Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
CLOBETASOL PROPIONATE
PIERRE FABRE DERMATOLOGIE
D07AD01
CLOBETASOL PROPIONATE
0.05% %w/w
Cutaneous Foam
Product subject to prescription which may not be renewed (A)
Corticosteroids, very potent (group IV)
Authorised
2005-03-18
CLARELUX 500 mg/g - Notice - Format : 185 x 350 mm - Taille du texte : 9 pt, interl. 10,8 pt Version UK - Dossier 4609 - 20/02/2015 NOIR PANTONE 185 PACKAGE LEAFLET: INFORMATION FOR THE USER 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 or your pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • 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. WHAT IS IN THIS LEAFLET: 1. What CLARELUX ® is and what it is used for 2. What you need to know before you use CLARELUX ® 3. How to use CLARELUX ® 4. Possible side effects 5. How to store CLARELUX ® 6. Contents of the pack and other information 1. WHAT CLARELUX ® IS AND WHAT IT IS USED FOR CLARELUX ® contains the active substance clobetasol propionate which belongs to a group of medicines known as topical corticosteroids. CLARELUX ® is a highly potent topical corticosteroids. CLARELUX ® is a foam to be applied to the skin. CLARELUX ® is used as a short-term treatment for scalp conditions, e.g. psoriasis of the scalp, which do not respond satisfactorily to weaker corticosteroids. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CLARELUX ® DO NOT USE CLARELUX ® : • If you are allergic to clobetasol propionate, to other corticosteroids or any of the other ingredients of CLARELUX ® ; • If you have an infectious skin disease, either viral (e.g. herpes, shingles, chickenpox…), bacterial (e.g. impetigo …), fungal (caused by microscopic fungi) or parasitic; • If you suffer from burns, ulcerated lesions or other skin condition such as rosacea, acne, skin inflammation around the mouth, itching (pruritus) around the anus or genitals. • On an Կարդացեք ամբողջական փաստաթուղթը
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CLARELUX 500 micrograms/g cutaneous foam in pressurised container. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cutaneous foam contains 500 micrograms clobetasol propionate. Excipients with known effect: cetyl alcohol 11.5 mg/g, stearyl alcohol 5.2 mg/g and propylene glycol 20.9 mg/g. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous foam in pressurised container. White foam that breaks down upon contact with skin. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-course treatment of steroid responsive dermatoses of the scalp such as psoriasis, which do not respond satisfactorily to less active steroids. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Use in adults_ CLARELUX is a highly potent topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used. Route of administration: for cutaneous use. CLARELUX should be applied to the affected area twice daily. There are no data from clinical studies evaluating the efficacy of once daily application. _Paediatric population_ As there are no data regarding the use of CLARELUX in children and adolescents, use in these patients is not recommended. Method of administration The foam application has been designed so that the preparation spreads easily without being too fluid and allows easy application direct to the affected area. _Note: for proper dispensing of foam, hold the container upside down and depress the actuator._ Invert the container and dispense a small amount (of the size of a walnut or one teaspoon) of CLARELUX directly on the lesions, or dispense a small amount into the cap of the container, onto a saucer or other cool surface, taking care to avoid contact with eyes, nose, and mouth. Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Gently massage into affected area until the foam disappear Կարդացեք ամբողջական փաստաթուղթը