ZINERIT

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ZINERYTâ (ZINERYTâ)

Composition:

Active substances: erythromycin, zinc acetate;

1 ml of prepared solution contains 40 mg of erythromycin and 12 mg of micronized zinc acetate dihydrate;

Excipients (solvent): diisopropyl sebacate, anhydrous ethanol.

Pharmaceutical form. Powder for solution for topical use, supplied with solvent and an applicator.

Main physicochemical characteristics: powder is white; solvent is a colorless, clear liquid.

Pharmacotherapeutic group. Antimicrobial agent for the treatment of acne vulgaris. ATC code D10AF52.

Pharmacological properties.

Pharmacodynamics.

Zinerit® is an erythromycin-zinc complex. It exerts anti-inflammatory, antimicrobial, and comedolytic effects. Erythromycin acts bacteriostatically against microorganisms causing acne vulgaris: Propionibacterium acnes and Streptococcus epidermidis. Zinc reduces sebaceous gland secretion and exerts an astringent effect.

Pharmacokinetics.

The complex binding of the components ensures good penetration of the active substances into the skin. Zinc is primarily bound to the follicular epithelium and is not absorbed into the systemic circulation. A small portion of erythromycin undergoes systemic distribution and is subsequently eliminated from the body.

Clinical characteristics.

Indications.

Treatment of acne vulgaris.

Contraindications.

Zinerit® is contraindicated in patients with hypersensitivity to erythromycin or to other macrolide antibiotics, or to zinc, di-isopropyl sebacate, or ethanol.

Interaction with other medicinal products and other forms of interaction.

To date, no interactions with other medicinal products have been established.

Special precautions for use.

Zineritâ is intended for topical use only; contact with the eyes and mucous membranes of the nose and oral cavity should be avoided.

Cross-resistance may occur when used with other macrolide antibiotics, as well as with lincomycin and clindamycin. Cross-resistance may also develop among macrolides.

Use during pregnancy or breastfeeding.

Pregnancy.

Available data on use during pregnancy do not indicate any harmful effects of erythromycin on pregnancy or the fetus. Erythromycin may be used during pregnancy.

Breastfeeding.

Only small amounts of erythromycin pass into breast milk; therefore, the drug may be used during lactation.

Fertility.

Data regarding fertility show no specific concerns.

Ability to affect reaction rate while driving or operating machinery.

There are no data on the effect of Zineritâ on the ability to drive or operate machinery. However, any such effect is unlikely.

Method of Administration and Dosage

Method of Administration

When starting treatment, the solvent from the vial must be transferred into the vial containing the powder. After this, the vial should be shaken until the powder is completely dissolved, then closed with the applicator cap provided.

Instructions for Preparation of Zineritâ Solution

1. The package contains two vials (Vial A and Vial B) and one applicator.
   Remove the caps from both vials. Keep the cap from Vial A, which contains the powder.

2. Transfer the solvent from Vial B into Vial A containing the powder. The empty Vial B can be discarded.

3. Close Vial A (containing the powder and solvent) using the cap saved earlier.

4. Shake Vial A immediately for 1 minute.

5. Remove the cap from Vial A and attach the applicator.

6. Insert the cap containing the applicator into the full vial and close tightly.

7. Now open the cap from the vial and check that the applicator is securely attached. If necessary, press firmly on the applicator to ensure it is fixed properly.

8. The solution remains stable for 5 weeks after preparation. Mark the expiration date on the vial.

Zineritâ should be applied as a thin layer to the facial skin or affected areas (not only directly on the lesion) until the entire area to be treated is covered (approximately 0.5 mL of the medicinal product should be used each time).

Application of Zineritâ is performed by tilting the vial with the applicator downward so that the applicator contacts the skin, then gently rubbing the applicator over the skin with light pressure. The amount of Zineritâ applied is controlled by the pressure applied.

Dosage. Zineritâ should be used twice daily, typically for 10–12 weeks. A noticeable therapeutic effect is usually achieved within the first 12 weeks. If no significant improvement is observed during this period, or if the condition worsens, the patient should consult a physician to evaluate the possibility of bacterial microflora resistance. If resistance develops, the use of the medicinal product should be discontinued for 2 months.

Children

The medicinal product can be used in children aged 12 years and older, based on clinical studies conducted in children who have reached sexual maturity.

Overdose

Considering the pharmaceutical form, accidental overdose is unlikely.

Acute intoxication following a single oral ingestion of the entire contents of a Zineritâ package will generally result in symptoms of transient toxic effects due to the presence of ethanol in the preparation.

Side effects.

*Erythema, skin irritation, and skin burning sensation are transient and minor clinical signs.

Shelf life. 2 years.

Storage conditions. Store at a temperature not exceeding 25 °C, in a place inaccessible to children.

The ready-to-use solution may be stored for 5 weeks at a temperature not exceeding 25 °C. If further treatment with Zineritâ is required, a new package should be obtained.

Packaging. Plastic bottle "A" containing powder for preparation of a solution for external use, plastic bottle "B" containing solvent, and an applicator (cap for preparation and dosing of the resulting solution), all contained in a cardboard box with instructions for medical use.

Availability. Over-the-counter (without prescription).

Manufacturer.

LEO Pharma A/S, Denmark.

Manufacturer's address and location of business operations.

Industriparken 55, Ballerup, 2750, Denmark.