Instructions Vitamin E soft capsules 400 mg blister No. 30
Composition
active ingredient: 1 capsule contains 100 mg or 200 mg or 400 mg of vitamin E;
excipients: sunflower oil; capsule shell: gelatin, glycerin, carmoisine (E 122).
Dosage form
Soft capsules.
Main physicochemical properties:
100 mg capsules: soft gelatin capsules of spherical or globular shape, with a seam, from light red to dark red in color, filled with an oily liquid from light yellow to dark yellow in color;
200 mg capsules: soft gelatin capsules of cylindrical shape with hemispherical ends, with a seam, from light red to dark red in color, filled with an oily liquid from light yellow to dark yellow in color;
400 mg capsules: soft gelatin capsules, oval in shape, with a seam, red in color, filled with a clear oily liquid from colorless to slightly greenish-yellow in color.
Pharmacotherapeutic group
Simple vitamin preparations. Tocopherol (Vitamin E).
ATX code A11N A03.
Pharmacological properties
Pharmacodynamics
Vitamin E is a fat-soluble vitamin that has a significant antioxidant and radioprotective effect, participates in the biosynthesis of heme and proteins, cell proliferation, and other important processes of cellular metabolism.
Vitamin E improves tissue oxygen consumption. It has an angioprotective effect, affecting the tone and permeability of blood vessels, stimulating the formation of new capillaries.
The immunomodulatory effect of vitamin E is due to the stimulation of T-cell and humoral immunity.
Tocopherol is indispensable for normal reproductive processes: fertilization, fetal development, formation and functioning of the reproductive system.
Vitamin E deficiency causes hypotension and dystrophy of skeletal muscles and myocardium, increased capillary permeability and fragility, photoreceptor degeneration, which causes vision impairment. Decreased sexual function in men and menstrual cycle disorders, and a tendency to miscarriage in women.
Vitamin E deficiency can lead to the development of hemolytic jaundice in newborns, as well as malabsorption syndrome and steatorrhea.
Pharmacokinetics
After absorption in the intestine, most of the tocopherol enters the lymph and blood, is rapidly distributed in the body's tissues with predominant accumulation in the liver, muscles, and adipose tissue. The highest concentration is observed in the adrenal glands, pituitary gland, gonads, and myocardium. Most of the drug is excreted from the body with urine, and partially with bile.
Indication
Hypovitaminosis and avitaminosis of vitamin E. In complex antioxidant therapy, during the period of convalescence after injuries, severe somatic diseases, during physical overload, with unbalanced nutrition.
As part of complex therapy:
to prevent pathologies of embryonic development, congenital anomalies (malformations) of the fetus;
threatened abortion;
menstrual cycle disorders, vulva kraurosis, climacteric disorders;
perceptual hearing disorders;
atrophic processes in the mucous membrane of the respiratory tract;
degenerative and proliferative changes in the joints and fibrous tissue of the spine and large joints; muscle weakness due to discogenic blockades in intervertebral disc diseases, scleroderma, lupus erythematosus, rheumatoid arthritis, and other systemic connective tissue diseases;
neurasthenia with exhaustion, mainly muscular dystrophy and muscle atrophy, secondary muscle weakness and myopathy in chronic arthritis;
autonomic disorders;
some endocrine disorders;
some cardiovascular diseases;
atrophic processes in the mucous membrane of the digestive system, nutritional disorders, malabsorption syndrome, alimentary anemia, chronic hepatitis;
some periodontal diseases;
eye diseases;
skin diseases: dermatitis, trophic ulcers, psoriasis, eczema;
in case of plastic induration of the penis, balanitis, libido disorders, dysfunction of the gonads in men, disorders of spermatogenesis and potency in men, infertility (in combination with vitamin A).
Hypervitaminosis A and D.
Contraindication
Increased individual sensitivity to the active substance and to any components of the drug, severe cardiosclerosis, acute myocardial infarction, thyrotoxicosis, hypervitaminosis E, children under 12 years of age.
Interaction with other medicinal products and other types of interactions
Vitamin E cannot be used together with iron preparations, silver, alkaline agents (sodium bicarbonate, trisamine), indirect anticoagulants (dicoumarin, neodicoumarin).
Vitamin E enhances the effect of steroidal and nonsteroidal anti-inflammatory drugs (diclofenac sodium, ibuprofen, prednisolone); reduces the toxic effect of cardiac glycosides (digitoxin, digoxin), vitamins A and D. The appointment of vitamin E in high doses can cause vitamin A deficiency in the body.
Vitamin E and its metabolites have an antagonistic effect on vitamin K.
Vitamin E increases the effectiveness of antiepileptic drugs in patients with epilepsy.
Cholestyramine, colestipol, and mineral oils reduce the absorption of vitamin E.
Application features
Use with caution in patients with atherosclerosis and increased risk of thromboembolism.
Creatinuria, increased creatine kinase activity, increased cholesterol concentration, thrombophlebitis, pulmonary embolism and thrombosis in predisposed patients are rare. In epidermolysis bullosa, white hair may begin to grow in areas affected by alopecia.
When using the drug, it is necessary to adhere to the dosage and duration of treatment prescribed by the doctor to prevent overdose and the occurrence of hypervitaminosis E.
With prolonged use of high doses of the drug, it is necessary to monitor blood clotting time.
Use during pregnancy or breastfeeding
The drug can be used under the supervision of a doctor in recommended doses during pregnancy or breastfeeding.
The drug partially penetrates the placental barrier; vitamin E enters the fetus, where its amount is 20-30% of the concentration of vitamin E in the mother's blood plasma.
Vitamin E also passes into breast milk.
Ability to influence reaction speed when driving or operating other mechanisms
If dizziness or blurred vision occurs, you should refrain from driving or operating other machinery.
Method of administration and doses
Vitamin E should be administered orally after meals, the dose should be selected individually, depending on the type of disease, the course of the disease, and the patient's condition. The capsule should be swallowed whole, with sufficient water.
Dosage for adults:
in complex antioxidant therapy: 200-400 mg 1-2 times a day;
for pathology of embryonic development, congenital anomalies (malformations) of the fetus: 100-200 mg once a day in the first trimester of pregnancy;
with the threat of miscarriage: 100 mg 1-2 times a day for 14 days;
for menstrual cycle disorders in complex treatment: 300-400 mg every other day, starting from the 17th day of the cycle (repeat 5 cycles);
for menstrual cycle disorders when using the drug before starting hormone therapy: 100 mg 1-2 times a day for 2-3 months;
for rheumatoid arthritis: 100-300 mg daily for several weeks;
for muscular dystrophies, diseases of the neuromuscular and tendon-joint apparatus: 100 mg 1-2 times a day for 30-60 days, repeated course - after 2-3 months;
for neurasthenia with exhaustion, take the drug at a dose of 100 mg once a day for 30-60 days;
for some endocrine disorders: 300-500 mg per day;
for certain cardiovascular diseases: 100 mg daily;
for nutritional anemia: 300 mg per day for 10 days;
for chronic hepatitis: 300 mg per day for a long time;
for some periodontal diseases: 200-300 mg per day;
for eye diseases: 100-200 mg 1-2 times a day for 1-3 weeks in combination with vitamin A;
for skin diseases: 100-200 mg 1-2 times a day for 20-40 days;
for plastic induration of the penis: 300-400 mg daily for several weeks, then as prescribed by a doctor;
For spermatogenesis and potency disorders in men: 100-300 mg per day in combination with hormone therapy for 30 days.
In other cases, the dosage and duration of treatment are determined by the doctor.
For adults, the average single dose is 100 mg, the highest single dose is 400 mg; the average daily dose is 200 mg, the highest daily dose is 1000 mg.
Vitamin E in a dose of 100 mg can be prescribed to children over 12 years of age.
Children
The drug is contraindicated in children under 12 years of age.
Overdose
Symptoms: When taking recommended doses, adverse reactions do not occur. Taking high doses of vitamin E (400-800 mg per day for a long time) may cause visual disturbances, diarrhea, dizziness, headache, nausea or abdominal cramps, extreme fatigue or weakness.
Very high doses (more than 800 mg per day for a long time) may lead to an increased risk of bleeding in patients with vitamin K deficiency; impaired metabolism of thyroid hormones and an increased risk of thrombophlebitis and thromboembolism in susceptible patients, increased creatine kinase activity, increased serum cholesterol and triglyceride concentrations, and increased urinary estrogen and androgen levels.
Treatment: Drug withdrawal, symptomatic therapy.
Side effects
The drug is usually well tolerated, however, with prolonged use of high doses in the range of 400 mg to 800 mg per day, increased hypothrombinemia, visual disturbances, dizziness, nausea, development of gastrointestinal bleeding, diarrhea, stomach pain, liver enlargement, creatinineuria, digestive disorders, increased fatigue, general weakness, headache. Allergic reactions are possible, including skin rashes, itching, redness of the skin and fever.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
Capsules of 100 mg. 10 capsules in blisters. 10 capsules in a blister; 1 blister in a pack. 10 capsules in a blister; 3 blisters in a pack. 10 capsules in a blister; 5 blisters in a pack. 20 capsules in a blister; 1 blister in a pack. 20 capsules in a blister; 2 blisters in a pack. 20 capsules in a blister; 3 blisters in a pack. 50 capsules in a blister; 1 blister in a pack.
Capsules of 200 mg. 10 capsules in blisters. 10 capsules in a blister; 3 blisters in a pack.
Capsules of 400 mg. 10 capsules in a blister; 1 blister in a pack. 10 capsules in a blister; 3 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "KYIV VITAMIN FACTORY".
Location of the manufacturer and address of its place of business
04073, Ukraine, Kyiv, Kopylivska St., 38.
Website: www.vitamin.com.ua.
