B vitamins are essential for nerve cell metabolism. Vitamin B1 is found in the drug in the form of benphothiamine, which is much better absorbed than the classic form and is better available in the body. Unlike thiamine, it does not cause constipation or unpleasant body odor. ???????? N ???????*50 WORWAG PHARMA Package leaflet: information for the user ???????? N 40 mg/90 mg/250 ?????????? ???? ??????? Milgamma N 40 mg/90 mg/250 micrograms capsules,soft Benfotiamine (fat-soluble derivative of vitamin B1) / Pyridoxine hydrochloride (vitamin B6)/ Cyanocobalamin (vitamin B12) (Benfotiamine (fat-soluble vitamin ?1 derivative)/Pyridoxine hydrochloride (vitamin B6)/ Cyanocobalamin (vitamin B12)) Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may have to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Don't pass it on to other people. It can harm them, even though the signs of their 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. See section 4. What is in this leaflet: 1. What milramma N soft capsules are and what it is used for 2. What you need to know before you take milgamma N soft capsules 3. How to take milgamma N soft capsules 4. Possible side effects 5. How to store milgamma N soft capsules 6. Contents of the pack and other information 1. What milgamma N soft capsules are and what it is used for Milgamma N soft capsules is a drug for the treatment of neuropathies. The active substances are benfotiamine (a fat-soluble derivative of vitamin Bi), pyridoxine hydrochloride (vitamin B6) and cyanocobalamin (vitamin B12). Milgamma N soft capsules is used to treat: diseases of the nervous system of various origins; inflammatory neurological diseases (neuritis); neurological diseases with pain syndrome (neuralgia); neurological diseases due to nerve damage from diabetes, alcoholism, etc.; migraine; painful muscular distortions (strains); syndrome of irritation of the nerve roots of the spine (radicular syndrome); cervical spine syndrome; shoulder-arm syndrome; herpes zoster; paralysis of the facial nerve; periods of prolonged healing processes in elderly patients, milgamma N soft capsules is used in adults. 2. What you need to know before you take milgamma N soft capsules Do not take milgamma N soft capsules: • if you are allergic to benfotiamine (a fat-soluble derivative of Viitamine B) pyridoxine hydrochloride (vitamin B6), cyanocobalamin (vitamin B12) or any of the other ingredients of this medicine (listed in section 6) if you are pregnant or breast-feeding. Warnings and precautions Talk to your doctor or pharmacist before taking milgamma N soft capsules. With prolonged intake (more than 6 months), milgamma N soft capsules can cause disorders in the functions of peripheral nerves. When taking high doses, the glycerol content in the drug can cause headaches, stomach upset and diarrhea. Due to the content of sorbitol, patients with hereditary fructose intolerance should not take this drug. Children and adolescents There is no experience in the use of milgamma N soft capsules in children up to 18 years of age. Milgamma N soft capsules should not be used in children up to 18 years of age for safety and efficacy reasons. Other medicines and milgamma N soft capsules Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is extremely important if you are taking or have taken the following medicines: Levodopa (used to treat Parkinson's disease); Isonicotinoylhydrazide (INH) and cycloserine (for the treatment of tuberculosis); D-penicillamine (for the treatment of rheumatoid arthritis); during a prolonged period of treatment with estrogen-containing contraceptives; 5-fluorouracil (for the treatment of cancer), milgamma N soft capsules with food, drink and alcohol Avoid alcohol because it reduces the effectiveness of treatment. Take the capsules after meals. The body's need for pyridoxine increases with the use of alcohol. 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 Since this drug contains 90 mg of vitamin B6 in each capsule, its use during pregnancy is not recommended. Lactation Since this medicinal product contains 90 mg of vitamin B6 in each capsule, its use during lactation is not recommended. Fertility No clinical data are available on the influence of milgamma N soft capsules on fertility. Driving and using machines Milgamma "N soft capsules do not affect the ability to drive and use machines, milgamma N soft capsules contain glycerol, sorbitol and mannitol. When taking high doses, the glycerol content in the drug can cause headaches, stomach upset and diarrhea. This medicine contains 7.89 mg of sorbitol in each capsule. Sorbitol is a source of fructose. If you have been told by your doctor that you are intolerant to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which people cannot break down fructose, talk to your doctor before taking or being given this medicine. This medicine contains less than 10 g of mannitol per capsule, that is, it is practically free of mannitol. 3. How to take milgamma N soft capsules Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: If not otherwise prescribed, 3-4 times a day 1 capsule. In milder cases and with a particularly favorable response - 1-2 capsules daily. Duration of treatment The duration of treatment is determined by a doctor. Please contact your doctor or pharmacist if you think that the action of milgamma N soft capsules is too strong or too weak. Method of administration: Capsules are taken after meals with a little liquid, without chewing. The capsule can be taken at any time of the day. Use in children and adolescents: Milgamma N soft capsules should not be used in children below the age of 18 years due to safety and efficacy reasons. If you take more milgamma N soft capsules than you should If you take more milgamma N soft capsules than you should, contact your doctor or the nearest hospital. An overdose of vitamin B6 can cause nerve disorders, and there may be a lack of coordination in muscle movement. Extremely high doses can cause seizures (seizures). In newborns and infants, deep sedation (looseness, drowsiness, unawakened deep sleep) may occur, blood pressure may decrease very strongly and breathing disorders may occur. If you forget to take milgamma N soft capsules Do not take a double dose to make up for a forgotten capsule. m^/^?*^ Continue to take milgamma N soft capsules as before, at the usual time and try to take the medicine regularly in the future. If you stop taking milgamma N soft capsules If you stop taking milgamma N soft capsules, you risk ruining the success of the therapy. If you experience any unpleasant side effects, please consult your doctor regarding continued treatment. 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. Rare side effects (may affect up to 1 in 1,000 people): Allergic reactions (hives, skin rash), shortness of breath, shock conditions, swelling of the eyes, face, tongue and throat. Very rare side effects (may affect up to 1 in 10,000 people): Acneiform and bullous rashes. Isolated cases: Gastrointestinal disturbances such as nausea and other gastrointestinal complaints have been documented as single cases in clinical trials with benfotiamine. Not known (cannot be estimated from the available data): Long-term administration, for periods longer than 6 months, may lead to impaired peripheral nerve function (see section . ). "Warnings and precautions"). When taking high doses, the glycerol content of the drug may cause headache, stomach upset and diarrhoea (see section 4.4). "Warnings and precautions").