Vitamin e-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VITAMINE-ZDOROVYE (VITAMINE-ZDOROVYE)

Composition:

Active substance: tocopherol;

1 soft capsule contains vitamin E 100 mg or 200 mg or 400 mg;

Excipients: sunflower oil;

capsule shell containing: gelatin, glycerin, methylparaben (E 218), propylparaben (E 216), Ponceau 4R (E 124).

Dosage form. Soft capsules.

Main physicochemical properties:

100 mg and 200 mg capsules – soft gelatin capsules, spherical or round-shaped, with a seam, from light red to dark red in color, filled with an oily liquid ranging from light yellow to dark yellow;

400 mg capsules – soft gelatin capsules, oval-shaped, with a seam, from light red to dark red in color, filled with an oily liquid ranging from light yellow to dark yellow.

Pharmacotherapeutic group. Vitamins. Other simple vitamin preparations. Tocopherol (vitamin E). ATC code A11H A03.

Pharmacological Properties.

Pharmacodynamics.

Vitamin E is a fat-soluble vitamin exhibiting antioxidant and radioprotective properties. It participates in the biosynthesis of heme and proteins, cell proliferation, and other essential cellular metabolic processes.

Vitamin E improves tissue oxygen uptake. It exerts an angioprotective effect by influencing vascular tone and permeability, and stimulates the formation of new capillaries.

The immunomodulatory effect of vitamin E is due to stimulation of T-cell-mediated and humoral immunity.

Tocopherol is essential for normal reproductive processes: fertilization, fetal development, and formation and functioning of the reproductive system.

Vitamin E deficiency leads to hypotonia and dystrophy of skeletal muscles and myocardium, increased capillary permeability and fragility, degeneration of photoreceptors causing visual disturbances, reduced sexual function in men, menstrual cycle disorders, and increased susceptibility to miscarriages in women.

Vitamin E deficiency may lead to hemolytic jaundice in newborns, as well as malabsorption syndrome and steatorrhea.

Pharmacokinetics.

After intestinal absorption, most of the tocopherol enters the lymph and blood, rapidly distributing throughout body tissues with predominant accumulation in the liver, muscles, and adipose tissue. The highest concentrations are observed in the adrenal glands, pituitary gland, sex glands, and myocardium. The majority of the drug is excreted from the body in urine, partially with bile.

Clinical characteristics.

Indications.

• Vitamin E deficiency.

• As part of complex antioxidant therapy during the period of convalescence after injuries, in severe somatic diseases, under physical overexertion, and in case of unbalanced nutrition.

• As part of complex therapy:

• for prevention of embryonic developmental disorders and congenital abnormalities (birth defects) of the fetus;

• in case of threatened pregnancy termination;

• menstrual cycle disorders, vulvar kraurosis, climacteric disorders;

• perceptual hearing disorders;

• atrophic disorders of the respiratory tract mucosa;

• degenerative and proliferative changes in joints and fibrous tissue of the spine and large joints; muscle weakness due to discogenic blockades in intervertebral disc diseases, scleroderma, systemic lupus erythematosus, rheumatoid arthritis, and other connective tissue diseases;

• neurasthenia with exhaustion, predominantly muscle dystrophy and atrophy, secondary muscle weakness and myopathy in chronic arthritis;

• vegetative disorders;

• endocrine disorders;

• cardiovascular diseases;

• atrophic processes in the mucous membrane of the gastrointestinal tract, nutritional disorders, malabsorption syndrome, alimentary anemia, chronic hepatitis;

• periodontopathies;

• eye diseases;

• skin diseases: dermatitis, trophic ulcers, psoriasis, eczema;

• penile plastic induration, balanitis, libido disorders, sexual gland dysfunction in men, disorders of spermatogenesis and potency in men, infertility (in combination with vitamin A).

• Hypervitaminosis A and D.

Contraindications.

Hypersensitivity to the active substance or to any component of the medicinal product, cardiosclerosis, acute phase of myocardial infarction, thyrotoxicosis, hypervitaminosis E, children under 12 years of age.

Interaction with other medicinal products and other forms of interaction.

It is known that vitamin E increases the tendency to bleeding in patients with vitamin K deficiency or those taking anticoagulants; therefore, it is recommended to monitor prothrombin time and international normalized ratio (INR) to detect any changes in hemostasis. Dose adjustment of anticoagulants may be necessary during and after vitamin E treatment.

Vitamin E may increase the risk of thrombosis in patients taking estrogens.

Vitamin E must not be used concomitantly with iron preparations, silver compounds, alkaline agents (sodium hydrocarbonate, tromethamine), or indirect-acting anticoagulants (dicoumarol, neodicoumarol).

Vitamin E enhances the effect of steroid and non-steroidal anti-inflammatory agents (sodium diclofenac, ibuprofen, prednisolone) and reduces the toxic effects of cardiac glycosides (digoxin, digitoxin) and of vitamins A and D.

Vitamin E and its metabolites exert antagonistic action towards vitamin K.

Vitamin E increases the efficacy of antiepileptic drugs in patients with epilepsy.

Cholestyramine, colestipol, and mineral oils reduce the absorption of vitamin E.

When high doses of vitamin E are administered, vitamin A stores in the body may decrease.

Special precautions for use.

The use of high doses of vitamin E may exacerbate coagulation disorders caused by vitamin K deficiency.

Use with caution in patients with marked atherosclerosis or an increased risk of thromboembolism.

Do not exceed the recommended dose.

Rarely observed are creatinuria, increased creatine kinase activity, elevated cholesterol concentration, thrombophlebitis, pulmonary artery thromboembolism, and thrombosis in predisposed patients. In patients with epidermolysis bullosa, white hair may begin to grow in areas affected by alopecia.

When high doses of the drug are used long-term, blood coagulation time should be monitored.

The medicinal product contains methylparaben (E 218) and propylparaben (E 216), which may cause allergic reactions (possibly delayed).

The medicinal product contains Ponceau 4R, which may cause allergic reactions.

Use during pregnancy or breastfeeding.

The drug may be used under medical supervision at recommended doses during pregnancy or breastfeeding.

The drug partially crosses the placental barrier; vitamin E reaches the fetal organism, where its levels amount to 20–30% of the vitamin E concentration in maternal plasma.

Vitamin E passes into breast milk.

Ability to influence reaction speed when driving or operating machinery.

Adverse reactions such as visual disturbances and dizziness may occur during the use of this drug. In such cases, patients should refrain from driving vehicles or operating complex machinery.

Method of Administration and Dosage

Vitamin E is taken orally after meals. The dose is individually adjusted depending on the type of disease, disease course, and patient's condition. The capsule should be swallowed whole with sufficient amount of water.

Dosage for adults:

• for antioxidant combination therapy: 0.2–0.4 g, 1–2 times daily;
• to prevent embryonal developmental disorders and congenital fetal abnormalities (developmental defects): 0.1–0.2 g once daily during the first trimester of pregnancy;
• in threatened miscarriage: 0.1 g, 1–2 times daily for 14 days;
• in menstrual cycle disorders: 0.3–0.4 g every other day, starting from the 17th day of the cycle (repeat for 5 cycles);
• in menstrual cycle disorders when the drug is used prior to initiation of hormonal therapy: 0.1 g, 1–2 times daily for 2–3 months;
• in rheumatoid arthritis: 0.1–0.3 g daily for several weeks;
• in muscular dystrophies and disorders of the neuromuscular and tendinous-joint apparatus: 0.1 g, 1–2 times daily for 30–60 days; repeat course after 2–3 months;
• in neurasthenia with exhaustion: 0.1 g once daily for 30–60 days;
• in endocrine disorders: 0.3–0.5 g per day;
• in cardiovascular diseases: 0.1 g daily;
• in nutritional anemia: 0.3 g per day for 10 days;
• in chronic hepatitis: 0.3 g per day for a prolonged period;
• in periodontal diseases: 0.2–0.3 g per day;
• in eye diseases: 0.1–0.2 g, 1–2 times daily for 1–3 weeks in combination with vitamin A;
• in skin diseases: 0.1–0.2 g, 1–2 times daily for 20–40 days;
• in penile plastic induration: 0.3–0.4 g daily for several weeks, then as directed by physician;
• in impaired spermatogenesis and potency in men: 0.1–0.3 g daily in combination with hormone therapy for 30 days.

In other cases, dosage and duration of treatment are determined by the physician.

For adults, the average single dose is 0.1 g, the maximum single dose is 0.4 g; the average daily dose is 0.2 g, the maximum daily dose is 1 g.

In pediatrics, vitamin E at a dose of 0.1 g may be prescribed to children aged 12 years and older.

Children. The medicinal product is contraindicated in children under 12 years of age.

Overdose.

When high doses of vitamin E are taken (400–800 mg daily for a prolonged period), possible adverse effects include visual disturbances, diarrhea, dizziness, headache, nausea or abdominal cramps, extreme fatigue or weakness.

Very high doses (over 800 mg for a prolonged period) may increase the risk of bleeding in patients with vitamin K deficiency; they may impair thyroid hormone metabolism and increase the risk of thrombophlebitis and thromboembolism in susceptible patients, as well as cause increased creatine kinase activity, elevated serum cholesterol and triglyceride levels, and increased urinary excretion of estrogens and androgens.

Treatment of overdose consists of discontinuation of the drug and symptomatic therapy.

Side effects.

With prolonged use of high doses ranging from 400 to 800 mg per day, the following may occur: increased hypotrombinemia, visual disturbances, dizziness, nausea, development of gastrointestinal bleeding, diarrhea, stomach pain, liver enlargement, creatinuria, digestive disorders, increased fatigue, general weakness, headache. Allergic reactions are possible, including skin rashes, itching, skin redness, and fever.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. Soft capsules 100 mg № 30 (10×3), № 50 (10×5) in blisters in a box.

Soft capsules 200 mg № 30 (10×3) in blisters in a box.

Soft capsules 400 mg № 30 (10×3) in blisters in a box.

Prescription status. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and place of business.

100, Shevchenka St., lit. B-II (Building 4), city of Boryspil, Kyiv region, Ukraine, 08301.

Website: www.zt.com.ua.