NEUROBION Coated tablet Ref.[4437] Active ingredients: Pyridoxine Vitamin B1 Vitamin B12

The clinical picture as well as the laboratory parameters of funicular myelosis or of pernicious anaemia can lose specificity by administration of vitamin B₁₂.

If symptoms of peripheral sensory neuropathy (paraesthesia) occur, the dosage should be reviewed and treatment with the medicinal product discontinued, if necessary. Neuropathies have been observed under long-term intake (over 6-12 months) of daily dosages exceeding 50 mg vitamin B₆ as well as in short-term intake (over 2 months) of more than 1 g vitamin B₆ per day. Therefore, regular monitoring is recommended under long-term treatment.

This drug contains sucrose; therefore its use is not recommended in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

Thiamine is inactivated by 5-fluorouracil as the latter competitively inhibits the phosphorylation of thiamine to thiamine pyrophosphate.

Antacids diminish the absorption of thiamine.

Loop diuretics, e.g. furosemide that inhibit tubular reabsorption may cause increased excretion of thiamine in long-term therapy and, thus, lowering of the thiamine serum level.

If taken simultaneously with L-dopa, vitamin B₆ can lessen the dopa effect.

The simultaneous administration of pyridoxine antagonists (e.g. isoniazide (INH), hydralazine, D-penicillamine or cycloserine) may decrease the efficacy of vitamin B₆ (pyridoxine).

Long term use of acid-lowering agents may lead to vitamin B₁₂ deficiency.

Alcohol and black tea diminish the absorption of thiamine.

Beverages containing sulphite (e.g. wine) enhance thiamine degradation.

Pregnancy

During pregnancy and the nursing period the generally recommended daily dosage of vitamin B₁ is 1.4 mg and of vitamin B₆ 1.9 mg.

These dosages may be exceeded in pregnant patients with manifest vitamin B₁ and B₆ deficiencies only as the safety of doses higher than the recommended daily dosage has not yet been demonstrated.

There are only insufficient animal studies on the effect of this medicinal product on pregnancy, embryo-foetal, prenatal and postnatal development. The possible risk for human beings is not known. The treating physician should decide about the use of this product during pregnancy after carefully weighing the risk-to-benefit ratio.

Breast-feeding

Vitamins B1, B₆ and B₁₂ are secreted into human breast milk. High concentrations of vitamin B₆ i.e. >600 mg daily, can inhibit the production of breast milk. Data on the extent of secretion into breast milk from animal studies are not available. Therefore, the advantages of breast-feeding for the infant should be carefully weighed against the therapeutic benefit for the women in order to decide to either discontinue breast-feeding or therapy with Neurobion.

Neurobion coated tablets do not affect the capability to drive a vehicle or to operate machinery.

In the following, the undesirable effects are classified by organ system and frequency. The assessment of undesirable effects is based on the following frequency grouping: Very common (≥1/10), Common (≥1/100, to <1/10), Uncommon (≥1/1.000, to <1/00), Rare (≥1/10.000, to <1/1.000), Very rare (<1/10.000), Not known (frequency cannot be estimated from the available data).

Nervous system disorders

Not known: Long-term intake (>6-12 months) of a daily dosage >50 mg vitamin B6 may cause peripheral sensory neuropathy.

Gastrointestinal disorders

Unknown: Gastrointestinal complaints such as nausea, vomiting, diarrhoea and abdominal pain.

Immune system disorders

Very rare: Hypersensitivity reactions such as sweating, tachycardia and skin reactions like itching and urticaria.

Renal and urinary disorders

Not known: Chromaturia (“reddish urine”, appeared during the first 8 hours after an administration and typically resolves within 48 hours).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

Not applicable.