SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Zimycan 2.5mg/g cutaneous paste

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Each gram paste contains 2.5 mg miconazole nitrate For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Cutaneous paste

White- white yellowish hydrophobic paste

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Zimycan is indicated for the treatment of nappy rash infected by Candida Spp., confirmed by microbiological investigations in infants and toddlers.

4.2 Posology and method of administration

Zimycan should be applied in an equalized thin layer to the entire affected area at each diaper change. Some symptomatic relief should be seen within 72 hours; however, treatment should be continued for a maximum of 7 days.

The physician should be consulted if the rash worsens or does not improve after 3 days.

The safety of the product in infants younger than two months has not been established.

For this reason, Zimycan is not indicated in infants younger than two months of age.

Not indicated for use in children 6 years or older and adults.

4.3 Contraindications

Known hypersensitivity to miconazole nitrate or any of the excipients.

4.4 Special warnings and precautions for use

The use of the Zimycan paste does not exclude other conventional hygiene measures. Regular changing of the nappy is of great importance. The affected skin must not be cleansed with scented soap, shampoos, lotions or wipes. Expose the nappy area to air whenever possible. It is recommended that general preventive measures are continued to prevent recurrence of the nappy rash in infants who had previous episodes of the condition.

Discontinue at the first appearance of any signs of local or general hypersensitivity or local irritation.

Avoid contact with the eyes.

Do not apply to open wounds or mucous membranes

4.5 Interaction with other medicinal products and other forms of interaction

No known drug-drug interactions have been reported during usage although no such drug interactions have been formally studied.

It is known that systemic use of miconazole nitrate inhibits CYP3A4/2C9 (e.g. warfarin, phenytoin, methylprednisolone). As there will be limited systemic availability of miconazole nitrate after topical application of Zimycan, clinically relevant interactions are unlikely.

4.6    Fertility, pregnancy and lactation

Not applicable.

4.7    Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

During clinical trials, topical application of Zimycan did not cause any adverse reactions considered related to treatment.

As with any substance applied to the skin:

Skin and subcutaneous tissue disorders: allergic reactions.

4.9 Overdose

Zimycan is intended for topical use only. Local overdose may cause skin sensitization or irritation. These symptoms disappear spontaneously after the interruption of therapy

The risk of an accidental ingestion is very low, but cannot be excluded in young children. Possible symptoms of systemic overdose are nausea, vomiting and diarrhoea.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Anti-fungals for topical use - imidazole and triazole derivatives.

ATC code: D 01 A C 02

Miconazole nitrate is a synthetic 1-phenethyl-imidazole derivative which is active against most pathogenic fungi and yeasts. The activity is based on the inhibition of the ergosterol biosynthesis in cellular membranes of the pathogen leading to accumulation of the precursors, on the interference with the synthesis of triglycerides and fatty acids, and on the inhibitory effect on cytochrome C peroxidase and catalase. The accumulation of ergosterol precursors and toxic peroxides results in apoptosis.

Spectrum:

The clinical efficacy of miconazole has been demonstrated against: dermatophytes, Candida spp. (incl. C. glabrata), Aspergillus spp. dimorpheous fungi, Cryptococcus neoformans and Malassezia furfur. Miconazole has an antibacterial activity against some gram-positive bacilli and cocci such as Propionibacterium acnes.

Candida albicans resistance to topical azoles is extremely rare and mutation is unlikely, even with long-term exposure (MIC 0.06 - 4 mcg/ml).

5.2 Pharmacokinetic properties

The systemic absorption after topical use of 0.25% miconazole nitrate paste was studied in male and female infants with nappy rash ranging in age from 1 to 12 months. After multiple applications for 7 days, the plasma levels of miconazole nitrate were non-detectable (<1ng/ml) in the majority (15 out of 18) of the patients and ranged between 3-3.8 ng/ml in the other three patients concerned.

5.3 Preclinical safety data

Preclinical data of miconazole reveal no special hazards for humans based on studies of single dose toxicity, genotoxicity and reproductive toxicity.

There is no indication of a carcinogenic potential of miconazole.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

White soft paraffin

Zinc oxide Trihydroxystearin

Lilac perfume (phenethyl alcohol, citronellol, hydroxycitronellal, diethyl phthalate and benzyl salicylate)

6.2    Incompatibilities

In the absence of compatibility studies this product must not be mixed with other medicinal products.

6.3    Shelf life

18 months.

6.4    Special precautions for storage

This product does not require any special storage conditions.

6.5    Nature and contents of container

Aluminium collapsible tube, internally coated with epoxyphenol resin, closed with a polypropylene screw cap

Pack sizes: tubes of 5g, 15g, 30g, 60g and 90g.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.