DAKTARIN AKTIV

Apply to infected area twice daily until the lesions are healed.

Method of Administration:

Cutaneous use.

Adverse drug reactions from spontaneous reports during the worldwide postmarketing experience with Daktarin that meet threshold criteria are included. 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, < 1/1,000 Very rare < 1/10,000, including isolated reports The frequencies provided below reflect reporting rates for adverse drug reactions from spontaneous reports, and do not represent more precise estimates of incidence that might be obtained in clinical or epidemiological studies.

Immune system disorders Very rare: anaphylactic reaction, hypersensitivity, Skin and subcutaneous tissue disorders Very rare: Angioedema, urticaria, contact dermatitis, rash, erythema, pruritus, skin burning sensation General disorders and administration site conditions Rare: application site reactions, including application site irritation 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The spray should be kept away from the eyes and mucous membranes. Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin Aktiv Spray 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 Aktiv Spray 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.

Daktarin Aktiv Spray Powder contains ethanol. This medicine contains 255 mg (10% w/w) ethanol in each gram powder. It may cause burning sensation on damaged skin. 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 Aktiv Spray Powder and warfarin or other vitamin K antagonists should be done with caution and the anticoagulant effect should be carefully monitored and titrated.

5).

1 Not to be used on hair infections, nail infections or broken skin.