Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Hydrocortisone; Miconazole nitrate
Janssen Sciences Ireland UC
D07CA; D07CA01
Hydrocortisone; Miconazole nitrate
2% / 1% percent weight/weight
Cream
Corticosteroids, weak, combinations with antibiotics; hydrocortisone and antibiotics
Marketed
1996-12-16
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER DAKTACORT ® 2% / 1% W/W CREAM Miconazole nitrate / hydrocortisone Daktacort is a registered trademark 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 Daktacort cream is and what it is used for 2 What you need to know before you use Daktacort cream 3 How to use Daktacort cream 4 Possible side effects 5 How to store Daktacort cream 6 Contents of the pack and other information 1 WHAT DAKTACORT CREAM IS AND WHAT IT IS USED FOR The name of your medicine is Daktacort 2% / 1% w/w cream. It is called ‘Daktacort cream’ in this leaflet. Daktacort cream is a medicine which is used to treat inflamed conditions of the skin such as eczema and dermatitis which may be caused by infection with certain fungi and bacteria. The cream contains the following ingredients: Miconazole nitrate - an antifungal which works by destroying both the fungus that causes the infection and some of the associated bacteria which may also be present. Hydrocortisone - a mild ‘topical steroid’ which reduces inflammation, swelling, redness and itching of the skin. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE DAKTACORT CREAM DO NOT USE DAKTACORT CREAM: if you are allergic to miconazole nitrate, hydrocortisone, any of the other ingredients of this medicine (listed in section 6) or to other similar antifungal medicines if you have any other skin problems such as cold sores, herpes, chicken pox or shingles. Only use it for the skin problem that you showed the doctor Baca dokumen lengkapnya
Health Products Regulatory Authority 03 November 2020 CRN009V66 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Daktacort 2% / 1% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Miconazole nitrate 2% w/w and hydrocortisone 1% w/w. Excipients with known effect Contains 0.2% w/w benzoic acid (E210) and 0.0052% w/w butylated hydroxyanisole (E320). 5 g: This medicine contains 10 mg benzoic acid in each tube of 5 g cream which is equivalent to 2 mg/g cream. 10 g: This medicine contains 20 mg benzoic acid in each tube of 10 g cream which is equivalent to 2 mg/g cream. 15 g: This medicine contains 30 mg benzoic acid in each tube of 15 g cream which is equivalent to 2 mg/g cream. 30 g: This medicine contains 60 mg benzoic acid in each tube of 30 g cream which is equivalent to 2 mg/g cream. 75 g: This medicine contains 150 mg benzoic acid in each tube of 75 g cream which is equivalent to 2 mg/g cream. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. White, homogenous, odourless cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Daktacort is used for the topical treatment of skin conditions where inflammation and infection by susceptible organisms co-exist. The properties of Daktacort indicate it particularly for the initial stages of treatment. Once the inflammatory symptoms have disappeared, treatment can be continued with miconazole nitrate 20mg/g cream. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous administration Apply one to three times daily to the affected area or as directed by the physician. Daktacort cream should be rubbed in gently until it has been completely penetrated into the skin. The treatment with Daktacort cream (or subsequently with miconazole nitrate 20 mg/g cream) should be continued without interruption until the lesion has completely disappeared (usually after 2 to 6 weeks). _Elderly_ Thinning of the skin occurs naturally and especially in the elderly, and is a common risk with prolonged/excessive use of corticosteroids. Baca dokumen lengkapnya