Milgamma N

Package Leaflet: Information for the Patient

Milgamma N, (50 mg + 50 mg + 0.5 mg)/ml, Solution for Injection

(Thiamine Hydrochloride +Pyridoxine Hydrochloride+Cyanocobalamin)

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. 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 pack 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, 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 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, or have recently taken, and about 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 severe allergic reactions (anaphylaxis),
• norepinephrine - used in depression and low blood pressure treatment,
• sulfonamides - antibiotics also used in inflammatory bowel disease treatment,
• L-dopa - used in Parkinson's disease treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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 higher daily doses than recommended has not been established.
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 higher daily doses than recommended has not been established.
Vitamins B1, B6, and B12 pass into breast milk. High doses of vitamin B6 may inhibit milk production.
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 used with caution and only when necessary, especially in patients with kidney 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, ask 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 correct dose for you and how often to use it.
The recommended dose is:
In severe and acute painful conditions and to quickly achieve high blood levels:
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.
No dose adjustment is necessary for elderly patients and patients with renal impairment.
There are insufficient data 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 impairment have not been established. Therefore, Milgamma N should not be used in patients with severe liver impairment.
Treatment should be monitored by a doctor at weekly intervals.
Oral treatment should be started as soon as possible.

Using more than the recommended dose of Milgamma N

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are listed by frequency:
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

Immediately inform your doctor in the following cases:

Rare:

• Allergic reactions (e.g., skin rash, wheezing, anaphylaxis, 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
• Spasms
• Systemic reactions (reactions that affect the whole body) are 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, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Milgamma N

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2-8°C).
Store in the original package to protect from light.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month stated.
Medicines should 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 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, substances for physiological pH adjustment (sodium hydroxide), potassium hexacyanoferrate III, sodium polyphosphate, water for injections.

What Milgamma N looks like and contents of the pack

Packaging contains:
5 ampoules or 25 ampoules of 2 ml solution for injection
Hospital packaging containing 100 or 500 ampoules of 2 ml solution for injection

Marketing authorization holder:

Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
D-71 034 Böblingen
Germany

Manufacturer:

Solupharm Pharmazeutische Erzeugnisse GmbH
Industriestrasse 3
D-34212 Melsungen,
Germany
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Woerwag Pharma Polska sp. z o.o.
ul. Józefa Piusa Dziekońskiego 1
00-728 Warsaw
tel. (+48) 22 863 72 81
fax (+48) 22 877 13 70

Date of last revision of the leaflet: