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Product Information Methylcobalamin (also known as met-Cbl; MeCbl; Methyl-B12) is an active endogenous Coenzyme form of Vitamin B12 that transfers a Methyl group from an inactive form of Folic Acid to Homocysteine forming Methionine. This is the only active endogenous coenzyme form of Vitamin B12 that is available as a supplement (in tablet form). Methylcobalamin accounts for approximately 70% of the total Blood Plasma Vitamin B12 reserves. Clinical trials have shown that supplemental Methylcobalamin is greatly superior to other forms of Vitamin B12 supplements in terms of its ability to enhance human health. The Liver converts approximately 1% of the Cyanocobalamin form of Vitamin B12 to Methylcobalamin. PRODUCT INFORMATION FOR METHYLCOBALAMIN PROPRIETARY NAME (and dosage form): Methylcobalamin (tablets) COMPOSITION: Each sublingual tablet contains the following as active ingredients: Methylcobalamin B12 1000µg Inactive ingredients: isomalt, strawberry flavour, sucralose and magnesium stearate (vegetarian flow agent). PHARMACOLOGICAL ACTION: Methylcobalamin is an essential water soluble vitamin B also known as vitamin B12. Vitamin B12 is required for nuclear-protein and myelin synthesis, cell reproduction, normal growth, and normal erythropoiesis. Vitamin B12 is converted to coenzyme B12, which is essential for the conversion of methylmalonate to succinate, and the synthesis of methionine from homocysteine. Vitamin B12 is involved in maintaining sulfhydryl groups in the reduced form required by enzymes involved in fat and carbohydrate metabolism, and protein synthesis. Vitamin B12 is involved in folate synthesis and a deficiency of methylcobalamin results in a functional folate deficiency. Vitamin B12 is required as part of the remethylation of homocysteine to methionine. Elevated levels of homocysteine has been linked to the increase risk of endothelial cell damage, impared endothelial-dependent vasodialation due to reduced nitric oxide activity, increased oxidation and arterial deposition of low-density lipoproteins (LDL), increased platelet adhesiveness, and activation of the clotting cascade. Vitamin B12 supplements have a small additive effect to folic acid in lowering fasting homocysteine levels, but probably only in people with vitamin B12 deficiency. Elevated homocysteine concentrations are possibly associated with other conditions such as decreased cognitive function, impaired memory, Alzheimer's disease, and vascular dementia. The methylcobalamin form of vitamin B12 might also influence melatonin levels. Methylcobalamin seems to improve alertness and reduce sleep time in humans with normal sleep patterns, possibly due to effects on melatonin. Pharmacokinetics: Vitamin B12 is absorbed via an active transport mechanism in the terminal ileum. This requires the glycoprotein, intrinsic factor, which is produced by the stomach. At normal gastric pH, vitamin B12 is cleaved from proteins in food. It then binds to intrinsic factor and is absorbed by ileal transport. Absorption may be reduced by increased gastric pH such as atrophic gastritis, use of acid-suppressing drugs, or partial gastrectomy. The half life of vitamin B12 is 6 hours and is secreted mainly via the bile. INDICATIONS: Primary Indication: Vitamin B12 deficiency. Other Indications: Vitamin B12 is a vitamin which assists with vegetarian diet deficiencies, cardiovascular health, brain and nerve function, and promotes healthy sleep. CONTRA-INDICATIONS: There are no known contra-indication. WARNINGS: Do not exceed recommended dosages unless on the advice of a healthcare provider. Do not use this product if you are allergic to any of the ingredients. If you are on any medication or suffering from any medical condition, it is advisable to seek medical advice before starting any new medicine, supplement or remedy. INTERACTIONS: Chloramphenicol: Limited case reports suggest that chloramphenicol can delay or interrupt the reticulocyte response to supplemental Vitamin B12 in some patients. Monitor blood levels carefully if the combination cannot be avoided. Absorption: The following medicines can reduce the absorption of Vitamin B12: aminosalicylic acid, antibiotics, colchicine, cholestyramine, H2 blockers, metformin, neomycin, nitrous oxide, oral contraceptives, phenytoin, phenobarbital, primidone, proton pump inhibitor, zidovudine. PREGNANCY AND BREAST-FEEDING: Safety in pregnancy and breast-feeding has not been established, do not use. DOSAGE AND DIRECTIONS FOR USE: Adults and children over 12 years of age: Take 1-4 tablets sublingually (under the tongue) or as recommended by your healthcare provider. The optimal daily requirement for correcting vitamin B12 deficiency is 1000-2000 µg (1-2 tablets) per day. Vegetarians are particularly prone to Vitamin B12 deficiency and should also take 1-2 tablets daily, as should people with high homocysteine levels or cardiovascular disease. A daily dose of 3000-4000 µg (3-4 tablets) is recommended for improving sleep patterns and people with memory problems. Tablets can be taken as a single dose and should be taken with or shortly after the main meal of the day. Children 7-12 years of age: Take half the adult dose. SIDE EFFECTS AND SPECIAL PRECAUTIONS: Side effects: Rarely reported side effects include: diarrhoea, itching, transitory rash and urticaria. Special Precautions: Excessive alcohol intake lasting longer than two weeks can decrease vitamin B12 absorption from the gastrointestinal tract. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Treatment should be symptomatic and supportive. In the case of accidental overdose of the product, contact the nearest hospital or poison control centre. IDENTIFICATION: 10mm scored pink tablet with dark speckles. PRESENTATION: White HDPE container with white HDPE screw cap and seal for protection. STORAGE INSTRUCTIONS: Store in a cool dry place, out of the reach of children.
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