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NEUROBION Tab. (2012)

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 40 mg lactose monohydrate and 133.22 mg sucrose.

For a complete list of excipients see section 6.1.

Chemical substance
Description
Vitamin B1

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

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.

Vitamin B12

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
Corn starch
Gelatin
Lactose monohydrate
Talc

Tablet coating:

Montan-glycol wax
Gelatin
Methylcellulose
Acacia
Glycerol
Povidone
Calcium carbonate
Colloidal silicon dioxide
Kaolin
Titanium dioxide (E171)
Sucrose

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

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

05.04.1971

Marketing authorization number:

794