Enat 200

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ENAT 200 ENAT (200)

Composition:

Active ingredient: 1 capsule contains vitamin E — 200 IU (D-alpha-tocopheryl acetate);

Excipients: soybean oil; gelatin capsule: gelatin, glycerin, purified water.

Pharmaceutical form. Soft capsules.

Main physicochemical properties: oval soft gelatin capsules filled with a clear light-yellow oily liquid.

Pharmacotherapeutic group.

Simple vitamin preparations. Tocopherol (vitamin E). ATC code A11H A03.

Pharmacological Properties.

Pharmacodynamics.

Vitamin E is a fat-soluble vitamin with high antioxidant and radioprotective activity. It participates in the biosynthesis of heme and proteins, cell proliferation, and other vital cellular metabolic processes. Vitamin E improves tissue oxygen utilization. It exhibits angioprotective effects by influencing vascular tone and permeability, as well as stimulating the formation of new capillaries.

The immunomodulatory effect of vitamin E is due to stimulation of T-cell 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, and degeneration of photoreceptors, resulting in visual disturbances. It also causes reduced sexual function in men and menstrual cycle disorders, as well as 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 absorption in the intestine, 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 drug is primarily excreted in urine and partially in bile.

Clinical characteristics.

Indications.

The medicinal product is used as part of combination therapy for the prevention of embryonal developmental disorders in the fetus, vegetative disorders, or as an adjunct in hormonal treatment of menstrual cycle disorders.

Atrophic processes in the mucous membranes of the respiratory and gastrointestinal tracts.

Used as an adjunct in neurosensory sleep disorders.

Neurasthenia in conditions accompanied by exhaustion, muscular dystrophy, and muscle atrophy.

Degenerative and proliferative changes in joints and fibrous tissues of the spine and large joints; secondary muscle weakness and myopathy in chronic arthritis, muscle weakness due to frequent relapses of discogenic blockades.

Used as an adjunct in certain endocrine disorders and as a therapeutic agent in combination with vitamin A in male infertility.

Nutritional disorders, malabsorption syndrome, alimentary anemia.

Used as part of therapy for chronic hepatitis.

Used as an adjunct in the treatment of certain cases of periodontal diseases.

Peyronie's disease, kraurosis of the vulva, scleroderma, eczema, balanitis.

Used as part of antioxidant therapy.

Contraindications.

Hypersensitivity to the active substance or to any component of the medicinal product; cardiosclerosis; acute phase of myocardial infarction; thyrotoxicosis; hypervitaminosis E; hypersensitivity to peanuts or soy. Children under 12 years of age.

Interaction with other medicinal products and other types of interactions.

Iron increases the daily requirement for vitamin E. It is known that vitamin E increases the risk of bleeding in patients with vitamin K deficiency or those taking anticoagulants; therefore, prothrombin time and international normalized ratio (INR) should be monitored to detect any changes in hemostasis. Dose adjustment of anticoagulants may be required during and after vitamin E treatment.

Vitamin E increases the risk of thrombosis in patients taking estrogens.

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

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

Vitamin E and its metabolites exert antagonistic effects on 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.

With high-dose vitamin E intake, vitamin A stores in the body may decrease.

Special precautions for use.

The use of high doses of vitamin E may enhance vitamin K deficiency-induced hypoprothrombinemia; therefore, blood coagulation time should be monitored.

The drug should be used with caution in patients with atherosclerosis and an increased risk of thromboembolism.

Particular caution is required in patients predisposed to developing creatinuria, elevated creatine kinase activity, increased serum cholesterol levels, thrombophlebitis, pulmonary artery thromboembolism, and thrombosis.

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

Dosage and duration of treatment prescribed by a physician must be strictly followed to prevent overdose and development of vitamin E hypervitaminosis.

The drug contains soybean oil. Patients who are allergic to peanuts or soy should not use this medication.

Use during pregnancy or breastfeeding.

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

The active substance partially crosses the placental barrier; vitamin E reaches the fetal circulation, where its concentration amounts to 20–30% of the maternal plasma vitamin E concentration.

Vitamin E is excreted into breast milk.

Ability to affect reaction speed when driving or operating machinery.

When using this medication, adverse reactions such as visual disturbances and dizziness may occur. In such cases, patients should refrain from driving or operating machinery.

Dosage and Administration

Vitamin E should be taken orally after meals. The dosage should be individually determined depending on the type and course of the disease, patient's condition, and child's age, following consultation with a physician. To achieve the prescribed dose, the medication should be used in the appropriate dosage strength. The capsule should be swallowed whole with sufficient amount of water.

Dosage for adults:

In menstrual cycle disorders (as an adjunct to ongoing hormonal therapy): 300–400 IU every other day, repeated 5 times consecutively, starting on day 17 of the cycle.

In menstrual cycle disorders in young girls, prior to initiating hormonal therapy: 100 IU once or twice daily for 2–3 months.

For prevention of embryonic developmental abnormalities: 100–200 IU once daily during the first trimester of pregnancy.

In rheumatological diseases: 100–300 IU daily for several weeks.

Neurasthenia in conditions accompanied by exhaustion: 100 IU daily.

In muscular dystrophies: 100 IU once or twice daily for 30–60 days; repeat course after 2–3 months.

In vascular diseases: 100 IU daily.

In endocrine disorders: 300–500 IU daily.

In nutritional anemia: 300 IU daily for 10 days.

In chronic active hepatitis: 300 IU daily for a prolonged period.

In periodontopathies: 200–300 IU daily.

In penile plastic induration: 300–400 IU daily for several weeks, then as directed by physician.

In other dermatological conditions: 100–200 IU (or higher) daily; dosage and duration of treatment determined by physician.

As part of antioxidant therapy: 200–400 IU once or twice daily.

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

For adults, the average single dose is 100 IU, maximum single dose is 400 IU; average daily dose is 200 IU, maximum daily dose is 1000 IU.

Children

The medication is contraindicated in children under 12 years of age.

Overdose

Symptoms: When high doses of vitamin E are taken (400–800 IU daily for a prolonged period), possible symptoms include visual disturbances, diarrhea, dizziness, headache, nausea or abdominal cramps, and severe fatigue or weakness.

Very high doses (over 800 IU for a prolonged period) may provoke bleeding in patients with vitamin K deficiency; may interfere with thyroid hormone metabolism and increase the risk of thrombophlebitis and thromboembolism in susceptible patients. Possible increase in creatine kinase activity, elevated serum cholesterol and triglyceride concentrations, and increased urinary excretion of estrogens and androgens.

Treatment of overdose consists of elimination of vitamin E from the body and symptomatic therapy.

Adverse reactions

When the recommended doses are followed, adverse effects generally do not occur.

The table below summarizes data on adverse effects of tocopherol, categorized according to MedDRA (Medical Dictionary for Regulatory Activities) terminology, with frequencies specified as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), and frequency not known (cannot be estimated based on available data).

* When using high doses from 400 IU to 800 IU daily over a prolonged period.

The medicinal product contains soybean oil, which may cause allergic reactions.

Reporting of suspected adverse reactions. Reporting of suspected adverse reactions after registration of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of effectiveness of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 capsules in a blister; 3 blisters in a cardboard box.

Supply category. Over-the-counter.

Manufacturer.

Mega Lifesciences Public Company Limited.

Manufacturer's address and site of operations.

Plant 2, 515/1 Moo 4, Soi 8, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280, Thailand / Plant 2, 515/1 Moo 4, Soi 8, Bangpoo Industrial Estate, Pattana 3 Road, Phraeksa, Mueang, Samutprakarn 10280, Thailand.