Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Milgamma N
(50 mg + 50 mg + 0.5 mg)/ml, solution for injection
Thiamini hydrochloridum + Pyridoxini hydrochloridum + Cyanocobalaminum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any doubts, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. 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 adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet:

What Milgamma N is and what it is used for
Important information before using Milgamma N
How to use Milgamma N
Possible side effects
How to store Milgamma N
Contents of the pack and other information

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

Milgamma N is a combination of B-group vitamins.
Milgamma N is used in adults in the following conditions:

Neurological disorders of various origins;
Neuritis;
Neuralgia;
Polyneuropathies (e.g. diabetic, alcoholic, etc.);
Muscle pain (myalgia);
Radicular syndrome;
Cervical tension syndrome;
Shoulder pain;
Certain forms of optic neuritis (retrobulbar optic neuritis);
Herpes zoster;
Facial nerve palsy;
And as a tonic agent.

2. Important information before using Milgamma N

When not to use Milgamma N:

if the patient is allergic to thiamine hydrochloride (vitamin B₁), pyridoxine hydrochloride (vitamin B₆), cyanocobalamin (vitamin B₁₂), or any of the other ingredients of this medicine (listed in section 6),
if there are conduction disturbances and uncontrolled heart failure,
during pregnancy and breastfeeding,
in children and adolescents under 18 years of age.

Warnings and precautions
Before starting treatment with Milgamma N, please discuss this with your doctor, pharmacist, or nurse.
Milgamma N is intended exclusively for intramuscular injection (i.m.) and not for intravenous administration (i.v.). Any accidental intravenous injection must be monitored by a physician or under hospital conditions, depending on the severity of symptoms arising from it.
This medicine may cause neuropathy if used for longer than six months.
No special precautions are required for elderly patients.

Milgamma N and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
This is particularly important for the following medicines:

solutions containing sulfites (vitamin B₆ degrades in solutions containing sulfites; other vitamins may be inactivated in the presence of vitamin B₆ degradation products),
5-fluorouracil – used in cancer treatment,
INH (isoniazid) – used in the treatment of tuberculosis,
D-penicillamine – used in the treatment of rheumatoid arthritis,
long-term use of oral contraceptives containing estrogens,
epinephrine – used in the treatment of severe allergic reactions (anaphylaxis),
norepinephrine – used in the treatment of depression and low blood pressure,
sulfonamides – antibiotics also used in the treatment of inflammatory bowel diseases,
L-dopa – used in the treatment of Parkinson's disease.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
During pregnancy, the recommended daily intake of vitamin B₁ is 1.2 mg (second trimester) to 1.3 mg (third trimester). The recommended daily intake of vitamin B₆ during pregnancy is 1.9 mg and of vitamin B₁₂ is 2.6 μg.
The safety of daily doses higher than recommended has not yet been sufficiently studied.
Milgamma N should not be used during pregnancy.

Breastfeeding
During breastfeeding, the recommended daily intake of vitamin B₁ is 1.3 mg, of vitamin B₆ is 1.9 mg, and of vitamin B₁₂ is 2.6 μg.
The safety of daily doses higher than recommended has not yet been sufficiently studied.
Vitamins B₁, B₆, and B₁₂ pass into breast milk. High doses of vitamin B₆ may inhibit milk secretion.
Milgamma N should not be used during breastfeeding.

Driving and operating machinery
There are no special restrictions.

The medicine contains benzyl alcohol, sodium, and potassium

Benzyl alcohol
Milgamma N contains 40 mg of benzyl alcohol per 2 ml ampoule. Large volumes of benzyl alcohol should be administered with caution and only if necessary, especially in patients with impaired renal or hepatic function due to the risk of accumulation and toxicity (metabolic acidosis).

Sodium
Milgamma N contains less than 1 mmol (23 mg) of sodium per 2 ml ampoule, meaning the medicine is considered "sodium-free".

Potassium
Milgamma N contains less than 1 mmol (39 mg) of potassium per 2 ml ampoule, meaning the medicine is considered "potassium-free".

3. How to use Milgamma N

This medicine should always be used according to the instructions given by the doctor or pharmacist. In case of doubt,
consult the doctor or pharmacist.
This medicine should be administered by intramuscular injection. Any accidental intravenous injection
must be monitored by a physician or under hospital conditions, depending on the severity
of symptoms arising from it.
The doctor will determine the appropriate dose and frequency of administration for the patient.
Recommended dose:
In severe and acute painful conditions and to achieve a rapid high blood concentration:
initial dose is 1 injection (2 ml) per day. After the acute phase has subsided and in case of
mild symptoms: 1 injection 2–3 times per week.
There is no need to adjust the dose in elderly patients or in patients with renal impairment.
There are insufficient studies on the use of Milgamma N in children and adolescents under
18 years of age. Therefore, Milgamma N should not be used in children and adolescents under
18 years of age. The safety and efficacy of Milgamma N have not been established in patients with hepatic impairment.
Therefore, Milgamma N should not be used in patients with severe hepatic impairment.
Weekly medical monitoring of treatment is recommended.
The treatment should be switched to oral administration as soon as possible.
Use of a higher than recommended dose of Milgamma N
This medicine is administered under medical supervision. It is unlikely that the dose would be too high
or too low; however, if the patient suspects this has occurred, the doctor or nurse should be informed immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects are listed according to their frequency of occurrence:
Very common: may occur in more than 1 in 10 patients
Common: may occur in up to 1 in 10 patients
Uncommon: may occur in up to 1 in 100 patients
Rare: may occur in up to 1 in 1,000 patients
Very rare: may occur in up to 1 in 10,000 patients
Frequency not known: frequency cannot be estimated from the available data

Immediately inform your doctor if any of the following occur:
Rare:

allergic reactions (e.g. skin rash, shortness of breath, shock, swelling of the eyes, face, tongue, and throat).

If any of the following adverse effects occur, consult your doctor as quickly as possible:
Very rare:

palpitations (tachycardia);
excessive sweating, acne, skin reactions with itching and urticaria.

Frequency not known:

dizziness, drowsiness;
slowing of the heart rate (bradycardia), heart rhythm disturbances;
vomiting;
convulsions;
systemic reactions (reactions affecting the whole body) may occur following rapid injection (accidental intravenous administration, injection into tissues with high blood flow) or overdose.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Milgamma N

This medicine should be stored in a place inaccessible and out of sight of children.
Store in a refrigerator (2°C-8°C). Keep in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Milgamma N contains
2 ml of solution for injection contain:
Active substances:
Thiamine hydrochloride (vitamin B ) 100 mg
Pyridoxine hydrochloride (vitamin B ) 100 mg
Cyanocobalamin (vitamin B ) 1 mg
Excipients:
Benzyl alcohol 40 mg, lidocaine hydrochloride 20 mg, sodium hydroxide, potassium
hexacyanoferrate (III), sodium polyphosphate, water for injections.
What Milgamma N looks like and contents of the pack:
The packaging contains: 5 ampoules with 2 ml solution for injection, 25 ampoules with 2 ml solution for
injection.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Lithuania, country of export:
Wörwag Pharma GmbH & Co.KG
Flugfeld-Allee 24
71034 Böblingen
Germany
Manufacturer:
Solupharm Pharmazeutische Erzeugnisse GmbH
Industriestrasse 3
34212 Melsungen
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation numbers in Lithuania, country of export: LT/1/97/2573/001
LT/1/97/2573/002
LT/1/97/2573/003
Parallel import authorisation number: 48/20