MILGAMMA PROTECT. 300 mg. 30 tablets
MILGAMMA PROTECT. 300 mg. 30 tablets
WHAT MILGAMMA PROTECT 300 MG FILM AND WHAT IT IS USED
Protect Milgamma 300 mg tablets is a medicine containing the vitamin. Benfotiamine is lipid-soluble form of vitamin B1 (thiamine)
Protect Milgamma 300 mg tablets is indicated for:
treatment and prevention of clinical conditions of B1 deficiency (e.g.. neuropathy and cardiovascular disease), where these conditions do not respond to diet;
treating diabetic and alcoholic polyneuropathy.
Clinical diagnosis of a deficiency of vitamin B1 may occur in cases of:
improper or inadequate diet and nutrition;
term parenteral nutrition (intravenous feeding);
malabsorption - a disorder in which the ingredients of the food are not absorbed properly in the small intestine;
increased requirements for vitamin B1 (eg. during pregnancy and lactation).
Protect Milgamma 300 mg film-coated tablets are used to treat neuropathy and cardiovascular disorders resulting from a deficiency of vitamin B1.
2 BEFORE YOU TAKE MILGAMMA PROTECT 300 MG FILM
Do not take Milgamma Protect 300 mg film-coated tablets:
if you are hypersensitive (allergic) to benfotiamine, thiamine or any of the excipients in the formulation of Milgamma Protect 300 mg film-coated tablets.
Taking Milgamma Protect 300 mg film-coated tablets with other drugs
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Thiamine can be deactivated by 5-fluorouracil (active substance of which is used for the treatment of cancer).
Taking Milgamma Protect 300 mg tablets with food and drink
No special precautions.
Fertility, Pregnancy and lactation
During pregnancy and lactation, the recommended daily dose of vitamin B1 is 1.4 - 1.6 mg. There is no safety at doses higher than the recommended daily dose.
During pregnancy, this dose may be increased, but only when you have a deficiency of vitamin B1.
Use a Milgamma Protect 300 mg tablets if your doctor determines that it is absolutely necessary.
During lactation, the recommended daily intake for vitamin B1 is 1,4 - 1,6 mg. The safety of doses higher than the recommended daily dose has not been established.
If you are breastfeeding, you should use Milgamma Protect 300 mg tablets if you have a confirmed deficiency of vitamin B1 and if your doctor believes that the use of Milgamma Protect 300 mg tablets is absolutely necessary.
Vitamin B1 passes into breast milk.
No clinical data on the impact of Milgamma Protect 300 mg tablets on fertility.
If you are pregnant or breast-feeding, you think you are pregnant or planning to become pregnant, ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Protect Milgamma 300 mg tablets does not affect the ability to drive and use machines.
Important information about some of the ingredients of Milgamma Protect 300 mg tablets
3 HOW TO PROTECT MILGAMMA 300 MG FILM
Always take Milgamma Protect 300 mg tablets exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.
The following information applies when your doctor advises otherwise. Please follow the instructions, otherwise Milgamma Protect 300 mg tablets will be able to exert its therapeutic effect!
Unless otherwise specified, the usual dosage in the treatment of clinical conditions, vitamin B1 deficiency and treatment of diabetic polyneuropathy and alcohol is one tablet (300 mg Milgamma Protect) once daily.
The usual dose for prevention of clinical conditions of vitamin B1 deficiency (eg. Neuropathies and cardiovascular diseases) in the event that can not be improved through diet is half a tablet Milgamma Protect 300 mg tablets once daily.
Use in children and adolescents
Safety and efficacy in children and adolescents below 18 years have not been established.
Normal recommended dosage regimen for the elderly.
Patients with renal impairment
In these patients Milgamma Protect 300 mg tablets may be administered in normal doses.
Patients with hepatic impairment
Safety and efficacy in patients with hepatic impairment have not been established.
Method of administration
Film-coated tablets should be swallowed with some liquid. The tablets can be taken at any time of day. The tablets can be divided into two equal halves.
Method and route of administration
Take all the tablet with a glass of water. The tablets can be taken at any time of day. The tablet can be divided into two equal halves.
Duration of use
The duration of use of Milgamma Protect 300 mg tablets is determined by the success of the treatment.
Initially Milgamma Protect 300 mg tablets are administered for a period of at least 3 weeks in the case of vitamin B1 deficiency and for a period of at least 4 weeks in the case of diabetic and alcoholic polyneuropathy. Then maintenance treatment is determined by the therapeutic response with 150 mg or 300 mg Milgamma Protect tablets. In an unsatisfactory therapeutic response or no after 3 weeks in the case of B1 deficiency or after 4 weeks in the case of diabetic and alcoholic polyneuropathy, therapy should be re-evaluated.
Consult your doctor or pharmacist if you feel that the effect of Milgamma Protect 300 mg tablets is too strong or too weak.
If you take more than you should Milgamma Protect 300 mg tablets
If you take more than you should Milgamma Protect 300 mg tablets usually do not need medical attention, however, contact your doctor as soon as possible.
If you forget to take Milgamma Protect 300 mg tablets
Do not take a double dose to make up for a missed dose.
Take your normal dose when the next administration, in the future, make sure you follow the instructions.
If you stop taking Milgamma Protect 300 mg tablets
If you stop taking jeopardizes the success of the treatment! If you experience side effects, please discuss further treatment with your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 POSSIBLE SIDE EFFECTS
Like all medicines, Milgamma Protect 300 mg tablets can cause side effects, although not everybody gets them.
Assessment of adverse events using the following frequency:
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, including isolated cases;
Not known: From the available data can not be estimated.
Important side effects or symptoms you should know and take the necessary steps if you are affected:
If any of the following side effects occur for you, please stop using Milgamma Protect 300 mg tablets immediately and consult a physician.
Immune system disorders:
Very rare: Hypersensitivity reactions (allergies) such as skin rashes, urticaria (hives).
Very rare: In clinical trials with benfotiamine documented individual cases of nausea and other gastrointestinal complaints.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5 HOW TO STORE MILGAMMA PROTECT 300 MG FILM
Keep out of reach of children.
Do not use the medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6 FURTHER INFORMATION
Protect contents Milgamma 300 mg tablets
Active substance: benfotiamine.
Each tablet contains 300 mg of benfotiamine.
Other ingredients are:
Microcrystalline cellulose, talc, povidone, anhydrous silicon dioxide, croscarmellose sodium, in particular long-chain glycerides.
Hypromellose, titanium dioxide, polyethylene glycol, sodium saccharin.
How Milgamma Protect tablets look like 300 mg tablets and contents of the pack
Protect Milgamma 300 mg tablets are white, film-coated tablets scored on both sides. The tablets can be divided into two equal halves.
Pack sizes: 30, 60 or 100 tablets.
Not all pack sizes may be marketed.