Daktarin 2% W/W Cream

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Daktarin 2% w/w cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Miconazole nitrate 2% w/w.

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

Excipients with known effect:

Benzoic acid 2 mg/g

Butylated hydroxyanisole 0.052 mg/g

For the full list of excipients, see Section 6.1

3 PHARMACEUTICAL FORM

Cream

White homogeneous cream.

4. CLINICAL PARTICULARS

4.1. Therapeutic Indications

For the treatment of mycotic infections of the skin and nails and

superinfections due to Gram-positive bacteria.

4.2 Posology and method of administration

Route of administration:

Cutaneous use.

Recommended dosage:

For all ages:

Fungal infections of the skin: Apply some cream to the lesions two times daily. Rub the cream into the skin with your finger until it has fully penetrated. If the powder is used with the cream, a once daily application of both formulations is recommended.

The duration of therapy varies from 2 to 6 weeks depending on the localisation and the severity of the lesion. Treatment should be continued at least one week after disappearance of all signs and symptoms.

Nail infections: Apply the cream once or twice daily to the lesions. Treatment should be prolonged for 10 days after all lesions have disappeared to prevent relapse.

4.3 Contraindications

Daktarin Cream is contraindicated in individuals with a known hypersensitivity to miconazole/miconazole nitrate, other imidazole derivatives or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin Cream and with other miconazole topical formulations (see section 4.8). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued. Daktarin Cream must not come into contact with the mucosa of the eyes.

Benzoic acid is mildly irritant to the skin, eyes and mucous membranes.

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

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 oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored..

4.6. Use during 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.

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.

4.7. Effects on Ability to Drive and Use Machines

Not applicable.

4.8 Undesirable effects

Adverse reactions reported among 426 patients who received miconazole 2% cream base in 21 double-blind clinical trials are presented in Table A below.

Based on pooled safety data from these clinical trials, the most commonly reported adverse reaction was Application site irritation (0.7%).

Including the above-mentioned adverse reaction,

Table A displays adverse reactions that have been reported with the use of topical, non-gynaecological, miconazole nitrate/miconazole from either clinical trial or postmarketing experiences.

The displayed frequency categories use the following convention: very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); and very rare (< 1/10,000, including isolated reports) and Not Known (cannot be estimated from the available data).

Table A: Adverse Reactions Reported in Clinical Trials and Postmarketing 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	Angioedema Urticaria Contact dermatitis Rash Erythema Pruritus
General Disorders and Administration Site	Application site reactions (including application site

System Organ Class	Adverse Reactions
	Frequency Category
	Uncommon (>1/1,000 to <1/100)	Not Known
Conditions	irritation, burning, pruritus, reaction NOS and 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.

4.9 Overdose

Symptoms

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

Accidental ingestion: Stomach irritation may occur.

Treatment

Daktarin 2% w/w cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, use appropriate supportive care.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

Miconazole nitrate 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.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

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.

6. PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

PEG-6, PEG-32 and glycol stearate Oleoyl macroglycerides Liquid paraffin Benzoic acid (E210)

Butylated hydroxyanisole (E320)

Purified water

6.2. Incompatibilities

None known.

6.3. Shelf Life

24 months.

6.4. Special Precautions for Storage

Do not store above 25 °C.

6.5 Nature and contents of container

Aluminium tube inner lined with heat polymerised epoxy-phenol resin with a white polypropylene cap containing 15 g, 30 g or 70 g of cream, or aluminium tube inner lined with heat polymerised epoxy-phenol resin with a high density polyethylene cap containing 5 g of cream.

*Not all pack sizes may be marketed.

6.6. Instructions for Use/Handling