Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone; Miconazole nitrate
Sigma Pharmaceuticals Plc
D01AC20
Hydrocortisone; Miconazole nitrate
10mg/1gram ; 20mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000
GB - AW_166006 ■ This medicine is used to treat inflamed sweat rash and Athlete’s Foot skin infections. ■ This medicine is for use by adults and children aged 10 years and over. ■ DO NOT USE THIS MEDICINE: ■ There are some people who should not use this medicine. _To find out if you are one of them. See Section 2_ c ■ If you are allergic to the active substance, other similar antifungal medicines or any of the other ingredients of this medicine (listed in section 6) c ■ SPEAK TO YOUR DOCTOR: ■ If you suffer from any of the conditions mentioned in _Section 2_ c ■ If you are taking any OTHER MEDICINES. _See Section 2_ c ■ FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS PRODUCT CAREFULLY. _See Section 3_ c NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. Keep the leaflet: you might need it again. 1 WHAT THE MEDICINE IS FOR Daktacort Hydrocortisone Cream is a medicine which is used to treat inflamed sweat rash or Athlete’s Foot. The cream contains the following ingredients: Hydrocortisone acetate is a mild ‘topical steroid’ which reduces inflammation, swelling, redness and itching of the skin. Miconazole nitrate is an antifungal which works by destroying both the fungus that causes the infection and some of the associated bacteria which may also be present. Sweat rash (candida intertrigo, or ‘thrush’ of the skin folds) is a sore, itchy red rash found in areas where the skin rubs together e.g. below or between the breasts, underarms, tops of legs or the groin or other skin areas. Athlete’s Foot is a fungal skin infection causing soreness, itching and flaking between the toes or on the soles or sides of the feet. If you have a fungal infection without any symptoms of inflammation, an antifungal medication without hydrocortisone acetate may be more appropriate. Ask your doctor or pharmacist if you are in doubt. This medicine is for use in adults and children aged 10 years and over. 2 BEFORE USING THIS MEDICINE This medicine is suitable for most adults and children but a few Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Daktacort Hydrocortisone Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Miconazole nitrate 2% w/w; Hydrocortisone acetate equivalent to hydrocortisone 1% w/w. For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Cream. White, homogeneous, odourless cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Athlete’s foot and candidal intertrigo where there are co-existing symptoms of inflammation. 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_. The properties of Daktacort Hydrocortisone Cream indicate it particularly for the initial stages of treatment. Once the inflammatory symptoms have disappeared, treatment can be continued with Daktarin cream or Daktarin powder. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical administration Apply the cream twice a day to the affected area, rubbing in gently until the cream has been absorbed by the skin. The maximum period of treatment is 7 days. ELDERLY Natural thinning of the skin occurs in the elderly, hence corticosteroids should be used sparingly and for short periods of time. 4.3 CONTRAINDICATIONS Known hypersensitivity to miconazole or other imidazole derivatives, hydrocortisone or to any of the excipients listed in section 6.1. Tubercular or viral infections of the skin or those caused by Gram-negative bacteria. Daktacort Hydrocortisone Cream should not be used in the following conditions: • If the skin is broken • On large areas of skin • Used for longer than 7 days • To treat cold sores and acne • Use on the face, eyes and mucous membranes • Children under 10 years of age, unless prescribed by a doctor • On the ano-genital region unless prescribed by a doctor • To treat ringworm unless prescribed by a doctor • To treat secondary infected conditions unless prescribed by a doctor 4.4 SPECIAL WARNINGS AND P Lees het volledige document