Neurovit fast

Package leaflet: Information for the patient

Neurovit Fast, (100 mg + 100 mg + 1 mg)/2 ml, solution for injections
Thiamine hydrochloride (vitamin B*1*), pyridoxine hydrochloride (vitamin B*6*), cyanocobalamin (vitamin B*12*)
Please read carefully all the information in this leaflet before using the medicine, because it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please 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 effects, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Neurovit Fast is and what it is used for
2. Important information before using Neurovit Fast
3. How to use Neurovit Fast
4. Possible side effects
5. How to store Neurovit Fast
6. Contents of the pack and other information

1. What Neurovit Fast is and what it is used for

Neurovit Fast contains a combination of vitamins B*1*, B*6*, and B*12*, which play important roles in maintaining normal nerve metabolism. Like other vitamins, they are essential nutrients that the body cannot produce on its own.
In the treatment of nervous system disorders, B-complex vitamins act by correcting vitamin B deficiencies in the body and stimulating natural processes occurring in nerve cells.
Neurovit Fast is used in the following conditions:

• Treatment of clinical (evident) and subclinical (hidden) vitamin B deficiency;
• Maintenance therapy in nervous system disorders of various origins (e.g., pain associated with nerve damage due to diabetes or alcohol abuse), supportive treatment in nerve inflammation and nerve pain (neuralgia), e.g., nerve irritation caused by degenerative spine diseases, lower back pain (lumbago), or sciatica.

2. Important information before using Neurovit Fast

When not to use Neurovit Fast

• In case of allergy to thiamine hydrochloride (vitamin B*1*), pyridoxine hydrochloride (vitamin B*6*), cyanocobalamin (vitamin B*12*), or any of the excipients listed in section 6;
• In children and adolescents under 18 years of age, due to the high vitamin content.

Warnings and precautions
Before starting treatment with Neurovit Fast, discuss it with your doctor.
When taking high doses of vitamin B*6* exceeding 50 mg per day for a prolonged period (6 to 12 months) or doses exceeding 1 g of vitamin B*6* per day for a shorter period (over 2 months), symptoms such as tingling or numbness in hands or feet (symptoms of peripheral neuropathy or paresthesia) may occur. If the patient experiences tingling, numbness, or any other adverse effects, they should contact their doctor, who may adjust the dosage or decide to discontinue treatment.
Only a clear, red-colored solution should be used for injections.

Children and adolescents
Due to the high doses of active substances, Neurovit Fast injection solution must not be used in children and adolescents under 18 years of age.

Neurovit Fast and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.

• The cytostatic agent 5-fluorouracil (a drug used in cancer treatment) inhibits the action of vitamin B*6*.
• Long-term use of diuretics may lead to vitamin B*1* deficiency, as large amounts are excreted in urine.
• Neurovit Fast may reduce the effect of L-dopa (a drug used in Parkinson's disease).
• If Neurovit Fast is used concomitantly with drugs affecting vitamin B*6* (so-called pyridoxine antagonists such as isoniazid (INH), hydralazine, D-penicillamine, or cycloserine), the requirement for vitamin B*6* may increase.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Neurovit Fast should generally not be used during pregnancy or breastfeeding.
During pregnancy and breastfeeding, daily vitamin requirements should be met through a balanced diet. Due to the amount of vitamins contained, this medicine is intended solely for the treatment of vitamin deficiencies and should be used only after careful consideration of the benefit-risk ratio.
Vitamins B*1*, B*6*, and B*12* pass into human milk. High doses of vitamin B*6* may reduce milk production.
The doctor will decide whether, in exceptional cases, Neurovit Fast may be used during pregnancy or lactation.

3. How to use Neurovit Fast

This medicine should always be used according to the doctor's instructions. In case of doubt, consult
your doctor or pharmacist.

Recommended dosage

• In severe and painful conditions: 1 injection per day until symptoms subside.
• In less severe conditions: 1 injection 2 to 3 times per week.

Method of administration
Neurovit Fast, solution for injections, should be administered deep intramuscularly into the gluteal muscle
by trained medical personnel. Intravenous injections should be avoided.

Duration of treatment
Neurovit Fast should not be used longer than necessary. The doctor will decide on the duration of treatment.
After a period of use not exceeding 4 weeks (injections and oral administration combined), the doctor should
make a decision on dose reduction.

Use in children and adolescents
Neurovit Fast must not be used in children and adolescents under 18 years of age.

Use in elderly patients and patients with renal or hepatic impairment
No dose adjustment is required.

Taking a higher than recommended dose of Neurovit Fast

Vitamin B₁
Thiamine has a wide therapeutic range. Very high doses (above 10 g) have a ganglion-blocking effect and, similarly to curare, suppress nerve impulse conduction.

Vitamin B₆
Taking more than 50 mg per day of vitamin B₆ for longer than 6–12 months, or exceeding 1 g per day for a shorter period (over 2 months), may lead to nerve damage (neurotoxic effect). Doses exceeding 2 g per day have caused nervous system damage manifested by motor disturbances, sensory disturbances (tingling, numbness), seizures, and, very rarely, blood abnormalities and inflammatory skin reactions.

Vitamin B₁₂
Rarely, allergic reactions, skin rashes, and mild acneiform eruptions have been observed following high-dose vitamin B₁₂ administration.

Seek medical advice if overdose is suspected.

Information for physicians:
Treatment of overdose is symptomatic.

If in doubt regarding the use of the medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not in everyone.
Rarely (affects 1 to 10 in 10,000 patients)

• Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain.
• Headache, dizziness.

Very rarely (affects less than 1 in 10,000 patients)

• Hypersensitivity reactions such as sweating, rapid heartbeat, and skin reactions such as rash and urticaria.
• There have been reports of allergic reactions, predominantly following intravenous administration, but also following intramuscular administration of vitamin B__ and vitamin B__. Frequency unknown (cannot be estimated based on available data)
• Long-term use (over 6–12 months) of vitamin B__ at daily doses exceeding 50 mg may cause peripheral neuropathy (nerve damage causing tingling and burning sensations).
• Local reactions may occur and, rarely, inflammation at the injection site.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Neurovit Fast
Store in a refrigerator (2°C–8°C).
Keep in the original packaging to protect from light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. 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 required. This will help protect the environment.

6. Contents of the package and other information

What Neurovit Fast contains
Active substances:
thiamine hydrochloride (vitamin B), pyridoxine hydrochloride (vitamin B), cyanocobalamin
(vitamin B).
1 ampoule (2 ml) contains:
thiamine hydrochloride (vitamin B) 100 mg
pyridoxine hydrochloride (vitamin B) 100 mg
cyanocobalamin (vitamin B) 1 mg
Excipients:
Water for injections, sodium hydroxide for pH adjustment, hydrochloric acid for pH adjustment
What Neurovit Fast looks like and contents of the pack
A clear red-coloured solution
pH 3.2–3.8
5 ampoules of 2 ml
Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
For further information, please contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]