PRESCRIBING INFORMATION

Presentation
E-fill 200: Each liquid-filled hard gelatin capsule contains Vitamin E USP 200 mg (as Alpha Tocopheryl Acetate).
E-fill 400: Each liquid-filled hard gelatin capsule contains Vitamin E USP 400 mg (as Alpha Tocopheryl Acetate).

Pharmacodynamic Properties
The main role of Vitamin E seems to act as a defense against lipid peroxidation and oxidative stress. In most cell membranes there is one molecule of Vitamin E for every 1000 lipid molecules. Vitamin E mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. It protects RBCs against hemolysis and stimulates a cofactor in steroid metabolism.

Pharmacokinetic Properties
Absorption: Vitamin E is absorbed from gastrointestinal tract and requires bile, pancreatic juice & dietary fat for sufficient absorption. * Metabolism: It follows hepatic metabolism to glucuronides and its gamma lactone. * Excretion: Vitamin E is excreted mainly in the bile and small amounts are excreted in urine.

Indications
As a dietary supplement for prophylactic use: * To meet raised requirements of vitamin E in pregnancy and lactation, high dietary intake of polyunsaturated fatty acids * For the prevention of vitamin E deficiency due to malabsorption syndrome caused by pancreatic, hepatobiliary & gastrointestinal disorders * For healthy hair & skin * As an antioxidant Therapeutic use: In cardiovascular disease, hemolytic anemia due to vitamin E deficiency, skin conditions, nocturnal leg cramps, sexual dysfunction, premenstrual syndrome, fibrocystic disease of the breast, aging, cancer, oxygen therapy, habitual abortion.

Dosage and Administration
Betterment of Cardiovascular health: 400 mg - 800 mg/day; Deficiency syndrome in adults: 200 mg - 400 mg/day; Deficiency syndrome in children: 200 mg/day; Thalassemia: 800 mg/day; Sickle-cell anemia: 400 mg/day; Betterment of Skin & Hair: 200 mg - 400 mg/day (Topical use is also established for beautification); Chronic cold in adults: 200 mg/day.

Contraindications
No absolute contraindication unless any known hypersensitivity to vitamin E.

Precautions
It may increase the risk of thrombosis in some patients who are taking estrogens.

Drug Interactions
High dose of Vitamin E can impair intestinal absorption of Vitamin A & K and may increase the effects of oral anticoagulants.

Side Effects
Vitamin E is usually well tolerated. Large doses (more than 1 gm/day) for prolonged period have been associated with a variety of less serious side effects including fatigue, weakness, headache, nausea, blurred vision, flatulence or diarrhoea.

Use in Pregnancy and Lactation
Pregnancy: Vitamin E may be used in pregnancy in the normally recommended dose but the safety of high dose therapy has not been established.
Lactating Mother: Vitamin E is distributed in human breast milk; however, problems have not been documented with normally recommended dose.

Overdose
Large doses of vitamin E (more than 1 gm/day) have been reported to increase bleeding tendency in vitamin K deficient patients such as those taking oral anticoagulants.

Storage Conditions
Store in a cool and dry place. Keep away from light and out of the reach of the children.

Commercial Pack
E-fill 200: Each air tight container contains 30 Liquid-Filled Hard Gelatin Capsules.
E-fill 400: Each air tight container contains 30 Liquid-Filled Hard Gelatin Capsules.