Film coated tablets
Each film coated tablet contains: 100 mg Vitamin B1 + 100 mg Vitamin B6 + 1000 mcg Vitamin B12
Lactose ,Microcrystaline cellulose, Povidone, Isopropyl alcohol , Sodium starch glycolate, Talc , Mg stearate.
Hydroxypropylmethyl cellulose, opaspray white ,Ferric oxide red , Dye Erytrosine EU 127, vanilin , Purified Water.
Chemical and pharmacological Properties of the product :
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 nerves has been shown in various investigations using the vitamins individually and in combination.
Vitamin B1, B6, B12 combination greatly enhances their therapeutic efficacy as compared to the effect of the respective vitamins given individually.
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.
The bioavailability of single oral doses of vitamins B1 and B12 is dependent on the amount presented.
Vitamins B1 and B12 are initially absorbed by active transport mechanisms. After the relatively rapid saturation of the carrier, however, passive concentration- dependent diffusion mechanisms set in. Thus, despite the relatively low rate of absorption with this alternative route, higher individual doses eventually lead to the desired increase in the serum level. Vitamin B6 is absorbed exclusively by passive diffusion.
Vitamin B1: After absorption, thiamine is distributed throughout almost all the tissues of the body. If the metabolic requirement is saturated and once the very limited storage capacity of the tissues is filled, this vitamin is immediately eliminated with the urine in the unaltered or metabolized form.
Vitamin B6: Storage of vitamin B6 takes place mainly in the liver, the musculature and the brain. Unutilized vitamin B6 is excreted with the urine within the first 24 hours post administration almost entirely in the unaltered form (a small fraction is excreted as 4-pyridoxic acid).
Vitamin B12: After absorption, vitamin B12 is very strongly bound to specific transport proteins, with the aid of which it is distributed throughout the individual tissues. In the liver, vitamin B12 is stored in the form of the active coenzyme up to about 5 - 10 mg at a turnover rate of only 0.5 - 8 mcg/day. About 3 - 8 mcg vitamin B12 is excreted with the bile per day, the greater part of which is reabsorbed in the ileum (enter hepatic circulation). Small amounts are also excreted renally at the same time.
The great stock of vitamin B12 explains the time lag between the start of a supply deficiency and the appearance of deficiency symptoms.
Mono- and polyneuropathies eg, diabetic, alcoholic or toxic neuropathies. Neuritis and neuralgia, especially cervical syndrome, shoulder-arm syndrome, lumbago, sciatica, root irritation due to degenerative changes of the vertebral column, herpes zoster, for the follow-up treatment of trigeminal neuralgia and for supportive treatment in facial paresis.
Deficiency or raised requirement of vitamins B1, B6 and B12.
Hypersensitivity to any of the active ingredients or excipients
• Hypersensitivity reactions to vitamin B1 e.g., sweating, tachycardia (rapid heartbeat), and skin reactions with itching and urticaria are very rare.
• Gastrointestinal complaints e.g., nausea, vomiting, diarrhea or abdominal pain
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.
No risks have become known associated with the use of this drug during pregnancy at the recommended dosage.
Vitamins B1, B6 and B12 are secreted into human breast milk, but risks of over dosage 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.
•The effect of levodopa may be reduced when vitamin B6 is administered concomitantly.
•Pyridoxine-Antagonists e.g. Isoniazid, Cycloserine, Penicillamine, 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:
• 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.
• The duration of the treatment is determined by the physician.
• The tablets are swallowed without chewing with a little liquid with or after meals
Prolonged overdosage of vitamin B6 , i.e., for longer than 2 months and >1 g daily, may lead to neurotoxic effects.
Store at room temperature below 25o C, Away from moisture and light.
20 film Coated Tablets .