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

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: P&G Health Germany GmbH, Sulzbacher Strasse 40, 65824 Schwalbach am Taunus, Germany

Therapeutic indications

Neurological diseases caused by vitamin B deficiencies.

Posology and method of administration

Posology

One coated tablet once daily. In individual cases, the dose may be increased to one coated tablet 3 times daily.

The coated tablets are to be swallowed whole with plenty of liquid after meals.

Duration of administration

The physician in charge should decide on the duration of administration.

After a maximum period of four weeks, it should be decided whether to reduce the dose. (See section 4.4 ‘Special warnings and precautions for use’).

Paediatric population

Neurobion coated tablets must not be used in children and adolescents (<18 years).

Overdose

Vitamin B1

Thiamine has a broad therapeutic range. Very high doses (over 10 g) have a ganglion-blocking effect, similar to that of curare, and suppress the conduction of nerve impulses.

Vitamin B6

The toxic potential of vitamin B6 can be considered as very low. Long-term intake (>6-12 months) of a daily dosage >50 mg vitamin B6 may, however, cause peripheral sensory neuropathy and other sensorial neuropathy syndromes. These symptoms improve gradually upon vitamin discontinuation..

Continuous intake of vitamin B6 at a daily dosage of more than 1 g over more than two months may produce neurotoxic effects.

Neuropathies with ataxia and sensitivity disorders, cerebral convulsions with EEG changes as well as, in individual cases, hypochromic anaemia and seborrhoeic dermatitis have been described after administration of more than 2 g daily.

Vitamin B12

Allergic reactions, eczematous skin changes and a benign form of acne have been observed after high parenteral doses (in rare cases also after oral doses).

Shelf life

2 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

PVC foil coated with PVDC (40 g/m²)

Aluminum Foil

Water based print primer lacquer outside

Package sizes: 20 coated tablets.

Special precautions for disposal and other handling

No special requirements.

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