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, coated tablets
Benfothiaminum + Pyridoxini hydrochloridum
Milgamma 100 and Milgamma are different trade names for the same medicinal product.
Please read the following leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are similar.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

What Milgamma 100 is and what it is used for
Important information before taking Milgamma 100
How to take Milgamma 100
Possible side effects
How to store Milgamma 100
Contents of the pack and other information

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

Milgamma 100 is a medicine containing two B vitamins: benfotiamine (a fat-soluble form of vitamin B\textsubscript{1}) and pyridoxine hydrochloride (vitamin B\textsubscript{6}).
It is used in the treatment of neurological disorders (generalized neurological diseases) caused by documented deficiency of vitamins B\textsubscript{1} and B\textsubscript{6}.
Since benfotiamine is fat-soluble, it is well absorbed by the human body. After absorption in the intestine, benfotiamine is converted into active vitamin B\textsubscript{1} (thiamine).
Thiamine and pyridoxine are essential nutrients (vitamins). Long-term insufficient dietary intake of these vitamins or certain diseases may lead to severe deficiency symptoms, including neurological disturbances. These may manifest as pain and sensory disturbances, particularly in the feet.

2. Important information before using Milgamma 100

When not to use Milgamma 100

if the patient has a known allergy (hypersensitivity) to thiamine, pyridoxine hydrochloride, or any of the other ingredients of the medicine.

When to exercise special caution with Milgamma 100

in cases of hypersensitivity reactions such as skin rashes, urticaria, photosensitivity, anaphylactic reactions (acute allergic reactions), treatment with the medicine should be discontinued. If necessary, the attending physician will initiate appropriate therapy.

Milgamma 100 and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, 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 together with these medicines should be made by the attending physician;
therapeutic doses of vitamin B₆ may reduce the effectiveness of L-dopa (a medicine used in Parkinson's disease);
alcohol consumption and long-term use of oral contraceptives containing estrogen may lead to vitamin B₆ deficiency;
anticancer drugs containing 5-fluorouracil may inactivate Milgamma 100.

Use of Milgamma 100 in children and elderly patients
There is no data available on the use of Milgamma 100 in these age groups.

Pregnancy, breastfeeding, and fertility
Before using any medicine, consult your doctor.
Pregnancy
Inform your attending physician if you become pregnant. Milgamma 100 should only be used during pregnancy if the physician considers it absolutely necessary.
The recommended daily intake of vitamin B₁ during pregnancy is approximately 1.4–1.6 mg, and vitamin B₆ 2.4–2.6 mg. These doses may be increased only if a deficiency in vitamin B₁ or B₆ is diagnosed, as the safety of doses higher than recommended has not been confirmed.

Breastfeeding:
During breastfeeding, the recommended daily intake of vitamin B₁ is approximately 1.4–1.6 mg, and vitamin B₆ 2.4–2.6 mg. These doses may be increased only if a deficiency in vitamin B₁ or B₆ is diagnosed, as the safety of higher-than-recommended doses has not been confirmed.
Vitamins B₁ and B₆ are excreted into breast milk.
High doses of vitamin B₆ may inhibit milk production.
Inform your attending physician if you are breastfeeding. The physician will decide whether to use Milgamma 100 after evaluating the benefits for the mother and potential risks.

Driving and operating machinery
Milgamma 100 has no influence on the ability to drive vehicles or 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 this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Milgamma 100

This medicine should always be taken as directed by the physician. In case of doubts, consult a
physician or pharmacist.
The usual dose of Milgamma 100 is 1 coated tablet 1 to 3 times daily. The medicine should be taken
with a glass of water.
After four weeks of treatment, the physician should decide whether continued use of the medicine
is necessary.
Taking more Milgamma 100 than recommended
Vitamin B1 has a wide therapeutic range, and symptoms of overdose are not known.
With long-term use of vitamin B6 for more than 2 months at doses exceeding 500 mg/day,
neurotoxic effects (affecting the nerves) may occur.
Symptoms resolve after discontinuation of pyridoxine.
There is no specific antidote.
If unexpected symptoms occur, contact a physician.
If more than the recommended dose of the medicine has been taken, seek immediate advice from a
physician or pharmacist.
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
regular time and try to take it regularly in the future.
Stopping Milgamma 100 treatment
Discontinuing the medicine may result in the treatment being ineffective.
If unpleasant side effects occur, contact the physician to determine further management.
In case of doubts regarding the use of the medicine, consult a physician.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
Adverse reactions during treatment with Milgamma 100 are rare.
The following adverse reactions have been observed:

Immune system disorders:
Very rare (less than 1/10,000): hypersensitivity reactions such as skin rashes, urticaria, photosensitivity, anaphylactic reactions (acute hypersensitivity reactions)

Nervous system disorders:
Rare (less than 1/1,000; more frequent or equal to 1/10,000): peripheral neuropathies (symptoms affecting nerves, such as numbness of hands or feet)

Gastrointestinal disorders:
Very rare (<1/10,000): In clinical studies, isolated cases of gastrointestinal disturbances such as nausea and other gastrointestinal complaints have been documented. However, their frequency of occurrence did not differ significantly from the placebo group. A causal relationship with vitamin B and B intake has not yet been sufficiently clarified and may be dose-dependent.

Remedial measures
In the event of systemic hypersensitivity reactions, immediate medical assistance may be required. If adverse reactions occur, the use of the medicine should be discontinued and a doctor should be informed as soon as possible.

In some individuals, other adverse reactions may occur during treatment with Milgamma 100.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 adverse reactions allows the collection of further information regarding the safety of the medicine.

5. How to store Milgamma 100

Store below 25°C. Protect from light. Keep the medicine in a place that is 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Milgamma 100 contains

The active substances are benfotiamine (100 mg) and pyridoxine hydrochloride (100 mg).
The other ingredients are: colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, povidone K 30, talc, gum arabic, partial long-chain glycerides, corn starch, titanium dioxide (E 171), macrogol 6000, glycerol 85%, polysorbate 80, glycol montan wax, shellac, sucrose, calcium carbonate. The product 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 an enteric-coated tablet.
Milgamma 100 is available in packs containing: 15, 30, 60, and 100 enteric-coated tablets.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing Authorisation Holder in Latvia, 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.
Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Latvia, country of export: 03-0125
Parallel Import Authorisation Number: 72/22