국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betamethasone valerate
Actavis UK Ltd
D07AC01
Betamethasone valerate
1mg/1gram
Cutaneous ointment
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5012617019134 5012617019141
ACCORD LOGO PACKAGE LEAFLET: INFORMATION FOR THE USER BETAMETHASONE VALERATE 0.1% W/W OINTMENT READ ALL OF THIS LEAFLET CAREFULLY 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. What is Betamethasone Valerate Ointment and what is it used for? 2. Before you use Betamethasone Valerate Ointment 3. How to use Betamethasone Valerate Ointment 4. Possible side effects 5. Storing Betamethasone Valerate Ointment 6. Further information 1. WHAT IS BETAMETHASONE VALERATE OINTMENT AND WHAT IS IT USED FOR? Betamethasone Valerate Ointment contains a medicine called betamethasone valerate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation. Betamethasone Valerate Ointment is used to help reduce the redness and itchiness of certain skin problems. These skin problems include eczema, psoriasis and dermatitis. 2. BEFORE YOU USE BETAMETHASONE VALERATE OINTMENT DO NOT USE BETAMETHASONE VALERATE OINTMENT: • if you are allergic (hypersensitive) to betamethasone valerate or any of the other ingredients of Betamethasone Valerate Ointment (listed in Section 6) • on a child under 1 years old • to treat any of the following skin problems, it could make them worse: • acne • severe flushing of skin on and around your nose (rosacea) • spotty red rash around your mouth (perioral dermatitis) • circular to oval red plaques found over the body and the scalp (plaque psoriasis) • itching around your back passage or private parts – unless your doctor has told you to do so • itchy skin which is not inflamed • viral infections, such as cold sores, herpes or chick 전체 문서 읽기
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 전체 문서 읽기