DAKTARIN AKTIV CREAM - summary of medicine characteristics

Daktarin Aktiv Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Miconazole nitrate 2.0% w/w

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

Also contains 2 mg/g of benzoic acid (E210) and 0.052 mg/g of butylated hydroxyanisole (E320).

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Cream

White homogeneous cream

4.1 Therapeutic indications

For the treatment of athlete's foot.

4.2 Posology and method of administration

For all ages.

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.

Method of administration: Cutaneous application.

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

Daktarin Aktiv Cream must not come into contact with the mucosa of the eyes.

Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin Aktiv Cream and with other miconazole topical formulations (see Adverse Reactions). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.

This medicine contains 2 mg of Benzoic acid (E210) per gram. Benzoic acid may cause local irritation. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

This medicine also contains 0.052 mg/g of Butylated hydroxyanisole (E320) which 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 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 Aktiv Cream 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 doubleblind 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

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

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.

6.1

PEG-6, PEG-32 and glycol stearate

Oleoyl macroglycerides

Liquid paraffin

Benzoic acid (E210)

Butylated hydroxyanisole (E320)

Purified water

6.2

None known.

6.3

Shelf life

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Aluminium tube lined with epoxyphenol resin. Cap made of white polypropylene for the 15, 30 and 70g sizes. Cap for 5g size made of high density polyethylene.

Daktarin Aktiv Cream may be supplied in packs of 5, 15, 30 and 70g.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

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

McNeil Products Limited 50 – 100 Holmers Farm Way High Wycombe

Buckinghamshire

HP12 4EG

UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 15513/0304