Neurovit

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Neurovit (Neuromultivit)
100 mg + 200 mg + 0.20 mg, coated tablets
Thiamini hydrochloridum + Pyridoxini hydrochloridum + Cyanocobalaminum
Neurovit and Neuromultivit are different brand names of the same medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Neurovit is and what it is 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 pack and other information

1. What Neurovit is and what it is used for

Neurovit contains a combination of vitamin B₁, B₆, and B₁₂, which are particularly important for maintaining normal metabolism in nerve cells. Like other vitamins, they are essential nutrients that cannot be synthesized by the body.
In the treatment of nervous system disorders, B-complex vitamins act by correcting associated deficiencies of vitamin B and by stimulating natural healing processes in nerve tissue.
There is evidence indicating analgesic (pain-relieving) effects of vitamin B₁₂.
Neurovit is used in nervous system disorders caused by deficiencies of B-complex vitamins.

2. Important information before using Neurovit

When not to use Neurovit

• If you are allergic to thiamine hydrochloride (vitamin B₁), pyridoxine hydrochloride (vitamin B₆), cyanocobalamin (vitamin B₁₂), 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 contained in the medicine.

Warnings and precautions
Before starting treatment with Neurovit, discuss it with your doctor or pharmacist.
If the daily dose of vitamin B₆ exceeds 50 mg over a prolonged period, or if the dose taken over a shorter period exceeds 1 g of vitamin B₆, symptoms such as prickling sensations and tingling in the hands or feet (symptoms of peripheral sensory neuropathy or paraesthesiae) may occur. If the patient experiences prickling, tingling, or other adverse effects, contact your doctor, who may adjust 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 contained in the medicine.
Neurovit and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to take.

• Vitamin B₆ may become ineffective when used concomitantly with the cytostatic agent 5-fluorouracil (a medicine used in cancer treatment).
• Antacids (used for gastric hyperacidity) reduce the absorption of vitamin B₁₂ by the body.
• Long-term use of certain diuretics, such as furosemide, may lead to vitamin B₁ deficiency due to increased excretion of vitamin B₁ in urine.
• Concurrent use with L-dopa (a medicine used in Parkinson's disease) may reduce the effectiveness of L-dopa.
• If Neurovit is used simultaneously with medicines that reduce vitamin B₆ levels in the body (so-called pyridoxine antagonists such as isoniazid, hydralazine, D-penicillamine, or cycloserine), the requirement for vitamin B₆ may increase.

Neurovit with food, drinks, and alcohol
Food increases the absorption of vitamin B₁ from the gastrointestinal tract; therefore, tablets should be taken after meals, with a small amount of liquid.
Alcohol and tea reduce the absorption of vitamin B₁₂.
If vitamin B₁ is taken together with beverages containing sulfites (e.g., wine), it may degrade and thereby lose its properties.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Neurovit should not be taken during pregnancy or breastfeeding.
During pregnancy and breastfeeding, daily vitamin requirements should be met through a balanced diet. Due to the high vitamin content of this medicine, Neurovit is intended for use only in cases of vitamin deficiency and should be used solely under medical supervision, with careful consideration of potential benefits and risks.
Vitamins B₁, B₆, and B₁₂ pass into human milk. High doses of vitamin B₆ may reduce milk secretion.
Your doctor will decide whether Neurovit may be used during pregnancy or breastfeeding in specific cases.
Driving and operating machinery
Neurovit has no effect on the ability to drive or operate machinery.

3. How to use Neurovit

This medicine should always be taken according to the instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1 tablet once daily.
In individual cases, the dose may be increased to 1 tablet three times daily.
Tablets should be swallowed whole, taken after meals and 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.

Taking more Neurovit than recommended
Vitamin B
Taking doses exceeding 50 mg of vitamin B per day for a prolonged period (longer than 6–12 months), or doses exceeding 1 g of vitamin B per day for a shorter period (over 2 months), may lead to nerve damage (neurotoxic effects). After ingestion of more than 2 g per day, nerve damage has been reported, manifesting as motor disturbances, sensory disturbances (tingling, numbness), convulsions, and in very rare cases, changes in blood picture as well as inflammatory skin reactions.

Vitamin B
In very rare cases, following ingestion of very high doses, allergic reactions, rashes, and mild acne have been observed.

If you miss a dose of Neurovit
Do not take a double dose to make up for a missed dose. Take the next dose at the scheduled time.
If you have any doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Neurovit may cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported with short-term or long-term use of Neurovit:

Rare (may occur in 1 to 10 out of 10,000 people):

• Nausea;
• Headache, dizziness.

Very rare (may occur in fewer than 1 out of 10,000 people):

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

Frequency cannot be determined from available data:

• Long-term intake of doses exceeding 50 mg of vitamin B* per day for prolonged periods (longer than 6–12 months) may lead to peripheral neuropathy (nerve damage causing tingling or numbness).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Neurovit

Keep this medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
Such measures help protect the environment.

6. Contents of the packaging and other information

What Neurovit contains
The active substances in this medicinal product are: thiamine hydrochloride (Thiamini hydrochloridum) (vitamin B ),
pyridoxine hydrochloride (Pyridoxini hydrochloridum) (vitamin B ), and cyanocobalamin
(Cyanocobalaminum) (vitamin B ).
Each 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

The other components are:
Core: modified pregelatinized starch, sodium citrate, citric acid monohydrate,
colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone.
Coating: macrogol 6000, titanium dioxide (E 171), talc, hypromellose, polyacrylate dispersion 30%.

What Neurovit looks like and contents of the pack
White or almost white, round, biconvex coated tablets.
PVC/PVDC/PVC/Aluminum or Aluminum/Aluminum blisters in a cardboard box containing 20 or 100 coated tablets.

For further detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation 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
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Austria, the country of export: 1-19222
Parallel Import Licence Number: 189/14