Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betamethasone valerate
A A H Pharmaceuticals Ltd
D07AC01
Betamethasone valerate
250microgram/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000
ACCORD LOGO PACKAGE LEAFLET: INFORMATION FOR THE USER BETAMETHASONE VALERATE 0.025% W/W CREAM & BETAMETHASONE VALERATE 0.025% 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 Cream/Ointment and what is it used for? 2. Before you use Betamethasone Valerate Cream/Ointment 3. How to use Betamethasone Valerate Cream/Ointment 4. Possible side effects 5. Storing Betamethasone Valerate Cream/Ointment 6. Further information 1. WHAT IS BETAMETHASONE VALERATE CREAM/OINTMENT AND WHAT IS IT USED FOR? Betamethasone Valerate Cream/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 Cream/Ointment is used to help reduce the redness and itchiness of certain skin problems. These skin problems include eczema, psoriasis and dermatitis. Betamethasone Valerate 0.025% w/w preparations contains less active ingredient than Betamethasone Valerate 0.1% preparations. It is used: • For milder skin problems, or • To keep your skin problem under control after Betamethasone Valerate 0.1% has improved it. 2. BEFORE YOU USE BETAMETHASONE VALERATE CREAM/OINTMENT DO NOT USE BETAMETHASONE VALERATE CREAM/OINTMENT: • if you are allergic (hypersensitive) to betamethasone valerate or any of the other ingredients of Betamethasone Valerate Cream/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 Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betamethasone Valerate 0.025% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of cream contains 0.25 mg of betamethasone (0.025% w/w) as valerate. Also contains 72 mg of cetostearyl alcohol and 1 mg of chlorocresol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream White to almost white cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betamethasone Valerate 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. Betamethasone Valerate 0.025% preparations are indicated for maintenance treatment when control has been achieved with Betamethasone Valerate 0.1%. 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. This regimen should be combined with routine daily use of emollients. Adults, adolescents and the elderly A small quantity of Betamethasone Valerate Cream should be applied to the affected area one to three times daily or as directed by physician 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% Cream. In the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effect of Betamethasone V Les hele dokumentet