McNeil Healthcare (Ireland) Ltd

Daktarin 2% w/w Cream

Contains miconazole nitrate 2% w/w (20mg/g).

Excipients; contains 0.2% w/w benzoic acid (E210) and 0.005% w/w butylated hydroxyanisole (E320)

For a full list of excipients, see section 6.1.

Cream

White homogeneous cream.

For the topical treatment of fungal infections of the skin and secondary infections due to Gram-positive bacteria.

For cutaneous administration.

Apply cream once or twice daily to affected areas until the lesions have completely healed.

Daktarin Cream is contra-indicated in individuals who have shown hypersensitivity to miconazole or another ingredient of Daktarin Cream.

Benzoic acid (E210) can mildly irritate the skin, eyes and mucosal membranes.

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

If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued and the physician consulted.

Avoid the introduction of Daktarin Cream into the eyes.

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after cutaneous application (See Section 5.2 Pharmacokinetic properties), clinically relevant interactions are unlikely to occur. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

The effects and side effects of some other drugs (e.g. oral hypoglycaemics and phenytoin), when co-administered with miconazole, can be increased and caution should be exercised.

Pregnancy

Daktarin Cream applied topically is minimally absorbed into the circulation (bioavailability < 1%). Although there is no evidence that miconazole is embryotoxic or teratogenic in animals, potential hazards of prescribing Daktarin Cream during pregnancy should always be weighed against the expected therapeutic benefits.

Lactation

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 applicable.

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:

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.

Symptoms

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

Treatment

Daktarin cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered necessary.

Pharmacotherapeutic classification: (Antifungals for dermatological/topical use; imidazole derivative) ATC code: D01A C02.

Miconazole nitrate is a synthetic imidazole agent with a broad spectrum of activity against pathogenic fungi (including yeasts and dermatophytes) and gram-positive bacteria (Staphylococcus and Streptococcus spp).

Absorption: Miconazole remains in the skin after cutaneous application for up to 4 days. Systemic absorption of miconazole is limited, with a bioavailability of less than 1% following cutaneous application of miconazole. Plasma concentrations of miconazole and/or its metabolites were measurable 24 and 48 hours after application.

Systemic absorption has also been demonstrated after repeated application of miconazole to infants with nappy rash. Plasma levels of miconazole were undetectable or low in all infants.

Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).

Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites over a four-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in urine.

Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.

Macrogol 6 (PEG 6)

Macrogol 32 (PEG 32)

Oleoylmacroglycerides

Liquid paraffin

Benzoic acid (E210)

Butylated hydroxyanisole (E320)

Purified water

Not applicable.

2 years

Do not store above 25°C.

Internally lacquered collapsible aluminium tube containing 15 g or 30 g of cream with white polypropylene cap.

Not all pack sizes are marketed

No special requirements

McNeil healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/59/1

31 March 1988/31 March 2008.

September 2009