Neurobion

Neurobion

Manufacturer:

P&G Health

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Vitamin B-complex.
Description
Each coated tablet contains vitamins B1 (thiamine disulfide) 100 mg, vitamin B6 (pyridoxine hydrochloride) 200 mg and vitamin B12 (cyanocobalamin) 200 mcg.
It also contains the following excipients: Montan-glycol wax, acacia, povidone, methyl cellulose, magnesium stearate, purified water, calcium carbonate, glycerol, mannitol, colloidal anhydrous silica, kaolin, gelatin, titanium dioxide (E 171), sodium starch glycolate, talc, sucrose.
Neurobion is a combination of the 3 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 B1 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 3 vitamins justify their combined use.
Action
Mode of Action: Vitamin B1, B6, B12 are indispensable to normal nerve cell metabolism and this combination greatly enhances their therapeutic efficacy as compared to the effect of the respective factors given individually.
Indications/Uses
Film-Coated Tablet: 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.
Treatment of neuritis and neuralgia of the spinal nerves, especially facial paresis, cervical syndrome, low back pain, and ischialgia.
Dosage/Direction for Use
Film-Coated Tablet: 1 tab 3 times daily to treat moderate cases, or to provide interval and follow-up therapy for a course of injections unless prescribed otherwise by physician.
The dosage and duration of the treatment is determined by the physician depending on the condition of the patient.
Administration: Neurobion tab are swallowed without chewing with a little liquid with or after meals.
Overdosage
Sensorial neuropathy and other sensorial neuropathy syndromes which can be caused by long-term administration of high doses of pyridoxine improve gradually upon vitamin discontinuation.
Contraindications
Hypersensitivity to any of the active ingredients or excipients of Neurobion (see Description).
Use in children: Neurobion film-coated tablets are not suitable for the treatment of children below the age of 14 years due to the high content of active ingredients.
Special Precautions
Neuropathies are described under long-term intake (6-12 months) of >50 mg mean daily dose of vitamin B6. Therefore, under long-term treatment, regular monitoring is recommended.
Neurobion film-coated tablets contain sucrose; therefore, its use is not recommended in patients with intolerance to some sugars (ie, rare hereditary galactose or fructose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency, or sucrose-isomaltase insufficiency). Contains fish gelatine.
Use in pregnancy & 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 overdosage for the infant are not known. In individual cases, high doses of vitamin B6 ie, >600 mg daily, may inhibit the production of breast milk.
Use In Pregnancy & 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 overdosage for the infant are not known. In individual cases, high doses of vitamin B6 ie, >600 mg daily, may inhibit the production of breast milk.
Adverse Reactions
Hypersensitivity reactions to vitamin B1 eg, sweating, tachycardia (rapid heart beat), and skin reactions with itching and urticaria are very rare.
Chromaturia ("reddish urine", appears during the first 8 hours after an administration and typically resolves within 8 hours after an administration and typically resolves within 48 hours) may occur.
Gastrointestinal complaints eg, nausea, vomiting, diarrhoea or abdominal pain may occur.
Drug Interactions
The effect of levodopa may be reduced when vitamin B6 is administered concomitantly.
Pyridoxine-Antagonists eg, Isoniazid, Cycloserine, Penicillamine, Hydralazine: The efficacy of vitamin B6 (pyridoxine) may be decreased.
Loop Diuretics eg, Furosemide: In long-term use, the blood level of thiamine may be reduced.
Long term use of acid lowering agents may lead to Vitamin B12 deficiency.
Storage
Do not store above 25°C. Do not use after the expiry date. Keep in a dry place.
ATC Classification
A11DB - Vitamin B1 in combination with vitamin B6 and/or vitamin B12 ; Used as dietary supplements.
Presentation/Packing
FC tab (almost white, shiny, round coated tablet, highly convex on both sides) 6 x 10's, 50 x 10's.
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