Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betamethasone valerate
Teva UK Ltd
D07AC01
Betamethasone valerate
1mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5017007299813 5017007299820
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 CREAM IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETAMETHASONE CREAM 3. HOW TO USE BETAMETHASONE CREAM 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE BETAMETHASONE CREAM 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT BETAMETHASONE CREAM IS AND WHAT IT IS USED FOR Betamethasone Valerate 0.1%w/w Cream (hereinafter referred to as Betamethasone cream) 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 cream 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 CREAM DO NOT USE BETAMETHASONE CREAM: if you are allergic (hypersensitive) to betamethasone valerate or any of the other ingredients of Betamethasone cream (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 on areas of itchiness where the sk Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betamethasone Valerate 0.1%w/w Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 0.1% betamethasone B.P. as the valerate ester Excipients with known effect: Chlorocresol Cetostearyl alcohol For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Aqueous Cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betamethasone valerate is a potent topical corticosteroid indicated for adults, elderly and children over 1 year for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses. These include the following: -Atopic dermatitis (including infantile atopic dermatitis) -Nummular dermatitis (discoid eczema) -Prurigo nodularis -Psoriasis (excluding widespread plaque psoriasis) -Lichen simplex chronicus (neurodermatitis) and lichen planus -Seborrhoeic dermatitis -Irritant or allergic contact dermatitis -Discoid lupus erythematosus -Adjunct to systemic steroid therapy in generalised erythroderma -Insect bite reactions 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Cutaneous Creams are especially appropriate for moist or weeping surfaces. Apply thinly and gently rub in using only enough to cover the entire affected area once or twice daily for up to 4 weeks until improvement occurs, then reduce the frequency of application or change the treatment to a less potent preparation. Allow adequate time for absorption after each application before applying an emollient. In the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effect of betamethasone valerate can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response in such lesions; thereafter, improvement can usually be maintained by regular application without occlusion. If the condition worsens or does not improve within 2-4 weeks, treatment and diagnosis should be re-evaluated. Therapy with Soma hati kamili