Vitrum^® Vitamin E (Capsules) Instructions for Use

Marketing Authorization Holder

Unipharm, Inc. (USA)

ATC Code

A11HA03 (Tocopherol (Vitamin E))

Active Substance

Tocopherol (Ph.Eur. European Pharmacopoeia)

Dosage Form

Vitrum® Vitamin E

Capsules 400 IU: 12, 24, 30 or 60 pcs.

Dosage Form, Packaging, and Composition

12 pcs. – blister packs (1) – cardboard packs.
12 pcs. – blister packs (2) – cardboard packs.
60 pcs. – polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Vitamin preparation

Pharmacotherapeutic Group

Vitamin

Pharmacological Action

It has antioxidant activity, participates in heme and protein biosynthesis, cell proliferation, tissue respiration, and other crucial processes of tissue metabolism.

It prevents increased permeability and fragility of capillaries, the development of atherosclerosis, degenerative-dystrophic changes in the heart muscle and skeletal muscles; normalizes reproductive function.

Pharmacokinetics

Approximately 50% is slowly absorbed from the gastrointestinal tract, with the maximum blood level reached in about 4 hours.

Bile acids are necessary for absorption.

During absorption, it forms a complex with lipoproteins, which are carriers of vitamin E.

It is stored in the adrenal glands, adipose and muscle tissue, and the liver.

It is metabolized and excreted from the body unchanged and as metabolites with bile (90%) and urine (6%).

Indications

• Treatment of hypovitaminosis, convalescent states after diseases accompanied by febrile syndrome, physical exertion;
• As part of complex therapy for the treatment of cardiovascular diseases, eye diseases;
• As part of measures to prevent atherosclerosis and other diseases of the cardiovascular system in elderly patients;
• Muscular dystrophies, dermatomyositis, amyotrophic lateral sclerosis;
• Degenerative and proliferative changes in the joints and ligamentous apparatus of the spine and large joints;
• Neurasthenia due to overwork, asthenic syndrome;
• Menstrual cycle disorders, climacteric vegetative disorders;
• Dysfunction of the gonads in men;
• Treatment of skin diseases, burns.

ICD codes

Dosage Regimen

Consult a doctor before use to determine the appropriate dosage and duration of therapy.

Take orally, one 400 IU capsule per day. Swallow the capsule whole with a small amount of water.

Administer during or immediately after a meal to enhance absorption, which requires the presence of bile.

Adhere strictly to the course of administration as prescribed by your physician. Do not exceed the recommended daily dose.

For long-term use at doses exceeding 400 IU daily, do so only under direct medical supervision.

Space the intake of oral iron-containing preparations by at least 8 hours after taking this capsule.

Discontinue use and consult a physician if symptoms of overdose or allergic reactions occur.

Adverse Reactions

When taken in high doses (more than 1 g/day), pain in the upper abdomen, diarrhea, and allergic reactions are possible.

Contraindications

• Hypersensitivity to the drug.

Special Precautions

Exercise caution when using vitamin E in high doses in cases of severe cardiosclerosis, increased risk of embolism, and in the acute period of myocardial infarction.

Overdose

Symptoms: creatinuria, diarrhea, epigastric pain.

If an allergic reaction occurs due to hypersensitivity to the drug, the dose should be reduced or a doctor should be consulted.

Drug Interactions

It enhances the effect of corticosteroids and NSAIDs, cardiac glycosides.

Iron-containing preparations are recommended to be taken orally no earlier than 8 hours after taking vitamin E.

Storage Conditions

Store at room temperature in a dry place, protected from light (ultraviolet rays destroy vitamin E), out of the reach of children, at a temperature below 30°C (86°F).

Shelf Life

Shelf life – 3 years. The drug should not be used after the expiration date.

Dispensing Status

Over-the-counter.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.