Zinc Renewal (Tablets) Instructions for Use

Marketing Authorization Holder

Triangle, LLC (Russia)

Manufactured By

Obnovlenie Pfc, JSC (Russia)

ATC Code

A12CB01 (Zinc sulfate)

Active Substance

Zinc sulfate (BP British Pharmacopoeia)

Dosage Form

Zinc Renewal

Film-coated tablets, 124 mg: 10, 15, 20, 30, 45, 60, 90, 100 or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white; minor surface roughness is allowed.

Excipients : lactose monohydrate, potato starch, povidone K30, talc, magnesium stearate; shell: polyvinyl alcohol (E1203), macrogol 3350 (polyethylene glycol), talc, titanium dioxide (E171) or a dry mixture for film coating, consisting of: polyvinyl alcohol (E1203), macrogol 3350 (polyethylene glycol), talc, titanium dioxide (E171).

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
15 pcs. – contour cell packaging (1) – cardboard packs.
15 pcs. – contour cell packaging (2) – cardboard packs.
15 pcs. – contour cell packaging (3) – cardboard packs.
15 pcs. – contour cell packaging (4) – cardboard packs.
15 pcs. – contour cell packaging (6) – cardboard packs.
15 pcs. – contour cell packaging (8) – cardboard packs.

Clinical-Pharmacological Group

Drug replenishing zinc deficiency in the body

Pharmacotherapeutic Group

Zinc preparation

Pharmacological Action

Zinc is a trace element that is involved in metabolism and the stabilization of cell membranes. It is part of the main enzymes and participates in various biochemical reactions. It affects regeneration processes and the transmission of nerve impulses. It enhances the action of insulin and promotes the synthesis of cortisol.

When taken orally, it stimulates skin regeneration processes and hair growth, has an immunomodulatory effect and, in high doses, an emetic effect. It is effective in the treatment of acne and alopecia. Zinc coagulates proteins with the formation of albuminates.

Antimicrobial activity is a consequence of the coagulation of microbial proteins. In micro amounts, it is resorbed and substrate-stimulates a number of enzyme systems (including alkaline phosphatase, angiotensin-converting enzyme, alcohol dehydrogenase, superoxide dismutase, carbonic anhydrase).

Zinc sulfate, when applied topically, has an antiseptic, astringent, drying, and local anti-inflammatory effect.

Indications

For oral administration: prevention and treatment of zinc deficiency caused by inadequate and unbalanced nutrition, malabsorption, and other conditions that impair zinc absorption and increase its loss by the body. Acrodermatitis enteropathica, acne pustulosa and acne phlegmonosa. During long-term treatment with corticosteroids, especially at the time of drug withdrawal. As an auxiliary treatment for hard-to-heal wounds.

For topical use: conjunctivitis, blepharitis; prevention of bacterial infection when a foreign body enters the conjunctival cavity.

ICD codes

Dosage Regimen

Administer orally with a sufficient amount of water. Take tablets 1 hour before or 2 hours after meals to maximize absorption.

For adults and children over 12 years of age, the standard dosage for zinc deficiency is one tablet (45 mg zinc) once daily.

For the treatment of acne, administer one to two tablets once daily. Adjust the dose based on clinical response and tolerability.

For acrodermatitis enteropathica, the typical dosage is one to two tablets three times daily. Titrate the dose to achieve clinical remission.

For pediatric patients 4 to 12 years of age, use only under medical supervision. The recommended dose is one tablet once daily.

The duration of treatment is determined by the physician based on the indication and laboratory parameters. For deficiency states, continue treatment until normalization of zinc levels.

For topical ophthalmic use, prepare a sterile solution. Instill one to two drops into the conjunctival sac of the affected eye(s) every two to four hours for conjunctivitis or blepharitis.

Do not exceed the recommended daily dose. Long-term administration of doses exceeding 50 mg elemental zinc daily requires monitoring for copper deficiency.

Avoid concurrent intake with dairy products, high-fiber foods, or iron supplements, as they can significantly reduce zinc absorption.

Adverse Reactions

When taken orally allergic reactions, nausea, diarrhea, heartburn, copper deficiency are possible; disorders of the hematopoietic system due to zinc-induced copper deficiency, including leukopenia (accompanied by fever, chills, sore throat), neutropenia (accompanied by the formation of ulcers in the oral cavity and pharynx), sideroblastic anemia (accompanied by a feeling of fatigue, weakness); headache, metallic taste in the mouth.

With topical use in ophthalmology redness of the mucous membrane of the eye, eye pain are possible.

Contraindications

Hypersensitivity to zinc sulfate; pregnancy, breastfeeding period; children’s age – depending on the dosage form; dry eye syndrome (for topical use in ophthalmology).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the instructions for zinc sulfate preparations regarding contraindications for the use of specific dosage forms of zinc sulfate in children of different ages.

Special Precautions

With long-term use of zinc preparations, the likelihood of copper ion deficiency in the body should be considered.

During the systemic use of zinc sulfate, the consumption of dairy products should be avoided, as this slows down the absorption of zinc salts from the gastrointestinal tract; avoid the consumption of alcoholic beverages.

Drug Interactions

With simultaneous use, Zinc sulfate reduces the absorption of tetracyclines, copper ions.

With simultaneous use, thiazide diuretics increase the excretion of zinc in the urine.

With simultaneous use, folic acid may slightly impair the absorption of zinc.

With simultaneous use, iron preparations in high doses, complexing agents (including penicillamine) significantly reduce the absorption of zinc.

Simultaneous use of several preparations containing zinc (for example, multivitamin preparations with minerals containing zinc) can lead to a high concentration of zinc in plasma.

Zinc sulfate is pharmaceutically incompatible with salts of silver, lead, quinine, ichthammol, citral (forms poorly soluble compounds), with alkali-reacting substances (forms zinc hydroxide oxide), with protargol (undergoes coagulation).

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.