Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Calcipotriol; Betamethasone
LEO Pharma A/S
D05AX; D05AX52
Calcipotriol; Betamethasone
50 mcg/g +0.5 milligram(s)/gram
Ointment
Product subject to prescription which may not be renewed (A)
Other antipsoriatics for topical use; calcipotriol, combinations
Not marketed
2002-02-08
PACKAGE LEAFLET: INFORMATION FOR THE USER DOVOBET® 50 MICROGRAMS/G + 0.5 MG/G OINTMENT calcipotriol/betamethasone 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, pharmacist or nurse. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4. WHAT IS IN THIS LEAFLET: 1. What Dovobet® is and what it is used for 2. What you need to know before you use Dovobet® 3. How to use Dovobet® 4. Possible side effects 5. How to store Dovobet® 6. Contents of the pack and other information 1. WHAT DOVOBET® IS AND WHAT IT IS USED FOR Dovobet ointment is used on the skin to treat plaque psoriasis (psoriasis vulgaris) in adults. Psoriasis is caused by your skin cells being produced too quickly. This causes redness, scaling and thickness of your skin. Dovobet ointment contains calcipotriol and betamethasone. Calcipotriol helps to bring the rate of skin cell growth back to normal and betamethasone acts to reduce inflammation. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DOVOBET® DO NOT USE DOVOBET If you are allergic (hypersensitive) to calcipotriol, betamethasone or any of the other ingredients of this medicine (listed in section 6) If you have problems with calcium levels in the body (ask your doctor) If you have certain types of psoriasis: these are erythrodermic, exfoliative and pustular (ask your doctor). AS DOVOBET CONTAINS A STRONG STEROID DO NOT USE ON SKIN AFFECTED BY skin infections caused by viruses (e.g. cold sores or chicken pox) skin infections caused by a fungus (e.g. athlete’s foot or ringworm) skin infections caused by bacteria skin infections caused by par Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dovobet ® 50 microgram/g + 0.5 mg/g ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of ointment contains 50 micrograms of Calcipotriol (as monohydrate) and 0.5mg of betamethasone (as dipropionate). Excipient with known effects: Butylhydroxytoluene (E321) 50 micrograms/g ointment For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment. Off-white to yellow. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dovobet ® ointment should be applied to the affected area once daily. The recommended treatment period is 4 weeks. There is experience with repeated courses of Dovobet ® up to 52 weeks. If it is necessary to continue or restart treatment after 4 weeks, treatment should be continued after medical review and under regular medical supervision. When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30% (see section 4.4). Special Populations _Renal and hepatic impairment_ The safety and efficacy of Dovobet ® ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. Paediatric population The safety and efficacy of Dovobet® ointment in children below 18 years have not been established. Currently available data in children aged 12 to 17 years are described in section 4.8 and 5.1 but no recommendation on a posology can be made. Method of Administration Dovobet ® ointment should be applied to the affected area. In order to achieve optimal effect, it is not recommended to take a shower or bath immediately after application of Dovobet ® ointment. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Prečítajte si celý dokument