Milgamma N

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Milgamma N (Milgamma N Injekt)

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

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed for a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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. Contents of the packaging 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 genesis;
• 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 palsy;
• and as a tonic.

2. Important information before using Milgamma N

When not to use Milgamma N:

• during pregnancy and breastfeeding,
• in children and adolescents under 18 years of age.

Warnings and precautions

Before starting to use Milgamma N, you should discuss it with your doctor, pharmacist, or nurse.
Milgamma N is intended exclusively for intramuscular injection (i.m.), and 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 drug may cause neuropathy if used for a period longer than six months.
There are no special precautions for elderly patients.

Milgamma N and other drugs

You should tell your doctor or pharmacist about all the drugs you are currently taking or have recently taken, as well as any drugs you plan to take.
This is especially important in the case of the following drugs:

• 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 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 intestinal inflammatory diseases,
• L-dopa - used in the treatment of Parkinson's disease.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this drug.
Pregnancy
The recommended daily dose of vitamin B1 is from 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 daily doses higher than recommended has not been sufficiently studied. Milgamma N should not be used during pregnancy.

• The recommended daily dose of vitamin B1 is from 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 daily doses higher than recommended has not been sufficiently studied. Milgamma N should not be used 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 daily 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.
Milgamma N should not be used during breastfeeding.

Driving and using machines

There are no special restrictions.

The drug 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 drug 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 drug is considered "potassium-free".

3. How to use Milgamma N

This drug should always be used in accordance with the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
This drug should be administered by intramuscular injection. Any accidental intravenous injection must be monitored by a doctor or in a hospital setting, depending on the severity of the resulting symptoms.
The doctor will determine the appropriate dose for the patient and the frequency of administration.
The recommended dose is:
In severe and acute pain states and in order to quickly achieve a high concentration in the blood:
the initial dose is 1 injection (2 ml) per day.
After the acute phase has subsided and in the case of mild symptoms: 1 injection 2-3 times a week.
There is no need to adjust the dose in elderly patients and in patients with renal failure.
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 in patients with liver failure have not been established. Therefore, Milgamma N should not be used in patients with severe liver failure.
Treatment control by a doctor at weekly intervals is recommended.
It is recommended to switch to oral administration as soon as possible.

Using a higher dose of Milgamma N than recommended

This drug is administered under the supervision of a doctor. It is unlikely that the dose of the drug will be too high or too low, but if the patient suspects that this has happened, they should inform their doctor or nurse.

4. Possible side effects

Like all drugs, Milgamma N can cause side effects, although they may not occur in every patient.
Side 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 available data

You should immediately inform your doctor in the following cases:

Rare:

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

If any of the following side effects occur, you should 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
• Spasms
• 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 after overdose

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform 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 181 C
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 drug.

5. How to store Milgamma N

This drug should be stored out of sight and reach of children.
Store in a refrigerator (2°C – 8°C). Store in the original packaging. Protect from light.
Do not use this drug after the expiration date stated on the packaging. The expiration date refers to the last day of the given month.
Drugs should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of drugs that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Milgamma N contains

2 ml of injection solution contains:
Active substances:
Thiamine hydrochloride (vitamin B1)
100 mg
Pyridoxine hydrochloride (vitamin B6)
100 mg
Cyanocobalamin (vitamin B12)
1 mg
Excipients:
Benzyl alcohol, lidocaine hydrochloride, sodium hydroxide, potassium hexacyanoferrate(III), sodium polyphosphate, water for injections.

What Milgamma N looks like and what the packaging contains

Packaging contains:
5 ampoules of 2 ml injection solution;
25 ampoules of 2 ml injection solution;
100 ampoules of 2 ml injection solution;
500 ampoules of 2 ml injection solution.
To obtain more detailed information, you should contact the marketing authorization holder or 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Latvia, the country of export: 99-0934

Parallel import authorization number: 183/16 Date of approval of the leaflet: 10.02.2022

[Information about the trademark]