Neurovit

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

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

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This drug has been prescribed to a specific person. Do not pass it on to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Neurovit and what is it used for
• 2. Important information before using Neurovit
• 3. How to use 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 tissue.
There are studies indicating that vitamin B has analgesic effects.
Neurovit is used in nervous system disorders caused by a deficiency of B vitamins.

2. Important information before using Neurovit

When not to use 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 use Neurovit, you should discuss it with your doctor or pharmacist.
If the daily dose of vitamin B exceeds 50 mg, or if the dose taken for a shorter period exceeds 1 g of vitamin B, numbness or tingling in the hands or feet (symptoms of peripheral neuropathy or paresthesia) may occur. If the patient experiences numbness or tingling or other side effects, they should contact their doctor, who will change the dosage or recommend discontinuing the drug.

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 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 drug 5-fluorouracil (a drug used in cancer treatment).
• Antacids (used in gastric hyperacidity) 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 used 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 meals and washed down with a small amount of liquid.
The absorption of vitamin B is reduced by alcohol and tea.
If vitamin B is taken with drinks containing sulfites (e.g., wine), it may decompose and lose its properties.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using 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 vitamin deficiencies and should be used only on the advice of a doctor 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 production.
The doctor will decide whether Neurovit can be used during pregnancy or breastfeeding in specific cases.

Driving and using machines

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

3. How to use 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 used in children and adolescents under 18 years of age.

Using 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, manifesting 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 mild 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 about using 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 like 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 numbness or tingling).

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, 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 side effects will 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.
Do not store above 25°C.
Do not use this drug after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Drugs should not be disposed of via wastewater 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 (Thiamini hydrochloridum) (vitamin B)
100 mg
pyridoxine hydrochloride (Pyridoxini hydrochloridum) (vitamin B)
200 mg
cyanocobalamin (Cyanocobalaminum) (vitamin B)
0.20 mg
Other ingredients are:
Core: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 pack contains

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

Marketing authorization 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number:1-19222
Parallel import authorization number:189/14

Date of leaflet approval: 13.05.2024

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