Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
imiquimod
Viatris Healthcare Limited
D06BB10
imiquimod
Antibiotics and chemotherapeutics for dermatological use
Keratosis; Keratosis, Actinic
Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.
Revision: 15
Authorised
2012-08-23
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE USER ZYCLARA 3.75% CREAM imiquimod READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their sign of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Zyclara is and what it is used for 2. What you need to know before you use Zyclara 3. How to use Zyclara 4. Possible side effects 5. How to store Zyclara 6. Content of the pack and other information 1. WHAT ZYCLARA IS AND WHAT IT IS USED FOR Zyclara 3.75% cream contains the active substance imiquimod, which is an Immune Response Modifier (to stimulate the human immune system). This medicine is prescribed for the treatment of actinic keratosis in adults. This medicine stimulates your body’s own immune system to produce _ _ natural substances which help fight your actinic keratosis. Actinic keratosis appears as rough areas of skin found in people who have been exposed to a lot of sunshine over the course of their lifetime. These areas can be the same colour as your skin or are greyish, pink, red or brown. They can be flat and scaly, or raised, rough, hard and warty. This medicine should only be used for actinic keratosis on the face or scalp if your doctor has decided that it is the most appropriate treatment for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ZYCLARA DO NOT USE ZYCLARA - if you are allergic to imiquimod or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Zyclara: • if you have previously used this medicine or other similar preparations in a differen Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zyclara 3.75% cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each sachet contains 9.375 mg of imiquimod in 250 mg cream (3.75%). Each gram of cream contains 37.5 mg of imiquimod. Excipients with known effects: Methyl parahydroxybenzoate (E 218) 2.0 mg/g cream Propyl parahydroxybenzoate (E 216) 0.2 mg/g cream Cetyl alcohol 22.0 mg/g cream Stearyl alcohol 31.0 mg/g cream Benzyl alcohol 20.0 mg/g cream For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream. White to faintly yellow cream with a uniform appearance. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zyclara is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, visible or palpable actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Zyclara (per application: up to 2 sachets, 250 mg imiquimod cream per sachet) should be applied once daily before bedtime to the skin of the affected treatment field (area) for two treatment cycles of 2 weeks each separated by a 2-week no-treatment cycle or as directed by the physician. The treatment area is the full face or balding scalp. Local skin reactions in the treatment area are in part anticipated and common due to its mode of action (see section 4.4). A rest period of several days may be taken if required by the patient’s discomfort or severity of the local skin reaction. However, neither 2-week treatment cycle should be extended due to missed doses or rest periods. A transient increase in actinic keratosis counts may be observed during treatment due to the likely effect of imiquimod to reveal and treat subclinical lesions. Response to treatment cannot be adequately assessed until resolution of local skin reactions. Patients should continue treatment as prescribed. Treatment should be continued for the fu Aqra d-dokument sħiħ