Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Azelaic acid
LEO Pharma
D10AX03
Azelaic acid
150mg/1gram
Cutaneous gel
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13060100; GTIN: 4260085520510
IIT003-00 - Page 1 of 2 - 148 x 420 mm – DRA_001123/LF0001 IIT002-00 - 28/01/2019 - OMA: Updated for CI project (CAPA 173674) Insert 148 x 420 mm IIT003-00 29/01/2019 JUG 100% All products Used for: Segrate keyline DRA_001123/LF0001 Comments: Approval: Date: Production site approval: Graphic approval: Revision info: WHAT IS IN THIS LEAFLET 1. WHAT FINACEA ® IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FINACEA ® 3. HOW TO USE FINACEA ® 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE FINACEA ® 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT FINACEA ® IS AND WHAT IT IS USED FOR Finacea 15 % Gel (Finacea) contains the active substance azelaic acid and belongs to the group of anti-acne preparations for external use (on the skin). Finacea 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 FINACEA ® DO NOT USE FINACEA • 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 or pharmacist before using Finacea. Finacea is for external use on the skin only. Take care to avoid contact with the eyes, mouth and other mucous membranes (the thin skin around body openings). 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 Finacea. It is advisable to avoid alcoholic cleansers, tinctures and astringents, abrasives and peeling agents when using Finacea for treatment of rosacea. Rarely, it has been reported that in some patients with asthma who were treated with azelaic acid worsening of asthma symptoms had occurred. CHILDREN AND ADOLESCENTS Safety and efficacy in the treatment of acne have been studied in 12-18 years old adolescen Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Finacea 15% Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g Finacea 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 For the relief of mild to moderate papular-pustular acne of the facial area. For the topical treatment of papulopustular rosacea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Finacea 15 % Gel is intended for cutaneous use only. Posology Finacea 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 Finacea Gel is administered to adolescents aged 12-18 years. The safety and efficacy of Finacea Gel for the treatment of acne vulgaris in children below the age of 12 years have not been established. The safety and efficacy of Finacea 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 Before Finacea 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 hands should be washed after applying the gel. In the event of skin irritation (see section 4.8 Undesirable effects), the amount of gel per application Đọc toàn bộ tài liệu