Oxyace^® (Capsules) Instructions for Use

Marketing Authorization Holder

Unique Pharmaceutical Laboratories (India)

Company Division

J. B. Chemicals & Pharmaceuticals, Ltd. (India)

ATC Code

A11JB (Vitamins in combination with minerals)

Dosage Form

Oxyace®

Capsules: 30 or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules soft gelatin, oblong, brown in color; the capsule contents are a paste-like mass from brick-red to brown in color.

Excipients: calcium hydrogen phosphate, peanut oil, hydrogenated vegetable oil, white beeswax, lecithin, gelatin mass.

10 pcs. – blister packs (1) – three-layer laminated paper bags (3) – cardboard packs.
10 pcs. – blister packs (1) – three-layer laminated paper bags (10) – cardboard packs.

Clinical-Pharmacological Group

Complex of vitamins with trace elements

Pharmacotherapeutic Group

Multivitamin agent + multimineral

Pharmacological Action

Oxyace^® is a combined preparation containing multivitamins, minerals, and trace elements that have an antioxidant effect.

Oxyace^® protects the body’s cells and tissues from the effects of adverse environmental factors caused by free radicals, protecting them from premature destruction. When taking the drug, the body’s resistance to infections and colds increases, the risk of developing atherosclerosis, cardiovascular and oncological diseases decreases, and the body’s resistance to infections increases. Oxyace^® helps to increase mental and physical performance, improve memory, and slows down the development of cataracts.

The pharmacological action of the drug is due to the composition of its components.

Betacarotene undergoes biotransformation in the body to form vitamin A. Vitamin A is involved in the normal functioning of the retina, ensures the integrity of epithelial tissues, regulates the processes of hair and nail regeneration, and regulates bone growth.

Vitamin E inhibits lipid peroxidation of cell membranes. It is involved in the biosynthesis of heme and proteins, in tissue respiration processes, in the formation of connective tissue fibers, smooth muscles of blood vessels, the digestive tract, and the intercellular substance.

Vitamin C activates the synthesis of collagen and tooth dentin, participates in the metabolism of folic acid and iron, plays an important role in the synthesis of steroid hormones and catecholamines, and stimulates the synthesis of antibodies and interferon.

Copper is involved in tissue respiration, hematopoiesis processes, and immune reactions.

Manganese affects the development of bone tissue, participates in tissue respiration, and immune reactions.

Zinc is involved in the metabolism of nucleic acids, proteins, fats, carbohydrates, fatty acids, and hormones.

Selenious acid solution 0.9% in 90% 2,2-dichloropropionic acid is involved in the regulation of tissue elasticity and has an antioxidant effect.

Indications

• For the prevention and treatment of hypovitaminosis and deficiency of minerals and trace elements caused by inadequate nutrition or impaired absorption in the body;
• During periods of heavy physical or mental stress;
• For the prevention of the consequences of stress;
• In the postoperative period, in burn disease;
• During long-term antibiotic or chemotherapy;
• For the prevention of atherosclerosis, cardiovascular diseases, thrombosis;
• Diabetes mellitus;
• Chronic dermatitis;
• Decreased visual acuity;
• Alcohol and nicotine abuse.

ICD codes

Dosage Regimen

Take one capsule daily with a meal. Swallow the capsule whole with a sufficient amount of water; do not chew.

Administer the dose to adults and children over 12 years of age only. The use of this product in children under 12 years is contraindicated.

Adhere strictly to the recommended daily dose. Do not exceed one capsule per day. Concurrent use with other multivitamin or mineral supplements is not recommended to avoid the risk of excessive cumulative intake.

In case of accidental overdose, such as ingestion of several capsules at once, seek immediate medical attention or contact a poison control center.

For long-term use beyond several months, consult a healthcare professional for evaluation. The duration of therapy is dependent on the indication and individual patient requirements.

Adverse Reactions

Allergic reactions to the components of the drug.

Contraindications

• Hypersensitivity to the components of the drug;
• Children’s age (under 12 years).

Pediatric Use

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

Special Precautions

When taking Oxyace^®, it is not recommended to take other multivitamin preparations with trace elements at the same time.

Do not exceed the recommended daily dose. In case of accidental intake of high doses, consult a doctor immediately.

Drug Interactions

Ascorbic acid increases the blood concentration of salicylates, ethinylestradiol, benzylpenicillin and tetracyclines, and reduces the concentration of oral contraceptives. Reduces the anticoagulant effect of coumarin derivatives.

Calcium preparations, cholestyramine, neomycin reduce the absorption of betacarotene (vitamin A).

Vitamin E enhances the effect of cardiac glycosides, steroid and non-steroidal anti-inflammatory drugs.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F) in a dry place, protected from light and out of the reach of children.

Shelf Life

Shelf life – 2 years. Do not use the drug after the expiration date.

Dispensing Status

Available 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.