PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the 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 using 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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. 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 B_, B_, and B_, 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 analgesic (pain-relieving) effects of vitamin B_.
Neurovit is used in nervous system disorders caused by deficiencies of B-complex vitamins.

2. Important information before taking Neurovit

When not to take Neurovit

If you are allergic to thiamine hydrochloride (vitamin B_), pyridoxine hydrochloride (vitamin B_), cyanocobalamin (vitamin B_), 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 B_ exceeds 50 mg over a prolonged period, or if the dose exceeds 1 g of vitamin B_ over a shorter period, you may experience prickling sensations or tingling in the hands or feet (symptoms of peripheral sensory neuropathy or paresthesia). If you experience tingling, prickling, 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
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Vitamin B_ 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 B_ by the body.
Long-term use of certain diuretics, such as furosemide, may lead to vitamin B_ deficiency due to increased urinary excretion of vitamin B_.
Concomitant use with L-dopa (a medicine used in Parkinson's disease) may reduce the effectiveness of L-dopa.
If Neurovit is taken simultaneously with medicines that reduce vitamin B_ levels in the body (so-called pyridoxine antagonists such as isoniazid, hydralazine, D-penicillamine, or cycloserine), the requirement for vitamin B_ may increase.

Neurovit with food, drink, and alcohol
Food enhances the absorption of vitamin B_ from the gastrointestinal tract; therefore, tablets should be taken after meals, with a small amount of liquid.
The absorption of vitamin B_ is reduced by alcohol and tea.
If vitamin B_ 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 or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Neurovit should not be taken during pregnancy or breastfeeding.
During pregnancy and lactation, daily vitamin requirements should be met through a balanced diet. Due to the high vitamin doses contained in Neurovit, this medicine is intended only for use in cases of vitamin deficiency and should be used only under medical supervision, with careful consideration of potential benefits and risks.
Vitamins B_, B_, and B_ pass into human milk. High doses of vitamin B_ 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 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 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 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 (over 2 months)
may lead to nerve damage (neurotoxic effects). After taking doses exceeding 2 g per
day, nerve damage has been reported, manifesting as motor disturbances, sensory disturbances (tingling,
numbness), convulsions and, very rarely, changes in blood parameters as well as inflammatory skin reactions.
Vitamin B
Very rarely, after taking 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 appropriate time.
If in doubt regarding the use of this medicine, consult a 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 with short-term or long-term use of
Neurovit:
Rare (may affect up to 1 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 available data:

Taking doses exceeding 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 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 of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 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 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 specified 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 pack 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

Other ingredients are: 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.
PVC/PVDC/Al or Al/Al blisters in a cardboard box.
The pack contains 20 or 100 coated tablets.
For more detailed 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
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 Authorisation number: 304/23