Milgamma N

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Milgamma N(Milgamma N Injection)
(50 mg + 50 mg + 0.5 mg)/ml, solution for injection
Thiamine hydrochloride + Pyridoxine hydrochloride + Cyanocobalamin
Milgamma N and Milgamma N Injection are different trade names for the same drug.

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

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

Table of Contents of the Leaflet:

• 1. What is Milgamma N and what is it used for
• 2. Important information before using Milgamma N
• 3. How to use Milgamma N
• 4. Possible side effects
• 5. How to store Milgamma N
• 6. Package contents and other information

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

Milgamma N is a mixture of B vitamins.
Milgamma N is used in adults in the following cases:

• diseases of the nervous system of various origins;
• neuritis;
• neuralgia;
• polyneuropathies (e.g., diabetic, alcoholic, etc.);
• muscle pain (myalgia);
• radiculitis;
• cervical syndrome;
• shoulder pain;
• certain forms of optic neuritis (retrobulbar optic neuritis);
• herpes zoster;
• facial nerve paralysis;
• and as a tonic.

2. Important information before using Milgamma N

When not to use Milgamma N:

• if you are 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 you have conduction disorders 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, discuss it with your doctor, pharmacist, or nurse.
Milgamma N is intended for intramuscular injection (i.m.) only, not for intravenous injections (i.v.). Any accidental intravenous injection must be monitored by a doctor or in a hospital setting, depending on the severity of the resulting symptoms.
This medicine may cause neuropathy if used for more than six months.
There are no special precautions for elderly patients.

Milgamma N and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
This is especially important for the following medicines:

• Solutions containing sulfites (vitamin B1 is degraded in solutions containing sulfites; other vitamins may be inactivated in the presence of vitamin B1 degradation products),
• 5-fluorouracil - used in cancer treatment,
• INH (isoniazid) - used in tuberculosis treatment,
• D-penicillamine - used in rheumatoid arthritis treatment,
• 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
The recommended daily dose of vitamin B1 is 1.2 mg (second trimester) to 1.3 mg (third trimester). During pregnancy, the recommended daily dose of vitamin B6 is 1.9 mg, and vitamin B12 is 2.6 μg. The safety of doses higher than recommended has not been sufficiently studied. Do not use Milgamma N during pregnancy.

• The safety of doses higher than recommended has not been sufficiently studied. Do not use Milgamma N during pregnancy.

Breastfeeding
The recommended daily dose of vitamin B1 is 1.3 mg, vitamin B6 - 1.9 mg, and vitamin B12 - 2.6 μg during breastfeeding.
The safety of doses higher than recommended has not been sufficiently studied.
Vitamins B1, B6, and B12 pass into breast milk. High doses of vitamin B6 may inhibit milk secretion.
Do not use Milgamma N during breastfeeding.

Driving and using machines

There are no special restrictions.

The medicine contains benzyl alcohol, sodium, and potassium

Benzyl alcohol

Milgamma N contains 40 mg of benzyl alcohol in 1 ampoule of 2 ml. Large volumes of benzyl alcohol should be administered with caution and only when necessary, especially in patients with renal or liver function disorders due to the risk of toxicity accumulation (metabolic acidosis).

Sodium

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

Potassium

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

3. How to use Milgamma N

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
This medicine is for intramuscular injection only. Any accidental intravenous injection must be monitored by a doctor or in a hospital setting, depending on the severity of the resulting symptoms.
Your doctor will determine the appropriate dose for you and how often to administer it.
The recommended dose is:
In severe and acute pain states and to quickly achieve high blood levels:
the initial dose is 1 injection (2 ml) per day. After the acute phase has subsided and in cases of mild symptoms: 1 injection 2-3 times a week.
There is no need to adjust the dose in elderly patients and 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 liver failure. Therefore, Milgamma N should not be used in patients with severe liver failure.
Treatment should be monitored by a doctor at weekly intervals.
It is recommended to switch to oral administration as soon as possible.

Using a higher dose of Milgamma N than recommended

This medicine is administered under medical supervision. It is unlikely that the dose of the medicine will be too high or too low, but if you suspect that this has happened, inform your doctor or nurse.

4. Possible side effects

Like all medicines, Milgamma N can cause side effects, although not everybody gets them.
Side effects are listed by frequency of occurrence:
Very common:may affect more than 1 in 10 people
Common:may affect up to 1 in 10 people
Uncommon:may affect up to 1 in 100 people
Rare:may affect up to 1 in 1,000 people
Very rare:may affect up to 1 in 10,000 people
Frequency not known:frequency cannot be estimated from the available data

Inform your doctor immediately in the following cases:

Rare:

• Allergic reactions (e.g., skin rash, difficulty breathing, shock, swelling of the eyes, face, tongue, and throat)

If you experience any of the following side effects, consult your doctor as soon as possible:
Very rare:

• Rapid heartbeat (tachycardia);
• Excessive sweating, acne, skin reactions with itching and hives;

Frequency not known:

• Dizziness, drowsiness;
• Slow heart rate (bradycardia), heart rhythm disorders;
• Vomiting;
• Cramps;
• The occurrence of systemic reactions (reactions that affect the entire body) is possible after rapid injection (accidental intravenous injection, injection into tissues with high blood flow) or overdose.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Milgamma N

Keep the medicine out of sight and reach of children.
Store in a refrigerator (2°C-8°C) in the original packaging. 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 month.
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. Package contents and other information

What Milgamma N contains

2 ml of solution for injection contains:
Active substances:
Thiamine hydrochloride (vitamin B1)
100 mg
Pyridoxine hydrochloride (vitamin B6)
100 mg
Cyanocobalamin (vitamin B12)
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 what the package contains:

The package contains: 5 ampoules of 2 ml solution for injection.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

Wörwag Pharma GmbH & Co.KG
Flugfeld-Allee 24
71034 Böblingen
Germany

Manufacturer:

Solupharm Pharmazeutische Erzeugnisse GmbH
Industriestrasse 3
D-34212 Melsungen
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:99-0934
Parallel import authorization number:350/16
Date of leaflet approval: 16.02.2022