SKIN CAP

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SKIN CAP (SkinCap)

Composition:

Active substance: zinc pyrithione;

100 ml of aerosol contains zinc pyrithione 0.2 g;

Excipients: sodium lauryl sulfate, isopropyl myristate, ethanol 96%, Tween-80, sorbitol solution (E 420), isobutane, propane, butane.

Pharmaceutical form. Aerosol.

Main physicochemical properties: yellowish aerosol with white particles and a characteristic odor.

Pharmacotherapeutic group.

Dermatological agents. ATC code D11AX12.

Pharmacological properties.

Pharmacodynamics.

The drug has high antibacterial activity against a range of pathogenic microorganisms such as streptococci, staphylococci, Pseudomonas aeruginosa, Escherichia coli, and Proteus. The antifungal activity of the drug is particularly pronounced against Pityrosporum ovale and Pityrosporum orbiculare, which cause inflammation and excessive desquamation in psoriasis and other skin diseases.

Zinc pyrithione inhibits the proliferation of skin epithelial cells, eliminating excessive desquamation in psoriasis and other skin disorders.

Pharmacokinetics.

When applied topically, zinc pyrithione accumulates at the sites of skin lesions. Systemic absorption occurs very slowly, so the drug is present in the blood only in trace amounts.

Clinical characteristics

Indications.

Psoriasis, atopic dermatitis, eczema, excessive skin desquamation, seborrheic dermatitis of the scalp.

Contraindications.

Hypersensitivity to pyrithione zinc or to any of the excipients of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Concomitant use with dermatological medicinal products containing glucocorticosteroids is not recommended.

Special precautions for use.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the medication should be used only if the expected benefit to the woman outweighs the potential risk to the fetus/child.

Ability to affect reaction rate when driving or operating machinery.

Not observed.

Administration and Dosage

The medication should be sprayed onto affected skin areas, holding the container approximately 15 cm from the skin surface. Affected areas should be treated 2–3 times daily until clinical improvement is achieved. To ensure sustained effect, continue using the medication for one week after symptoms have disappeared.

Before use, the canister must be shaken several times. During spraying, the canister should be held in an upright position.

To treat affected areas of the scalp, use the special nozzle provided.

Children.

This medication is not recommended for children under 3 years of age.

Overdose. Not reported.

Possible intensification of adverse effects may occur.

Side effects.

Allergic reactions are possible, including redness, itching, and skin rashes.

Shelf life. 5 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C, in a place inaccessible to children.

Packaging.

50 ml, 100 ml, or 200 ml in an aluminum monobloc-canister.

1 monobloc-canister per cardboard box.

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

Manufacturers.

Chemnova Internacional, S. A.

"RESIFARM PARETS, S.L."

Manufacturers' address and place of business.

Calle Magarena, 14, Madrid, Spain.

C/Ramón y Cajal, 2, 08150 Paret del Vallès (Barcelona), Spain.