Neurovit

LEAFLET INCLUDED IN THE PACKAGING: 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

Thiamine hydrochloride + Pyridoxine hydrochloride + Cyanocobalamin
Neurovit and Neuromultivit are different trade names for the same drug.

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• It is necessary to keep this leaflet, so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Neurovit and what is it used for
• 2. Important information before taking Neurovit
• 3. How to take Neurovit
• 4. Possible side effects
• 5. How to store Neurovit
• 6. Contents of the packaging and other information

1. What is Neurovit and what is it used for

Neurovit contains a mixture of vitamins B, B, and B, which are particularly important for maintaining proper metabolism in nerve cells. Like other vitamins, they are essential components of food that cannot be produced by the body.
In the treatment of nervous system disorders, B vitamins work by supplementing the associated vitamin B deficiencies and stimulating natural healing processes in nerve tissues.
There are studies indicating the analgesic effect of vitamin B.
Neurovit is used in nervous system disorders caused by a deficiency of B vitamins.

2. Important information before taking Neurovit

When not to take Neurovit

• In case of allergy to thiamine hydrochloride (vitamin B), pyridoxine hydrochloride (vitamin B), cyanocobalamin (vitamin B), or any of the other ingredients of this drug (listed in section 6).
• In children and adolescents (under 18 years of age) due to the high dose of vitamins in the drug.

Warnings and precautions

Before starting to take Neurovit, you should discuss it with your doctor or pharmacist.
If the daily dose of vitamin B taken for a longer period exceeds 50 mg, or if the dose taken for a shorter period exceeds 1 g of vitamin B, a feeling of tingling and numbness in the hands or feet (symptoms of peripheral neuropathy or paresthesia) may occur. If the patient experiences a feeling of tingling or numbness or other adverse reactions, they should contact their doctor, who will change the dosage or recommend discontinuation of the drug.

Children and adolescents

Neurovit should not be taken by children and adolescents (under 18 years of age) due to the high doses of active substances in the drug.

Neurovit and other drugs

You should tell your doctor or pharmacist about all the drugs you are currently taking or have recently taken, as well as any drugs you plan to take.

• Vitamin B may be ineffective if taken with the cytostatic 5-fluorouracil (a drug used in cancer treatment).
• Antacids (used in hyperacidity of the stomach) reduce the absorption of vitamin B by the body.
• Long-term use of certain diuretics, such as furosemide, may cause vitamin B deficiencies due to increased excretion of vitamin B in the urine.
• Concomitant use with L-dopa (a drug used in Parkinson's disease) may reduce the effectiveness of L-dopa.
• If Neurovit is taken with drugs that lower the level of vitamin B in the body (such as pyridoxine antagonists, e.g., isoniazid, hydralazine, D-penicillamine, or cycloserine), the need for vitamin B may increase.

Neurovit with food, drink, and alcohol

Food increases the absorption of vitamin B from the gastrointestinal tract, so tablets should be taken after a meal, with a small amount of liquid.
The absorption of vitamin B is reduced by alcohol and tea.
If vitamin B is taken with beverages containing sulfites (e.g., wine), it may break down and lose its properties.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this drug.
Neurovit should not be taken during pregnancy or breastfeeding.
During pregnancy and breastfeeding, the daily need for vitamins should be covered by a balanced diet. Due to the high dose of vitamins in the drug, Neurovit is intended for use only in case of vitamin deficiency and should be used only on the doctor's prescription, who will carefully weigh the potential benefits and risks.
Vitamins B, B, and B pass into breast milk. High doses of vitamin B may reduce milk secretion.
The doctor will decide whether Neurovit can be used during pregnancy or breastfeeding in special cases.

Driving and using machines

Neurovit does not affect the ability to drive and use machines.

3. How to take Neurovit

This drug should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
The recommended dose is 1 tablet once a day.
In individual cases, the dose may be increased to 1 tablet three times a day.
Tablets should be swallowed whole, taken after meals, and washed down with a small amount of liquid.

Use in children and adolescents

Neurovit should not be taken by children and adolescents under 18 years of age.

Taking a higher dose of Neurovit than recommended

Vitamin B
Taking doses higher than 50 mg of vitamin B per day for a longer period (more 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 effect). After taking a dose higher than 2 g per day, nerve damage has been reported, manifested as movement disorders, sensory disturbances (tingling, numbness), seizures, and in very rare cases, changes in blood tests and inflammatory skin reactions.
Vitamin B
In very rare cases, after taking very high doses, allergic reactions, rashes, and a mild form of acne have been observed.

Missing a dose of Neurovit

You should not take a double dose to make up for a missed dose, but take the next dose at the right time.
In case of doubts related to the use of the drug, you should consult a doctor or pharmacist.

4. Possible side effects

Like all drugs, Neurovit can cause side effects, although not everybody gets them.
The following side effects have been reported after 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 less than 1 in 10,000 people):

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

Frequency cannot be estimated from the available data:

• Taking doses higher than 50 mg of vitamin B per day for a longer period (more than 6-12 months) may lead to the development of peripheral neuropathy (nerve damage causing a feeling of tingling or numbness)

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store Neurovit

The drug should be stored out of sight and reach of children.
Store in a temperature below 25°C, in the original packaging.
Do not use this drug after the expiry date stated on the packaging. The expiry date is the last day of the given month.
Drugs should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Contents of the packaging and other information

What Neurovit contains

• The active substances of the drug are: thiamine hydrochloride (Thiamini hydrochloridum) (vitamin B), pyridoxine hydrochloride (Pyridoxini hydrochloridum) (vitamin B), and cyanocobalamin (Cyanocobalaminum) (vitamin B)

1 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 starch, sodium citrate, citric acid monohydrate, colloidal silica, microcrystalline cellulose, magnesium stearate, povidone, coating: macrogol 6000, titanium dioxide (E 171), talc, hypromellose, polyacrylate dispersion 30%.

What Neurovit looks like and what the packaging contains

White or almost white, round, and biconvex coated tablets.
PVC/PVDC/Al or Al/Al blisters in a cardboard box.
The packaging contains 20 or 100 coated tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the 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 by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Number of the marketing authorization in Romania, the country of export: 3060/2010/01
3060/2010/02
3060/2010/03
3060/2010/04
3060/2010/05
3060/2010/06

Number of the parallel import authorization: 304/23

Date of approval of the leaflet: 22.12.2023

[Information about the trademark]