Company: Kora Healthcare.
Legal category: Prescription. GMS reimbursable. Sport permitted.
Active ingredient: Camellia sinensis (green tea) leaf extract 100mg/g.
Description: Ointment.
Presentation: 15g tube, €42.59.
Indications: Cutaneous treatment of external genital and perianal warts (condylomata acuminata) in immunocompetent patients.
Pharmacology: Green tea leaf extract acts by inhibiting the growth of activated keratinocytes and by anti-oxidative effects at the site of application.
Dosage: Adult: Up to 250mg as total single dose (approx. 0.5cm of ointment strand) three times daily (maximum) until clearance of warts. Maximum duration 16 weeks in total (even if new warts develop). Elderly: As per adults. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy.
Special precautions: Not recommended: Unhealed skin from surgical/ drug treatment, multiple treatment courses. Do not use in patients with severe hepatic impairment. Avoid contact with mucous membranes, open wounds, broken or inflamed skin. Do not expose treated area to sunlight or UV irradiation. Vulvar region genital warts (caution, associated with severe local adverse reactions). Uncircumcised males with warts under foreskin, stop treatment if signs of stricture occur. Temporary mild local skin reactions may occur; suspend treatment if severe or associated with lymph node reaction. Exclude genital herpes if vesicular local reaction occurs. May weaken condoms and vaginal diaphragms (wash off before sexual contact), consider additional methods of contraception. Lactation. Contains propylene glycol monopalmitostearate, isopropyl myristate.
Drug interactions: Immunomodulatory drugs. Avoid: Other local treatments, high-dosed oral green tea extract preparations.
Adverse drug reactions: Local application site reactions: Erythema, pruritus, irritation/burning, pain, ulcer, oedema, induration, vesicles, exfoliation, discharge, bleeding, swelling. Inguinal lymphadenitis/lymphadenopathy, phimosis.
Full prescribing information and references available from Kora Healthcare. Telephone: 01-8900406.
E-mail: medinfo@korahealthcare.com