NEUROBION Coated tablet

Active ingredients: Vitamin B1 Pyridoxine Vitamin B12

Product name and form

Neurobion coated tablets.

Pharmaceutical Form

Coated tablet

White, shiny, round, biconvex coated tablet.

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 133.22 mg sucrose.

For a complete list of excipients see section 6.1.

Active Ingredient
Description

Thiamine pyrophosphate (TPP), the coenzymatic form of thiamine, is involved in two main types of metabolic reactions: decarboxylation of α-ketoacids (e.g. pyruvate, α-ketoglutarate and branched-chain keto acids) and transketolation (e.g. among hexose and pentose phosphates). Therefore, the principal physiological role of thiamine is as a coenzyme in carbohydrate metabolism, where TPP is required for several stages in the breakdown of glucose to provide energy.

Pyridoxine hydrochloride is Vitamin B6. It is converted to pyridoxal phosphate which is the co-enzyme for a variety of metabolic transformations. It is essential for human nutrition.

Hydroxocobalamin is used in the treatment and prevention of Vitamin B12 deficiency. For adults, the daily requirement of Vitamin B12 is probably about 1 to 2 micrograms and this amount is present in most normal diets. However, Vitamin B12 only occurs in animal products, not in vegetables, and therefore strict vegetarian or vegan diets that exclude dairy products may provide an inadequate amount, although a deficiency may not be apparent for many years.

List of Excipients

Tablet core:

Magnesium stearate
Methyl cellulose
Sodium starch glycolate
Gelatin
Mannitol
Talc
Glycerol 85%
Colloidal anhydrous silica
Purified water

Tablet coating:

Montan-glycol wax
Gelatin
Methyl cellulose
Acacia
Glycerol 85%
Povidone
Calcium carbonate
Colloidal anhydrous silica
Kaolin
Titanium dioxide (E171)
Talc
Sucrose

Pack sizes and marketing

PVC foil coated with PVDC (40 g/m²)

Aluminum Foil

Water based print primer lacquer outside

Package sizes: 20 coated tablets.

Marketing Authorization Holder
Authorization Dates

P&G Health Germany GmbH, Sulzbacher Strasse 40, 65824 Schwalbach am Taunus, Germany

05.04.1971

Marketing authorization number:

794

Drugs

Drug
Countries
Austria, Cyprus, Hong Kong, Singapore