Lifevit (Capsules) Instructions for Use

Marketing Authorization Holder

Opella Healthcare, LLC (Russia)

Manufactured By

Saneca Pharmaceuticals, a.s. (Slovakia)

Contact Information

SANOFI

ATC Code

A11HA03 (Tocopherol (Vitamin E))

Active Substance

Tocopherol (Ph.Eur. European Pharmacopoeia)

Dosage Forms

	Lifevit	Capsules 100 mg: 30 pcs.
		Capsules 200 mg: 30 pcs.
		Capsules 400 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Capsules red, oval; the capsule contents are a transparent light yellow oil.

Excipients: sunflower oil, capsule shell (gelatin, glycerol 85%, methylparaben, dye ponceau 4R [Ponceau 4R] (E124), purified water).

30 pcs. – dark glass bottles (1) – cardboard packs.

Capsules red, oval; the capsule contents are a transparent light yellow oil.

Excipients: sunflower oil, capsule shell (gelatin, glycerol 85%, methylparaben, dye ponceau 4R [Ponceau 4R] (E124), purified water).

30 pcs. – dark glass bottles (1) – cardboard packs.

Capsules red, oval; the capsule contents are a transparent light yellow oil.

Excipients: sunflower oil, capsule shell (gelatin, glycerol 85%, methylparaben, dye ponceau 4R [Ponceau 4R] (E124), purified water).

30 pcs. – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Vitamin preparation

Pharmacotherapeutic Group

Vitamin

Pharmacological Action

Biologically active tocopherols protect intermediate compounds of cellular respiration from oxidation of functional groups of their molecules. Active tocopherols can be oxidized to semiquinones, which are again reduced in the body to tocopherols. If tocopherols are present in the human body in sufficient quantities, they protect unstable mediators and metabolites of cellular respiration from oxidation. In redox processes at the level of cellular metabolism under pathological conditions, they play a buffering role.

Vitamin E (alpha-Tocopherol), the most effective of the tocopherols, acts in the human body as a cellular antioxidant and a substance that binds free oxygen radicals. Vitamin E has an antioxidant effect, participates in heme and protein biosynthesis, cell proliferation, and other important processes of tissue metabolism, and prevents hemolysis of erythrocytes. It is necessary for the development and functioning of connective tissue, as well as for strengthening the walls of blood vessels. It is a natural antioxidant, inhibits lipid peroxidation by free radicals. It activates phagocytosis and is used to maintain normal erythrocyte resistance. In high doses, it prevents platelet aggregation.

Pharmacokinetics

Absorption

When taken orally, 20-40% is absorbed from the duodenum (the presence of bile salts, fats, and normal pancreatic function is necessary). T_max is 4 hours. With an increase in dose, the degree of absorption decreases.

Distribution

It is deposited in all organs and tissues, especially in adipose tissue. It penetrates the placental barrier in insufficient quantities: 20-30% of the concentration in the mother’s blood enters the fetal blood. It is excreted in breast milk.

Excretion

Excretion is mainly through the intestines, with bile – more than 90%, less than 6% is excreted by the kidneys in the form of glucuronides and other metabolites.

Indications

Prevention and treatment of vitamin E hypovitaminosis, incl.

• For degenerative and proliferative changes in the musculoskeletal system, in particular for muscular dystrophy;
• For amyotrophic lateral sclerosis (as part of complex therapy);
• For chronic hepatitis (as part of complex therapy);
• In a state of convalescence after serious illnesses, injuries, operations;
• For severe physical exertion;
• For menstrual cycle disorders (as part of complex therapy for hormonal treatment of menstrual cycle disorders).

ICD codes

Dosage Regimen

The drug is intended for adults.

Treatment of vitamin E hypovitaminosis: 100 mg (1 caps.) once/day until the symptoms of hypovitaminosis are eliminated.

Vitamin E hypovitaminosis accompanied by degenerative and proliferative changes in the musculoskeletal system, in particular muscular dystrophy, amyotrophic lateral sclerosis (as part of complex therapy): 100 mg (1 caps.) once/day for 1-2 months.

Vitamin E hypovitaminosis accompanied by chronic hepatitis (as part of complex therapy): 100 mg (1 caps.) once/day.

Vitamin E hypovitaminosis in states of convalescence after serious illnesses, injuries, operations 100 mg (1 caps.) once/day for 1-2 weeks.

Vitamin E hypovitaminosis during increased physical exertion 100 mg (1 caps.) once/day during periods of increased physical exertion.

Vitamin E hypovitaminosis accompanied by menstrual cycle disorders (as part of complex therapy for hormonal treatment of menstrual cycle disorders): 300-400 mg every other day sequentially, starting from the 17th day of the cycle until the last day of the cycle (the day before the first day of menstruation).

Adverse Reactions

As a rule, when used in recommended doses, side effects are not observed.

From the immune system: allergic reactions.

From the digestive system: diarrhea, nausea, gastralgia.

From the metabolism: hypercreatininuria, increased activity of CPK, increased serum cholesterol concentration.

From the cardiovascular system: thrombophlebitis, pulmonary embolism.

Contraindications

• Acute myocardial infarction;
• Childhood;
• Hypersensitivity to the components of the drug.

Use with caution in patients with severe cardiosclerosis, previous myocardial infarction, with an increased risk of thromboembolism; hypoprothrombinemia caused by vitamin K deficiency may worsen with the use of vitamin E in a dose of more than 400 IU (1 mg=1.21 IU).

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, the drug can be taken only as prescribed by a doctor and subject to the dosage regimen recommended by the doctor.

Pediatric Use

The use of the drug in children is contraindicated.

Special Precautions

In congenital bullous epidermolysis, white hair may begin to grow in areas affected by alopecia.

Vitamin K deficiency in the body, causing hypoprothrombinemia, may increase with the use of vitamin E in high doses (more than 400 IU/day).

Vitamin E enhances the effect of anticoagulants if doses exceed 400 IU/day.

To avoid overdose, it is not recommended to take other vitamin complexes containing vitamin E at the same time.

Effect on the ability to drive vehicles and mechanisms

Taking Lifevit does not affect the ability to drive vehicles or mechanisms.

Overdose

Symptoms high doses of vitamin E (400-800 mg/day for a long time) can cause visual disturbances, diarrhea, dizziness, headache, nausea, severe fatigue, fainting, growth of white hair in areas of alopecia in bullous epidermolysis.

Very high doses (exceeding 800 mg for a long time) can cause bleeding in patients with vitamin K deficiency; they can disrupt thyroid hormone metabolism and increase the risk of thrombophlebitis and thromboembolism in sensitive patients.

Treatment symptomatic therapy, drug withdrawal, prescription of corticosteroids.

Drug Interactions

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

Increases the effectiveness of antiepileptic drugs in patients with epilepsy (who have an increased content of lipid peroxidation products in the blood).

High doses of iron enhance oxidative processes in the body, which increases the need for vitamin E.

Vitamin E enhances the effect of anticoagulants if doses exceed 400 IU/day. Simultaneous use of vitamin E in a dose of more than 400 IU/day with anticoagulants (coumarin and indandione derivatives) increases the risk of hypothrombinemia and bleeding.

It is not recommended to take other vitamin complexes containing vitamin E at the same time to avoid overdose.

Prescription of vitamin E in high doses can cause vitamin A deficiency in the body.

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

Storage Conditions

The drug should be stored in the original packaging in a place inaccessible to children at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed without a prescription.

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.