Gynocanesten Vaginal Cream 30 g 2%

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 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.

ACTIVE INGREDIENTS

GYNO-CANESTEN 2% vaginal cream 5 g of vaginal cream contains: Active ingredient: clotrimazole 100 mg Excipient with known effects: cetostearyl alcohol and benzyl alcohol GYNO-CANESTEN 100 mg vaginal tablets One vaginal tablet contains: Active ingredient: clotrimazole 100 mg For the full list of excipients, see section 6.1.

EXCIPIENTS

GYNO-CANESTEN 2% vaginal cream Sorbitan stearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol, purified water GYNO-CANESTEN 100 mg vaginal tablets Lactose monohydrate, corn starch, magnesium stearate, colloidal anhydrous silica, calcium lactate pentahydrate, crospovidone, lactic acid, hypromellose, microcrystalline cellulose

CONTRAINDICATIONS AND SIDE EFFECTS

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

DOSAGE

Apply as deeply as possible into the vagina once a day, preferably in the evening, at bedtime. In case of Candida vulvitis or balanitis, apply a thin layer of Gyno-Canesten cream 2-3 times a day on the entire perineal area (urogenital and anal). In case of balanitis, apply the cream also on the foreskin. Facilitate the absorption of the cream applied locally with a light massage. GYNO-CANESTEN 2% vaginal cream Apply as deeply as possible into the vagina once a day, preferably in the evening, at bedtime, for 3 consecutive days. If necessary, the treatment can be continued for another 3 days. Application method: The applicator should be used only once and then discarded in order to avoid possible reinfections. 1. Pull the piston out of the disposable applicator until it stops. 2. Open the tube. Insert the disposable applicator into the latter and hold it firmly. Fill the applicator by exerting careful pressure on the tube. 3. Once you have assumed the supine position with your legs slightly bent, remove the disposable applicator, introduce it as deeply as possible into the vagina and empty it by regular and continuous pressure on the piston. 4. Remove the applicator and throw it away. GYNO-CANESTEN 100 mg vaginal tablets Apply one tablet as deeply as possible into the vagina once a day, preferably in the evening, at bedtime for six consecutive days or, alternatively, apply 2 for only 3 consecutive days. Application method: After having washed your hands thoroughly, once you are in the supine position with your legs slightly bent, introduce the vaginal tablet directly with your finger as deeply as possible into the vagina. In chronic relapsing forms, the daily dosage can be increased to 2 vaginal tablets in the evening, for a period of 6-12 days. The vagina must have an adequate level of humidity to allow Gyno-Canesten vaginal tablets to dissolve completely. Failure to do so may result in undissolved fragments of the tablet coming out. To avoid this, it is important that the medicine is inserted as deeply as possible into the vagina at bedtime. If, despite this precaution, the tablet does not dissolve completely overnight, the use of vaginal cream should be considered. Duration of treatment The maximum duration of treatment is 7 days, if symptoms persist re-evaluate the clinical picture. In case of vulvitis or balanitis the treatment must be continued for 1-2 weeks.

CONSERVATION

GYNO-CANESTEN 2% vaginal cream This medicinal product does not require any special storage conditions. GYNO-CANESTEN 100 mg vaginal tablets Store at a temperature not exceeding 25°C

WARNINGS

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.

OVERDOSE

No risk of acute intoxication is expected since it is unlikely to occur after a single vaginal or topical application of an overdose (application over a large area in conditions favorable to absorption) or through involuntary oral intake. There is no specific antidote.

PREGNANCY AND BREASTFEEDING

Fertility: No studies have been conducted in humans on the effects of clotrimazole on fertility, however animal studies have not shown reproductive toxicity effects (see section 5.3). Pregnancy Available clinical data regarding the risk in pregnancy are limited. Administration of Gyno-canesten during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the fetus or child. Breastfeeding No data are available on the excretion of clotrimazole in breast milk. However, systemic absorption is minimal following topical administration and is unlikely to lead to systemic effects. Clotrimazole can be used during breast-feeding.

EFFECTS ON DRIVING ABILITY

The medicine has no or negligible influence on the ability to drive or use machinery.