Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betamethasone valerate
Waymade Healthcare Plc
D07AC01
Betamethasone valerate
1mg/1gram
Cutaneous foam
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000
• 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 infection • You have open wounds on your scalp • You are taking any other medicine, including medicines obtained without a prescription. CHILDREN AND ADOLESCENTS Do not give this medicine to children under the age of 6 years. OTHER MEDICINES AND BETTAMOUSSE Tell your doctor or pharmacist if you are taking, using, have recently taken or used or might take or use any other medicines. PREGNANCY AND BREAST-FEEDING If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. DRIVING AND USING MACHINES There are no known effects on driving or using machines. BETTAMOUSSE CONTAINS CETYL ALCOHOL AND STEARYL ALCOHOL which may cause local skin reactions (e.g. contact dermatitis) BETTAMOUSSE CONTAINS PROPYLENE GLYCOL which may cause skin irritation. 3. HOW TO USE BETTAMOUSSE ALWAYS USE THIS MEDICINE EXACTLY AS YOUR DOCTOR OR PHARMACIST HAS TOLD YOU. YOUR DOSE WILL BE SHOWN CLEARLY ON THE LABEL THAT YOUR PHARMACIST PUTS ON YOUR MEDICINE. CHECK WITH YOUR DOCTOR OR PHARMACIST IF YOU ARE NOT SURE. REMEMBER: • USE AS LITTLE BETTAMOUSSE AS POSSIBLE FOR THE SHORTEST POSSIBLE TIME • Avoid contact with your eyes. If Bettamousse gets into your eyes, rinse well with cold water. If your eyes continue to sting, contact your doctor • Avoid contact with the inside of your nose and mouth • Avoid contact with any open wounds. 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 onl Przeczytaj cały dokument
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 betamethasone (0.1 %) as valerate Excipients with known effect: Cetyl Alcohol 1.10 % w/w, Stearyl alcohol 0.50 % w/w) and Propylene glycol 2.00 % w/w For a 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 To be massaged into the affected areas of the scalp. Patients should be advised to use the product sparingly. 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 initiated. Dermatoses in children under six years of age. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid contact with the eyes, open wounds and mucosae. Do not use near a naked flame. The least amount of mousse required to control the disease should be used for the shortest possible time. This should minimise the potential for long term side effects. This is particularly the case in children, as adrenal suppression can oc Przeczytaj cały dokument