METHYCOBAL Tablet Ref.[11043] Active ingredients: Mecobalamin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Medilink Pharmaceuticals Ltd., 30 Armenias, 2003 Strovolos, Nicosia, Cyprus

Product name and form

Methycobal 500μg Tablets.

Pharmaceutical Form

Methycobal Tablets is available as a white, round, biconvex, sugar-coated tablet marked with “E322” on one side.

Clinical Particulars

Methycobal Tablets is a mecobalamin preparation developed by Eisai Co., Ltd. as a treatment for peripheral neuropathies. Methycobal Tablets contains mecobalamin, a vitamin Β12-coenzyme that occurs in the blood and cerebrospinal fluid; it is taken up by nerve tissues more actively and extensively than other homologues of vitamin Β12.

Biochemically, mecobalamin promotes the metabolic pathways of nucleic acids, proteins and lipids through its involvement in the transmethylation reaction; thus, it exerts a repairing effect on injured nerve tissues. Clinically, Methycobal is the first pharmaceutical product that has been shown, by double blind clinical trials, to be effective and useful for the treatment of numbness, pain, and paralysis due to peripheral neuropathies such as diabetic neuropathy and polyneuritis.

Qualitative and quantitative composition

Each tablet contains 500μg of mecobalamin.

Active Ingredient Description
Mecobalamin

Methylcobalamin is a cobalamin, a form of vitamin B12. Mecobalamin is a kind of endogenous coenzyme B12. Mecobalamin plays an important role in transmethylation as a coenzyme of methionine synthetase in the synthesis of methionine from homocysteine. Mecobalamin promotes axonal transport and axonal regeneration. Mecobalamin promotes myelination (phospholipid synthesis). Methylcobalamin is used in the treatment of peripheral neuropathy, diabetic neuropathy, and as a preliminary treatment for amyotrophic lateral sclerosis.

List of Excipients

Carnauba wax
Microcrystalline cellulose
Titanium oxide
Stearic acid
Calcium stearate
Sucrose
Talc
Precipitated calcium carbonate
Corn starch
Lactose hydrate
White shellac
Hydroxypropylcellulose
Pullulan
Povidone
Macrogol 6000
Hydrated silicon dioxide

Pack sizes and marketing

PTP (Press-Through-Package) blister pack in Aluminium pillow.

Boxes of 30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Medilink Pharmaceuticals Ltd., 30 Armenias, 2003 Strovolos, Nicosia, Cyprus

Marketing authorization dates and numbers

20202

Date of first authorisation: 19 November 1998

Drugs

Drug Countries
METHYCOBAL Cyprus, Hong Kong, Japan, Singapore

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