Gynocanesten Vaginal Cream 30 g 2%

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Treatment of localized symptoms such as itching, leucorrhea, redness and sensation of swelling of the vaginal mucosa and glans, burning when passing urine if these symptoms are the result of vulvovaginal infections and balanitis caused by candida previously diagnosed in adults and adolescents over 12 years of age.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

WARNINGS AND PRECAUTIONS FOR USE

In case of fever, lower abdominal pain, back pain, foul-smelling vaginal discharge, nausea, vaginal bleeding and/or shoulder pain, the clinical picture should be re-evaluated. Recurrent infections that recur within 2 months may be secondary to conditions such as diabetes or HIV infection that require in-depth clinical examinations. It is preferable to start and end treatment in the intermenstrual period. Tampons, vaginal douches, spermicides or other vaginal products should not be used during therapy with Gyno-Canesten. Recommend abstinence from vaginal intercourse because the infection could be transmitted to the partner. Furthermore, in order to avoid reinfection, particularly in the presence of Candida vulvitis or balanitis, recommend local treatment of the partner. During pregnancy, use vaginal tablets and insert them without the aid of the applicator. During treatment with Gyno-Canesten the effectiveness and safety of latex-based products such as condoms and diaphragms may be reduced. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case, it is necessary to stop treatment and adopt appropriate therapeutic measures. Avoid contact with eyes. Do not ingest. Important information about some excipients: Gyno-Canesten cream contains cetostearyl alcohol: may cause local skin reactions (e.g. contact dermatitis). Gyno-Canesten cream contains 20mg/g of benzyl alcohol - may cause allergic reactions; - may cause mild local irritation.

INTERACTIONS

Concomitant treatment with vaginal clotrimazole and oral tacrolimus (an immunosuppressant) may result in increased plasma levels of tacrolimus and similarly with sirolimus. Patients should therefore be carefully monitored for the onset of symptoms of tacrolimus or sirolimus overdose, if necessary by determining plasma drug levels.

SIDE EFFECTS

The adverse reactions reported below are indicated according to the MedDRA System Organ Class. Since they derive from spontaneous post-marketing reports, their frequency is indicated as not known (the frequency cannot be defined on the basis of the available data). Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity Vascular pathologies: syncope, hypotension Respiratory, thoracic and mediastinal disorders: dyspnoea Gastrointestinal disorders: abdominal pain, nausea Skin and subcutaneous tissue disorders: skin rash, urticaria Reproductive system and breast disorders: exfoliation, vaginal discharge, vaginal bleeding, discomfort, erythema, burning, itching, pain. Systemic disorders and conditions relating to the administration site: irritation at the application site, edema, pain. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.