Merz spezial dragees (Dragee) Instructions for Use

Marketing Authorization Holder

Merz Pharma, GmbH & Co. KGaA (Germany)

Manufactured By

Rottendorf Pharma, GmbH (Germany)

Labeled By

MERZ PHARMA, GmbH & Co. KGaA (Germany)

ATC Code

A11AB (Multivitamins in combination with other drugs)

Dosage Form

Merz spezial dragees

Dragees: 60 pcs.

Dosage Form, Packaging, and Composition

Dragees are light pink in color, round in shape, biconvex, with a smooth and shiny surface.

Excipients: microcrystalline cellulose, colloidal silicon dioxide, purified water, acacia gum, cellacefate, iron oxide red (dye E172), dextrose syrup, indigo carmine, corn starch, carnauba wax, castor oil, sucrose, talc, titanium dioxide.

60 pcs. – glass bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Multivitamins with trace elements and components of natural origin

Pharmacotherapeutic Group

Multivitamin agent + multimineral

Pharmacological Action

A combined preparation, the action of which is determined by the properties of the substances that make up the preparation.

Cystine is one of the main amino acids and plays an important role in the process of hair and nail growth.

Retinol (vitamin A) maintains the integrity of epithelial cells, improves skin blood supply, and restores its firmness and elasticity.

Beta-carotene (provitamin A) has antioxidant properties.

Tocopherol (vitamin E) is involved in tissue respiration processes and has an antioxidant effect.

Ascorbic acid (vitamin C) reduces vascular wall permeability.

Thiamine (vitamin B₁) plays a leading role in carbohydrate metabolism, which is necessary for the normal functioning of the nervous system.

Riboflavin (vitamin B₂) is a most important catalyst for cellular respiration processes.

Calcium pantothenate (vitamin B₅) enhances the water metabolism of skin cells.

Pyridoxine (vitamin B₆) is involved in protein metabolism.

Cyanocobalamin (vitamin B₁₂) is necessary for normal hematopoiesis.

Nicotinamide (vitamin PP) is involved in the processes of tissue respiration, fat and carbohydrate metabolism.

Biotin (vitamin H) is necessary for hair and nail growth.

Iron is involved in erythropoiesis.

Yeast extract (a natural source of B vitamins, minerals, and amino acids) supports the normal condition of the skin, hair, nails, and the epithelium of mucous membranes.

Pharmacokinetics

The effect of the drug is the result of the combined action of its components, therefore conducting kinetic observations is not possible; all the components together cannot be tracked using markers or bioassays. For the same reason, it is impossible to detect the drug’s metabolites.

Indications

• Prevention of hypovitaminosis and avitaminosis, iron deficiency.

ICD codes

Dosage Regimen

Take one dragee orally twice daily, in the morning and in the evening.

Swallow the dragee whole with a sufficient amount of liquid; do not chew.

This dosage is intended for adults and adolescents over 12 years of age for the prevention of vitamin and iron deficiencies.

Strictly adhere to the recommended dosage; do not exceed the stated daily intake.

If you accidentally take a higher dose, seek immediate medical advice or contact a poison control center.

The duration of continuous use should not exceed three to four months without consulting a physician.

Do not use this product concomitantly with other vitamin A or D containing preparations due to the risk of cumulative overdose.

Consult a doctor before use if you are pregnant, breastfeeding, have a known iron storage disorder, or have impaired kidney or liver function.

Store the bottle tightly closed in a dry place, protected from light, at temperatures not exceeding 25°C (77°F).

Keep the drug out of the sight and reach of children to prevent accidental ingestion.

Adverse Reactions

Allergic reactions to any of the components of the drug are possible.

Contraindications

• Overdose of vitamins A and D;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

When used in the recommended doses, the risk has not been proven. Since vitamin A in high doses can cause a teratogenic effect, during pregnancy, the intake of the drug should not be combined with other preparations containing vitamin A.

Special Precautions

The doses of the drug are established taking into account the body’s daily requirement for vitamins, but the preparation contains iron, which in large doses can have a harmful effect. The recommended daily doses should not be exceeded.

In case of accidental intake of the drug in high doses, a doctor’s consultation is necessary.

Overdose

Data on drug overdose are not provided.

Drug Interactions

If it is necessary to take it in combination with other drugs, a doctor’s consultation is required.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.