Neurovit

Leaflet included in the packaging: patient information

Neurovit, 100 mg + 200 mg + 0.20 mg, coated tablets

(Thiamine hydrochloride + Pyridoxine hydrochloride + Cyanocobalamin)
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you for a specific reason. 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 undesirable effects, including any undesirable effects not mentioned 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 undesirable 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 B1, B6, and B12, which are particularly important for maintaining
proper metabolism in nerve cells. Like other vitamins, they are essential components of nutrition that cannot be produced by the body.
In the treatment of nervous system disorders, B-group vitamins work by supplementing the associated vitamin B deficiencies and stimulating natural healing processes in nerve tissue.
There are studies indicating that vitamin B6 has analgesic effects.
Neurovit is used in nervous system disorders caused by B-group vitamin deficiencies.

2. Important information before taking Neurovit

When not to take Neurovit

• In case of allergy to thiamine hydrochloride (vitamin B1), pyridoxine hydrochloride (vitamin B6), cyanocobalamin (vitamin B12), or any other component 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 take Neurovit, you should discuss it with your doctor or pharmacist.
If the daily dose of vitamin B6 exceeds 50 mg for a longer period, or if the dose exceeds 1 g of vitamin B6 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 undesirable 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 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 B6 may be ineffective if taken with the cytostatic agent 5-fluorouracil (a medicine used to treat cancer).
• Antacids (used to treat stomach acid) may reduce the absorption of vitamin B6 by the body.
• Long-term use of certain diuretics, such as furosemide, may cause vitamin B6 deficiencies due to increased excretion of vitamin B6 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 reduce the level of vitamin B6 in the body (such as isoniazid, hydralazine, D-penicillamine, or cycloserine), the need for vitamin B6 may increase.

Neurovit with food, drink, and alcohol

Food increases the absorption of vitamin B6 from the gastrointestinal tract, so the tablets should be taken after a meal, with a small amount of liquid.
The absorption of vitamin B6 is reduced by alcohol and tea.
If vitamin B6 is taken with beverages 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 taking this medicine.
Neurovit should not be taken during pregnancy or breastfeeding.
During pregnancy and breastfeeding, the daily need for vitamins should be met through 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 B1, B6, and B12 pass into breast milk. High doses of vitamin B6 may reduce milk production.
The doctor will decide whether Neurovit can be taken during pregnancy or breastfeeding in specific cases.

Driving and operating machinery

Neurovit does not affect the ability to drive or operate machinery.

3. How to take Neurovit

This medicine 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.
The 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 of age.

Taking a higher dose of Neurovit than recommended

Vitamin B6
Taking doses higher than 50 mg of vitamin B6 per day for a longer period (more than 6-12 months) or doses exceeding 1 g of vitamin B6 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 test results and inflammatory skin reactions.
Vitamin B6
In very rare cases, after taking very high doses, allergic reactions, rashes, and a mild form of angioedema 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 related to the use of the medicine, you should consult a doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, Neurovit can cause undesirable effects, although not everybody gets them.
The following undesirable 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 hives and urticaria.

Frequency cannot be estimated from the available data:

• Taking doses higher than 50 mg of vitamin B6 per day for a longer period (more than 6-12 months) may lead to peripheral neuropathy (nerve damage causing tingling or numbness).

Reporting undesirable effects

If any undesirable effects occur, including any undesirable effects not mentioned in the leaflet, you should inform your doctor or pharmacist. Undesirable effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Reporting undesirable effects helps to gather more information on the safety of the medicine.

5. How to store Neurovit

The medicine should be stored out of sight and reach of children.
Store at a temperature not exceeding 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 given month.
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 B1), pyridoxine hydrochloride (Pyridoxini hydrochloridum) (vitamin B6), and cyanocobalamin (Cyanocobalaminum) (vitamin B12)

1 coated tablet contains:
thiamine hydrochloride (vitamin B1)
100 mg
pyridoxine hydrochloride (vitamin B6)
200 mg
cyanocobalamin (vitamin B12)
0.20 mg

• Other ingredients are: corn starch, sodium citrate, citric acid monohydrate, colloidal silica, anhydrous, microcrystalline cellulose, magnesium stearate, povidone, macrogol 6000, titanium dioxide, 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/Al or Al/Al in a cardboard box.
20 or 100 coated tablets

Marketing authorization holder and manufacturer

G.L. Pharma GmbH
Schloβplatz 1
A-8502 Lannach
Austria
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Phone: 022/ 636 52 23; 636 53 02
e-mail: biuro@gl-pharma.pl

Date of the last update of the leaflet: