Vulvar Mycosis Cream - Clotrimazole 1% - MycoHydralin 20g

1. NAME OF THE MEDICINAL PRODUCT

MYCOHYDRALIN cream

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Clotrimazole ...................................................................... 1.0 g per 100 g of cream. Notable excipient: Cetostearyl alcohol For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Cream.

4. CLINICAL DATA

4.1. Therapeutic indications Candidiasis Skin candidiasis encountered in human clinics is usually due to Candida albicans. However, the detection of Candida on the skin cannot in itself constitute an indication. · Treatment of intertrigo, particularly genito-crural, anal and perianal, vulvitis, balanitis. · Adjunctive treatment of a Candida superinfection of a dermatosis. In some cases, it is recommended to simultaneously treat the digestive tract. Dermatophyties · Treatment of dermatophytes of glabrous skin. · Treatment or adjunctive treatment of genital and crural intertrigos, intertrigos of the toes. · Adjunctive treatment of ringworm, Trichophyton rubrum folliculitis. Pityriasis versicolor Erythrasma 4.2. Dosage and method of administration The product must be applied locally in the morning and evening after washing and drying the lesions to be treated. After application, massage gently and regularly until completely absorbed. The duration of treatment depends on the infecting organisms at the site of infection. Duration of treatment Candidiasis · Candidiasis of the folds: 1 to 2 weeks · Interdigital candidiasis: 1 to 2 weeks · Onyxis and candidal perionyxis: 2 months Dermatophytia · Intertrigos of the toes: 2 to 4 weeks (up to 6 weeks) · Cutaneous trichophytia: 2 to 4 weeks Pityriasis versicolor: 2 to 3 weeks Erythrasma: 1 week 4.3. Contraindications Intolerance or sensitization to imidazole derivatives or to one of the other constituents mentioned in section 6.1.4.4. Special warnings and precautions for use For the treatment of candidiasis, it is not recommended to use a soap with an acidic pH (pH favoring the multiplication of Candida). Avoid application near the eyes. This product contains cetostearyl alcohol and may cause local skin reactions (e.g. eczema). 4.5. Interactions with other medicinal products and other forms of interaction No drug interaction studies have been performed. 4.6. Pregnancy and lactation Pregnancy Data from the use of clotrimazole in pregnant women are limited. Animal studies do not indicate reproductive harm (see section 5.3). As a precaution, it is best to avoid the use of clotrimazole during the first trimester of pregnancy. Breastfeeding Pharmacodynamic and toxicological data in animals have shown excretion of clotrimazole and its metabolites in milk. As a precaution, breast-feeding should be discontinued for the duration of clotrimazole treatment. 4.7. Effects on ability to drive and use machines Not applicable. 4.8. Undesirable effects Due to the low resorption rate of clotrimazole on healthy skin, the risk of the appearance of systematic effects can practically be excluded. However, on damaged skin, a large surface area and in infants (due to the surface/weight ratio and the occlusion effect of the layers), attention must be paid to this possibility. Locally, the rare manifestations of intolerance are: · Urticaria, rash, pruritus, irritations, burns, edema; Syncope, hypotension, dyspnoea; Genital discomfort. These manifestations only rarely lead to stopping treatment (around 2.7% of cases). Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit/risk ratio of the drug. Healthcare professionals must report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Pharmacovigilance Centers. Website: www.ansm.sante.fr. 4.9. Overdose Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties Pharmacotherapeutic group: ANTIFUNGAL, ATC code D01AC01 (D: Dermatology). Clotrimazole is a synthetic imidazole derivative with a broad-spectrum antifungal effect. It is active on dermatophytes, molds and yeasts. Depending on its concentration at the site of infection, clotrimazole may have a fungistatic or fungicidal effect. It acts by inhibiting the synthesis of ergosterol causing structural and functional dysfunctions of the cytoplasmic membrane. In vitro, activity is limited to elements promoting fungal proliferation; the spores are slightly sensitive. In addition to its antimycotic action, clotrimazole also acts on gram-positive microorganisms (Streptococci, staphylococci, Gardnerella vaginalis), and on gram-negative bacteria (Bacteroides). It is very rare to observe resistant strains belonging to sensitive fungal species. Indeed, the development of secondary resistance during therapeutic use has only been observed in isolated cases. 5.2. Pharmacokinetic properties Clotrimazole in unmetabolized form penetrates the different dermal cell layers, with decreasing concentrations from the epidermis to the deep dermis. In the keratinized layer and along the hair follicles, clotrimazole reaches maximum concentrations. The systematic resorption rate is undetectable, approximately 0.1% and 0.5% of the applied dose are found in the urine. Transcutaneous passage can be increased on damaged skin. 5.3. Preclinical safety data Preclinical data (repeated dose toxicity, genotoxicity, carcinogenicity, reprotoxicity) did not reveal any particular risk in humans. Animal studies have demonstrated no effect of the drug on fertility. However, in humans, no studies of the effects of clotrimazole on fertility have been conducted.

6. PHARMACEUTICAL DATA

6.1. List of excipients Sorbitan stearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol, purified water. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 3 years. 6.4. Special precautions for storage No special requirements. 6.5. Nature and contents of outer container Painted aluminum tube of 20 g or 30 g. Not all presentations may be marketed. 6.6. Special precautions for disposal and handling No special requirements.

7. MARKETING AUTHORIZATION HOLDER

BAYER HEALTHCARE SAS 220 AVENUE DE LA RESERCHE 59120 LOOS

8. MARKETING AUTHORIZATION NUMBER(S)

· 341 947-8: 20 g in tube (Painted aluminum). · 340 118-8: 30 g in tube (Painted aluminum).

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

[to be completed by the holder]

10. TEXT UPDATED DATE

[to be completed by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

CONDITIONS OF PRESCRIPTION AND DELIVERY

Medicinal product not subject to medical prescription.