Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Betamethasone valerate
RPH Pharmaceuticals AB
D07AC; D07AC01
Betamethasone valerate
1 (0.1%) milligram(s)/gram
Cutaneous foam
Product subject to prescription which may be renewed (B)
Corticosteroids, potent (group III); betamethasone
Marketed
1998-11-13
PACKAGE LEAFLET: INFORMATION FOR THE USER BETTAMOUSSE ® 1MG/G (0.1%) CUTANEOUS FOAM Betamethasone 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 pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. - In this leaflet, Bettamousse 1mg/g (0.1%) cutaneous foam will be called Bettamousse. WHAT IS IN THIS LEAFLET 1. What Bettamousse is and what it is used for 2. What you need to know before you use Bettamousse 3. How to use Bettamousse 4. Possible side effects 5. How to store Bettamousse 6. Contents of the pack and other information 1. WHAT BETTAMOUSSE IS AND WHAT IT IS USED FOR Bettamousse contains the active substance Betamethasone as valerate. Bettamousse belongs to a group of medicines called corticosteroids (‘steroids’ for short). Bettamousse is used to treat skin disorders of the scalp such as psoriasis (raised red patches of skin covered in silvery scales) that may feel itchy, tight or sore. Bettamousse works by reducing inflammation (redness, itching and soreness). It is important to use this medicine to prevent damage to the skin and infections from developing. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETTAMOUSSE DO NOT USE BETTAMOUSSE: - If you are allergic to betamethasone valerate or any of the other ingredients of this medicine (listed in section 6). - If you have any kind of infection of the scalp, unless this is already being treated - On a child under 6 years of age. If any of the above applies to you, talk to your doctor or pharmacist. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Bettamousse if: - You have any kind of skin infec Læs hele dokumentet
Health Products Regulatory Authority 24 October 2022 CRN00CY2N Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bettamousse 1mg/g (0.1%) cutaneous foam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of foam contains 1 mg of betamethasone (0.1 %) as valerate. Excipients with known effect: Cetyl Alcohol 1.1% w/w Stearyl Alcohol 0.5% w/w Propylene Glycol (E1520) 2.0% w/w Ethanol 57.79% w/w For the full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Cutaneous foam White, foam mousse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bettamousse is indicated for steroid responsive dermatoses of the scalp, such as psoriasis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS, THE ELDERLY AND CHILDREN (OVER THE AGE OF SIX YEARS): No more than a "golf-ball" sized amount of mousse (containing approximately 3.5mg betamethasone), or proportionately less for children twice daily (in the morning and evening) until the condition improves. If there is no improvement after 7 days, treatment should be discontinued. Once the condition has improved, application is reduced to once a day and after daily treatment it may be possible to maintain improvement by applying even less frequently. _Paediatric population_ In children over the age of 6 years, this product should not, in general, be used for longer than 5 to 7 days. Method of administration For topical use. Shake the can well before use. Remove the cap, invert the can and dispense required amount of mousse onto a clean saucer or something similar. Dispensing directly onto hands should be avoided as the mousse will begin to melt when it touches skin. Massage sparingly into the affected areas of the scalp. Wash hands immediately after use. Do not wash hair immediately after use, allow the mouse to work overnight or through the day. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Bacterial, fungal, parasitic or viral infections of the scalp unless simultaneous treatment is in Læs hele dokumentet