KLYNTOPIC

Klyntopic

Gel, 10 mg/50 mg/g

One gram of gel contains the active substances clindamycin (as clindamycin phosphate) 10 mg and anhydrous benzoyl peroxide 50 mg.

Excipients: carbomer, dimeticone, disodium lauryl sulfosuccinate, sodium hydroxide, disodium edetate, hydrated colloidal silicon dioxide, glycerol, poloxamer 182, purified water.

A combination topical gel with antibacterial and mild keratolytic action, indicated for the treatment of mild-to-moderate acne vulgaris (especially inflammatory lesions) in adults and adolescents aged 12 years and over.

Clindamycin is an antibiotic that inhibits bacterial protein synthesis and acts against Propionibacterium acnes, the bacterium involved in acne vulgaris. Benzoyl peroxide is an oxidising agent with bactericidal, mild keratolytic and sebostatic action. The combination reduces the risk of bacterial resistance to clindamycin compared with antibiotic monotherapy. The therapeutic effect can be seen after 2–5 weeks of treatment.

Apply to the skin (external use), once a day in the evening, to the entire affected area in a thin layer after gentle cleansing and thorough drying. Wash your hands after applying.

Treatment must not exceed 12 weeks. Do not apply excessively (this increases the risk of irritation without improving efficacy). If excessive dryness or peeling occurs, reduce the frequency or temporarily stop use. Not recommended in children under 12 years.

Do not use this medicine if you are allergic to clindamycin, lincomycin, anhydrous benzoyl peroxide or to any of its excipients.

Important to know

Avoid contact with the eyes, mouth, lips, mucous membranes and irritated skin. Benzoyl peroxide increases skin sensitivity to the sun: avoid prolonged or deliberate sun exposure and UV lamps; if unavoidable, use sunscreen and wear protective clothing. Do not use at the same time as erythromycin-containing products (antagonism with clindamycin); take care with tretinoin, isotretinoin, tazarotene or other irritating products (including alcohol or abrasives); if combination is needed, apply them at different times of day (morning/evening).

Benzoyl peroxide can bleach hair and coloured fabrics: avoid contact. Stop treatment immediately if persistent diarrhoea or abdominal cramps occur (risk of antibiotic-associated colitis). During pregnancy and breast-feeding, use only after careful benefit-risk assessment; during breast-feeding, do not apply to the breast area. Read the package leaflet carefully before use.

Possible side effects

Very common: mild erythema, peeling and dryness (especially at the start of treatment).

Common: burning sensation, photosensitivity, headache, pain at the application site.

Uncommon: dermatitis, itching, skin rash, temporary worsening of acne.

Frequency not known: colitis (including pseudomembranous), haemorrhagic diarrhoea, severe allergic reactions (hypersensitivity, anaphylaxis), urticaria, skin discolouration.

If side effects occur, stop using the product and consult a doctor or pharmacist.

Before opening: store in a refrigerator (2–8 °C). Do not freeze. After opening: store below 25 °C. Keep out of the reach of children. Shelf life: 24 months; after opening the tube: 2 months.

For questions about the medicine, please consult your doctor or pharmacist. Manufacturer: FARMAPRIM SRL, 5 Crinilor str., Porumbeni village, Criuleni district, Republic of Moldova, MD-4829. Pharmacovigilance: safety@farmaprim.md.

Brief information prepared on the basis of the approved Summary of Product Characteristics. It does not replace consultation with a doctor or pharmacist and does not contain all information about the medicine. Always read the package leaflet.