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 of the same medicinal product.
Please read the entire leaflet carefully before using 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. The medicine may harm others, 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 of the leaflet:

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 the body cannot produce on its own.
In the treatment of nervous system disorders, B vitamins act by correcting associated deficiencies of vitamin B and by stimulating natural healing processes in nerve tissue.
There is evidence indicating analgesic (pain-relieving) effects 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 paraesthesia). If such symptoms occur, or any other adverse effects, you should 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 should inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

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 be degraded 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 content of this medicine, Neurovit is intended for use only in cases of vitamin deficiency and should be used solely on a doctor's advice, 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 Neurovit may be used during pregnancy or breastfeeding in specific cases.

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

3. How to use the medicine Neurovit

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If you have any doubts, 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 should not be used in children and adolescents under 18 years of age.
Taking a higher than recommended dose of Neurovit
Vitamin B
Taking doses higher than 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 taking doses greater 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. Instead, take the next dose at the usual 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 experiences 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 per 10,000):

Nausea
Headache, dizziness

Very rare (may occur in less than 1 person per 10,000):

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 the development of peripheral neuropathy (nerve damage causing tingling or numbness sensations).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Neurovit

Keep this medicine out of the sight and reach of children.
Store below 25°C in the original packaging.
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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Neurovit contains

The active substances are: thiamine hydrochloride (Thiamini hydrochloridum) (vitamin B ), pyridoxine hydrochloride (Pyridoxini hydrochloridum) (vitamin B ), and cyanocobalamin (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

The other ingredients are: pregelatinized starch, sodium citrate, citric acid monohydrate, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone; coating: polyethylene glycol 6000, titanium dioxide, talc, hypromellose, polyacrylate dispersion 30%.

What Neurovit looks like and contents of the pack
White or almost white, round, biconvex coated tablets.
Packs of PVC-PVDC/Al or Al/Al blisters in a cardboard box.
20 or 100 coated tablets.
For further information, contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Romania, country of export:
Lannacher Heilmittel Ges.m.b.H
Schlossplatz 1
8502 Lannach
Austria

Manufacturer:
Lannacher Heilmittel Ges.m.b.H
Schlossplatz 1
8502 Lannach
Austria

Parallel Importer:
Allpharm Sp. z o.o. sp.k.
M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Poland

Marketing Authorisation Numbers in Romania, country of export: 3060/2010/01
3060/2010/02
3060/2010/03
3060/2010/04
3060/2010/05
3060/2010/06

Parallel Import Licence Number: 364/24