Document: Cortimyk cream ENG SmPC change

• Cortimyk cream SmPC
• Cortimyk cream ENG SmPC

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summary of the product characteristics

Cortimyk 20 mg/g + 10 mg/g cream

1 gram of cream contains 20 mg miconazole nitrate and 10 mg hydrocortisone.

For the full list of excipients, see section 6.1.

Cream

Tinea (dermatophytoses caused by Trichophyton, Epidermophyton and Microsporum species) and cutaneous candidiasis with inflammatory elements and/or where itching is troublesome.

The cream is thinly applied to the infected skin areas twice a day. Rub the cream into the skin with your finger until it has fully penetrated. In the event of athlete’s foot the feet should be washed and dried carefully before application. The duration of therapy varies from 2 to 6 weeks depending on the localization and the severity of the lesion. To avoid recurrence the treatment should continue for at least one week after the symptoms have disappeared.

Hypersensitivity to miconazole, hydrocortisone or to any of the excipients listed in section 6.1. Herpes simplex, vaccinia, all forms of varicella and tuberculous skin disease.

If signs of irritation or hypersensitivity occur, treatment should be discontinued. Avoid getting the cream in your eyes. In the event of long-term treatment of severe eczema on large body areas in small children the risk of systemic effect should be taken into consideration.

Normal hygiene should be observed to prevent infection or recurrence of the infection.

Cortimyk contains benzoic acid which may be a mildly irritant to the skin, eyes and mucous membranes. Cortimyk contains butylhydroxyanisole which 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. 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

No effects during pregnancy are anticipated, since systemic exposure to hydrocortisione and miconazole is negligible. Cortimyk can be used during pregnancy.

However, in the event of long-term treatment on large body areas, the risk of systemic effects should be taken into consideration.

Lactation

Hydrocortisone is excreted in human milk, but at therapeutic doses of Cortimyk no effects on the breastfed newborns/infants are anticipated. Since systemic exposure of the breastfeeding woman to miconazole is negligible no effects on the breastfed newborn/infant are anticipated.

Cortimyk can be used during breast-feeding but should not be applied on breasts before breast-feeding.

Not relevant.

Side effects can be expected to occur in about 1% of patients.

Skin and subcutaneous tissue disorders
Uncommon (≥1/1,000 to ≤1/100):	Irritation
Rare (≥1/10,000 to ≤1/1,000):	Allergic contact dermatitis (miconazole, hydrocortisone)

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 national reporting system listed in Appendix V

Excessive use can lead to skin irritation, the symptoms of which usually disappear when treatment is discontinued. Locally applied corticosteroids can be absorbed in sufficient amounts to cause systemic effects.

ATC code: D01A C20

Pharmacotherapeutic group: Broad-spectrum antimycotic + mild glucocorticoid (Group I)

Cortimyk cream contains the active components miconazole and hydrocortisone. Miconazole is an imidazole derivative with a fungicidal effect both in vitro and in vivo against most pathogenic fungi. The spectrum of action includes dermatophytes (Trichophyton, Epidermophyton and Microsporum species), Candida spp. and Pityrosporum spp.

Miconazole inhibits biosynthesis of ergosterol in the fungus and thus changes other lipids’ composition in the cell membrane, leading to necrosis in the fungal cell.

Hydrocortisone is a Group I corticosteroid with an anti-inflammatory and antipruritic effect.

Cortimyk does not discolour skin and clothes and can be washed off with soap and water.

Miconazole is absorbed to a very small degree when locally applied.

Hydrocortisone penetrates the skin well and is absorbed to various degrees depending on the type and localisation of the infection. Hydrocortisone is metabolised in the liver and the tissues, the metabolites are eliminated via the urine together with a small amount of hydrocortisone in unchanged form.

There are no preclinical data considered relevant to the safety assessment beyond what has already been taken into consideration in other parts of the SPC.

Pegoxol 7 stearate, oleoyl macrogolglycerides, light liquid paraffin, anhydrous disodium edetate, benzoic acid, butylhydroxyanisole and water.

Sodium hydroxide and hydrochloric acid for adjustment of the pH.

Not relevant.

2 years.

Do not store above 25ºC.

Aluminium laminate tube, 20 g, 2 x 20 g and 50 g.

No special requirements.

CCS Healthcare AB

Box 10054

SE-781 10 Borlänge

12627

1995-11-08/2010-11-08

26 March 2015