Neurobion/Neurobion Forte

Neurobion/Neurobion Forte

Manufacturer:

P&G Phil

Distributor:

Zuellig
Full Prescribing Info
Contents
Vitamins B1, B6, B12.
Description
Neurobion tab: See Table 1.

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Neurobion Forte tab: Each film-coated tablet contains thiamine mononitrate (Vitamin B1) 100 mg, pyridoxine hydrochloride (Vitamin B6) 100 mg, cyanocobalamin (Vitamin B12) 5 mg.
The massive doses of vitamins B1, B6 and B12 contained in Neurobion Forte coated tablets are intended for antalgic therapy. Neuritis of infectious, traumatic and toxic origin, and other algias usually respond very well to high doses of these vitamins.
Neurobion Forte soln for inj: See Table 2.

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Action
Pharmacologic Category: Vitamins.
Pharmacology: Neurobion tab: Vitamins B1 + B6 + B12 (NEUROBION) tablet contains ingredients that effectively nourish the nerves as well as protect and regenerate nerves. Thiamine mononitrate (Vitamin B1) is involved in the conduction of nerve impulses. Pyridoxine hydrochloride (Vitamin B6) plays an essential role in the nervous system, especially in the enzymatically controlled neurotransmitter metabolism. Cyanocobalamin (Vitamin B12) is involved in the methylation of the myelin basic protein, a constituent of the myelin sheaths of the nervous system.
Pharmacodynamics/Pharmacokinetics: Neurobion Forte soln for inj: Vitamins B1, B6 and B12 (NEUROBION Forte) is a combination of three essential neurotropic vitamins (B1, B6 and B12) in high dose preparation. Vitamins B1, B6 and B12 are of special importance as they are indispensable components in normal nerve cell metabolism. The combination greatly enhances their therapeutic efficacy as compared to their effect individually.
In the human body, thiamine hydrochloride is converted to thiamine pyrophosphate (active form), which is a coenzyme in the decarboxylation of a-keto acids.
On the other hand, pyridoxol HCI will be transformed to pyridoxol phosphate, it is a coenzyme chemical involved in protein and amino acid metabolism. Vitamin B12 is essential in nucleic acid and myelin protein synthesis; for cell growth and replication and maintaining the integrity of the nervous tissue.
Indications/Uses
Neurobion tab: Vitamins B1 + B6 + B12 (NEUROBION) tablet is indicated for: Neuritis and neuralgia, especially cervical syndrome, shoulder-arm syndrome, lumbalgia, sciatica, facial paresis. Alcoholic polyneuropathy. Diabetic neuropathy, including impotence due to autonomic neuropathy. Metabolic and neuropathic changes due to pregnancy and oral contraceptives. Nausea and vomiting of pregnancy. Drug-induced neuropathies. Supplemental therapy following major surgery or debilitating illness.
Neurobion Forte tab: Diabetic neuropathy; neuralgias and neuritis, algias of rheumatic and traumatic origin; degenerative conditions of the spine or surgical operations carried out thereon, herpes zoster, hermicrania and facial paresis; nausea and vomiting of pregnancy.
The coated tablets lend themselves very well to continuation of the treatment started with the ampuls or alternatively started with injections in order to speed up the treatment and also, at the end of treatment, for avoiding relapses.
Neurobion Forte soln for inj: Treatment of disorders associated with Vitamin B-complex deficiency. Pronounced analgesic and neuro-regenerative effects are produced by this high dosage combination and is therefore particularly valuable in the treatment of disorders of peripheral nervous system: polyneuritis, neuralgia, sciatica and shoulder-arm syndrome, lumbago-lumbalgia, intercostal neuralgia, trigeminal neuralgia, facial palsy due to herpes zoster, diabetic neuropathy, optic neuritis, numbness of the extremities, as a supplement to therapy with INH, reserpine and phenothiazines, nausea and vomiting of pregnancy, vitamin B deficiency, cerebrovascular accidents.
Dosage/Direction for Use
Neurobion tab: Unless otherwise prescribed by the physician, 1 tablet one to three times daily to treat moderate cases, or to provide interval and follow-up therapy for a course of injections.
Missed dose: If the patient forgot to take Vitamins B1 + B6 + B12 (NEUROBION), the patient should not make up for it by doubling the next dose. Simply take the next dose at the usual time.
Neurobion Forte tab: Two to four tablets in divided doses per day are taken, without chewing them, with a small amount of liquid, after meals. In more severe cases, the doses can be increased at the discretion of the physician.
Neurobion Forte soln for inj: Vitamins B1 + B6 + B12 (NEUROBION Forte) is administered through intramuscular injection.
For initial treatment of severe cases, 1 ampoule pair per day is given until the acute symptoms subside. For follow-up therapy, 2-3 ampoule pairs are given per week.
The duration of the treatment is determined by the doctor.
Overdosage
Neurobion tab: Signs and Symptoms: 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.
No cases of overdose with thiamine or cyanocobalamin have been described.
What to do when patient has taken more than the recommended dosage: Observe for adverse reactions as a result of overdose. Consult a physician immediately when these manifest.
Neurobion Forte soln for inj: 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
Neurobion tab: The patient should not take this medicine if the patient is hypersensitive to any of the active ingredients or excipients of this product. This should not be taken by children below 14 years of age. Consult physician if symptoms persist, use in pregnant women or planning pregnancy and patients under treatment.
Neurobion Forte soln for inj: Vitamins B1, B6 and B12 (NEUROBION Forte) must not be used in patients hypersensitive to any of the active ingredients or excipients of the product. This product should not be given to children below 14 years of age.
Special Precautions
Neurobion tab: Before taking the tablet, please ensure that it was stored in a cool dry place, not exceeding 25°C. The packaging should not be severely damaged at the time of purchase as there might be danger of product degradation or exposure to contaminants.
Neuropathies are described in the literature following long-term intake (6-12 months) of more than 50 mg mean daily dose of vitamin B6. Therefore, regular monitoring is recommended under long-term treatment.
Vitamins B1 + B6 + B12 (NEUROBION) tablet contains lactose and sucrose; therefore its use is not recommended in patients with rare hereditary galactose or fructose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency, or sucrase-isomaltase insufficiency.
In individual cases, high doses of vitamin B6, i.e. > 600 mg daily, may inhibit the production of breast milk.
No effects of the product on the ability to drive or use machines are known.
Take Vitamins B1 + B6 + B12 (NEUROBION) tablet only as recommended or as supervised by a physician.
Neurobion Forte soln for inj: 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.
Do not re-use syringes and needles. Syringes and needles must be disposed immediately after use. Used syringes and needles must not be disposed in waste bins or toilets, but they must be disposed in a special sharps container.
This medication is used to treat lack or deficiency of vitamins when the form taken by mouth cannot be used or would not work as well as the injection.
Do not share this medication with others. This product is not a substitute for a proper diet. Remember that it is best to get vitamins from healthy foods.
Use In Pregnancy & Lactation
Neurobion Forte soln for inj: No risks have become known associated with the use Vitamins B1 + B6 + B12 (NEUROBION Forte) 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 Reactions
Immune system disorders: Hypersensitivity reactions, such as sweating, tachycardia, and skin reactions with itching and urticaria. In single cases, conditions of shock have been observed after treatment with vitamin B1 or B12 injections.
Gastrointestinal disorders: Gastrointestinal complaints, such as nausea, vomiting, diarrhea and abdominal pain.
Renal and urinary disorders: Chromaturia ("reddish urine" appears during the first 8 hours after an administration and typically resolves within 48 hours).
Stop taking this product and consult with a physician if the above effects are observed.
Drug Interactions
Vitamin B6 (pyridoxine) may decrease the effect of L-DOPA.
Pyridoxine antagonists such as isoniazid, cycloserine, penicillamine, or hydralazine may decrease the efficacy of vitamin B6 (pyridoxine).
Long-term use of loop diuretics such as furosemide may accelerate the elimination and thus decrease the serum levels of vitamin B1 (thiamine).
Long-term use of acid-lowering agents may lead to vitamin B12 deficiency.
Caution For Usage
Neurobion Forte soln for inj: Incompatibilities: It is not recommended to use Vitamins B1 + B6 + B12 (Neurobion Forte) solution for injection together with other medicinal products in a "mixed injection" or infusion.
Vitamin B1 is completely degraded by sulfite-containing infusion solutions.
Other vitamins, especially cyanocobalamin, may be inactivated in the presence of Vitamin B degradation products.
Storage
Neurobion tab: Store at temperatures not exceeding 25°C.
Neurobion Forte tab, Neurobion Forte soln for inj: Store at temperatures not exceeding 30°C.
ATC Classification
A11DB - Vitamin B1 in combination with vitamin B6 and/or vitamin B12 ; Used as dietary supplements.
Tab:Non-Rx;Inj:Rx
Presentation/Packing
Neurobion tab (white, round, biconvex, shiny sugar coated) 10's, 30's, 100's. Neurobion Forte tab 10's, 50's. Neurobion Forte soln for inj (amp) 2 mL x 20 pairs.
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