Daktarin cream – Summary of Product Characteristics (SmPC) for healthcare professionals

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 20 mg of miconazole nitrate)

Excipients with known effect:

Benzoic acid (E210): 2 mg per gram of cream

Butylated hydroxyanisole (E320): 0.052 mg per gram of cream

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

Hypersensitivity to the active substance, 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 miconazole and with other miconazole topical formulations (see section 4.8). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.

Miconazole must not come into contact with the mucosa of the eyes.

Excipients:

This medicine contains 2 mg benzoic acid in each gram of cream. Benzoic acid may cause local irritation and may increase jaundice in new-born babies (up to 4 weeks old).

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

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 2% w/w Cream 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).

If symptoms persist or get worse, or if new symptoms occur, stop use and consult a doctor.

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.

Patients who are pregnant or breastfeeding should seek advice from a doctor before using miconazole.

4.7 Effects on ability to drive and use machines

It is not known if miconazole or miconazole nitrate has an effect on the ability to drive or use machines.

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); very rare (< 1/10,000) and Not Known (cannot be estimated from the available data).

Table A: Adverse Reactions Reported in Clinical Trials and Post-marketing Experience

Table 1: Adverse reactions in clinical trials and post-marketing experience

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

Miconazole (topical) is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, use appropriate supportive care.

Keep out of reach of children. If swallowed, get medical help straight away.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: (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: Miconazole remains in the skin after topical application for up to 4 days. Systemic absorption of miconazole is limited, with a bioavailability of less than 1% following topical 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 diaper dermatitis. 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: No studies have been found describing the metabolism of topical miconazole in humans.

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.

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 Special precautions for disposal

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

McNeil Products Limited

1 Station Hill Square

Station Hill

Reading

RG1 1LN

UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 15513/0414

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

Date of first authorisation: 13/05/1974

Renewal: 08/12/2008

10 DATE OF REVISION OF THE TEXT

18/09/2026