Vitamin a+e-zdorovya

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VITAMIN A+E-ZDOROVYE (VITAMIN A+E-ZDOROVYE)

Composition:

Active substances: retinol, tocopherol;

1 soft capsule contains vitamin A 100,000 IU, vitamin E 100 mg;

Excipients: sunflower oil;

capsule shell containing: gelatin, glycerin, methylparaben (E 218), propylparaben (E 216).

Pharmaceutical form. Soft capsules.

Main physicochemical properties: soft gelatin capsules of oval or spherical shape, with a seam, yellow to light brown in color, filled with an oily liquid ranging from light yellow to dark yellow.

Pharmacotherapeutic group. Combined vitamin preparations. ATC code A11 JA.

Pharmacological Properties.

Pharmacodynamics.

The properties of the medicinal product are determined by the pharmacological effects of the fat-soluble vitamins A and E contained in its composition. The medicinal product affects the nuclei of target organ cells and initiates the synthesis of enzyme proteins or structural tissue components, stimulates regenerative processes, and enhances both specific and non-specific resistance of the organism. The drug normalizes metabolism, exerts a pronounced antioxidant effect, restores capillary circulation, 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 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 via 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 eliminated by the kidneys, intestine, and lungs. Elimination of vitamin A occurs slowly—within 3 weeks, 34% of the administered drug dose is excreted from the body. Excess vitamin E is deposited in tissues, forming depots (particularly in the liver), thereby maintaining normal plasma vitamin E levels. In the body, vitamin E undergoes biotransformation, forming a series of metabolites with a quinone structure. Unchanged vitamin E is excreted via bile, while its metabolites are excreted in urine.

Clinical characteristics.

Indications.

Treatment of diseases and conditions requiring prolonged administration of high doses of vitamin A in combination with vitamin E, such as: atherosclerotic vascular changes, tissue trophic disorders, obliterating endarteritis, psoriasis, systemic lupus erythematosus, optic nerve atrophy, pigmentary retinitis.

Complex therapy of cardiovascular diseases (hypertensive disease with signs of left ventricular overload, stable angina pectoris of functional classes I and II).

Contraindications.

Hypersensitivity to the components of the drug, hypervitaminosis A and E, thyrotoxicosis, chronic glomerulonephritis, cholelithiasis, decompensated heart failure, history of sarcoidosis, chronic pancreatitis, marked cardiomyosclerosis, myocardial infarction.

Interaction with other medicinal products and other types of interactions.

The drug must not be prescribed simultaneously with estrogens, as they increase the risk of hypervitaminosis A; with nitrates and cholestyramine, which impair absorption of vitamin A.

Vitamin A reduces the anti-inflammatory effect of glucocorticoids.

The preparation must not be used together with other vitamin A derivatives due to the risk of overdose and development of hypervitaminosis A.

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

Special precautions for use.

The drug should be used with caution in patients at increased risk of thromboembolism, severe coronary atherosclerosis, chronic circulatory insufficiency, acute or chronic nephritis, cholecystitis, and in cases of severe hepatobiliary system disorders.

The drug should not be prescribed concurrently with other medicinal products containing vitamin A and its synthetic analogs due to the risk of developing hypervitaminosis A.

Vitamin A has the property of accumulating in the body and remaining there for a prolonged period. Women who have taken high doses of retinol should not plan pregnancy earlier than 6–12 months after discontinuation. This is due to the risk of fetal developmental abnormalities caused by high levels of vitamin A in the body during this period.

The presence of methylparaben (E 218) and propylparaben (E 216) in the formulation may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy and breastfeeding.

If use of the drug is necessary, breastfeeding should be discontinued.

Ability to influence reaction rate when driving or operating machinery.

There is no data available regarding the effect of the drug on the ability to drive a vehicle or operate complex machinery.

Method of Administration and Dosage.

Take orally after meals, 1 capsule daily for 30–40 days. Repeat the course if necessary after 3–6 months.

Children.

The medicinal product is not intended for use in children.

Overdose.

A single intake of a large amount of the medicinal product may lead to a sudden increase in cerebrospinal fluid pressure (without pathological changes in the cerebrospinal fluid itself), severe headache, drowsiness, and visual disturbances (diplopia). In severe cases, seizures and cardiac failure may develop. With prolonged use of the medicinal product, chronic hypervitaminosis A may occur, manifesting as nervous system disorders (headache, insomnia, irritability, apathy, paresthesias), general weakness, loss of appetite, fever, skin changes (dryness and cracking of the skin on palms and soles, appearance of pigmented spots, hair loss, seborrheic eruptions), jaundice, blood count abnormalities, bone and muscle pain, gait disturbances, and enlargement of the liver and spleen. With long-term use of high doses, creatinuria, increased concentrations of cholesterol and triglycerides, elevated creatine kinase activity, decreased serum concentrations of thyroxine and triiodothyronine, increased urinary excretion of estrogens and androgens, impaired blood coagulation, and gastrointestinal bleeding may occur. If symptoms of overdose occur, administration of the medicinal product must be discontinued. Treatment is symptomatic.

Side effects.

Central nervous system and sensory organs: fatigue, drowsiness, lethargy, irritability, headache, insomnia.

Gastrointestinal tract: loss of appetite, nausea, dyspeptic disorders (epigastric pain, diarrhea); very rarely – vomiting.

Skin and subcutaneous tissue: allergic reactions, including itching and rash; dry, peeling skin.

General disorders: increased body temperature; facial flushing.

Other: with prolonged use – hair loss, pain in the bones of lower extremities; possible exacerbation of cholelithiasis and chronic pancreatitis. Prolonged intake of high doses of vitamin A may lead to development of hypervitaminosis A.

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 № 30 (10×3), № 50 (10×5) in blisters, in a box.

Availability. Over-the-counter (without prescription).

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

Manufacturer's address and place of business.

100, Shevchenka St., lit. B-II (building 4), m. Boryspil, Kyiv region, 08301, Ukraine.