Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
BENZOYL PEROXIDE HYDROUS ; POTASSIUM HYDROXYQUINOLIN SULFATE
Alliance Pharmaceuticals Ltd.
D10AE01
BENZOYL PEROXIDE HYDROUS ; POTASSIUM HYDROXYQUINOLIN SULFATE
10 + 0.5 %w/w
Cream
Product subject to prescription which may be renewed (B)
benzoyl peroxide
Not marketed
1981-04-24
Artwork Information Product Title: Quinoderm cream 10% IRE PIL Date: 03-10-17 Product Size: 125mm x 160mm (Flat size) 125mm x 80mm (Finished size) Label Number: 16-148 Colours Used: Black Fonts Used: Arial Regular and Bold Font size: (min) 7pt Version: 2 1. WHAT QUINODERM CREAM IS AND WHAT IT IS USED FOR Quinoderm Cream belongs to a group of medicines called peroxides. It contains two active ingredients; benzoyl peroxide, which provides a peeling action, and potassium hydroxyquinoline sulfate, which has antimicrobial and antifungal properties. Quinoderm Cream is used for the treatment of acne vulgaris (common acne), acneform eruptions (an acne like rash) and folliculitis (a mild infection of the hair follicles). READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • 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. • You must talk to a doctor if you do not feel better or if you feel worse after 3 months. WHAT IS IN THIS LEAFLET 1. What Quinoderm Cream is and what it is used for 2. What you need to know before you use Quinoderm Cream 3. How to use Quinoderm Cream 4. Possible side effects 5. How to store Quinoderm Cream 6. Contents of the pack and other information PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 10% W/W + 0.5% W/W CREAM BENZOYL PEROXIDE, HYDROUS / POTASSIUM HYDROXYQUINOLINE SULFATE XXXXXX to use Quinoderm Cream whilst you are breast-feeding, you should ensure that the infant’s skin does not come into direct contact with the areas of skin that have been treated. QUINODERM CREAM CONTAINS CETOSTEARYL ALCOHOL: Quinoderm Cream contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatit Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quinoderm 10% w/w + 0.5% w/w Cream. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benzoyl Peroxide, hydrous 10.0% w/w Potassium Hydroxyquinoline Sulfate 0.5% w/w Excipient(s) with known effect Cetostearyl alcohol 5.25 % - 6.375 % w/w Macrogol 40 castor oil 0.75 % - 1.5 % w/w For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. White, astringent vanishing cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acne vulgaris, acneform eruptions, folliculitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults, Children and the Elderly By gentle massage over all the affected area two or three times daily. A single course of treatment should not extend beyond three months unless there is clear evidence of response. Method of administration For topical use only. 4.3 CONTRAINDICATIONS Acne Rosacea. Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid contact with eyes, mouth and mucous membranes. May bleach hair or dyed fabrics. Avoid exposure to excessive sunlight. In the few isolated cases, overreaction to Quinoderm Cream may occur. To minimise this possibility, select a small area of skin behind the ear, apply the cream and leave for twelve hours. If severe irritation or pronounced redness occurs, do not proceed with treatment and a doctor or pharmacist should be consulted_._ The product should only be used with caution in areas of thin or sensitive skin. Fair skinned individuals are likely to be particularly sensitive to irritation. 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