CANDIPLAS Cream Ref.[28049] Active ingredients: Miconazole

• Candiplas must not come into contact with the eyes.
• If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued.

Candiplas contains chlorocresol which may cause allergic reactions.

Candiplas also contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

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

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.

Not relevant.

Adverse drug reactions reported among 834 patients who received miconazole nitrate 2% cream (n=426) and/or placebo cream base (n=408) in 21 double-blind clinical trials are presented in Table 1 below. Moreover, adverse drug reactions from spontaneous reports during the worldwide postmarketing experience with miconazole 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 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 data).

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 reported in clinical trials and post-marketing experience:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

Not applicable.