Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Neurovit (Neuromultivit)
100 mg + 200 mg + 0.20 mg, coated tablets
Thiamini hydrochloridum + Pyridoxini hydrochloridum + Cyanocobalaminum
Neurovit and Neuromultivit are different trade names for the same medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What is Neurovit and what is it used for
Important information before taking Neurovit
How to take Neurovit
Possible side effects
How to store Neurovit
Contents of the pack and other information

1. What is Neurovit and what is it used for

Neurovit contains a combination of vitamin B₁, B₆, and B₁₂, which are particularly important for maintaining normal metabolism in nerve cells. Like other vitamins, they are essential nutrients that cannot be synthesized by the body. In the treatment of nervous system disorders, B-complex vitamins act by correcting associated vitamin B deficiencies and stimulating natural healing processes in nerve tissue. There is evidence indicating the analgesic effect of vitamin B₁₂.
Neurovit is used in nervous system disorders caused by deficiencies of B-complex vitamins.

2. Important information before using Neurovit

When not to use Neurovit

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).
In children and adolescents (under 18 years of age) due to the high dose of vitamins contained in the medicine.

Warnings and precautions
Before starting to use Neurovit, discuss it with your doctor or pharmacist.
If the daily dose of vitamin B₆ taken over a prolonged period exceeds 50 mg, or if the dose taken for a shorter period exceeds 1 g of vitamin B₆, you may experience prickling sensations and tingling in the hands or feet (symptoms of peripheral sensory neuropathy or paraesthesiae). If you experience prickling, tingling, or any other adverse reactions, contact your doctor, who may adjust the dosage or recommend discontinuation of the medicine.
Children and adolescents
Neurovit should not be used in children and adolescents (under 18 years of age) due to the high doses of active substances contained in the medicine.
Neurovit and other medicines
You must tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.

Vitamin B₆ may be ineffective if used concomitantly with the cytostatic agent 5-fluorouracil (a medicine used in cancer treatment).
Antacids (used for gastric hyperacidity) reduce the absorption of vitamin B₁₂ by the body.
Long-term use of certain diuretics, such as furosemide, may lead to vitamin B₁ deficiency due to increased excretion of vitamin B₁ in urine.
Concomitant use with L-dopa (a medicine used in Parkinson's disease) may reduce the effectiveness of L-dopa.
If Neurovit is used simultaneously with medicines that reduce vitamin B₆ levels in the body (so-called pyridoxine antagonists such as isoniazid, hydralazine, D-penicillamine, or cycloserine), the requirement for vitamin B₆ may increase.

Neurovit with food, drink, and alcohol
Food increases the absorption of vitamin B₁ from the gastrointestinal tract; therefore, tablets should be taken after meals, with a small amount of liquid.
The absorption of vitamin B₆ is reduced by alcohol and tea.
If vitamin B₁ is taken together with beverages containing sulfites (e.g. wine), it may degrade and thus lose its properties.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Neurovit should not be taken during pregnancy or breastfeeding.
During pregnancy and breastfeeding, daily vitamin requirements should be met through a balanced diet. Due to the high vitamin dose contained in the medicine, Neurovit is intended for use only in cases of vitamin deficiency and should be used solely on a doctor's prescription, who will carefully assess the potential benefits and risks.
Vitamins B₁, B₆, and B₁₂ pass into human milk. High doses of vitamin B₆ may reduce milk secretion.
Your doctor will decide whether, in exceptional cases, Neurovit may be used during pregnancy or breastfeeding.
Driving and operating machinery
Neurovit has no influence on the ability to drive or operate machinery.
Neurovit contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Neurovit

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose is 1 tablet once daily.
In individual cases, the dose may be increased to 1 tablet three times daily.
Tablets should be swallowed whole, taken after meals and with a small amount of liquid.
Use in children and adolescents
Neurovit should not be used in children and adolescents under 18 years of age.
Taking more Neurovit than recommended
Vitamin B
Taking doses exceeding 50 mg of vitamin B per day for a prolonged period (longer than 6–12 months) or doses exceeding 1 g of vitamin B per day for a shorter period (more than 2 months) may lead to nerve damage (neurotoxic effects). After ingestion of more than 2 g per day, nerve damage has been reported, manifesting as motor disturbances, sensory disturbances (tingling, numbness), convulsions, and in very rare cases, changes in blood picture as well as inflammatory skin reactions.
Vitamin B
In very rare cases, following ingestion of very high doses, allergic reactions, rashes, and mild acne have been observed.
Missed dose of Neurovit
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.
If in doubt regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Neurovit may cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported with short-term or long-term use of Neurovit:

Rare (may affect up to 1 to 10 in 10,000 people):

Nausea
Headache, dizziness

Very rare (may affect fewer than 1 in 10,000 people):

Hypersensitivity reactions such as sweating, rapid heartbeat, and skin reactions such as itching and urticaria.

Frequency cannot be estimated from the available data:

Taking doses greater than 50 mg of vitamin B__ per day over a prolonged period (longer than 6–12 months) may lead to peripheral neuropathy (nerve damage causing tingling or numbness sensations).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 this medicine.

5. How to store Neurovit

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the container. 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 Neurovit contains

The active substances in Neurovit are: thiamine hydrochloride (Thiamini hydrochloridum) (vitamin B), pyridoxine hydrochloride (Pyridoxini hydrochloridum) (vitamin B), and cyanocobalaminum (Cyanocobalaminum) (vitamin B).

Each coated tablet contains:
thiamine hydrochloride (vitamin B) 100 mg
pyridoxine hydrochloride (vitamin B) 200 mg
cyanocobalamin (vitamin B) 0.20 mg

Other components are: Core: modified pregelatinized starch, sodium citrate, citric acid monohydrate, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone. Coating: macrogol 6000, titanium dioxide (E 171), talc, hypromellose, polyacrylate dispersion 30%.

What Neurovit looks like and contents of the pack
White or almost white, round, biconvex coated tablets.
Packs containing 20 or 100 coated tablets in PVC/PVDC/Al or Al/Al blisters, in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
G. L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria
Manufacturer:
G. L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in Latvia, country of export: 99-0698
Parallel Import Licence Number: 376/24