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 your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on 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 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 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 normal metabolism in nerve cells. Like other vitamins, they are essential components of the diet 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 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 of the other ingredients 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 (more than 6-12 months) or exceeds 1 g of vitamin B for a shorter period (more than 2 months), 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 the medicines you are 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 taken 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 the 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 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, consult your 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.

3. How to take Neurovit

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, 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.
Swallow the tablets whole, taking them after meals and with a small amount of liquid.

Use in children and adolescents

Do not take Neurovit in 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 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, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Neurovit

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 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 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: maize starch, sodium citrate, citric acid monohydrate, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone; coating: macrogol 6000, titanium dioxide, talc, hypromellose, polyacrylate dispersion 30%.

What Neurovit looks like and what the pack 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, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Lannacher Heilmittel Ges.m.b.H
Schlossplatz 1
8502 Lannach
Austria

Manufacturer:

Lannacher Heilmittel Ges.m.b.H
Schlossplatz 1
8502 Lannach
Austria

Parallel importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp.
komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

Marketing authorization number in Romania, the country of export:

3060/2010/01
3060/2010/02
3060/2010/03
3060/2010/04
3060/2010/05
3060/2010/06

Parallel import authorization number: 364/24

Date of leaflet approval: 17.10.2024

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