Supradyn^® (Tablets) Instructions for Use

Marketing Authorization Holder

BAYER, JSC (Russia)

Manufactured By

Delpharm Gaillard (France)

Or

Dragenopharm Apotheker Puschl, GmbH & Co. KG (Germany)

Contact Information

BAYER AG (Germany)

ATC Code

A11AA04 (Multivitamins and trace elements)

Dosage Forms

	Supradyn®	Effervescent tablets: 10 or 20 pcs.
		Film-coated tablets: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Effervescent tablets cylindrical, flat, from pale yellow to light yellow in color, with inclusions of darker and lighter color, dissolve in water with the release of bubbles, forming a greenish-yellow, opaque, slightly sedimented solution with a lemon odor.

Excipients : sucrose – 1086.384 mg, mannitol – 17.25 mg, tartaric acid – 1600 mg, sodium bicarbonate – 1100 mg, sodium saccharin – 18 mg, lemon flavor permaseal 60.827-7 – 60 mg, lemon flavor permastable 3206 – 100 mg.

10 pcs. – aluminum cylinders (1) – cardboard packs.
10 pcs. – aluminum cylinders (2) – cardboard packs.
10 pcs. – polypropylene cylinders (1) – cardboard packs.
10 pcs. – polypropylene cylinders (2) – cardboard packs.

Film-coated tablets orange-red in color, oval, biconvex.

Excipients : microcrystalline cellulose – 103.932 mg, povidone K90 – 45.04 mg, lactose monohydrate – 7.775 mg, crospovidone – 25 mg, magnesium stearate – 9 mg, mannitol – 10.8 mg, sucrose – 2.475 mg.

Coating composition acacia gum dry spray – 2.979 mg, rice starch – 15.833 mg, canthaxanthin 10%⁵ – 500 mcg, paraffin – 198 mcg, liquid paraffin – 33 mcg, sucrose – 303.64 mg, talc – 44.417 mg, titanium dioxide – 2.4 mg.

10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.

¹ in the form of dry retinol palmitate 250 CWS (1 g contains: vitamin A palmitate 148 mg, butylated hydroxyanisole – 2 mg, butylated hydroxytoluene – 9 mg, D,L-alpha-tocopherol – 3 mg, gelatin – 330 mg, sucrose – 330 mg, corn starch – 178 mg);
² in the form of dry vitamin E 50% SD (1 g contains: D,L-alpha-tocopherol acetate – 500 mg, gelatin – 470 mg, silicon dioxide – 30 mg);
³ in the form of dry colecalciferol 100 CWS (1 g contains: Colecalciferol – 2.5 mg, D,L-alpha-tocopherol – 2 mg, soybean oil – 75 mg, gelatin – 380 mg, sucrose – 380 mg, corn starch – 160.5 mg);
⁴ in the form of an aqueous solution of cyanocobalamin 0.1% WS (1 g contains: Cyanocobalamin – 1.1 mg, sodium citrate – 30 mg, citric acid – 10 mg, maltodextrin – 959 mg);
⁵ in the form of canthaxanthin 10% CWS/S (canthaxanthin, D,L-alpha-tocopherol, corn oil, corn starch, modified food starch).

Clinical-Pharmacological Group

Multivitamins with macro- and microelements

Pharmacotherapeutic Group

Multivitamin agent + minerals

Pharmacological Action

Multivitamins with macro- and microelements.

The complex contains 12 vitamins in combination with minerals and trace elements, which are important factors in metabolic processes.

Vitamin A promotes normal growth, participates in the formation and maintenance of the structure and function of bones, teeth, skin, and participates in the synthesis of visual pigment.

Vitamin B₁ promotes normal functioning of the nervous system.

Vitamin B₂ participates in tissue respiration, protein, carbohydrate and fat metabolism.

Vitamin B₆ helps maintain the structure and function of bones, teeth, gums, and affects erythropoiesis.

Vitamin B₁₂ participates in erythropoiesis, promotes normal functioning of the nervous system.

Vitamin C participates in the formation and maintenance of the structure and function of bones, teeth and gums; strengthens capillary walls.

Vitamin D₃ regulates the metabolism of phosphorus and calcium in the body, promoting the absorption of these substances from the intestine and their timely deposition in bones.

Vitamin E ensures normal functioning of red blood cells and protects cell membranes from damage.

Biotin participates in metabolic processes and promotes protein absorption.

Pantothenic acid participates in the metabolism of fats, proteins and carbohydrates.

Folic acid participates in erythropoiesis.

Nicotinamide participates in redox processes and ensures the transfer of hydrogen and phosphate.

Calcium participates in the formation of bones and teeth and promotes normal blood clotting.

Magnesium participates in the formation of muscle and bone tissue and also participates in protein synthesis.

Iron participates in erythropoiesis; is an important component of hemoglobin, which ensures the transport of oxygen to tissues.

Phosphorus, along with calcium, participates in the formation of bones and teeth, and also participates in energy metabolism processes.

Manganese promotes proper bone mineralization.

Copper is necessary for the normal function of red blood cells and iron metabolism.

Zinc is part of about 70 enzymes involved in the synthesis and metabolism of hormones (mainly glucocorticosteroids), as well as the division and interaction of immunocompetent cells.

Molybdenum is part of enzymes and coenzymes involved in many redox reactions in the body.

Indications

Prevention and treatment of hypo- and avitaminosis and mineral deficiency, including with inadequate and unbalanced nutrition (diets); with increased physical and mental stress; during the recovery period after prolonged and/or severe illnesses, including infectious ones; in the complex therapy of chronic alcoholism, when prescribing antibiotic therapy, chemotherapy.

ICD codes

Dosage Regimen

Take the drug orally with a meal.

For adults and adolescents over 12 years of age, take one effervescent tablet or one film-coated tabletonce daily.

Dissolve the effervescent tablet in a glass of water (approximately 200 ml) before ingestion.

Swallow the film-coated tablet whole with a sufficient amount of liquid; do not chew.

The standard treatment course is 1 to 2 months.

Do not exceed the recommended daily dose.

A repeated course of treatment requires prior consultation with a physician.

Adverse Reactions

Allergic reactions rash, facial swelling, shortness of breath, skin redness, itching, blisters, shock. If an allergic reaction occurs, you should stop taking the drug and consult a doctor.

From the digestive system stomach pain, intestinal pain, constipation, diarrhea, nausea, vomiting.

From the nervous system headache, dizziness, insomnia, nervousness.

From the metabolism hypercalciuria.

Contraindications

Hypersensitivity to the components of the drug; hypervitaminosis of vitamin A; hypervitaminosis of vitamin D; impaired iron and copper metabolism; hypercalcemia; severe hypercalciuria; renal failure; period of treatment with retinoids; sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (for film-coated tablets); children under 12 years of age; allergic reaction to peanuts or soy (for film-coated tablets).

Use in Pregnancy and Lactation

The drug can be taken during pregnancy and breastfeeding provided the recommended daily dose is followed. There are no data indicating a risk to the fetus when taking the drug in recommended doses during pregnancy.

Use in Renal Impairment

Contraindicated in renal failure.

Pediatric Use

Contraindicated for use in children under 12 years of age.

Special Precautions

When taking other medications concomitantly, you should consult your doctor in advance.

The recommended dose of the drug should not be exceeded, since very high doses of some ingredients of the drug, in particular vitamin A, vitamin D, iron and copper, can have an adverse effect on the human body.

Urine may turn yellow, which is completely harmless and is explained by the presence of riboflavin in the drug.

In case of hypersensitivity to lactose, this vitamin complex should be taken in the form of effervescent tablets.

An effervescent tablet contains about 300 mg of sodium (equivalent to 700 mg of table salt). Patients on a low-salt diet are recommended to take the drug in the form of film-coated tablets.

A tablet contains about 1000 mg of crystalline sugar (sucrose). When taking the recommended daily dose, this amount is negligible even if it is necessary to follow an anti-diabetic diet (1 g of crystalline sugar corresponds to 0.1 XE).

Drug Interactions

Other multivitamin preparations should not be taken simultaneously.

Preparations containing vitamin E should be used with caution in patients receiving anticoagulants or drugs that affect platelet aggregation.

Vitamin B₆, even in small doses, enhances the peripheral metabolism of levodopa, as a result of which the therapeutic effect of levodopa in the treatment of Parkinson’s disease may be reduced.

Preparations containing Iron, Calcium, Magnesium, Copper and Zinc may delay the absorption of oral antibiotics from the tetracycline group and antiviral drugs. An interval of at least 1-2 hours should be maintained between taking these drugs.

Simultaneous use of laxatives, such as paraffin oil, may cause impaired absorption of vitamin D in the gastrointestinal tract.

Consumption of foods containing oxalates (sorrel, spinach, rhubarb) and phytic acid (whole grain cereals) reduces the absorption of calcium, so the drug should not be taken within 2 hours after eating food containing significant amounts of oxalic and phytic acids.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.