VITAMIN E

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INFORMATION FOR MEDICAL STAFF

COMPOSITION:
Vitamin E (dl-alpha tocopheryl acetate) ....... 400 IU
Excipients q.s................................... 1 soft capsule
(Refined soybean oil, gelatin 150 bloom, sorbitol liquid, glycerin, potassium sorbate, vanillin).
PHARMACEUTICAL FORM: Soft capsule.
PHARMACODYNAMIC PROPERTIES:
ATC CODE: A11HA03
Vitamin E is a fat-soluble vitamin, is widely distributed in food. The richest sources of vitamin E are vegetable oils, especially wheat-germ oil, sunflower oil, cottonseed oil; cereals and eggs are also good sources of vitamin E. Significant losses of vitamin E from food may occur during cooking and storage. The daily requirement of vitamin E is about 4 - 15 mg.
Deficiency of vitamin E is rare but develops in people who cannot absorb vitamin E and in those suffering from some genetic diseases which prevents a normal maintenance of blood vitamin E concentrations.
Exact biological function of vitamin E in human is completely unknown. Vitamin E is considered an antioxidant. Vitamin E prevents oxidation of unsaturated polymeric fatty acids, as well as other oxygen-sensitive substances such as vitamin A and vitamin C. Free radicals generated by cellular reaction processes are capable of damaging to cell membranes, proteins and nucleic acids, leading to dysfunctions and causing a disease to cells. Vitamin E reacts with free radicals, loses peroxyl radicals. In the course of the reaction, vitamin E does not generate another free radical.
Due to the antioxidant property of vitamin E, there have been many studies using vitamin E to relieve mild dementia of early Alzheimer's disease or aging, macular degeneration related to age, cancers, arteriosclerosis, coronary heart disease, cataracts, etc. but efficacy so far has not been clearly proven.
PHARMACOKINETIC PROPERTIES:
Absorption: Absorption of vitamin E from the gastrointestinal tract is dependent on the presence of bile and on normal pancreatic function. The amount of vitamin E absorbed appears to decrease as the dose is increased. Approximately 20 - 60% of vitamins are absorbed from food sources. In patients with malabsorption syndrome and low birth weight premature infants, absorption of vitamin E can be greatly reduced. Water-dispersed preparations can be absorbed through the intestine better than oily preparations.
Distribution: It enters the blood via the chylomicrons in the lymph and is transported to the liver. Vitamin E is secreted by the liver as low density lipoprotein (VLDL) and serum concentrations of vitamin E depend on the liver. The liver preferentially resecretes only R-alpha-tocopherol via the hepatic alpha-tocopherol transfer protein. Vitamin E is widely distributed to all tissues, stored in adipose tissue. Plasma concentrations of tocopherol normally is 6 - 14 micrograms per ml or less than 800 micrograms of vitamin E per gram of lipid within several months that is seen as reflecting a deficiency of vitamin E. After high doses of vitamin E is orally taken, plasma tocopherol concentrations may be high up in 1 - 2 days. Total reserves of vitamin E in the body is estimated as 3 - 8 g and can meet the body's needs for 4 years or more in case of poor vitamin dietary intake. Alpha tocopherol is distributed in eyes and achieves concentrations higher in cornea than in choroid or lens. The concentrations may be increased when vitamin is added. Vitamin E appears in breast milk but is poorly transferred across the placenta. Plasma tocopherol concentrations in neonates is 20 - 30% of those in the mother; low vitamin E concentrations are also found in low birth-weight infants.
Secretion: Some vitamin E is metabolised in the liver to glucuronides of tocopheronic acid and its gamma-lactone. Some is excreted in the urine, but most of a dose is slowly excreted in the bile.
PRESENTATION: Box of 10 blisters x 10 soft capsules.
THERAPEUTIC INDICATIONS:
Treatment and prevention of vitamin E deficiency (poor dietary intake of vitamin E, children with pancreatic cirrhosis or lipid malabsorption due to biliary atrophy or abetalipoproteinaemia, premature, very low birth-weight infants).
The major signs of vitamin E deficiency are the development of myopathic and neurological disorders such as hyporeflexia, gait abnormalities, hyposensitivity to vibrations and personal sensibilities, ophthalmoplegia, retinopathy, axon degeneration.
DOSAGE & ADMINISTRATION:
For treatment and prevention of vitamin E deficiency: The recommended dose is 1 soft capsule once daily after meals.
CONTRAINDICATIONS: Hypersensitivity to one of the components of the drug.
PRECAUTIONS: A higher incidence of necrotising enterocolitis has been noted in premature infants weighing less than 1.5 kg treated with vitamin E.
Large doses of vitamin E have been reported to increase bleeding tendency in vitamin-K deficient patients such as those taking oral anticoagulants.
Vitamin E's effects are mostly studied in a few weeks or months; so chronic lifelong effects during high doses and prolonged administration of vitamin E are still unclear. However, caution should be exercised during the treatment; high doses of vitamin E 400 IU in patients with chronic diseases related to mortality rate from all causes should be noted.
Pregnancy: During pregnancy, lack or excess of vitamin E do not cause complications for the mother or fetus. Vitamin E requirement in a pregnant woman and a normal woman is not different. The mother with good nutrition is not necessary to supplement vitamin E due to adequate amount of vitamin E in food. A demand of vitamin E should be daily supplemented during pregnancy if it is a poor dietary intake.
Lactation: Vitamin E appears in breast milk. Vitamin E in human milk has 5 times higher than cow's milk and is more effective in maintaining adequate amount of serum concentrations of vitamin E in children up to 1 year old.
Daily demand of vitamin E while breastfeeding is 19 mg. The mother should have been supplemented vitamin E if it was not be provided sufficiently during the daily dietary intake.
Effects on works: The drug causes no effects on machine users, drivers, workers at height, and other cases.
INTERACTIONS: Vitamin E or its metabolites may alter the effect of vitamin K actions and may increase the effects of anticoagulants.
Concurrent use of vitamin E and acetylsalicylic acid may cause a risk of bleeding.
Vitamin E may increase the absorption, use, and storage of vitamin A. Vitamin E protects vitamin A from oxidative degeneration which makes an increased cellular concentrations of vitamin A; Vitamin E also protects against the effect of excess vitamin A. However, the effect is still being debated.
Dose of vitamin E more than 10 IU/kg may slow response of iron treatment in children with iron-deficiency anemia. Low birth-weight infants supplemented with iron may increase hemolytic anemia due to vitamin E deficiency.
Excessive use of mineral oil can reduce the absorption of vitamin E.
Various drugs may interfere with the absorption of vitamin E including colestyramine, colestipol, and orlistat. The interval between oral doses should be 2 hours.
UNDESIRABLE EFFECTS (ADRs): Vitamin E is often tolerated. ADRs can occur with high doses, prolonged administration, and intravenous injection, especially when used for premature, low birth-weight infants.
Central nervous system disorders: headache, dizziness.
Eyes disorders: blurred vision.
Gastrointestinal disorders: nausea, diarrhea, abdominal pain, dyspepsia, necrotizing enterocolitis.
Endocrine and metabolic disorders: gonad abnormalities, breast pain, increased serum cholesterol and triglycerides, decreased serum thyroxin and triiodothyronine.
Renal disorders: urinary creatine, increased serum creatine kinase, increased urinary estrogen and androgen.
Others: rash, dermatitis, fatigue, thrombus phlebitis.
OVERDOSE: No found.
Read the directions carefully before use.
Consult the physician for more information.
STORAGE CONDITIONS: Store in dry places, not exceeding 30oC, protect from light.
SHELF-LIFE: 36 months from the manufacturing date.
DATE OF REVISION OF THE TEXT: September 19, 2017INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine.
Keep out of reach of children.
Immediately tell your doctor or pharmacist of undesirable effects encountered during the treatment.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Vitamin E (dl-alpha tocopheryl acetate) ....... 400 IU
Excipients q.s.................................. 1 soft capsule
(Refined soybean oil, gelatin 150 bloom, sorbitol liquid, glycerin, potassium sorbate, vanillin).
PRODUCT DESCRIPTION:
A light yellow, oval shaped soft capsule with clear solution inside.
PRESENTATION: Box of 10 blisters x 10 soft capsules.
WHAT THE DRUG IS USED FOR: Vitamin E has an antioxidant effect in protecting cells from damage caused by free radicals.
Treatment and prophylaxis against vitamin E deficiency.
HOW TO TAKE THIS MEDICINE: Method of administration: oral route.
Dosage: Orally take 1 soft capsule once daily after meals.
WHEN NOT TO TAKE THIS MEDICINE:
Hypersensitivity to one of the components of the drug.
UNDESIRABLE EFFECTS (ADRs): Vitamin E is often tolerated. ADRs can occur with high doses, prolonged administration, and intravenous injection, especially when used for premature, low birth-weight infants.
Central nervous system disorders: headache, dizziness.
Eyes disorders: blurred vision.
Gastrointestinal disorders: nausea, diarrhea, abdominal pain, dyspepsia, necrotizing enterocolitis.
Endocrine and metabolic disorders: gonad abnormalities, breast pain, increased serum cholesterol and triglycerides, decreased serum thyroxin and triiodothyronine.
Renal disorders: urinary creatine, increased serum creatine kinase, increased urinary estrogen and androgen.
Others: rash, dermatitis, fatigue, thrombus phlebitis.
WHICH MEDICINES OR FOOD SHOULD BE AVOIDED WHILE TAKING THIS MEDICINE:
Vitamin E or its metabolites may alter the effect of vitamin K actions and may increase the effects of anticoagulants.
Concurrent use of vitamin E and acetylsalicylic acid may cause a risk of bleeding.
Vitamin E may increase the absorption, use, and storage of vitamin A. Vitamin E protects vitamin A from oxidative degeneration which makes an increased cellular concentrations of vitamin A; Vitamin E also protects against the effect of excess vitamin A. However, the effect is still being debated.
Dose of vitamin E more than 10 IU/kg may slow response of iron treatment in children with iron-deficiency anemia. Low birth-weight infants supplemented with iron may increase hemolytic anemia due to vitamin E deficiency.
Excessive use of mineral oil can reduce the absorption of vitamin E.
Various drugs may interfere with the absorption of vitamin E including colestyramine, colestipol, and orlistat. The interval between oral doses should be 2 hours.
IF YOU FORGET TO TAKE THE DRUG:
The next dose should be taken as directed. Do not take extra medicine to make up the missed dose to avoid overdose.
HOW TO STORE THIS MEDICINE:
Store in dry places, not exceeding 30oC, protect from light.
SIGNS AND SYMPTOMS OF DRUG OVERDOSE: No found.
WHAT HAPPENS IF OVERDOSE: No found.
WHAT ARE THE PRECAUTIONS WHEN TAKING THIS MEDICINE: A higher incidence of necrotising enterocolitis has been noted in premature infants weighing less than 1.5 kg treated with vitamin E.
Large doses of vitamin E have been reported to increase bleeding tendency in vitamin-K deficient patients such as those taking oral anticoagulants.
Vitamin E's effects are mostly studied in a few weeks or months; so chronic lifelong effects during high doses and prolonged administration of vitamin E are still unclear. However, caution should be exercised during the treatment; high doses of vitamin E 400 IU in patients with chronic diseases related to mortality rate from all causes should be noted.
Pregnancy:
During pregnancy, lack or excess of vitamin E do not cause complications for the mother or fetus. Vitamin E requirement in a pregnant woman and a normal woman is not different. The mother with good nutrition is not necessary to supplement vitamin E due to adequate amount of vitamin E in food. A demand of vitamin E should be daily supplemented during pregnancy if it is a poor dietary intake.
Lactation: Vitamin E appears in breast milk. Vitamin E in human milk has 5 times higher than cow's milk and is more effective in maintaining adequate amount of serum concentrations of vitamin E in children up to 1 year old.
Daily demand of vitamin E while breastfeeding is 19 mg. The mother should have been supplemented vitamin E if it was not be provided sufficiently during the daily dietary intake.
Effects on works: The drug causes no effects on machine users, drivers, workers at height, and other cases.
WHEN YOU SHOULD MEET YOUR DOCTOR, PHARMACIST:
If you need further information, please consult your doctor or pharmacist.
SHELF-LIFE: 36 months from the manufacturing date.
DATE OF REVISION OF THE TEXT: September 19, 2017

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