some of the ingredients of Riboksīns This medicinal product contains sugar (sucrose). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. The medicine contains the colouring agent sunset yellow E110, which can cause allergic reactions. 3. HOW TO USE RIBOKSĪNS Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Take the medicine orally before meals. The initial dose is 200 mg 3-4 times daily. The daily dose is 600-800 mg. If the drug is well tolerated, the dose may be increased gradually within 2-3 days until 1200, 1600 or 2400 mg 2
daily. The course of treatment can last from 4 weeks to 1.5-3 months. Patients with renal impairment should use this drug cautiously because of the risk of hyperuricaemia. Elderly patients should begin with the lowest daily dose that can be increased gradually with caution. If you take more Riboksīns than you should If you take the medicine more than a dose indicated for you, there is no need in a special treatment, but consult your doctor. If you forget to take Riboksīns If you forget a dose, take it as soon as you remember it. Do not take a double dose to make up for the forgotten tablets. If you stop using Riboksīns You can safely stop using the product. 4. Possible side effects Like all medicines Riboksīns can cause side effects, although not everybody gets them. Undesirable effects are usually observed in a light form. 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 Rare - nausea, abdominal discomfort (using in large doses). Very rare - itchy skin, skin flushing, urticaria. In these cases, the drug should be discontinued. If you notice any side effects not listed in this package leaflet, consult your doctor. This also refers to possible side effects that are not indicated in this package leaflet. 5. HOW TO STORE RIBOKSĪNS 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 Riboksīns contains Active substance: inosine (Inosinum). Each film - coated tablet contains 200 mg of inosine. 3
The other ingredients are potato starch, sucrose (10 mg), methylcellulose, pregelatinized maize starch, stearic acid. Coating content: hypromellose, macrogol, colouring agents: titanium dioxide (Е171), quinoline yellow (E104), sunset yellow (E110). What Riboksīns looks like and contents of the pack Round, biconvex tablets with yellow coating, in the break of the tablet white or off-white with yellowish tint tablet core is visible. 10 film-coated tables in blister, 5 blisters (50 film- coated tablets) with package leaflet in the carton pack. Marketing Authorisation Holder and Manufacturer Joint-Stock Company OLAINFARM Address: 5, Rupnicu St., Olaine, LV 2114 Country: Latvia Telephone: +371-67013701 Telefax: +371-67013777 E-mail: olainfarm@olainfarm.lv This leaflet was last revised in 02.2012 Translation from Latvian according to the original document. Translation was carried by Larisa Želnina, Senior Regulatory Affairs specialist Date:26.03.2013. 4
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