Aevit® light

INSTRUCTION for medical use of the medicinal product AEvit® Light (AEvit® Light)

Composition:

Active substances: 1 capsule contains vitamin A 3000 IU, vitamin E 200 mg;

Excipients: sunflower oil; capsule shell: gelatin, glycerin.

Pharmaceutical form. Soft capsules.

Main physicochemical properties: soft gelatin capsules, oval-shaped, with a seam, from yellow to light brown in color, filled with an oily liquid from light yellow to dark yellow.

Pharmacotherapeutic group. Combined vitamin preparations. ATC code A11J A.

Pharmacological Properties.

Pharmacodynamics.

The properties of the medicinal product are determined by the pharmacological effects of fat-soluble vitamins A and E contained in its composition. The medicinal product affects target organ cell nuclei and initiates the synthesis of enzyme proteins or structural tissue components, stimulates regenerative processes, and enhances both specific and non-specific resistance of the body.

The medicinal product normalizes metabolism, exhibits pronounced antioxidant activity, restores capillary blood flow, and improves tissue and vascular permeability, increasing tissue resistance to hypoxia.

Pharmacokinetics.

The medicinal product is well absorbed from the gastrointestinal tract. Subsequently, vitamins A and E are transported into the lymph, then into the blood plasma, where they bind to specific proteins and are carried to organs and tissues. Excess vitamin A is stored in the liver, predominantly in the form of palmitic acid esters. Vitamin A is excreted with bile into the intestine and participates in enterohepatic circulation. In the liver, it undergoes biotransformation, first converting into active metabolites and then into inactive metabolic products, which are excreted by the kidneys, intestine, and lungs. Elimination of vitamin A is slow — within 3 weeks, 34% of the administered dose of the medicinal product is eliminated from the body. Excess vitamin E is deposited in tissues, forming storage depots (particularly in the liver), thereby maintaining normal plasma levels of vitamin E. In the body, vitamin E undergoes biotransformation into several metabolites with a quinone structure. Unchanged vitamin E is excreted in bile, while its metabolites are excreted in urine.

Clinical characteristics.

Indications.

• Vitamin E and A deficiency.

• As part of complex antioxidant therapy during the period of convalescence after injuries, severe somatic diseases, after surgical interventions, in case of physical overexertion, sports activities, unbalanced nutrition or diets with very low fat content.

• As part of complex therapy:

  • acne (acne vulgaris), dermatitis, trophic ulcers, psoriasis, eczema;
  • eye diseases (superficial keratitis, corneal lesions, conjunctivitis, pyoderma, age-related macular degeneration);
  • alimentary deficiency, chronic hepatitis, malabsorption syndrome;
  • cystic fibrosis;
  • atrophic processes in the mucous membranes of the respiratory and gastrointestinal tracts;
  • disorders of spermatogenesis.

Contraindications.

Hypersensitivity to components of the drug, hypervitaminosis E and A, thyrotoxicosis, history of sarcoidosis, pronounced cardiac sclerosis, acute phase of myocardial infarction, age under 14 years, chronic glomerulonephritis, cholelithiasis, decompensated heart failure, chronic pancreatitis.

Interaction with other medicinal products and other types of interactions.

The drug must not be used concomitantly with iron preparations, silver compounds, alkaline agents (sodium bicarbonate, trisamin), indirect-acting anticoagulants (dicoumarol, neodicoumarol).

Vitamin E enhances the effect of steroid and non-steroidal anti-inflammatory drugs (diclofenac sodium, ibuprofen, prednisolone); reduces the toxic effect of cardiac glycosides (digitoxin, digoxin), and vitamins A and D. Administration of vitamin E in high doses may cause vitamin A deficiency in the body.

Vitamin E and its metabolites exert antagonistic effects on vitamin K. Vitamin E increases the efficacy of antiepileptic drugs in patients with epilepsy.

The use of vitamin E in very high doses (>800 mg/day for a prolonged period) increases the risk of bleeding in patients with vitamin K deficiency.

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

Special precautions for use.

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

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

When using the medicinal product, the duration of treatment prescribed by the physician should be strictly followed to prevent overdose and the development of vitamin E hypervitaminosis.

During prolonged use of the medicinal product, blood coagulation time should be monitored regularly.

The medicinal product must not be used concomitantly with other vitamin A derivatives due to the risk of overdose.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the medicinal product should be taken only on the advice of a physician.

For pregnant women and women planning pregnancy, the dose of vitamin A should not exceed 5000 IU. Large doses of retinol (more than 10,000 IU) should not be taken during breastfeeding due to the risk of developing hypervitaminosis A in infants.

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

Vitamin E is also excreted into breast milk.

Ability to influence reaction rate when driving or operating machinery.

If dizziness or blurred vision occurs, patients should refrain from driving or operating machinery.

Method of Administration and Dosage

Administer the medicinal product orally after meals to adults and children aged 14 years and older:

• Children aged 14 years: 1 capsule per day.
• Adults: 1–2 capsules per day for 30–40 days.

The capsule should be swallowed whole with sufficient amount of water.

The duration of treatment is determined individually by a physician.

Children

The medicinal product is indicated for children aged 14 years and older.

Overdose

Symptoms: When taken at recommended doses, adverse reactions do not occur.

Prolonged intake of the medicinal product may cause visual disturbances, dizziness, headache, extreme fatigue or weakness, nausea or abdominal spasms, and diarrhea.

Treatment: symptomatic therapy.

Acute ingestion of a large amount of the medicinal product is accompanied by a sudden increase in cerebrospinal fluid pressure (without pathological changes in the cerebrospinal fluid itself), severe headache, drowsiness, visual disturbances (diplopia). In severe cases, seizures and cardiac failure may develop.

Adverse Reactions.

Central and peripheral nervous system disorders: increased fatigue, general weakness, headache, dizziness, visual disturbances (blurred vision).

Gastrointestinal disorders: nausea, development of gastrointestinal bleeding, diarrhea, stomach pain, digestive disturbances; liver enlargement.

Possible allergic reactions, including skin rashes, itching, skin redness, and fever.

Blood and lymphatic system disorders: exacerbation of hypotrombinaemia.

Laboratory findings: creatinuria.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after marketing authorisation is of considerable importance. This allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and pharmaceutical workers, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

10 capsules in a blister; 1 blister per carton.

10 capsules in a blister; 3 blisters per carton.

Supply classification. Over-the-counter (without prescription).

Manufacturer. JSC "KYIV VITAMIN PLANT".

Manufacturer's address and location of operations.

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua