国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Calcipotriol; Betamethasone
LEO Pharma A/S
D05AX; D05AX52
Calcipotriol; Betamethasone
50 mcg/g + 0.5 milligram(s)/gram
Cutaneous foam
Product subject to prescription which may not be renewed (A)
Other antipsoriatics for topical use; calcipotriol, combinations
Marketed
2016-04-29
1 (00502366, ver. 8.0) PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ENSTILAR ® 50 MICROGRAMS/G + 0.5 MG/G CUTANEOUS FOAM 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 Enstilar ® is and what it is used for 2. What you need to know before you use Enstilar ® 3. How to use Enstilar ® 4. Possible side effects 5. How to store Enstilar ® 6. Contents of the pack and other information 1. WHAT ENSTILAR ® IS AND WHAT IT IS USED FOR Enstilar is used on the skin to treat psoriasis vulgaris in adults. Psoriasis is caused by your skin cells being produced too quickly. This causes redness, scaling and thickness of your skin. Enstilar contains calcipotriol and betamethasone. Calcipotriol helps to bring the rate of skin cell growth back to normal and betamethasone helps to reduce the inflammation. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ENSTILAR ® DO NOT USE ENSTILAR: ■ if you are allergic to calcipotriol, betamethasone or any of the other ingredients of this medicine (listed in section 6) ■ if you have problems with calcium levels in your blood (ask your doctor) ■ if you have certain types of psoriasis called: erythrodermic psoriasis or pustular psoriasis (ask your doctor if you are unsure). AS ENSTILAR CONTAINS A STRONG STEROID, DO NOT USE ENSTILAR ON SKIN AREAS 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 and ringworm) ■ skin infections caused by bacteria 完全なドキュメントを読む
Health Products Regulatory Authority 05 August 2022 CRN00CG7H Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Enstilar 50 micrograms/g + 0.5 mg/g cutaneous foam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of cutaneous foam contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate). Excipient with known effect Butylhydroxytoluene (E321) 50 micrograms/g cutaneous foam. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous foam. After spraying, a white to off-white foam is formed. The foam has the appearance of a non-expanding foam that gradually collapses after spraying. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of psoriasis vulgaris in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Flare treatment_ Enstilar foam should be applied to the affected area once daily. The recommended treatment period is 4 weeks. If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular supervision. _Long-term maintenance treatment_ Patients who have responded at 4 weeks' treatment using Enstilaronce daily are suitable for long-term maintenance treatment. Enstilar should be applied twice weekly on two non-consecutive days to areas previously affected by psoriasis vulgaris. Between applications there should be 2-3 days without Enstilar treatment. If signs of a relapse occur, flare treatment, as described above, should be re-initiated. _Maximum dose_ The daily maximum dose of Enstilar should not exceed 15 g, i.e. one 60 g can should last for at least 4 days of treatment. 15 g corresponds to the amount administered from the can if the actuator is fully depressed for approximately one minute. A two-second application delivers approximately 0.5 g. As a guide, 0.5 g of foam should cover an area of skin roughly corresponding to the surface area of an adult hand. If using other topical products containing calcipotriol 完全なドキュメントを読む