Milgamma 100

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Milgamma 100 (Milgamma)

100 mg + 100 mg, sugar-coated tablets
Benfothiaminum + Pyridoxini hydrochloridum
Milgamma 100 and Milgamma are different trade names for the same drug.

Read the Leaflet Carefully Before Taking the Medication, 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 medication has been prescribed to a specific person. Do not pass it on to others. The medication 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 inform 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. Package contents and other information

1. What is Milgamma 100 and what is it used for

Milgamma 100 is a medication containing two vitamins from the B group: benfotiamine (a fat-soluble form of vitamin B1) and pyridoxine hydrochloride (vitamin B6).
The medication 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 nervous system disorders. 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 medication should be discontinued. If necessary, the attending physician will provide appropriate treatment.

Milgamma 100 and other medications

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

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

Taking 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 medication, consult your doctor.
Pregnancy
Inform your doctor about the pregnancy. During pregnancy, Milgamma 100 may be taken 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 if a deficiency of vitamin B1 or B6 is diagnosed, as the safety of taking higher doses than recommended 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 if a deficiency of vitamin B1 or B6 is diagnosed, as the safety of taking higher doses than recommended 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 taking Milgamma 100 after analyzing the benefits for the mother and potential risks.

Driving and operating machinery:

The medication does not affect the ability to drive and operate machinery.

Milgamma 100 contains sucrose (sugar)

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

3. How to take Milgamma 100

Always take this medication according to your doctor's instructions. If you have any doubts, consult your doctor or pharmacist.
Typically, the recommended dose of Milgamma 100 is 1 sugar-coated tablet 1 to 3 times a day. The medication should be taken with a glass of water.
After four weeks of treatment, the doctor should decide whether it is necessary to continue taking the medication.

Overdose of Milgamma 100

Vitamin B1 has a wide therapeutic range, and symptoms of overdose are unknown.
In cases 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 medication, 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 medication at the usual time and try to take it regularly in the future.

Stopping Milgamma 100

Stopping the medication may render the treatment ineffective.
If you experience any unpleasant side effects, consult your doctor to determine further treatment.
If you have any doubts about taking the medication, consult your doctor.

4. Possible side effects

Like all medications, Milgamma 100 can cause side effects, although not everyone will experience 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 or equal to 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, single 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 intake of vitamins B1 and B6 is not yet fully explained and may depend on the dose.
Measures to be taken
In cases of systemic hypersensitivity reactions, immediate medical attention may be necessary. If side effects occur, discontinue the medication and inform your doctor as soon as possible.
Some people may experience other side effects while taking Milgamma 100.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +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 medication.

5. How to store Milgamma 100

Store in a temperature below 25°C. Protect from light. The medication should be stored in a place out of sight and reach of children.
Do not take Milgamma 100 after the expiration date stated on the packaging.
The expiration date refers to the last day of the specified month.
Medications should not be disposed of in the sewage system or household waste containers. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Milgamma 100 contains

• The active substances of the medication are benfotiamine (100 mg) and pyridoxine hydrochloride (100 mg)
• The other ingredients are: colloidal silica, microcrystalline cellulose, sodium croscarmellose, povidone K 30, talc, arabic gum, partial glycerides, corn starch, titanium dioxide (E 171), macrogol 6000, glycerol 85%, polysorbate 80, Montana glycol wax, shellac, sucrose, calcium carbonate. The medication contains excipients with known effects: sucrose (see section 2 of the leaflet)

What Milgamma 100 looks like and what the package contains

Milgamma 100 is a sugar-coated tablet.
Milgamma 100 is available in packages containing: 15, 30, 60, 100 sugar-coated tablets.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Latvia, the country of export:

WÖRWAG Pharma GmbH & Co. KG
Calwer Str. 7
71034 Böblingen
Germany

Manufacturer:

Mauermann Arzneimittel KG
Heinrich-Knote-Str. 2
82343 Pöcking
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:03-0125

Parallel import authorization number: 72/22 Date of approval of the leaflet: 03.02.2022