Package leaflet: Information for the user

Neurobion Advance
100 mg + 50 mg + 1 mg, coated tablets
Thiamini nitras + Pyridoxini hydrochloridum + Cyanocobalaminum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always take this medicine exactly as described in this patient leaflet, or as your doctor, pharmacist or nurse has advised.

Keep this leaflet. You may need to read it again.
If you need advice or more information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. See section 4.
If there is no improvement after 30 days, or if you feel worse, please consult your doctor.

Contents of the leaflet

What Neurobion Advance is and what it is used for
What you need to know before taking Neurobion Advance
How to take Neurobion Advance
Possible side effects
How to store Neurobion Advance
Contents of the pack and other information

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

Neurobion Advance is a medicine containing thiamine (vitamin B_), pyridoxine (vitamin B_), and cyanocobalamin (vitamin B_), intended for use in adults only. It may be taken to prevent low levels of these vitamins in the body or to treat a deficiency (insufficient amounts of these vitamins in the body).

Low levels of vitamins B_, B_, or B_ may occur when:

the patient does not consume enough 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 medical conditions, such as certain inflammatory diseases, leading to increased use of these vitamins by the body;
the patient has conditions such as kidney disease, which may cause the body to eliminate more vitamins than normal.

Low levels of vitamin B_, B_, or B_ may be more common in elderly individuals or in patients with neurological disorders, diabetes, or gastrointestinal diseases such as inflammatory bowel disease or celiac disease. In cases of low vitamin B_, B_, or B_ levels, there may initially be no symptoms, but symptoms such as fatigue, tingling, or numbness in the hands and feet may develop.

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

2. 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 components of this medicine (listed in section 6);
if the patient is under 18 years of age.

Warnings and precautions
Before starting to take Neurobion Advance, discuss this with your doctor,
pharmacist or nurse:

if the patient suffers from megaloblastic anaemia. Vitamin B₁₂ (cyanocobalamin) may alleviate megaloblastic anaemia caused by folic acid deficiency. Treatment with Neurobion Advance may relieve this condition due to the presence of vitamin B₁₂ (cyanocobalamin); therefore, caution should be exercised so that the correct diagnosis is not masked.

If any new symptoms occur after taking Neurobion Advance,
the patient should stop taking the product and consult a doctor, pharmacist or nurse.
Children and adolescents
Neurobion Advance must not be used in children and adolescents under 18 years of age due to
its high content of vitamins B₁, B₆ and B₁₂.
Neurobion Advance and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Vitamin B₆ may increase the severity of adverse effects and reduce the therapeutic effect of levodopa. Medicines containing dopamine decarboxylase inhibitors (e.g. medicines used in the treatment of Parkinson's disease) may cause vitamin B₆ deficiency.
Pyridoxine antagonists such as isoniazid, cycloserine, penicillamine or hydralazine may reduce the effectiveness of vitamin B₆.
Long-term use of loop diuretics (medicines causing increased urine production and excretion), such as furosemide, may accelerate the elimination of vitamin B₁ and reduce its blood concentration, as well as may reduce vitamin B₆ blood levels.
Taking Neurobion Advance with food, drink and alcohol
Alcohol impairs the absorption of vitamin B₁₂.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
No effects of Neurobion Advance on the ability to drive or operate machinery have been observed.
Neurobion Advance contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. the medicine is considered "sodium-free".

3. How to take Neurobion Advance

This medicine should always be taken exactly as described in this patient leaflet, or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

The recommended dose for adults is 1 tablet per day. The tablet should be swallowed with liquid, during or after a meal.

If there is no improvement after 30 days, or if symptoms worsen, consult your doctor.

Do not use this medicine for longer than 30 days without consulting a doctor. Consult your doctor if you wish to continue treatment.

Use in children and adolescents
Neurobion Advance must not be used in children and adolescents under 18 years of age due to its high content of vitamin B_, B_, and B_.

Accidental overdose of Neurobion Advance
If an excessive dose of Neurobion Advance is taken by mistake, inform your doctor or pharmacist, or contact the nearest hospital emergency department for further 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, diminished reflexes, or other neurological symptoms.

In such cases, discontinue use of the product and consult your doctor, pharmacist, or nurse.

Missed dose of Neurobion Advance
If a dose of Neurobion Advance is missed, take one dose as soon as possible during the next meal on the same day.

Do not take a double dose to make up for a missed tablet.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with Neurobion Advance,
with unknown frequency (frequency cannot be estimated from the available data):

symptoms of allergic reactions such as sweating, tachycardia (increased heart rate), and skin reactions with accompanying itching and urticaria;
gastrointestinal disorders such as nausea, vomiting, diarrhoea, and abdominal pain;
change in urine colour (red discoloration of urine, which may occur within the first hours after taking the tablet and usually resolves shortly after discontinuation of treatment);
headache.

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

5. How to store Neurobion Advance

No special storage instructions are required.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after: EXP. 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Neurobion Advance contains
The active substances in this 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 carboxymethyl starch (type A)
Transparent coating:
Polyvinyl alcohol, talc, glycerol monooctanoate, sodium lauryl sulfate
White coating:
Hypromellose, polidextrose, titanium dioxide, macrogol
Coating:
White beeswax, carnauba wax

What Neurobion Advance looks like and contents of the pack
White, round, biconvex coated tablets.
Supplied in blisters packed in cardboard boxes, available in packs of 30 tablets.

Marketing Authorisation Holder
P&G Health Germany GmbH
Sulzbacher Strasse 40
65824 Schwalbach am Taunus
Germany
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Procter & Gamble Health Poland Sp. z o.o.
ul. Zabraniecka 20, 03-872 Warszawa
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 authorised in the European Economic Area member states 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