EDIVA 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 solution 70%, glycerin, potassium sorbate, vanillin).
PHARMACEUTICAL FORM: Soft capsule.
PHARMACODYNAMIC PROPERTIES:
ATC CODE: A11HA03
Vitamin E has an antioxidant effect in protecting cells from damage caused by oxidation of free radicals.
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. In malabsorption syndrome patients and premature, low birth-weight babies, absorption of vitamin E can be greatly reduced.
Distribution: It enters the blood via the chylomicrons in the lymph, then goes to the liver and widely distributed to all tissues, and stored in adipose tissue. Plasma vitamin E concentrations under 5 micrograms of vitamin E per ml or under 800 micrograms of vitamin E per gram of plasma lipid for several months is considered to reflect a deficiency of vitamin E.
Excretion: 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 3 blisters x 10 soft capsules.
                     Box of 10 blisters x 10 soft capsules.
THERAPEUTIC INDICATIONS: Treatment and prevention of vitamin E deficiency (vitamin E deficiency dietary, children with cystic fibrosis or abnormalities of lipid transport due to biliary atrophy or abetalipoproteinaemia, premature, very low birth-weight babies).
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 sensitivity, ophthalmoplegia, retinopathy, axon degeneration.
DOSAGE & ADMINISTRATION: For treatment and prevention of vitamin E deficiency: The recommended oral dose is 1 soft capsule daily, given after meals.
CONTRAINDICATIONS:
Hypersensitivity to one of the components of the drug.
PRECAUTIONS:
A higher incidence of necrotising enterocolitis has been noted in lower weight premature infants (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.
Vitamin E has been reported to increase the risk of thrombosis in patients taking oestrogens. This finding should be borne in mind when selecting patients for treatment, in particular women taking oral contraceptives containing oestrogens.
Pregnancy: During pregnancy, excess or shortage of vitamin E will not cause complications for the mother or fetus. If the mother gets a poor dietary, it is advised to complement daily needs.
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 dietary intake.
Effects on works: No impact on persons who are using machines, driving, working at height, and other cases. However, patients should be informed of the potential for headache, dizziness during vitamin E therapy.
INTERACTION:
Vitamin E may alter the effect of vitamin K actions on clotting factors.
A risk of bleeding has been reported by concurrent administration of vitamin E and acetylsalicylic acid.
Excessive use of mineral oil can reduce the absorption of vitamin E. Cholestyramine, colestipol, orlistat may interfere with the absorption of vitamin E. The interval between oral doses should be at least 2 hours.
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.
Vitamin E may increase the risk of thrombosis in patients taking oestrogens.
UNDESIRABLE EFFECTS:
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.
CNS 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: Transient gastro-intestinal disturbances have been reported with doses greater than 1g daily and where necessary, general supportive measures should be employed.
Read the direction 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: July 5, 2018.

INFORMATION 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 solution 70%, glycerin, potassium sorbate, vanillin).
PRODUCT DESCRIPTION:
An oblong, light yellow, soft capsule containing a clear solution.
PRESENTATION:
 Box of 3 blisters x 10 soft capsules.
 Box of 10 blisters x 10 soft capsules.
WHAT THE DRUG IS USED FOR:
EDIVA E has an antioxidant effect in protecting cells from damage caused by oxidation of free radicals.
Treatment and prophylaxis of vitamin E deficiency (vitamin E deficiency dietary, children with cystic fibrosis or abnormalities of lipid transport due to biliary atrophy or abetalipoproteinaemia, premature, very low birth-weight babies).
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 sensitivity, ophthalmoplegia, retinopathy, axon degeneration.
HOW TO TAKE THIS MEDICINE:
Method of administration: Oral route.
Dosage & administration:
One soft capsule daily after meals.
WHEN NOT TO TAKE THIS MEDICINE:
Hypersensitivity to one of the components of the drug.
UNDESIRABLE EFFECTS: 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.
CNS 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 FOODS SHOULD BE AVOIDED WHILE TAKING THIS MEDICINE:
Vitamin E may alter the effect of vitamin K actions on clotting factors.
A risk of bleeding has been reported by concurrent administration of vitamin E and acetylsalicylic acid.
Excessive use of mineral oil can reduce the absorption of vitamin E. Cholestyramine, colestipol, orlistat may interfere with vitamin E absorption. The interval between oral doses should be at least 2 hours.
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.
Vitamin E may increase the risk of thrombosis in patients taking oestrogens.
WHAT TO DO IF YOU MISS A DOSE:
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: Transient gastro-intestinal disturbances have been reported with doses greater than 1g daily
WHAT TO DO IF OVERDOSE:
Where necessary, general supportive measures should be employed.
WHAT ARE THE PRECAUTIONS WHEN TAKING THIS MEDICINE:
A higher incidence of necrotising enterocolitis has been noted in lower weight premature infants (less than 1.5kg) 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.
Vitamin E has been reported to increase the risk of thrombosis in patients taking oestrogens. This finding should be borne in mind when selecting patients for treatment, in particular women taking oral contraceptives containing oestrogens.
Pregnancy: During pregnancy, excess or shortage of vitamin E will not cause complications for the mother or fetus. If the mother gets a poor dietary, it is advised to complement daily needs.
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 dietary intake.
Effects on works: No impact on persons who are using machines, driving, working at height, and other cases. However, patients should be informed of the potential for headache, dizziness during vitamin E therapy.
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: July 5, 2018.

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