DAKTARIN

Daktarin powder is for cutaneous administration. Adults Twice daily application of powder to the lesions, treatment being prolonged for some 10 days after all lesions have disappeared to prevent relapse. Elderly and children As for adults.

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 in clinical trials and post-marketing experience Adverse Reactions Frequency Category System Organ Class Uncommon (≥1/1,000 to <1/100) Not known Immune System Disorders Anaphylactic reaction Hypersensitivity Skin and Subcutaneous Tissue Disorders Skin burning sensation Skin inflammation Skin hypopigmentation Angioedema Urticaria Contact dermatitis Rash Erythema Pruritus General Disorders and Administration Site Conditions 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.

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

Daktarin Powder must not come into contact with the mucosa of the eyes. Daktarin Powder contains talc. Avoid inhalation of the powder to prevent irritation of the airways. In particular, when treating infants and children, careful application should be used to prevent inhalation by the child.

Miconazole administered systemically is known to inhibit CYP3A4/2C9, which can lead to prolonged effects of warfarin or other vitamin K antagonists. While systemic absorption is limited with topical formulations, the concomitant use of Daktarin Powder and warfarin or other vitamin K antagonists should be done with caution and the anticoagulant effect should be carefully monitored and titrated.

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1 The powder should not be recommended for the treatment of infections of the hair and nails.