Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
BENZOYL PEROXIDE
Galderma (UK) Ltd
D10AE01
BENZOYL PEROXIDE
5 %w/w
Gel
Product not subject to medical prescription
benzoyl peroxide
Marketed
1984-04-17
BENZOYL PEROXIDE 5% W/W GEL _LAUNCHING DEPARTMENT - Z.I. Galderma_ _74540 ALBY-SUR-CHERAN - FRANCE_ PMS 432U DIELINES Artwork approved by: Date: Signature: Product code: MOCK UP Product description: ACNECIDE 5 GEL 60 Market: IRL Article: Leaflet Flat size: 135x210 Fold size: 135x26,25 Font size: 8 pt Pharmacode: TBD Specification n° MT.09.MPS.0109 This approval applies to WHOLE TEXT , including barcodes, pre-printed mentions and legal or special labelling constraints. PLEASE CHECK PROOF CAREFULLY TO ENSURE ALL ELEMENTS ARE CORRECT. PACKAGE LEAFLET: INFORMATION FOR THE USER ACNECIDE 5% 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 Acnecide 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 contact a doctor if your symptoms worsen or do not improve within four weeks. - If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Acnecide is and what it is used for 2. What you need to know before you use Acnecide 3. How to use Acnecide 4. Possible side effects 5. How to store Acnecide 6. Contents of the pack and other information 1. WHAT ACNECIDE IS AND WHAT IT IS USED FOR • Acnecide contains the active substance benzoyl peroxide which attacks the bacteria (germs) known as Propionibacterium acnes, one of the main causes of acne. • Your doctor or pharmacist has recommended this medicine to treat your acne. Acne appears as blackheads and whiteheads which people often refer to as pimples or spots. • Acne of the face, chest or back may be treated with this medicine. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ACNECIDE DO NOT USE ACNECIDE IF YOU ARE: • Allergic (hypersensitive) to benzoyl peroxide or any of the other ingredients of this medicine (listed in Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acnecide 5% w/w Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrous benzoyl peroxide equivalent to Benzoyl Peroxide 5 % w/w. Excipients: Propylene glycol 40mg/g For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel. White to off-white, smooth gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acnecide is indicated in the management of acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Topical administration only. Adults and children: Before each application, the skin should be cleaned and dried. Apply in a thin layer once or twice daily or as directed to the affected areas. Persons with sensitive skin should be directed to apply the gel once daily before going to bed. The extent of any drying or peeling may be adjusted by modifying the dosage schedule. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. For external use only. 2. Acnecide may cause swelling and blistering of the skin, if any of these symptoms occur, medication has to be discontinued. 3. If no response occurs within four weeks the use of the product should be discontinued and a doctor consulted. In any event a single course of treatment should not extend beyond three months. 4. This product should be kept from contact with eyes, mouth, angles of the nose or mucous membranes. If accidental contact occurs, rinse with water. 5. Repeated exposure to sunlight or UV radiation should be avoided. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Citiți documentul complet