Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Miconazole nitrate; Hydrocortisone
Waymade Healthcare Plc
D01AC20
Miconazole nitrate; Hydrocortisone
20mg/1gram ; 10mg/1gram
Cutaneous ointment
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000
- 1 - PACKAGE LEAFLET: INFORMATION FOR THE USER DAKTACORT ® 2% / 1% W/W OINTMENT Miconazole nitrate and 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 ointment is and what it is used for 2. What you need to know before you use Daktacort ointment 3. How to use Daktacort ointment 4. Possible side effects 5. How to store Daktacort ointment 6. Contents of the pack and other information 1. WHAT DAKTACORT OINTMENT IS AND WHAT IT IS USED FOR The name of your medicine is Daktacort 2% / 1% w/w ointment. It is called Daktacort ointment in this leaflet. Daktacort ointment 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 ointment 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 OINTMENT DO NOT USE DAKTACORT OINTMENT 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. • You have any other skin problems such as cold sores, herpes, chicken pox or shingles. Only use it for the skin problem that y Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Daktacort 2% / 1% w/w ointment. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Miconazole nitrate 2% w/w and hydrocortisone 1% w/w. 3. PHARMACEUTICAL FORM White, odourless, fatty ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation co-exist, eg intertrigo and infected eczema. Moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrhoeic eczema including that associated with acne. Intertriginous eczema including inframammary intertrigo, perianal and genital dermatitis. Organisms which are susceptible to miconazole are dermatophytes and pathogenic yeasts (eg _Candida_ spp.). Also many Gram-positive bacteria including most strains of _Streptococcus_ and _Staphylococcus_. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical administration. Apply the ointment two or three times a day to the affected area, rubbing in gently until the ointment has been absorbed by the skin. The properties of Daktacort indicate its use particularly for the initial stages of treatment. Because of its corticosteroid content avoid long-term treatment with Daktacort. Once the inflammatory symptoms have disappeared (after about 7 days), treatment can be continued where necessary with miconazole nitrate 20mg/g cream or powder. Treatment should be continued without interruption until the lesion has completely disappeared (usually after 2 to 5 weeks). If after about 7 days’ application, no improvement has occurred, cultural isolation of the offending organism should be followed by appropriate local or systemic antimicrobial therapy. The same dosage applies to both adults and children. _Elderly _ Natural thinning of the skin occurs in the elderly, hence corticosteroids should be used sparingly and for short periods of time. _Paediatrics _ In infants and children, caution is advised when Daktacort Ointment is appl Read the complete document