DAKTARIN INTENSIV Cream Ref.[6931] Active ingredients: Ketoconazole Miconazole

Daktarin Intensiv cream is not for ophthalmic use.

To prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids it is recommended to continue applying a mild topical corticosteroid in the morning and to apply Daktarin Intensiv cream in the evening, and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.

This medicine contains cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). Also contains propylene glycol which may cause skin irritation.

None known.

There are no adequate and well-controlled studies in pregnant or lactating women. To date, no other relevant epidemiological data are available. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity at doses that are not relevant to the topical administration of ketoconazole.

Plasma concentrations of ketoconazole are not detectable after topical application of Daktarin Intensiv cream to the skin of non-pregnant humans (See Pharmacokinetic properties, section 5.2). There are no known risks associated with the use of Daktarin Intensiv cream in pregnancy or lactation.

This medicine has no influence on the ability to drive and use machines.

The safety of ketoconazole cream was evaluated in 1079 subjects who participated in 30 clinical trials. Ketoconazole cream was applied topically to the skin.

Based on pooled safety data from these clinical trials, the most commonly reported (≥1% incidence) ADRs were (with % incidence): application site pruritus (2%), skin burning sensation (1.9%), and application site erythema (1%). Including the above-mentioned adverse drug reactions (ADRs), the following table displays ADRs that have been reported with the use of ketoconazole cream from either clinical trial or postmarketing experiences.

The displayed frequency categories use the following convention: Very Common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not Known (cannot be estimated from the available clinical trial data).

Immune System Disorders

Uncommon: Hypersensitivity

Skin and Subcutaneous Tissue Disorders

Common: Skin burning sensation

Uncommon: Bullous eruption, Dermatitis contact, Rash, Skin exfoliation, Sticky skin

Not Known: Urticaria

General Disorders and Administration Site Conditions

Common: Application site erythema, Application site pruritus

Uncommon: Application site bleeding, Application site discomfort, Application site dryness, Application site inflammation, Application site irritation, Application site paraesthesia, Application site reaction

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.