Milgamma Protect Tablets 300 mg*30 Worwag and similar items

MILGAMMA PROTECT tablets 300 mg*30 WORWAG PHARMA Package leaflet: User Information ???????? ??????? 300 mg ????????? ???????? milgamma Protect 300 mg film-coated tablets ??????????? (Benfotiamine) 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 have to read it again. If you need further information or advice, ask your pharmacist. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. If after 21 days you do not feel better or your condition worsens, you should seek medical attention. What is in this leaflet: 1. What milgamma Protect 300 mg film-coated tablets is and what it is used for 2. What you need to know before you take milgamma Protect 300 mg film-coated tablets . How to take milgamma Protect 3 mg film-coated tablets 300. Possible side effects 4. How to store milgamma Protect 5 mg film-coated tablets 300. Contents of the pack and other information 1. What milgamma Protect 300 mg film-coated tablets is and what it is used for Milgamma Protect 300 mg film-coated tablets is a medicinal product containing a vitamin. Benfotiamine is a fat-soluble form of vitamin B1 (thiamine). Therapeutic indications: Milgamma Protect 300 mg film-coated tablets is indicated in: treatment and prevention of clinical conditions due to vitamin B deficiency1 (e.g. neuropathies and cardiovascular diseases) in cases where these conditions do not respond to diet. treatment of diabetic and alcoholic polyneuropathy. Clinically diagnosed vitamin B deficiency1 may occur in cases of: improper or inadequate diet and nutrition prolonged parenteral nutrition (venous feeding) Postene hemodialysis malabsorption - a disorder in which the ingredients of food are not properly absorbed in the small intestine chronic alcoholism increased needs for vitamin B1 (e.g. in pregnancy and lactation). Milgamma Protect 300 mg film-coated tablets is also used to treat neuropathies and cardiovascular disorders that result from vitamin B deficiency1. 2. What you need to know before you take milgamma Protect 300 mg film-coated tablets Do not take milgamma Protect 300 mg film-coated tablets: • if you are allergic to benfotiamine, thiamine or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking milgamma Protect 300 mg film-coated tablets. Children and adolescents The safety and efficacy of milgamma Protect 300 mg film-coated tablets in children up to 18 years of age have not been established. No data are available. Other medicines and milgamma Protect 300 mg film-coated tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Thiamine can be deactivated by 5-fluorouracil (an active substance that is used to treat cancer). Milgamma Protect 300 mg film-coated tablets with food, drink and alcohol No special precautions are imposed. 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 or pharmacist for advice before taking this medicine. Pregnancy During pregnancy, the recommended daily intake of vitamin B1 1.4 - 1.6 mg. There are no safety data for doses higher than the recommended daily dose. During pregnancy, this dose can be increased, but only if you are deficient in vitamin B.1. Use milgamma Protect 300 mg film-coated tablets only if your doctor deems it absolutely necessary. Lactation During breastfeeding, the recommended daily dose for vitamin B1 1.4 - 1.6 mg. The safety of doses higher than the recommended daily dose has not been established. If you are breast-feeding, you should use milgamma Protect 300 mg film-coated tablets only if you suffer from confirmed vitamin B deficiency1 and if your doctor believes that the use of milgamma Protect 300 mg film-coated tablets is absolutely necessary. Vitamin B1 passes into mother's milk. Fertility There are no clinical data on the influence of milgamma Protect 300 mg film-coated tablets on fertility. Driving and using machines Milgamma Protect 300 mg film-coated tablets has no influence on the ability to drive and use machines. Milgamma Protect 300 mg film-coated tablets contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it can be said to be essentially sodium free. 3. How to take milgamma Protect 300 mg film-coated tablets 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. The recommended dose is: Mature In the treatment of clinical conditions of vitamin B deficiency1 and treatment of diabetic and alcoholic polyneuropathy - 1 film-coated tablet (300 mg milgamma Protect) once a day. In the prevention of clinical conditions of vitamin B deficiency1 (e.g. neuropathies and cardiovascular diseases), in case they cannot be improved by diet, is half a film-coated tablet milgamma Protect 300 mg film-coated tablets once a day. Use in children and adolescents The safety and efficacy of milgamma Protect 300 mg film-coated tablets in children up to 18 years of age have not been established. Elderly patients (over 65 years of age) A normal dosing regimen is recommended for elderly patients. Patients with renal impairment In these patients, milgamma Protect 300 mg film-coated tablets may be administered at a normal dose. Patients with hepatic impairment Safety and efficacy in patients with hepatic impairment have not been established. Route of administration The film-coated tablet should be swallowed with a little liquid. The tablets can be taken at any time of the day. Tablets can be divided into two equal halves. Duration of use The duration of use of milgamma Protect 300 mg film-coated tablets is determined by the success of treatment. Initially, milgamma Protect 300 mg film-coated tablets is administered for at least 3 weeks in case of vitamin B deficiency1 and for a period of at least 4 weeks in cases of diabetic and alcoholic polyneuropathy. Maintenance treatment is then determined by the therapeutic response with 150 mg or 300 mg milgamma Protect film-coated tablets. If there is an inadequate therapeutic response or lack thereof after 3 weeks in cases of vitamin B deficiency1 or after 4 weeks in cases of diabetic and alcoholic polyneuropathy, treatment should be re-evaluated. Consult your doctor or pharmacist if you feel that the effect of milgamma Protect 300 mg film-coated tablets is too strong or too weak. If you take more milgamma Protect 300 mg film-coated tablets than you should If you take more milgamma Protect 300 mg film-coated tablets than you should, no medical intervention is usually required, however, contact your doctor as soon as possible. If you forget to take milgamma Protect 300 mg film-coated tablets Do not take a double dose to make up for a forgotten tablet. Take your usual dose at the next dose, and in the future try to follow the instructions accurately. If you stop taking milgamma Protect 300 mg film-coated tablets If you stop taking it, you put the success of the treatment at risk! If side effects occur, please discuss further treatment with your doctor. 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. Very rare side effects (may affect up to 1 in 10,000 people): Hypersensitivity reactions (allergies) such as skin rashes, urticaria (hives) In clinical trials with benfotiamine, isolated cases of nausea and other gastrointestinal complaints have been documented. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Bulgarian Drug Agency, ul. Damyan Gruev" No 8, 1303 Sofia, Tel.: +35 928903417, website: www.bda.bg. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store milgamma Protect 300 mg film-coated tablets Keep out of the reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.