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.

You should carefully read the contents of the leaflet before using the medicine, 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 medicine has been prescribed to a specific person. Do not pass it on to others. The medicine 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 tell 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 medicine (listed in section 6).
• In children and adolescents (under 18 years of age) due to the high dose of vitamins in the medicine.

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, it may cause a feeling of tingling and numbness in the hands or feet (symptoms of peripheral neuropathy or paresthesia). If the patient experiences a feeling of tingling or numbness or other side effects, they should contact their doctor, who will change 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 in the medicine.

Neurovit and other medicines

You should tell 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 B may be ineffective if taken with the cytostatic 5-fluorouracil (a medicine used to treat cancer).
• Antacids (used to treat stomach acid) 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 medicine used to treat Parkinson's disease) may reduce the effectiveness of L-dopa.
• If Neurovit is used concomitantly with medicines that lower the level of vitamin B in the body (such as 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.
Alcohol and tea reduce the absorption of vitamin B.
If vitamin B is taken with drinks containing sulfites (e.g., wine), it may break down and lose its properties.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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, the daily need for vitamins should be covered by a balanced diet. Due to the high dose of vitamins in the medicine, Neurovit is intended for use only in cases of vitamin deficiency 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 special cases.

Driving and using machines

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

3. How to use Neurovit

This medicine should always be taken according to the doctor's or pharmacist's instructions. 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 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 about using the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, 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 this leaflet, you should tell your doctor or pharmacist. 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Neurovit

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Neurovit contains

• The active substances of the medicine 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: Tablet 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 packaging contains

White or almost white, round, and biconvex coated tablets.
Blisters of PVC/PVDC/PVC/Aluminum or Aluminum/Aluminum in a cardboard box.
20 or 100 coated tablets
To obtain more detailed information, you should contact the marketing authorization holder or the 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Austria, the country of export: 1-19222
Parallel import authorization number: 312/19

Date of approval of the leaflet: 18.07.2024

[Information about the trademark]