Milgamma 100

Package Leaflet: Information for the Patient

Milgamma 100

(Benfotiamine +Pyridoxine Hydrochloride)
100 mg + 100 mg, tablets

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Milgamma 100 and what is it used for
• 2. Important information before taking Milgamma 100
• 3. How to take Milgamma 100
• 4. Possible side effects
• 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 medicine that contains two B vitamins: benfotiamine (a fat-soluble form of vitamin B1) and pyridoxine hydrochloride (vitamin B6).
The medicine is used to treat diseases of the nervous system (systemic neurological diseases) caused by a documented deficiency of vitamins B1 and B6. Since benfotiamine is fat-soluble, it is well absorbed by the human body. After absorption in the intestine, benfotiamine is converted into active vitamin B1 (thiamine).
Thiamine and pyridoxine are essential nutrients (vitamins). Prolonged inadequate intake of these vitamins with food or certain diseases can cause severe deficiency symptoms, with disorders of the nervous system. The consequence may be pain and sensory disturbances, mainly in the feet.

2. Important information before taking Milgamma 100

When not to take Milgamma 100

When to exercise special caution when taking Milgamma 100

• In cases of hypersensitivity reactions, such as skin rashes, hives, hypersensitivity to light, anaphylactic reactions (acute hypersensitivity reactions), the use of the medicine should be discontinued. If necessary, the attending physician will apply appropriate treatment.

Milgamma 100 and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Interactions with other medicines:

• interactions occur with isoniazid, D-penicillamine, and cycloserine. The decision to use Milgamma 100 simultaneously with these medicines should be made by the attending physician;
• therapeutic doses of vitamin B6 may weaken the effect of L-dopa (a medicine used in Parkinson's disease);
• drinking alcohol and long-term use of oral contraceptives containing estrogen may cause a deficiency of vitamin B6;
• anticancer medicines containing 5-fluorouracil may inactivate Milgamma 100.

Using Milgamma 100 in children and the elderly:

There is no data on the use of Milgamma 100 in these age groups.

Pregnancy, breastfeeding, and fertility

Before taking any medicine, consult your doctor.
Pregnancy
Inform your doctor about your pregnancy. During pregnancy, Milgamma 100 may be used only if the doctor considers it absolutely necessary.
During pregnancy, the recommended daily dose of vitamin B6 is about 1.4-1.6 mg, and vitamin B1 is 2.4-2.6 mg. These doses may be increased only in case of a diagnosed deficiency of vitamin B1 or B6, as the safety of using higher than recommended doses has not been confirmed.
Breastfeeding:
During breastfeeding, the recommended daily dose of vitamin B6 is about 1.4-1.6 mg, and vitamin B1 is 2.4-2.6 mg. These doses may be increased only in case of a diagnosed deficiency of vitamin B1 or B6, as the safety of using higher than recommended doses has not been confirmed.
Vitamins B1 and B6 pass into breast milk.
High doses of vitamin B6 may inhibit milk production.
Inform your doctor about breastfeeding. The doctor will decide on the use of Milgamma 100 after analyzing the benefits for the mother and potential risks.

Driving and using machines:

The medicine does not affect the ability to drive and use machines.

Milgamma 100 contains sugar

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Milgamma 100

Take this medicine always as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Usually, the recommended dose of Milgamma 100 is 1 tablet 1 to 3 times a day. Take the medicine with a glass of water.
After four weeks of treatment, the doctor should decide whether further use of the medicine is necessary.

Overdose of Milgamma 100

Vitamin B6 has a wide therapeutic range, and symptoms of overdose are not known.
In case of long-term use of vitamin B6 for more than 2 months in doses exceeding 500 mg/day, neurotoxic effects (related to nerves) may occur.
Symptoms disappear after discontinuation of pyridoxine.
There is no specific antidote.
Consult your doctor if you experience any unexpected symptoms.
If you have taken more than the recommended dose of the medicine, consult your doctor or pharmacist immediately.

Missing a dose of Milgamma 100

Do not take a double dose to make up for a missed dose. Continue taking the medicine at the usual time and try to take it regularly in the future.

Stopping the use of Milgamma 100

Stopping the use of the medicine may cause the treatment to be ineffective. If unpleasant side effects occur, consult your doctor to determine further treatment.
If you have any doubts about taking the medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects during treatment with Milgamma 100 are rare.
The following side effects have been observed:
Immune system disorders:
Very rare (less than 1/10,000): hypersensitivity reactions, such as skin rashes, hives, hypersensitivity to light, anaphylactic reactions (acute hypersensitivity reactions)
Nervous system disorders:
Rare (less than 1/1,000; more than 1/10,000): peripheral neuropathies (symptoms related to nerves, such as numbness of hands or feet)
Gastrointestinal disorders:
Very rare (less than 1/10,000): In clinical trials, individual cases of gastrointestinal disorders such as nausea and other gastrointestinal complaints have been documented. However, their frequency did not differ significantly from the placebo group. The causal relationship with the use of vitamins B1 and B6 is not yet fully explained and may depend on the dose.
Measures to be taken
In case of systemic hypersensitivity reactions, immediate medical attention may be necessary. If side effects occur, stop taking the medicine and inform your doctor as soon as possible.
Some people may experience other side effects when taking Milgamma 100.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Milgamma 100

Store in a temperature below 25°C (2-25°C), protect from light. The medicine should be stored out of sight and reach of children.
Do not use Milgamma 100 after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Milgamma 100 contains

• The active substances of the medicine are benfotiamine (100 mg) and pyridoxine hydrochloride (100 mg)
• The other ingredients are: silicon dioxide, microcrystalline cellulose, sodium carboxymethyl cellulose, povidone K 30, talc, arabic gum, glycerol behenate, corn starch, titanium dioxide, macrogol 6000, glycerol 85%, polysorbate 80, montan wax, shellac, triethyl citrate, sucrose, calcium carbonate. The medicine contains excipients with known effects: sucrose (see section 2 of the leaflet)

What Milgamma 100 looks like and contents of the pack

Milgamma 100 is available in the form of tablets.
Milgamma 100 is available in packs containing: 15, 30, 60, 100, 500*, 1000*, 5000*, 10000* tablets
(*packs used in hospital settings)
Marketing Authorization Holder:
Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
71034 Böblingen, Germany

Manufacturer:

Mauermann Arzneimittel KG
Heinrich-Knote-Str. 2, 82343 Pöcking, Germany
Wörwag Pharma Production GmbH & Co. KG
Gewerbeallee 1, 82343 Pöcking, Germany
To obtain more detailed information, contact the local representative of the Marketing Authorization Holder:
Woerwag Pharma Polska sp. z o.o.
ul. Józefa Piusa Dziekońskiego 1
00-728 Warsaw
phone (+48) 22 863 72 81
fax (+48) 22 877 13 70

Date of the last revision of the leaflet: May 2024