Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Benzoyl peroxide
Haleon UK Ltd
D10AE01
Benzoyl peroxide
100mg/1gram
Cutaneous gel
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13060100; GTIN: 5011091100567
PACKAGE LEAFLET: INFORMATION FOR THE USER PANOXYL 10 GEL 10% W/W GEL BENZOYL PEROXIDE. READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use PanOxyl carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must see your doctor if your symptoms worsen or do not improve. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What PanOxyl is and what it is used for 2. Before you use PanOxyl 3. How to use PanOxyl 4. Possible side effects 5. How to store PanOxyl 6. Further information 1. WHAT PANOXYL IS AND WHAT IT IS USED FOR The name of your medicine is PanOxyl 10 Gel (called PanOxyl in this leaflet). PanOxyl contains an active ingredient called benzoyl peroxide. Benzoyl peroxide works by killing the bacteria on your skin that can cause acne PanOxyl is used to treat acne (spots). PanOxyl is for use by adults and adolescents with acne. IT IS NOT FOR USE BY CHILDREN. 2. BEFORE YOU USE PANOXYL DO NOT USE PANOXYL IF: • you are allergic (_hypersensitive_) to benzoyl peroxide or any of the other ingredients (listed in Section 6). Do not use PanOxyl if the above applies to you. If you are not sure, ask your pharmacist or doctor before you use this medicine. TAKE SPECIAL CARE WITH PANOXYL • Only use PanOxyl on your skin. Avoid contact with the eyes, eyelids, mouth, lips and inside the nose. If contact occurs, rinse with water. • TAKE CARE NOT TO USE PANOXYL ON AREAS OF BROKEN SKIN, such as cuts or grazes. If contact with these areas occurs, wash the affected area immediately with water. Page 1 of 10 • Take care when applying this product to the neck and other sensitive areas, since skin irritation is more likely to occur. • PanOxyl can make your skin more sensitive to the harmful effect Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT PanOxyl 10 Gel PanOxyl 10 Acnegel 10%w/w Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benzoyl peroxide 10.0% w/w For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel for cutaneous use 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Panoxyl 10 Gel is indicated for the treatment of acne vulgaris 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and adolescents _ Apply a thin film to the whole of the affected area once daily preferably after washing and drying the skin. If excessive dryness or peeling occurs application should be temporarily interrupted as per physician instruction or patient tolerability. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continued use is normally required to maintain a clinical response. _Elderly Patients _ There are no specific recommendations for use in the elderly. _ _ _Paediatric Population _ Safety and effectiveness of topical benzoyl peroxide in children under the age of 12 has not been established. 4.3 CONTRAINDICATIONS Patients with a known hypersensitivity to any of the ingredients should not use the product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid contact with the eyes, eyelids, mouth, lips and other mucous membranes. Contact with broken skin should be avoided. Care should be taken when applying the product to the neck and other sensitive areas. During the first weeks of treatment, a sudden increase in peeling and reddening will occur in most patients and will normally subside in a day or two if treatment is temporarily discontinued. Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy may occur, which sometimes may be severe, especially with the use of peeling, desquamating, or abrasive agents. If severe local irritancy occurs (e.g. severe erythema, se Прочетете целия документ