PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet. 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 brand 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, as you may need to read it again.
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. It may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Neurovit is and what it is 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 Neurovit is and what it is 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 deficiencies of vitamin B and stimulating natural healing processes in nerve tissue.
There is evidence indicating the analgesic (pain-relieving) effect of vitamin B₁₂.
Neurovit is used in nervous system disorders caused by deficiency 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, you should discuss this 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 over 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 paresthesia). If you experience prickling, tingling, or any other adverse effects, 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 with other medicines
You must inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Vitamin B₆ may become 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 B₁ by the body.
Long-term use of certain diuretics, such as furosemide, may lead to vitamin B₁ deficiency due to increased urinary excretion of vitamin B₁.
Concurrent 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 lower 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 a meal, with a small amount of liquid.
The absorption of vitamin B₆ is reduced by alcohol and tea.
If vitamin B₆ is taken together with beverages containing sulfites (e.g. wine), it may degrade and thereby lose its properties.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to have a child, you should consult your doctor or pharmacist before using this medicine.
Neurovit should not be used during pregnancy or breastfeeding.
During pregnancy and breastfeeding, daily vitamin requirements should be met through a balanced diet. Due to the high dose of vitamins 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, after careful consideration of 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 special circumstances, Neurovit may be used during pregnancy or breastfeeding.

Driving and operating machinery
Neurovit has no influence on the ability to drive or operate machinery.

3. How to take Neurovit

This medicine should always be taken according to the instructions provided by your doctor or pharmacist. If in doubt, consult your 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 must 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 B6 daily for prolonged periods (longer than 6–12 months) or doses exceeding 1 g of vitamin B6 daily for shorter periods (more than 2 months) may lead to nerve damage (neurotoxic effects). After taking doses exceeding 2 g daily, nerve damage has been reported, manifesting as motor disturbances, sensory disturbances (tingling, numbness), seizures, and, very rarely, changes in blood parameters and inflammatory skin reactions.

Vitamin B
In very rare cases, following ingestion of very high doses, allergic reactions, rashes and mild acne have been observed.

If you forget to take Neurovit
Do not take a double dose to make up for a missed dose. Instead, take the next dose at the correct time.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Neurovit may cause adverse reactions, although not everyone will experience them.

The following adverse reactions have been reported after short-term or long-term use of Neurovit:

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

Nausea
Headache, dizziness

Very rare (may occur in 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 determined from available data:

Long-term intake of doses exceeding 50 mg of vitamin B__ per day for longer than 6–12 months may lead to peripheral neuropathy (nerve damage causing tingling or numbness)

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 reactions helps to provide more information on the safety of the medicine.

5. How to store Neurovit

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must 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 pack and other information

What Neurovit contains

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

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

Other components are: Tablet 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.
Blister packs made of PVC/PVDC/PVC/Aluminium or Aluminium/Aluminium, in a cardboard box.
20 or 100 coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Austria, the country of export:
G.L. Pharma GmbH
Schloßplatz 1
8502 Lannach
Austria
Manufacturer:
G.L. Pharma GmbH
Schloßplatz 1
8502 Lannach
Austria
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Austria, the country of export: 1-19222
Parallel Import Licence number: 312/19