Daktarin Aktiv Powder

Miconazole nitrate 2.0% w/w

(Each gram of powder contains 20mg of miconazole nitrate)

For excipients, see Section 6.1

Cutaneous powder

White Powder

For the treatment of athlete's foot.

Adults

Twice daily application of the powder to the lesions, treatment being prolonged for some 10 days after all lesions have disappeared to prevent relapse.

Elderly

As for adults.

Children

As for adults.

Method of administration: Cutaneous use.

Known hypersensitivity to miconazole or any other component of this product.

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

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

Daktarin Aktiv Powder must not come into contact with the eyes.

Daktarin Aktiv 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. 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.

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:

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, angioneurotic edema

Skin and subcutaneous tissue disorders

Very rare: urticaria, contact dermatitis, rash, erythema, pruritus, skin burning sensation

General disorders and administration site conditions

Rare: application site reactions, including application site irritation

Symptoms

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

Treatment

Daktarin Aktiv Powder 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 desirable.

Accidental inhalation of talc-containing powder: Massive accidental aspiration of Daktarin Aktiv 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.

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

Miconazole is an imidazole antifungal agent and may act by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial activity.

Absorption: There is little absorption through skin or mucous membranes when miconazole nitrate is applied topically.

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.

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.

Talc

Zinc oxide

Colloidal anhydrous silica

Not applicable.

36 months

Do not store above 25^o C.

High density polyethylene bottle with polypropylene dredger cap and screw cap containing 20 g or 30 g* of powder.

*Not all pack sizes may be marketed.

No special instructions.

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

PL 15513/0305

01 July 2008

01 July 2008