MILGAMMA

MILGAMMA 100 mg coated tablets

Important notes (mandatory information)

milgamma 100 coated tablets. Areas of application: for diseases of the nervous system (neurological system diseases) due to 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 100 coated tablets
Active ingredients: Benfotiamine (fat-soluble vitamin B1 derivative) 100 mg, pyridoxine hydrochloride (vitamin B6) 100 mg

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

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

What this leaflet contains

1. WHAT IS MILGAMMA 100 AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MILGAMMA 100?
3. HOW TO TAKE MILGAMMA 100?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE MILGAMMA 100?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MILGAMMA 100 AND WHAT IS IT USED FOR?

milgamma 100 is a neuropathy drug.

Area of application

milgamma 100 is used for diseases of the nervous system (neurological system diseases) due to proven deficiency of vitamins B1 and B6.

If you do not feel better or even worse, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MILGAMMA 100?

milgamma 100 must not be taken if you are allergic to thiamine, benfotiamine, pyridoxine hydrochloride or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before taking milgamma 100. milgamma 100 can cause neuropathy if taken for a period of more than 6 months. We have no knowledge of the use of milgamma 100 in children and the elderly.

Taking milgamma 100 with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or plan to take any other medicines. Thiamine is inactivated by 5-fluorouracil (a chemotherapy agent). The concomitant 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 B6. milgamma 100 can reduce the effect of L-dopa. Please note that this information may also apply to medicines that have been used recently.

Taking milgamma 100 with food and drink

No special precautions are required.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

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 100 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 of vitamin B6 1.9 mg 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 100 if your doctor considers it absolutely necessary. The recommended daily intake of vitamin B1 during breastfeeding is 1.3 mg and of vitamin B6 1.9 mg. 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 using machines

No special precautions are required.

milgamma 100 contains sucrose (sugar)

Therefore, please only take milgamma 100 after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW TO TAKE MILGAMMA 100?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed, adults take one milgamma 100 coated tablet once a day. In acute cases, the dose can be increased to up to 3 x 1 coated tablet daily after consultation with the attending physician.

Method of application

Please take the 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 coated tablet daily) is still indicated. If necessary, the dosage should be reduced to 1 x daily 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 100 is too strong or too weak.

If you have taken more milgamma 100 than you should

High doses of vitamin B6 can lead to neurotoxic effects if taken for a short period of time (doses over 1 g/day). If symptoms occur, a doctor should be consulted if necessary.

If you forget to take milgamma 100

Do not take twice the amount if you have forgotten to take the previous dose.

If you stop taking milgamma 100

If you interrupt the treatment, you endanger the success of the treatment! If you experience any unpleasant side effects, please talk to your doctor about further treatment.

If you have any further questions about taking this 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.

Possible side effects

Very rare (affects less than 1 in 10,000 people)

In individual cases, hypersensitivity reactions with skin reactions (hives, rash) and shock conditions can occur. If you notice any signs of a hypersensitivity reaction, contact a doctor immediately. Individual cases of gastrointestinal disorders such as nausea or other complaints have been documented in clinical studies.

Frequency not known (frequency cannot be estimated from the available data)

milgamma 100 can cause neuropathy if taken for a period of more than 6 months.

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 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 about the safety of this medicine.

5. HOW TO STORE MILGAMMA 100?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the container and the folding box after "use by". The expiry date refers to the last day of the month indicated.

Storage conditions

Store protected from light and not above 25°C.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND FURTHER INFORMATION

What milgamma 100 contains

The active ingredients are: Benfotiamine (fat-soluble vitamin B1 derivative) and pyridoxine hydrochloride (vitamin B6). 1 coated tablet contains 100 mg benfotiamine and 100 mg pyridoxine hydrochloride. The other ingredients are: Highly dispersed silicon dioxide, microcrystalline cellulose, croscarmellose sodium, povidone, talc, long-chain partial glycerides, shellac, sucrose, calcium carbonate, gum arabic, corn starch, titanium dioxide (E171), macrogol 6000, glycerol 85%, polysorbate 80, montan glycol wax. Gluten-free, contains no lactose.

What milgamma 100 looks like and contents of the pack

milgamma 100 is available in original packs of 30 (N1), 60 (N2) and 100 (N3) 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

Mauermann Arzneimittel KG
Heinrich-Knote-Straße 2
82343 Pöcking

Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning

This leaflet was last revised in November 2015.

Source: Information from the package leaflet
Status: 07/2020
Areas of application: for diseases of the nervous system (neurological system diseases) due to proven deficiency of vitamins B1 and B6.