4.1. Therapeutic indications

For the treatment of mycotic infections of the skin and superinfections due to Gram positive bacteria.

4.2. Posology and method of administration

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.

4.3. Contraindications

Hypersensitivity to the active substance, other imidazole derivatives or to any of the excipients listed in section 6.1

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

4.4. Special warnings and precautions for use

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. Patients should be advised of the symptoms of bleeding events and to immediately stop treatment with miconazole and seek medical advice should they occur (see section 4.5).

4.5. Interaction with other medicinal products and other forms of interaction

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 warfarin or other vitamin K antagonists, caution should be exercised and anticoagulant effect should be monitored.

4.6. Fertility, pregnancy and lactation

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.

4.7. Effects on ability to drive and use machines

Daktarin Powder has no influence on the ability to drive and use machines.

4.8. Undesirable effects

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

System Organ Class

Adverse Reactions

Frequency Category

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. 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.

4.9. Overdose

Symptoms

Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.

Treatment

Daktarin Powder is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, use appropriate supportive care.

Accidental inhalation of talc-containing powder: Massive accidental aspiration of Daktarin Powder may cause impaction blockage of airways. Respiratory arrest should be treated with intensive supportive therapy and oxygen. If respiration is compromised, endotracheal intubation, removal of impacted material, and assisted breathing should be considered.