Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Azelaic acid
LEO Pharma A/S
D10AX; D10AX03
Azelaic acid
15 percent
Gel
Other anti-acne preparations for topical use; azelaic acid
Marketed
2003-06-30
PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ SKINOREN ® 15 % GEL Azelaic acid 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, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT SKINOREN ® GEL IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SKINOREN ® GEL 3. HOW TO USE SKINOREN ® GEL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SKINOREN ® GEL 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SKINOREN ® GEL IS AND WHAT IT IS USED FOR Skinoren Gel contains the active substance azelaic acid and belongs to the group of anti-acne preparation for external (cutaneous) use. Skinoren Gel is for the relief of mild to moderate papulopustular acne of the face and the treatment of papulopustular rosacea. Papulopustular acne and rosacea are associated with inflamed papules and pustules. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SKINOREN ® GEL DO NOT USE SKINOREN GEL - if you are allergic to azelaic acid or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Skinoren Gel. Skinoren Gel is for external (cutaneous) use only. Take care to avoid contact with the eyes, mouth and other mucous membranes. In the event of an accidental contact, wash the eyes, mouth and/or affected mucous membranes with large amounts of water. You should consult a doctor or pharmacist if an eye irritation persists. Please wash your hands after each application of Skinoren Gel. It is advisable to avoid alcoholic cleansers, tinctures and astringents, abrasive Прочитајте комплетан документ
Health Products Regulatory Authority 07 April 2021 CRN009ZXQ Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Skinoren 15% Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1g Skinoren Gel contains 150 mg (15%) azelaic acid. Excipients with known effect 1 mg Benzoic acid /g Gel 0.12 g Propylene glycol /g Gel For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel White to yellowish-white opaque gel 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS o For the relief of mild to moderate papular-pustular acne of the facial area. o For the topical treatment of papulopustular rosacea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Skinoren 15 % Gel is intended for cutaneous use only. Posology Skinoren Gel should be applied to the affected skin areas twice a day (in the morning and in the evening) and rubbed in gently. Approximately 0.5 g = 2.5 cm (1 inch) of gel is sufficient for the entire facial area. _Pediatric population_ Use in adolescents (12‑18 years of age) for the treatment of acne vulgaris. Dose adjustment is not required when Skinoren Gel is administered to adolescents aged 12‑18 years. The safety and efficacy of Skinoren Gel for the treatment of acne vulgaris in children below the age of 12 years have not been established. The safety and efficacy of Skinoren Gel for the treatment of papulopustular rosacea in children below the age of 18 years have not been established. _Geriatric patients_ No targeted studies have been performed in patients aged 65 and over. _Patients with hepatic impairment_ No targeted studies have been performed in patients with hepatic impairment. _Patients with renal impairment_ No targeted studies have been performed in patients with renal impairment. Method of administration Health Products Regulatory Authority 07 April 2021 CRN009ZXQ Page 2 of 7 Before Skinoren Gel is applied, the skin should be thoroughly cleaned with plain water and dried. A mild skin-cleansing agent may be used. Occlusive dressing or wrappings should not be used, and Прочитајте комплетан документ