MILGAMMA

MILGAMMA protekt film-coated tablets

Important notes (mandatory information)

milgamma protekt film-coated tablets. Active ingredient: Benfotiamine 300 mg.

Area of application

The only approved areas of application for the monopreparations are exclusively the therapy or prophylaxis of clinical vitamin B1 deficiency states, provided that these cannot be remedied through nutrition; treatment of neuropathies and cardiovascular disorders caused by vitamin B1 deficiency.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

milgamma protekt film-coated tablets
Active ingredient: Benfotiamine 300 mg

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. (See section 4)
• If you do not feel better or if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT IS MILGAMMA PROTEKT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MILGAMMA PROTEKT?
3. HOW TO TAKE MILGAMMA PROTEKT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE MILGAMMA PROTEKT?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MILGAMMA PROTEKT AND WHAT IS IT USED FOR?

milgamma protekt is a vitamin preparation.

Area of application

The only approved areas of application for the monopreparations are exclusively the therapy or prophylaxis of clinical vitamin B1 deficiency states, provided that these cannot be remedied through nutrition. Clinically proven vitamin B1 deficiency can occur in the following cases: malnutrition and nutritional deficiencies (e.g. beriberi), long-term parenteral nutrition, zero diet, haemodialysis, malabsorption, chronic alcoholism (alcohol-toxic cardiomyopathy, Wernicke encephalopathy, Korsakow syndrome), increased demand (e.g. pregnancy and lactation). Treatment of neuropathies and cardiovascular disorders caused by vitamin B1 deficiency.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MILGAMMA PROTEKT?

milgamma protekt must not be taken if you are allergic to benfotiamine, thiamine (chemical name for vitamin B1) or any of the other ingredients of this medicine listed in section 6.

Taking milgamma protekt together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Thiamine is inactivated by 5-fluorouracil (a drug used to treat cancer) because 5-fluorouracil competitively inhibits the phosphorylation of thiamine to thiamine pyrophosphate.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. If you are pregnant, this medicine is only useful for treating a proven vitamin B1 deficiency due to the amount of active ingredient it contains. You should therefore only use milgamma protekt if your doctor considers it absolutely necessary. The recommended daily intake of vitamin B1 during pregnancy is 1.2 mg in the 2nd trimester and 1.3 mg in the 3rd trimester. The safety of using a dose higher than the daily recommended dose has not yet been proven. If you are breast-feeding, this medicine is only useful for treating a proven vitamin B1 deficiency due to the amount of active ingredient it contains. You should therefore only use milgamma protekt if your doctor considers it absolutely necessary. The recommended daily intake of vitamin B1 during breast-feeding is 1.3 mg. The safety of using a dose higher than the daily recommended dose has not yet been proven. Vitamin B1 passes into breast milk.

Driving and using machines

No special precautions are required.

3. HOW TO TAKE MILGAMMA PROTEKT?

Always take milgamma protekt exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The following information applies unless your doctor has prescribed milgamma protekt differently. Please adhere to the instructions for use, otherwise milgamma protekt will not be able to work properly! The recommended dose is 1 film-coated tablet once a day. The film-coated tablets are taken whole with a little liquid. For the treatment of neuropathies, milgamma protekt should initially be taken over a period of at least 3 weeks. The treatment is then continued according to the therapeutic success.

Duration of use

The duration of taking milgamma protekt depends on the therapeutic success. If no or insufficient effect is noticeable after four weeks, the therapy of the symptoms should be reviewed.

Please talk to your doctor or pharmacist if you have the impression that the effect of milgamma protekt is too strong or too weak.

If you have taken more milgamma protekt than you should

No medical measures are generally required.

If you forget to take milgamma protekt

Do not take twice the amount if you have forgotten to take the previous dose. Try to take the medicine regularly in the future.

If you stop taking milgamma protekt

If you stop taking the medicine, you risk the success of the treatment. If you notice any unpleasant side effects, talk to your doctor about further treatment.

If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 people treated
Common:	1 to 10 in 100 people treated
Uncommon:	1 to 10 in 1,000 people treated
Rare:	1 to 10 in 10,000 people treated
Very rare:	less than 1 in 10,000 people treated
Not known:	frequency cannot be estimated from the available data.

Important side effects or signs to watch out for, and what to do if you are affected

If you are affected by any of the following side effects, stop taking milgamma protekt and see your doctor as soon as possible. In individual cases, hypersensitivity reactions (hives, rash) may occur. In clinical studies, individual cases of gastrointestinal disorders such as nausea or other complaints have been documented. A causal relationship with vitamin B1 and a possible dose dependency have not yet been sufficiently clarified.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MILGAMMA PROTEKT?

Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the carton after "Use by". The expiry date refers to the last day of the month. Storage conditions: Store in the original package. Do not dispose of medicines in wastewater. You thus help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What milgamma protekt contains

The active ingredient is benfotiamine. 1 film-coated tablet contains 300 mg benfotiamine (fat-soluble vitamin B1 derivative). The other ingredients are: microcrystalline cellulose, talc, povidone (K30), highly dispersed silicon dioxide, croscarmellose sodium, higher chain partial glycerides, hypromellose, titanium dioxide, polyethylene glycol, saccharin sodium.

What milgamma protekt looks like and contents of the pack

milgamma protekt are white, oblong film-coated tablets with a break notch. milgamma protekt is available as an original pack of 30 or 90 film-coated tablets.

Pharmaceutical entrepreneur and manufacturer

Wörwag Pharma GmbH & Co KG
Calwer Straße 7
71034 Böblingen
Phone: 07031/6204-0
Fax: 07031/6204-31
E-mail: info@woerwagpharma.com

Manufacturer

Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning

This package leaflet was last revised in March 2016.

Source: Information from the package leaflet
Status: 07/2020
Active ingredient: Benfotiamine 300 mg. Area of application: The only approved areas of application for the monopreparations are exclusively the therapy or prophylaxis of clinical vitamin B1 deficiency states, provided that these cannot be remedied through nutrition; treatment of neuropathies and cardiovascular disorders caused by vitamin B1 deficiency.