CANDIPLAS H Cream Ref.[28051] Active ingredients: Hydrocortisone Miconazole

When Candiplas H cream is used by patients taking oral anticoagulants, the anticoagulant effect should be carefully monitored.

Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with miconazole topical formulations. If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued. Candiplas H cream must not come into contact with the mucosa of the eyes.

As with any topical corticosteroid, caution is advised with infants and children when Candiplas H cream is to be applied to extensive surface areas or under occlusive dressings including baby napkins; similarly, application to the face should be avoided.

In infants, long term continuous topical corticosteroid therapy should be avoided. Adrenal suppression can occur even without occlusion.

Because of its corticosteroid content avoid long-term treatment with Candiplas H cream. Once the inflammatory symptoms have disappeared treatment may be continued with miconazole nitrate 20mg/g cream or powder. (See section 4.1)

Candiplas H cream can damage certain synthetic materials. Therefore, it is recommended to wear cotton underwear if this clothing comes into contact with the affected area.

Contact should be avoided between latex products such as contraceptive diaphragms or condoms and Candiplas H cream since the constituents of Candiplas H cream may damage the latex.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Candiplas H cream contains cetostearyl alcohol which may cause local skin reaction (e.g. contact dermatitis).

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application (see section 5.2), clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

Miconazole is a CYP3A4 inhibitor that can decrease the rate of metabolism of hydrocortisone. Serum concentrations of hydrocortisone may be higher with the use of Candiplas H cream compared with topical preparations containing hydrocortisone alone.

Pregnancy

Clinical data on the use of miconazole nitrate and hydrocortisone cream in pregnancy are limited. In animals, corticosteroids are known to cross the placenta and consequently can affect the foetus (see section 5.3). Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of these findings to humans has not been established.

As a precautionary measure, it is preferable to avoid the use of Candiplas H cream during pregnancy. Treatment of large surfaces and the application under occlusive dressing is not recommended.

Breast-feeding

There are no adequate and well-controlled studies on the topical administration of Candiplas H cream during breastfeeding. It is not known whether concomitant topical administration of Candiplas H cream to the skin could result in sufficient systemic absorption to produce detectable quantities of hydrocortisone and miconazole in breast milk in humans.

A risk to the newborn child cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Candiplas H cream therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Treatment of large surfaces and the application under occlusive dressing is not recommended.

None known.

The safety of miconazole nitrate and hydrocortisone cream was evaluated in 480 patients who participated in 13 clinical trials (six double-blind and seven open-label trials) of miconazole nitrate and hydrocortisone cream. These studies examined patients from 1 month to 95 years of age with infections of the skin caused by dermatophytes or Candida species in which inflammatory symptoms were prominent.

All Patients

No adverse reactions were reported by ≥1% of the 480 miconazole nitrate and hydrocortisone cream -treated patients (adult and paediatric patients combined).

The 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), not known (cannot be estimated from the available clinical trial data).

Of the three adverse reactions identified from the 13 clinical trials of miconazole nitrate and hydrocortisone cream, skin irritation was reported in one clinical trial that included patients aged 17 to 84 years, skin burning sensation in two clinical trials that included patients aged 13 to 84 years, and irritability in one clinical trial of infants aged 1 to 34 months.

Paediatric population

The safety of miconazole nitrate and hydrocortisone cream was evaluated in 63 paediatric patients (1 month to 14 years of age) who were treated in 3 of the 13 clinical trials noted above. One adverse reaction term (irritability) was reported in these 3 trials. The frequency of irritability in paediatric patients was common (3.2%).

All events of irritability occurred in one clinical trial of infants (aged 1 to 34 months) with napkin (diaper) dermatitis. The frequency, type, and severity of other adverse reactions in paediatric patients are expected to be similar to those in adults. Adverse reactions were reported by ≥1% of the 480 miconazole nitrate and hydrocortisone cream -treated patients (adult and paediatric patients combined).

Adverse Reactions in adult and paediatric patients treated with miconazole nitrate and hydrocortisone cream:

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 to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

Contact should be avoided between latex products such as contraceptive diaphragms or condoms and Candiplas H cream since the constituents of Candiplas H cream may damage the latex.