PSORICAP®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PSORICAP® (PSORICAP)

Composition:

Active substance: 1 g of cream contains 2 mg of zinc pyrithione;

Excipients: methylparaben (methyl p-hydroxybenzoate) (E 218), butylhydroxytoluene (E 321), glycerol monostearate, polyglyceryl-3 methylglucose distearate, sucrose cocoate, methyl gluceth-10, stearyl alcohol, octyldodecanol, isopropyl palmitate, cyclomethicone, glycerin, citric acid monohydrate, purified water.

Dosage form. Cream.

Main physicochemical characteristics: white-colored cream.

Pharmacotherapeutic group. Dermatological agents. ATC code: D11AX12.

Pharmacological properties.

Pharmacodynamics.

The drug exhibits 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. The drug acts against microorganisms located both on the surface and in the deeper layers of the epidermis.

The special formulation of the cream has hydrating properties, enhances the antibacterial and antifungal effects of pyrithione zinc, and helps relieve burning and itching. Activated pyrithione zinc contained in the cream suppresses pathological cell growth in the superficial skin layers that are in a state of pathological hyperproliferation, thus eliminating excessive desquamation in psoriasis and other skin disorders. The drug acts against microorganisms located both on the surface and in the deeper layers of the epidermis.

Pharmacokinetics.

When applied topically, pyrithione zinc is deposited in the superficial (epidermal) layers of the skin. Systemic absorption occurs slowly and is detectable in the blood only in trace amounts.

Clinical characteristics.

Indications.

Psoriasis, atopic dermatitis, seborrheic eczema in adults and children from 1 year of age, especially in widespread forms, as well as in cases of itching, irritation, inflammation, and increased skin dryness.

Contraindications.

Hypersensitivity to any component of the product.

Interaction with other medicinal products and other forms of interaction.

Concomitant use with ointments and creams containing glucocorticosteroids is not recommended.

Special precautions for use.

Avoid contact of the cream with the eyes. If the cream gets into the eyes, rinse thoroughly with plenty of running water and consult a physician.

Increased frequency of cream application may lead to mild, transient local burning sensation of the skin.

The drug can be used during remission for maintenance therapy and prevention of relapses, which allows rapid elimination of the manifest phase and accelerates clinical recovery. During remission, the cream should be applied to the affected skin areas at the first signs of disease exacerbation.

The presence of methylparahydroxybenzoate (E 218) in the formulation may cause allergic reactions (possibly delayed).

The presence of butylhydroxytoluene (E 321) in the formulation may cause local skin reactions (e.g. contact dermatitis) or irritation of eyes and mucous membranes.

Use during pregnancy or breastfeeding.

The drug should be used during pregnancy or breastfeeding only when the expected benefit outweighs the potential risk to the fetus/infant. The cream should not be applied to the nipples during breastfeeding.

Ability to influence reaction rate while driving or operating machinery. Does not affect.

Administration and dosage.

Apply to affected skin twice daily.

For psoriasis, the treatment course lasts 1–1.5 months; for atopic dermatitis, 3–4 weeks; for other conditions, apply the cream until symptoms completely disappear. In cases of residual symptoms (hyperemia, dryness, desquamation, pigmentation), continue using the cream for 1–2 weeks.

Children. Do not use in children under 1 year of age.

Overdose.

May intensify the manifestations of adverse reactions.

Side effects.

Possible hypersensitivity reactions, including skin rash, redness, itching, changes and burning sensation at the application site.

Shelf life.

2 years.

Storage conditions.

In the original packaging at a temperature not exceeding 25 °C. Do not freeze.

Keep out of reach of children.

Packaging.

30 g in a tube, 1 tube in a carton.

Availability.

Over-the-counter (without prescription).

Manufacturer/Applicant.

PJSC "Kyivmedpreparat".

Manufacturer's address and place of business / Applicant's address and/or representative's address.

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.