Complivit^® Zhelezo (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmstandard-UfaVITA OJSC (Russia)

Dosage Form

Complivit® Zhelezo

Tablets: 60 pcs.

Dosage Form, Packaging, and Product Composition

Composition retinol acetate, alpha-tocopherol acetate, thiamine hydrochloride, riboflavin, pyridoxine hydrochloride, ascorbic acid, nicotinamide, folic acid, calcium pantothenate, cyanocobalamin, copper (sulfate), zinc oxide, iron fumarate, sodium iodide, lactose, hydroxypropyl methylcellulose (E464) potato starch, citric acid (E330), calcium stearate (E470), talc (E553), povidone (E 1201), titanium dioxide (E 171), polyethylene glycol 4000 (E1521), azorubine (E122), tropaeolin O, aerosil (E551), indigo carmine (E132).

Content of biologically active components per 1 tab.: retinol acetate (vitamin A) – 0.5 mg±25% (1453.5 IU±25%), E – 10 mg±20%, B1- 1 mg±20%, B2 -2. mg±20%, B6 – 2.5 mg±20%, C-100 mg±20%, PP – 10 mg±25%, folic acid – 0.4 mg±35%, calcium pantothenate – 10 mg ±30%, B12 – 3 mcg± 35%, copper – 0.75 mg±20%, zinc – 2.0 mg±20%, iodine – 0.07 mg±40%, iron – 15 mg±20%.

Release form and packaging
Tablets 525 mg. 60 tablets in a jar, 1 jar in a cardboard pack.

Therapeutic Category

Dietary supplement – source of vitamins and trace elements

Scope of Application

Of the Complivit^® Zhelezo product

Recommended as a dietary supplement – an additional source of vitamins: A, C, E, group B (B1, B2, B6, B12, calcium pantothenate), folic acid, nicotinamide, mineral elements: copper, zinc, iron, iodine.

Indications

• Use as an additional dietary source of vitamins A, C, E, B1, B2, B6, B12, calcium pantothenate, folic acid, and nicotinamide.
• Use as an additional dietary source of the mineral elements copper, zinc, iron, and iodine.
• Intended to help correct micronutrient deficiencies in the diet.

ICD codes

Dosage Regimen

Take one tablet orally once daily with a meal to improve gastrointestinal tolerance.

The recommended duration of continuous use is one month.

Do not exceed the stated recommended daily dosage.

Swallow the tablet whole with a sufficient amount of water; do not chew.

Consult a physician before use to determine the appropriateness and required duration of supplementation.

Is not a medicine.

Adverse Reactions

Adverse reactions are uncommon and typically associated with individual sensitivity.

Report any allergic reactions, such as skin rash, itching, or urticaria, which may occur due to intolerance to active ingredients or excipients like azorubine (E122). Discontinue use immediately if such reactions occur.

Gastrointestinal discomfort, including nausea or epigastric pain, is possible, particularly if taken on an empty stomach.

Drug Interactions

Avoid concurrent administration with other vitamin-mineral complexes to prevent excessive intake and potential toxic effects.

The iron content may reduce the absorption of tetracycline antibiotics, fluoroquinolones, levodopa, levothyroxine, and penicillamine; separate administration by at least 2 hours.

Ascorbic acid can enhance iron absorption. Antacids containing calcium, magnesium, or aluminum may decrease iron absorption.

Contraindications

• Do not use in cases of known individual hypersensitivity or allergy to any component of the product, including the dyes azorubine (E122) and indigo carmine (E132).
• Contraindicated in conditions of iron overload, such as hemochromatosis or hemosiderosis.
• Not for use in cases of hypervitaminosis A or D, or severe hypercalcemia.

Overdose

Symptoms of acute overdose may include severe gastrointestinal disturbances such as nausea, vomiting, diarrhea, and abdominal pain, primarily due to iron content.

Chronic excessive intake can lead to accumulation of fat-soluble vitamins (A, E) and minerals (copper, zinc, iron), resulting in toxicity. In case of suspected overdose, discontinue use immediately and seek medical attention. Treatment is symptomatic and supportive.

Dispensing Status

Sale to the public through the pharmacy network and specialized stores, departments of the trading network.

Storage Conditions

Store in a dry place, protected from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

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.