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SPC, Greece: NEUROBION Tab. (2012)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Neurobion coated tablets.

Qualitative and quantitative composition

One coated tablet contains: Thiamine disulphide (vitamin B1): 100 mg Pyridoxine hydrochloride (vitamin B6): 200 mg Cyanocobalamin (vitamin B12): 200 μg Excipients: Contains 40 mg lactose monohydrate and ...

Pharmaceutical form

Coated tablet. White, shiny, round, biconvex coated tablet.

Therapeutic indications

Neurological diseases caused by vitamin B deficiencies.

Posology and method of administration

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 ...

Contraindications

Hypersensitivity to the active substances or to any of the excipients. Neurobion coated tablets must not be used in children and adolescents due to their high active substance content.

Special warnings and precautions for use

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 ...

Interaction with other medicinal products and other forms of interaction

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. ...

Pregnancy and lactation

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 ...

Effects on ability to drive and use machines

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

Undesirable effects

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, ...

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Vitamin B1 in combination with vitamin B6 and/or vitamin B12 ATC Code: A11DB Neurobion coated tablets contain a combination of neurotropic active substances of the vitamin B ...

Pharmacokinetic properties

Thiamine Has after oral administration a dose-dependent dual transport mechanism: Active absorption up to concentrations of 2 μmol and passive diffusion in concentrations over 2 μmol). The elimination ...

Preclinical safety data

The toxicity of vitamins B1, B6 and B12 is very low. The data available to date do not suggest any potential risk for humans. The literature available on the subject does not contain any findings indicating ...

List of excipients

Tablet core: Magnesium stearate Methyl cellulose Corn starch Gelatin Lactose monohydrate Talc Tablet coating: Montan-glycol wax Gelatin Methylcellulose Acacia Glycerol Povidone Calcium carbonate Colloidal ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Blister pack consisting of base film (hard PVC, transparent, coated with PVDC) and cover foil (aluminium foil coated with heat-sealing lacquer). Package sizes: 20 coated tablets.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Merck A.E. 41-45 Kifisias ave. (Building B') 15123 Marousi Athens Greece

Marketing authorization number(s)

794

Date of first authorization / renewal of the authorization

05.04.1971

Date of revision of the text

13/09/2012

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