GYNOCANESTEN 12CPR VAG 100MG

GYNO-CANESTEN

active ingredients

GYNO-CANESTEN 2% vaginal cream 5 g vaginal cream contain: Active ingredient: clotrimazole 100 mg Excipient with known effects: cetostearilic alcohol and benzig alcohol GYNO-CANESTEN 100 mg vaginal tablets A vaginal tablet contains: Active ingredient: clotrimazole 100 mg For full list of excipients, see paragraph 6.1.

Excellent

GYNO-CANESTEN 2% vaginal cream Sorbitan stearate, polysorbate 60, cetil palmitato, cetosteari alcohol, octildodecanol, benzig alcohol, purified water GYNO-CANESTEN 100 mg vaginal tablets Lactose monohydrate, maize starch, magnesium stearate, colloidal silica anidra, calcium lactate pentahydrate, chrospovidone, lactic acid, hypromellose, microcrystalline cellulose

Therapeutic indications

Treatment of localized symptoms such as itching, leucorrea, redness and swelling of the vaginal mucosa and the glans, burning to the passage of urine if such symptoms are related to vulvovaginal infections and balanites sustained by candidas previously diagnosed in adults and adolescents aged 12 years.

Contraindications

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

Population

Apply as deeply as possible in the vagina once a day, preferably in the evening, at the time of bedtime. In case of vulvite or balanite by Candida apply a thin layer of Gyno-Canesten cream 2-3 times a day on the whole perineal area (urogenital and anal). In case of balanite apply the cream also on the foreskin. Facilitate the absorption of the cream applied locally with a mild massage. GYNO-CANESTEN 2% vaginal cream Apply as deeply as possible in the vagina once a day, preferably in the evening, at the time of bedtime, for 3 consecutive days. If necessary, treatment can be protracted for another 3 days. Application mode: The applicator should be used only once and then eliminated in order to avoid possible reinfection. 1. Extract the piston from the disposable applicator until its stop. 2. Open the pipe. Insert the disposable applicator into the latter and hold it well. Fill the applicator with a cautious pressure on the tube. 3. Once you take the supine position with your legs slightly flexibly, parade the disposable applicator, introduce it as deeply as possible in the vagina and empty it by regular and continuous pressure on the piston. 4. Extract the applicator and throw it. GYNO-CANESTEN 100 mg vaginal tablets Apply a tablet as deeply as possible in the vagina once a day, preferably in the evening, at the time of bedtime for six consecutive days or, alternatively, apply 2 for only 3 consecutive days. Application mode: After thoroughly washing your hands, once you take the supine position with slightly flexed legs, introduce the vaginal tablet directly with your finger as deeply as possible in the vagina. In recurrent chronic forms, daily posology can be increased to 2 vaginal tablets in the evening, for a period of 6-12 days. It is necessary that the vagina present an adequate degree of humidity to allow Gyno-Canesten vaginal tablets to dissolve completely. Otherwise, the undissolved fragments of the tablet may occur. To avoid this, it is important that the medicine be inserted as deeply as possible in the vagina at the time of bedtime. If, despite this precaution, the tablet should not completely dissolve in one night, the use of vaginal cream should be considered. Duration of treatment The maximum duration of treatment is 7 days, if symptoms persist in reevaluating the clinical picture. In case of vulvite or balanite treatment must be protracted for 1-2 weeks.

Conservation

GYNO-CANESTEN 2% vaginal cream This medicine does not require any special condition of conservation. GYNO-CANESTEN 100 mg vaginal tablets Store at a temperature not exceeding 25°C

Warnings

In case of fever, low-rise pain, back pain, male-dating vaginal losses, nausea, vaginal hemorrhage and/or back pain you have to reevaluate the clinical picture. Recurring infections recurring within 2 months may be secondary to conditions such as diabetes or HIV infection requiring extensive clinical examinations. It is preferable to start and finish the treatment in the intermenstrual period. In Gyno-Canesten therapy, swabs, vaginal lavenders, spermicides or other vaginal products must not be used. Recommend abstinence from vaginal relationships because the infection could be transmitted to the partner. In addition, in order to avoid reinfection, in particular in the presence of vulvite or balanite by Candida, recommend the local treatment of the partner. In pregnancy use the vaginal tablets and insert them without the aid of the applicator. During treatment with Gyno-Canesten the effectiveness and safety of latex products, such as condoms and diaphragms can be reduced. The use, especially if prolonged, of products for topical use, can give rise to phenomena of sensitization. In this case, it is necessary to stop treatment and take appropriate therapeutic measures. Avoid contact with eyes. Don't swallow. Important information about some excipients: Gyno-Canesten cream contains cetostearilic alcohol: can cause local skin reactions (e.g. contact dermatitis). Gyno-Canesten cream contains 20mg/g benzilic alcohol - it can cause allergic reactions; - can cause mild local irritation.

Interactions

Concurrent treatment with vaginal clotrimazole and oral tacrolimus (an immunosuppressant) can give rise to plasma levels of increased tacrolimus and similarly with sirmusoli. Patients must therefore be carefully monitored for the occurrence of overdose symptoms of tacrolimus or sirolimus, if necessary through the determination of plasma levels of the drug.

Effects

The following adverse reactions are indicated according to the classification for MedDRA Systems and Organs. As they come from spontaneous post marketing reports, their frequency is indicated with unknown (the frequency cannot be defined on the basis of the available data). Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity Vascular pathologies: syncope, hypotension Respiratory, chest and mediastinic pathologies: dispnea Gastrointestinal diseases: abdominal pain, nausea Pathologies of skin and subcutaneous tissue: skin rash, hives Pathologies of the reproductive apparatus and of the breast: exfoliation, vaginal losses, vaginal hemorrhage, discomfort, erythema, burning, itching, pain. Systemic pathologies and conditions for administration: irritation to the application site, edema, pain. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

There is no risk of acute intoxication since it is unlikely that the same occurs after individual vaginal or topical application of an overdose (application on an extended area under conditions favourable to absorption) or involuntary oral intake. There is no specific antidote.

Fertility: Studies have not been carried out in man on the effects of clotrimazole on fertility however studies on animals have not shown reproductive toxicity effects (see paragraph 5.3). Pregnancy Clinical data available for pregnant risks are limited. The administration of Gyno-canesten during pregnancy should be taken into account only if the expected benefit for the mother exceeds the risk for the fetus or child. Nursing There are no data on the excretion of clotrimazole in breast milk. However, systemic absorption is minimal after topical administration and is unlikely to lead to systemic effects. Clotrimazole can be used during breastfeeding with breast milk.

Source: Farmadati