Neurobion Advance

Package Leaflet: Information for the Patient

Neurobion Advance

100 mg + 50 mg + 1 mg, coated tablets

Thiamine nitrate+ Pyridoxine hydrochloride+ Cyanocobalamin

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

This medicine should always be taken exactly as described in this package leaflet for the patient, or as directed by a doctor, pharmacist, or nurse.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 30 days, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is Neurobion Advance and what is it used for
• 2. Important information before taking Neurobion Advance
• 3. How to take Neurobion Advance
• 4. Possible side effects
• 5. How to store Neurobion Advance
• 6. Contents of the pack and other information

1. What is Neurobion Advance and what is it used for

Neurobion Advance is a medicine containing thiamine (vitamin B1), pyridoxine (vitamin B6), and cyanocobalamin (vitamin B12), intended for use only in adults. It can be taken to prevent a decrease in the level of these vitamins in the body or to treat their deficiency (insufficient amount of these vitamins in the body). A low level of vitamins B1, B6, or B12 may occur when:

• the patient does not consume sufficient amounts of foods containing these vitamins;
• the patient's body is unable to absorb these vitamins from food;
• the patient has undergone stomach or intestinal surgery, which may affect the absorption of nutrients;
• the patient has certain diseases, such as inflammatory diseases, which may cause an increased consumption of vitamins by the body;
• the patient has diseases such as kidney disease, which may cause the removal of more vitamins from the body than normal. A low level of vitamin B1, B6, or B12 may occur more frequently in older adults or patients with neurological diseases, diabetes, or gastrointestinal diseases, such as inflammatory bowel disease or celiac disease. Initially, there may be no symptoms of a low level of vitamin B1, B6, or B12, but symptoms such as fatigue or a feeling of numbness and tingling in the hands and feet may occur.

This medicine should only be used when the patient has any of the above-mentioned symptoms or diseases (i.e., diagnosis has been confirmed by a doctor), and their treatment has been recommended by a doctor.

2. Important information before taking Neurobion Advance

When not to take Neurobion Advance:

• if the patient is allergic to vitamin B1, B6, B12, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is under 18 years old.

Warnings and precautions

Before taking Neurobion Advance, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient has megaloblastic anemia. Vitamin B12 (cyanocobalamin) may mask the symptoms of megaloblastic anemia due to folate deficiency. Taking Neurobion Advance may mask this condition due to the presence of vitamin B12 (cyanocobalamin), so caution should be exercised to avoid masking the correct diagnosis.

If the patient experiences any new symptoms after taking Neurobion Advance, they should stop taking the product and consult their doctor, pharmacist, or nurse.

Children and adolescents

Neurobion Advance should not be used in children and adolescents under 18 years old due to the high content of vitamins B1, B6, and B12.

Neurobion Advance and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Vitamin B6 may increase the severity of side effects and reduce the therapeutic effect of levodopa. Medicines containing substances such as dopamine decarboxylase inhibitors (e.g., medicines used to treat Parkinson's disease) may cause a deficiency of vitamin B6. Pyridoxine antagonists, such as isoniazid, cycloserine, penicillamine, or hydralazine, may reduce the effectiveness of vitamin B6. Long-term use of loop diuretics (medicines that increase urine production and excretion), such as furosemide, may cause accelerated elimination of vitamin B1 and a decrease in its blood level, as well as a decrease in the blood level of vitamin B6.

Taking Neurobion Advance with food, drink, and alcohol

Alcohol impairs the absorption of vitamin B1.

Pregnancy, breastfeeding, and fertility

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.

Driving and using machines

No effects of Neurobion Advance on the ability to drive or use machines have been observed.

Neurobion Advance contains sodium

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

3. How to take Neurobion Advance

This medicine should always be taken exactly as described in this package leaflet for the patient, or as directed by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse. The recommended dose for adults is 1 tablet per day. The tablet should be swallowed with a liquid, during or after a meal. If there is no improvement or the patient feels worse after 30 days, they should contact their doctor. This medicine should not be taken for more than 30 days without consulting a doctor. The patient should consult their doctor if they wish to continue treatment.

Use in children and adolescents

Neurobion Advance should not be used in children and adolescents under 18 years old due to the high content of vitamins B1, B6, and B12.

Overdose of Neurobion Advance

In case of accidental overdose of Neurobion Advance, the patient should inform their doctor or pharmacist or contact the nearest hospital emergency department for additional advice. Symptoms of neuropathy may occur when taking more than one tablet per day for six months or longer, such as increased or decreased sensation of pressure, temperature, and pain in the arms, hands, feet, or legs, numbness, tingling, muscle weakness, decreased reflexes, or other neurological symptoms. In such a case, the patient should stop taking the product and consult their doctor, pharmacist, or nurse.

Missed dose of Neurobion Advance

If the patient forgets to take Neurobion Advance, they should take one dose as soon as possible during the next meal on the same day. The patient should not take a double dose to make up for the missed tablet. In case of further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Neurobion Advance can cause side effects, although not everybody gets them. The following side effects may occur with an unknown frequency (frequency cannot be estimated from the available data) during treatment with Neurobion Advance:

• symptoms of allergic reactions, such as sweating, tachycardia (rapid heart rate), and skin reactions with accompanying itching and hives;
• gastrointestinal disorders, such as nausea, vomiting, diarrhea, and abdominal pain;
• change in urine color (red discoloration of urine, which may occur in the first hours after taking the tablet and usually disappears shortly after treatment is discontinued).
• headache.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their 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, 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Neurobion Advance

There are no special precautions for storage. The medicine should be stored out of sight and reach of children. The medicine should not be used after the expiration date stated on the label after EXP. The expiration date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Neurobion Advance contains

The active substances of the medicine are thiamine nitrate, pyridoxine hydrochloride, and cyanocobalamin. Each coated tablet contains 100 mg of thiamine nitrate, 50 mg of pyridoxine hydrochloride, and 1 mg of cyanocobalamin. The other ingredients are: Tablet core:microcrystalline cellulose, gelatin, sodium croscarmellose, hypromellose, magnesium stearate, colloidal anhydrous silica, sodium carboxymethylcellulose (type A) Clear coating:polyvinyl alcohol, talc, glycerol monocaprylate, sodium lauryl sulfate White coating:hypromellose, polydextrose, titanium dioxide, macrogol Coating:white beeswax, carnauba wax

What Neurobion Advance looks like and contents of the pack

White, round, biconvex coated tablets Blister packs in a cardboard box, available in packs of 30 tablets.

Marketing authorization holder

P&G Health Germany GmbH Sulzbacher Strasse 40 65824 Schwalbach am Taunus Germany For more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder: Procter & Gamble Health Poland Sp. z o.o. ul. Zabraniecka 20, 03-872 Warsaw tel. 801 25 88 25

Manufacturer

P&G Health Austria GmbH. & Co. OG Hösslgasse 20 9800 Spittal an der Drau Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic Neurobion Hungary Neurobion 100 mg/50 mg/1 mg filmtabletta Poland Neurobion Advance Slovakia Neurobion 100 mg/50 mg/1 mg filmom obalené tablety

Date of last revision of the package leaflet: 12/2023