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DAKTACORTTM 2% / 1% w/w CREAM AND OINTMENT PRESCRIBING INFORMATION

ACTIVE INGREDIENT(S):

miconazole nitrate 2% w/w and hydrocortisone 1% w/w

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

The DAKTACORT SmPCs are available at:

Please click the following product name to access the full SmPC
Daktacort 2% / 1% w/w cream
Daktacort 2% / 1% w/w ointment

INDICATION(S):

Topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation co-exist. Moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrhoeic eczema including that associated with acne. Also intertriginous eczema including inframammary intertrigo, perianal and genital dermatitis.

DOSAGE & ADMINISTRATION:

For initial stages of treatment. Once inflammatory symptoms have disappeared (after about 7 days) continue treatment if necessary with miconazole nitrate cream or powder.
Adults and children: Apply topically to affected area two or three times daily.
Use in elderly: Due to natural thinning of the skin, corticosteroids should be used sparingly and for short periods. If no improvement after about 7 days treatment, cultural isolation of the organism should be carried out.

CONTRAINDICATIONS:

Hypersensitivity. Tubercular or viral infections of the skin or those caused by Gram negative bacteria.

SPECIAL WARNINGS & PRECAUTIONS:

Severe hypersensitivity may occur, requiring discontinuation of treatment.
Infants & children: Care when applied to extensive surface areas or under occlusive dressings including baby napkins; avoid facial applications; avoid long term topical corticosteroid therapy; adrenal suppression can occur even without occlusion; avoid contact with synthetic materials; avoid contact with latex products eg diaphragms, condoms. Must not come into contact with mucosa of eyes.

SIDE EFFECTS:

Serious side-effects: anaphylactic reaction, angioedema, hypersensitivity.

Refer to SmPC for other side effects

PREGNANCY:

Avoid during pregnancy.

LACTATION:

Only if considered necessary. Treatment of large surfaces and use under occlusive dressing not recommended.

INTERACTIONS:

Caution in patients on oral anticoagulants, such as warfarin. In these cases, monitor anticoagulant effect.

Refer to SmPC for full details of interactions.

LEGAL CATEGORY: POM

PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S) & BASIC NHS COSTS:

PRESENTATIONS PACK SIZES MARKETING AUTHORISATION NUMBER(S) BASIC NHS COST
Daktacort Cream
containing miconazole nitrate 2% w/w
and hydrocortisone 1% w/w
30g PL 00242/0042 £2.49
Daktacort Ointment
containing miconazole nitrate 2% w/w
and hydrocortisone 1% w/w
30g PL 00242/0130 £2.50

FURTHER INFORMATION IS AVAILABLE FROM THE MARKETING AUTHORISATION HOLDER: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.

Prescribing information last revised: October 2015.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com.