Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betamethasone valerate
Accord-UK Ltd
D07AC01
Betamethasone valerate
250microgram/1gram
Cutaneous ointment
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5060032242866
PACKAGE LEAFLET: INFORMATION FOR THE USER AUDAVATE TM RD 0.025% W/W OINTMENT betamethasone valerate _ _ _ _ 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. The full name of this medicine is Audavate TM RD 0.025% w/w Ointment but within this leaflet it will be referred to as Audavate RD._ _ WHAT IS IN THIS LEAFLET_ _ 1. WHAT AUDAVATE RD IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AUDAVATE RD 3. HOW TO USE AUDAVATE RD 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE AUDAVATE RD 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT AUDAVATE RD IS AND WHAT IT IS USED FOR Audavate RD contains a medicine called betamethasone valerate. It belongs to a group of medicines called steroids that reduce swelling and irritation. Audavate RD is used to help reduce the redness and itchiness of certain skin problems, such as eczema, psoriasis and dermatitis. RD stands for ‘Ready Diluted’, it contains less active ingredient than Audavate 0.1% preparations. It is used: for milder skin problems, or to keep your skin problem under control after Audavate 0.1% has improved it. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AUDAVATE RD DO NOT USE AUDAVATE RD: if you are allergic (hypersensitive) to betamethasone valerate or any of the other ingredients of this medicine (listed in Section 6) on a child under 1 year 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 Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Audavate RD 0.025% w/w Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of ointment contains 0.25 mg of betamethasone (0.025% w/w) as valerate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment Opaque ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betamethasone valerate ready diluted (Audavate RD) preparations are indicated for maintenance treatment once an acute episode has been treated effectively with a continuous course of betamethasone valerate (Audavate). 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 Posology Ointments are especially appropriate for dry, lichenified or scaly lesions. Once an acute episode has been treated effectively with a continuous course of betamethasone valerate, improvement may be maintained with a small amount of ready diluted betamethasone valerate applied once or twice a day. This regimen should be combined with routine daily use of emollients. The condition and the benefits and risks of continued treatment must be re-evaluated on a regular basis. _Paediatric population _ Betamethasone valerate is contraindicated in children under one year of age. Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults; therefore, courses Read the complete document