Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging 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 taking this 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 doubts, 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 someone else, even if their symptoms are the same.
If you experience any adverse reactions, 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 treatment with Neurovit, discuss it with your doctor or pharmacist.
If the daily dose of vitamin B₆ exceeds 50 mg when taken for a prolonged period, or if the dose taken over a shorter period exceeds 1 g of vitamin B₆, a sensation of pricking and tingling in the hands or feet (symptoms of peripheral sensory neuropathy or paraesthesia) may occur. If the patient experiences pricking, tingling or other adverse effects, contact the 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
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.

Vitamin B₆ may become ineffective if used concomitantly with the cytostatic agent 5-fluorouracil (a medicine used in cancer treatment).
Antacids (used in 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 urinary excretion of vitamin B₁.
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 B₁₂ 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, 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 taken 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 Neurovit may be used during pregnancy or breastfeeding in specific cases.

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

3. How to use the medicine Neurovit

This medicine should always be taken according to the doctor's or pharmacist's instructions. 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 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 a dose greater than 2 g
per day, nerve damage has been reported, manifesting as motor disturbances, sensory disturbances (tingling, numbness), seizures, and in very rare cases, changes in blood picture as well as inflammatory skin reactions.
Vitamin B
In very rare cases, following very high doses, allergic reactions, rashes and mild acne have been observed.
If you miss a dose of 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 experiences them. The following adverse reactions have been reported after 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 less 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 higher than 50 mg of vitamin B**6** per day over a prolonged period (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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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 provide more information on the safety of the medicine.

5. How to store Neurovit

Keep this medicine out of 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package 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).

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: pregelatinized modified 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.
PVC-PVDC/Al or Al/Al blisters in a cardboard box.
20 or 100 coated tablets.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
Lannacher Heilmittel Ges.m.b.H.
Schlossplatz 1
A-8502 Lannach
Austria
Manufacturer:
Lannacher Heilmittel Ges.m.b.H.
Schlossplatz 1
A-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 numbers in Romania, country of export: 3060/2010/01
3060/2010/02
3060/2010/04
3060/2010/05
3060/2010/06
Parallel import authorisation number: 204/16