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Neurobion

Active ingredients: Vitamins of the B group ( B1, B6, B12 )

 

Composition
Each coated tablet contains, as active ingredients, 100 mg vitamin B, (thiamine disulfide), 200 mg vitamin B6 (pyridoxine hydrochloride), 200 microgram vitamin B12 (cyanocobalamin).


Excipients: montan-glycol wax, gelatin, methyl cellulose, acacia, magnesium stearate, glycerol 85%, povidone 25, calcium carbonate, colloidal silicon dioxide, corn starch, kaolin, lactose monohydrate, talc, sucrose, titanium dioxide.


Product description
Almost white shiny round coated tablets, highly convex on both sides.


Properties
Neurobion is a combination of three essential neurotropic vitamins (B1, B6 and B12) in high dosage. Vitamins B1, B6 and B12 are of special importance for the metabolism in the peripheral and central nervous system. Their effect on the regeneration of nerves has been shown in various investigations using the vitamins individually and in combination.


Vitamin B, plays an important role in major metabolic processes. Vitamin B6 has an analgesic effect. Vitamin B12 ensures blood cell formation and prevents degenerative processes of the nervous system. Both the individual function and the beneficial biochemical links between the three vitamins justify their combined use.


Indication
Neurobion is indicated for neurological and other disorders associated with disturbance of metabolic functions influenced by B complex vitamins, including diabetic polyneuropathy, alcoholic peripheral neuritis and post influenzal neuropathies.


Neurobion is also recommended for the treatment of neuritis and neuralgia of the spinal nerves, especially facial paresis, cervical syndrome, low back pain, ischialgia.


Contraindications
Neurobion must not be used in patients hypersensitive to any of the active ingredients or excipients of the product (see 'Composition').


Neurobion coated tablets are not suitable for the treatment of children due to the high content of active ingredients.


Warnings and precautions
In the literature neuropathies are described under long term intake (6-12 months) of more than 50 mg mean daily dose of vitamin B6. Therefore, under long-term treatment regular monitoring is recommended.


Neurobion coated tablets contain lactose and sucrose; therefore its use is not recommended in patients with intolerance to some sugars (i.e. rare hereditary galactose or fructose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency, or sucrose-isomaltase insufficiency).

 

Pregnancy and lactation
No risks have become known associated with the use of Neurobion during pregnancy at the recommended dosage.

 

Vitamins B1, B6 and B12 are secreted into human breast milk, but risks of overdose for the infant are not known. In individual cases, high doses of vitamin B6, i.e. > 600 mg daily, may inhibit the production of breast milk.


Adverse effects
Hypersensitivity reactions to vitamin B1, such as sweating, tachycardia (rapid heart beat), and skin reactions with itching and urticaria are very rare.


Gastrointestinal complaints, such as nausea, vomiting, diarrhoea or abdominal pain may occur.


Please speak to your doctor, if such symptoms or other unwanted effects occur.


Interactions
The effect of L-dopa may be reduced when vitamin B6 is administered concomitantly.


Pyridoxine-antagonists, e.g. isoniazid (INH), cycloserin, penicillamin, hydralazine: the efficacy of vitamin B6 (pyridoxine) may be decreased.


Loop diuretics, e.g. furosemide: In long-term use, the blood level of thiamine may be reduced.


Dosage and administration
1 coated tablet three times daily to treat moderate cases, or to provide interval and follow-up therapy for a course of injections.


Neurobion coated tablets are swallowed without chewing with a little liquid with or after meals.The duration of the treatment is determined by the doctor.


Overdose
Prolonged overdose of vitamin B6, i. e. for longer than 2 months and more than 1 g per day, may lead to neurotoxic effects.


Storage and stability
Do not store above 25C.
Do not use after the expiry date. Keep in a dry place.
Keep medicines out of the reach of children.


Presentations
10, 30, 60, 90, 100 and 500 coated tablets.
Not all containers or pack sizes may be registered or marketed.

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