País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betamethasone valerate
Teva UK Ltd
D07AC01
Betamethasone valerate
1mg/1gram
Cutaneous ointment
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5017007299837 5017007299844
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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT BETAMETHASONE OINTMENT IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETAMETHASONE OINTMENT 3. HOW TO USE BETAMETHASONE OINTMENT 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE BETAMETHASONE OINTMENT 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT BETAMETHASONE OINTMENT IS AND WHAT IT IS USED FOR Betamethasone Valerate 0.1%w/w Ointment (hereinafter referred to as Betamethasone ointment) contains a topical steroid. ‘Topical’ means that it is put on the skin. Topical steroids are used on certain types of inflamed skin, to reduce the redness and itchiness. Betamethasone ointment is used to treat inflamed skin conditions, such as eczema, in patients unresponsive to less potent creams or ointments. These steroids should not be confused with “anabolic” steroids misused by some body builders and athletes and taken as tablets or injections. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETAMETHASONE OINTMENT DO NOT USE BETAMETHASONE OINTMENT: if you are allergic (hypersensitive) to betamethasone valerate or any of the other ingredients of Betamethasone ointment (listed in section 6) on infants under one year of age on areas of skin which have the following conditions: acne rosacea (redness and spots or blisters in the centre of the face around the nose) peri-oral dermatitis (spotty red rash around the mouth) skin infections caused by viruses, bacteria or fungi, such as cold sores, herpes, chickenpox, impetigo, ringworm, athlete’s foot, thrush o Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betamethasone Valerate 0.1% w/w Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of ointment contains 1mg of betamethasone (0.1% w/w) as valerate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment Opaque ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betamethasone Valerate Ointment preparations are indicated for the treatment of: eczema in children over 1 year elderly and adults; including atopic and discoid eczemas; prurigo nodularis; psoriasis (excluding widespread plaque psoriasis); neurodermatoses, including lichen simplex, lichen planus; seborrhoeic dermatitis; contact sensitivity reactions; discoid lupus erythematosus and they may be used as an adjunct to systemic steroid therapy in generalised erythroderma. In general, ointment preparations are particularly appropriate for dry, lichenified or scaly skin conditions whereas a cream preparation may be more suitable in the case of moist or weeping lesions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical use only. If no improvement is seen after two to four weeks, the diagnosis should be reconsidered and specialist referral may be necessary. Adults, adolescents and the elderly A small quantity of Betamethasone Valerate Ointment should be applied to the affected area one to three times daily until improvement occurs. It may then be possible to maintain improvement by applying once a day, or even less often, or by using the appropriate ready diluted (1 in 4) preparation, Betamethasone Valerate 0.025% Ointment. Allow adequate time for absorption after each application before applying an emollient. If no improvement is seen within two to four weeks, reassessment of the diagnosis, or referral, may be necessary. In the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effect of Betamethasone Valerate Ointmentcan be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight Leer el documento completo