MILGAMMA

MILGAMMA 300 mg film-coated tablets

Important notes (mandatory information)

milgamma 300 mg film-coated tablets. Areas of application: for neurological system diseases caused by proven deficiency of vitamins B1 and B6.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

milgamma 300 mg film-coated tablets
Active ingredients: benfotiamine 300 mg, pyridoxine hydrochloride 100 mg

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, milgamma 300 mg film-coated tablets must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 14 days, you must see a doctor in any case.
• If any of the listed side effects affect you significantly or if you notice side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

This package leaflet includes

1. WHAT IS MILGAMMA 300 MG FILM-COATED TABLETS AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING MILGAMMA 300 MG FILM-COATED TABLETS?
3. HOW TO TAKE MILGAMMA 300 MG FILM-COATED TABLETS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE MILGAMMA 300 MG FILM-COATED TABLETS?
6. FURTHER INFORMATION

1. WHAT IS MILGAMMA 300 MG FILM-COATED TABLETS AND WHAT IS IT USED FOR?

Substance or indication group or mode of action milgamma 300 mg film-coated tablets is a neuropathy preparation.

Area of application

milgamma 300 mg film-coated tablets are used for neurological system diseases caused by proven deficiency of vitamins B1 and B6.

2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING MILGAMMA 300 MG FILM-COATED TABLETS?

In case of known benfotiamine or thiamine hypersensitivity and/or hypersensitivity to pyridoxine hydrochloride or any of the other ingredients of milgamma 300 mg film-coated tablets, the preparation should not be taken or only under medical supervision.

Special care is required when taking milgamma 300 mg film-coated tablets

milgamma 300 mg film-coated tablets can cause neuropathies if taken for a period of more than 6 months.

Note

We have no knowledge of the use of milgamma 300 mg film-coated tablets in children and the elderly.

When taking milgamma 300 mg film-coated tablets with other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. Thiamine is inactivated by 5-fluorouracil (a chemotherapy agent). The simultaneous administration of pyridoxine antagonists (e.g. hydralazine, isoniazid (INH), cycloserine, D-penicillamine), alcohol and the long-term use of estrogen-containing oral contraceptives can increase the need for vitamin B1. milgamma 300 mg film-coated tablets can reduce the effect of L-dopa.

Pregnancy and

breastfeeding

Pregnancy

If you are pregnant, this medicine is only useful for treating a proven vitamin B1 and B6 deficiency due to the amount of active ingredient it contains. Therefore, you should only use milgamma 300 mg film-coated tablets 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 and 1.9 mg of vitamin B6 (from the 4th month). The safety of using doses higher than the daily recommended doses has not yet been proven.

Breastfeeding

If you are breastfeeding, this medicine is only useful for treating a proven vitamin B1 and B6 deficiency due to the amount of active ingredient it contains. Therefore, you should only use milgamma 300 mg film-coated tablets if your doctor considers it absolutely necessary. The recommended daily intake of vitamin B1 during breastfeeding is 1.3 mg and 1.9 mg of vitamin B6. The safety of using doses higher than the daily recommended doses has not yet been proven. Vitamin B1 and B6 pass into breast milk. High doses of vitamin B6 can inhibit milk production.

Driving and operating machinery

No special precautions are required.

3. HOW TO TAKE MILGAMMA 300 MG FILM-COATED TABLETS?

Always take milgamma 300 mg film-coated tablets exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure. The following information applies unless your doctor has prescribed milgamma 300 mg film-coated tablets differently. Please adhere to the instructions for use, otherwise milgamma 300 mg film-coated tablets will not work properly! Unless otherwise prescribed, adults take 1 film-coated tablet of milgamma 300 mg film-coated tablets once a day. In acute cases, the dose can be increased to up to 3 times 1 film-coated tablet daily after consultation with the attending physician.

Type of use

You should take the film-coated tablets with sufficient liquid. The time of intake can be chosen at will.

Duration of use

After a maximum of 4 weeks, the attending physician should decide whether the administration of vitamin B6 and vitamin B1 in the increased dosage (3 x 1 film-coated tablet daily) is still indicated. If necessary, the dosage should be reduced to 1 daily dose in order to reduce the risk of neuropathy associated with vitamin B6.

Please talk to your doctor or pharmacist if you have the impression that the effect of milgamma 300 mg film-coated tablets is too strong or too weak.

If you have taken more milgamma 300 mg film-coated tablets than you should

High doses of vitamin B1 can lead to neurotoxic effects if taken for a short period of time (doses over 1 g/day). If symptoms occur, the attending physician should be consulted.

If you forget to take milgamma 300 mg film-coated tablets

Do not take a double dose if you have forgotten the previous dose. Continue taking milgamma 300 mg film-coated tablets as before at the usual times and remember to take it regularly in the future.

If you stop taking milgamma 300 mg film-coated tablets

If you interrupt the treatment, you are endangering the success of the treatment!

If you experience any unpleasant side effects, please talk to your doctor about further treatment.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, milgamma 300 mg film-coated tablets can have side effects, although not everybody gets them.

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

Please inform your doctor or pharmacist if any of the listed side effects affect you significantly or if you notice side effects not listed in this leaflet.

Significant side effects or signs to watch out for, and measures to take if you are affected

In individual cases, hypersensitivity reactions with skin reactions (urticaria, exanthema) and shock conditions can occur. In the event of systemic hypersensitivity reactions, emergency measures may have to be taken. In clinical studies, individual cases of gastrointestinal disorders such as nausea or other complaints have been documented. A causal relationship with vitamins B1 and/or B1 and a possible dose dependency have not yet been sufficiently clarified. milgamma 300 mg film-coated tablets can cause neuropathies if taken for a period of more than 6 months.

Reporting side effects

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

5. HOW TO STORE MILGAMMA 300 MG FILM-COATED TABLETS?

Please store this medicine carefully and out of the reach of children.
The expiry date is printed on this pack. Do not use the medicine after this date!

Storage conditions

Store protected from light and not above 25 °C!

6. FURTHER INFORMATION

What milgamma 300 mg film-coated tablets contain

The active ingredients are: benfotiamine and pyridoxine hydrochloride. 1 film-coated tablet with a break notch on both sides contains 300 mg benfotiamine and 100 mg pyridoxine hydrochloride. The other ingredients are: microcrystalline cellulose, cellulose powder, corn starch, gelatin, magnesium stearate (Ph. Eur.), hypromellose, propylene glycol, titanium dioxide (E171), iron(III) hydroxide oxide x H2O (E 172), talc, macrogol 6000. Gluten-free, contains no lactose.

Contents of the pack

milgamma 300 mg film-coated tablets are available in packs of 30 (N1), 60 (N2) and 90 (N3) 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

Artesan Pharma GmbH & Co. KG
Wendlandstraße 1
29439 Lüchow

This leaflet was last revised in March 2016.

Source: Information from the package leaflet
Status: 07/2020
Areas of application: for neurological system diseases caused by proven deficiency of vitamins B1 and B6.