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.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not give it to others. The medicine may harm another person, even if their symptoms 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 taking Neurovit
• 3. How to take Neurovit
• 4. Possible side effects
• 5. How to store Neurovit
• 6. Package contents 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 related vitamin B deficiencies and stimulating natural healing processes in nerve tissues. There are studies indicating that vitamin B has analgesic properties.
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 other component of this medicine (listed in section 6).
• In children and adolescents (under 18 years) due to the high dose of vitamins in the medicine.

Warnings and precautions

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

Children and adolescents

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

Neurovit and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or 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 taken with medicines that lower vitamin B levels in the body (such as pyridoxine antagonists like 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, 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 break down 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 taking 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 has carefully weighed 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 taken during pregnancy or breastfeeding in special cases.

Driving and using machines

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

Neurovit contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Neurovit

This medicine should always be taken according to the doctor's or pharmacist's recommendations. If you have any doubts, consult your 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.

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, 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

Do not take a double dose to make up for a missed dose, but take the next dose at the right time.
If you have any doubts about taking the medicine, consult your 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 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 tingling or numbness).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell 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 provide more information on the safety of the medicine.

5. How to store Neurovit

Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Store in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should 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. Package contents and other information

What Neurovit contains

• The active substances of the medicine are: thiamine hydrochloride (Thiamine hydrochloride) (vitamin B), pyridoxine hydrochloride (Pyridoxine hydrochloride) (vitamin B), and cyanocobalamin (Cyanocobalamin) (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: 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 package contains

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

Marketing authorization holder in Latvia, 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:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Latvia, the country of export: 99-0698

Parallel import authorization number: 376/24

Date of leaflet approval: 29.10.2024

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