Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Betamethasone
GlaxoSmithKline (Ireland) Limited
D07AC; D07AC01
Betamethasone
0.1 percent weight/volume
Cutaneous solution
Product subject to prescription which may be renewed (B)
Corticosteroids, potent (group III); betamethasone
Marketed
1984-03-05
Reason for update: HPRA PAC- ADDITION OF PROTECT FORM LIGHT & MOISTURE STATEMENT Market: Ireland Agency Approval Date: Text Date: 13/04/2022 Text Issue and Draft No.: Issue 6, Draft 2 PACKAGE LEAFLET: INFORMATION FOR THE USER BETNOVATE SCALP APPLICATION 0.1% W/W CUTANEOUS SOLUTION betamethasone (as 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. • In this leaflet, Betnovate Scalp Application 0.1% w/w Cutaneous Solution will be called Betnovate. WHAT IS IN THIS LEAFLET 1. What Betnovate is and what it is used for 2. What you need to know before you use Betnovate 3. How to use Betnovate 4. Possible side effects 5. How to store Betnovate 6. Contents of the pack and other information 1 WHAT BETNOVATE IS AND WHAT IT IS USED FOR Betnovate contains the active substance betamethasone valerate which belongs to a group of medicines called corticosteroids that help to reduce redness, swelling and irritation of the skin. These should not be confused with “anabolic steroids” misused by some body builders and taken as tablets or injections. Betnovate is used to help reduce the redness and itchiness of certain scalp problems, such as psoriasis (thickened patches of inflamed, red skin, often covered by silvery scales), an inflamed scalp due to severe dandruff, and dermatitis in adults and children over the age of 1 year. Betnovate also contains an alcohol which has an antiseptic effect. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE BETNOVATE DO NOT USE BETNOVATE: • if you are allergic (hypersensitive) to betamethasone valera Soma hati kamili
Health Products Regulatory Authority 20 September 2022 CRN00CYFT Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betnovate Scalp Application 0.1% w/v Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 ml of cutaneous solution contains 0.01 g betamethasone (0.1% w/w) as betamethasone valerate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous Solution A colourless, hazy, slightly viscous liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betnovate Scalp Application is a topical corticosteroid used in the management of steroid-responsive dermatoses of the scalp, such as psoriasis, seborrhoea capitis and inflammation associated with severe dandruff. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults, Elderly and Children over 1 year_ A small quantity of Betnovate Scalp Application should be applied to the scalp night and morning until improvement is noticeable for up to 4 weeks. It may then be possible to sustain improvement by applying once a day, or even less frequently. Due to the flammable nature of Betnovate Scalp Application, patients should avoid smoking or being near an open flame during application and immediately after use. Administration in Children Betamethasone valerate is contraindicated in children under 1 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. Care should be taken when using betamethasone valerate to ensure the amount applied is the minimum that provides therapeutic benefit. Administration in the Elderly Clinical studies have not identified differences in responses between the elderly and younger patients. Since renal and hepatic dysfunctions are more common in the elderly population, elimination could be reduced in the case of systemic absorption. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit. A Soma hati kamili