DAKTARIN Cream Ref.[6991] Active ingredients: Miconazole

Daktarin Cream must not come into contact with the mucosa of the eyes.

Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin Cream and with other miconazole topical formulations (see Adverse Reactions). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.

Benzoic acid (E210) is mildly irritant to the skin, eyes and mucous membranes.

Butylated hydroxyanisole (E320) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

Pregnancy

In animals miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses. Only small amounts of miconazole nitrate are absorbed following topical administration. However, as with other imidazoles, miconazole nitrate should be used with caution during pregnancy.

Breast-feeding

Topically applied miconazole is minimally absorbed into the systemic circulation, and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied miconazole products during lactation.

Not relevant.

Adverse drug reactions reported among 834 patients who received miconazole nitrate 2% cream (n=426) and/or placebo cream base (n=408) in 21 double-blind clinical trials are presented in Table 1 below. Moreover, adverse drug reactions from spontaneous reports during the worldwide post-marketing experience with Daktarin that meet threshold criteria are included in Table 1.

The adverse drug reactions are ranked by frequency, using the following convention: Very common ≥1/10, Common ≥1/100 and <1/10, Uncommon ≥1/1,000 and <1/100, Rare ≥1/10,000 and <1/1,000, Very rare <1/10,000, including isolated reports.

Adverse reactions obtained from clinical studies and post-marketing surveillance are presented by frequency category based on incidence in clinical trials or epidemiology studies, when known.

Table 1. Adverse reactions reported in clinical trials and post-marketing experience:

Immune System Disorders

Not known: Anaphylactic reaction

Hypersensitivity

Skin and Subcutaneous Tissue Disorders

Uncommon: Skin burning sensation, Skin inflammation, Skin hypopigmentation

Not known: Angioedema, Urticaria, Contact dermatitis, Rash, Erythema, Pruritus

General Disorders and Administration Site Conditions

Uncommon: Application site irritation, Application site burning, Application site pruritus, Application site reaction NOS, Application site warmth

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.

Not applicable.