GYNOCANESTEN*VAG CREAM 30G 2%

Gyno Canesten vaginal cream and vaginal tablets are used for: - treatment of localized symptoms such as itching, leucorrhoea, redness and swelling sensation of the vaginal mucosa, burning when passing urine if these symptoms are a consequence of vulvovaginal infections caused by candida

Therapeutic indications

Gyno Canesten vaginal cream and vaginal tablets are used for: - treatment of localized symptoms such as itching, leucorrhoea, redness and swelling sensation of the vaginal mucosa, burning when passing urine if these symptoms are a consequence of vulvovaginal infections caused by candida previously diagnosed by the doctor.

Dosage and method of use

The tablets or cream should be introduced as deeply as possible into the vagina in the evening and for this purpose the patient should assume the supine position with slightly bent legs. The treatment should be appropriately started and ended in the intermenstrual period. If symptoms persist for more than 7 days, it may be a condition that requires medical treatment. If necessary, the treatment can be repeated. However, recurring infections may indicate an underlying condition, such as diabetes or HIV infection. If symptoms recur within 2 months, the patient should seek medical attention. Do not use tampons, douches, spermicides, or other vaginal products while using the product. During the use of the product it is recommended to avoid vaginal intercourse, because the infection could be transmitted to the partner. During pregnancy, use vaginal tablets, inserting them without an applicator. The product is intended for use by adults and adolescents over 12 years of age. GYNO-CANESTEN 2% vaginal cream Unless otherwise prescribed by a doctor, it is administered daily, ie in the evening, for 3 consecutive days, introducing the contents of an applicator (about 5 g) deeply into the vagina (see below). If necessary, a second 3-day treatment can be performed. Method of application: The applicator should be used only once and then thrown away in order to avoid possible reinfections. 1. First pull the plunger out of the disposable applicator until it stops. 2. Open the tube. Insert the disposable applicator in the latter and hold it firmly. Fill the applicator by carefully pressing the tube. 3. Remove the disposable applicator, introduce it as deeply as possible into the vagina (it is advisable to lie down) and empty it by regular and continuous pressure on the piston. 4. Remove the applicator and then discard it. In case of Candida vulvitis or balanitis, treatment should be continued for 1-2 weeks. Furthermore, it is recommended to apply Gyno-Canesten cream externally, on the perineal area up to the anal region. This is done by applying the cream in a thin layer 2-3 times a day and making it penetrate with a light massage. In order to avoid re-infection, especially in the presence of Candida vulvitis or balanitis, the partner should be treated locally (glans and foreskin) at the same time. GYNO-CANESTEN 100 mg vaginal tablets One tablet in the evening for six consecutive days; alternatively, the dosage of 2 tablets can be taken in the evening before going to bed, for 3 consecutive days. Method of application: After having thoroughly washed your hands, introduce the vaginal tablet directly with your finger as deeply as possible into the vagina (the best way is with the patient lying on her back, with her legs slightly bent). In chronic relapsing forms, the daily dosage can be increased to 2 vaginal tablets in the evening, for a period of 6-12 days. Furthermore, it is recommended to apply Gyno-Canesten cream externally, on the perineal area up to the anal region. This is done by applying the cream in a thin layer 2-3 times a day; we also recommend, especially in the case of Candida vulvitis, the simultaneous local treatment of the partner (glans and foreskin) with Gyno-Canesten cream. For Gyno-Canesten tablets to dissolve completely it is necessary that the vagina has an adequate degree of humidity. Otherwise, undissolved tablet fragments may come 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.

Contraindications

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

Side effects

The following adverse reactions have been identified since the approval of clotrimazole. Since these reactions result from spontaneous reports from a population of uncertain size, it is not always possible to define their frequency. Immune system disorders: allergic reaction (syncope, hypotension, dyspnoea, urticaria). Reproductive system and breast disorders desquamation of the genital area, pruritus, rash, oedema, erythema, discomfort, burning, irritation, pelvic pain, vaginal bleeding. Gastrointestinal disorders: abdominal pain. Reporting of suspected adverse reactions. Reporting suspected adverse reactions after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

If the patient has fever (38°C or higher), lower abdominal pain, back pain, foul-smelling vaginal discharge, nausea, vaginal bleeding and/or shoulder pain, she should consult a doctor. Gyno-Canesten cream may reduce the efficacy and safety of latex-based products, such as condoms and diaphragms, when applied to the genital area (women: labia and areas adjacent to the vulva; men: foreskin and glans penis). The effect is temporary and only occurs during treatment. The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena. In this case, it is necessary to interrupt the treatment and adopt appropriate therapeutic measures. Keep the medicine out of the reach and sight of children. Avoid contact with eyes. Do not swallow. Important information about some of the excipients : Gyno-Canesten cream contains cetostearyl alcohol: it can cause local skin reactions (e.g. contact dermatitis).

Pregnancy and breastfeeding

Fertility: Human studies on the effects of clotrimazole on fertility have not been conducted; however, animal studies have shown no effect of the drug on fertility. Pregnancy There is a limited amount of data on the use of clotrimazole in pregnancy. Animal studies do not demonstrate direct or indirect harmful effects in terms of reproductive toxicity (see section 5.3). As a precautionary measure, the use of clotrimazole in the first trimester of pregnancy should be avoided. During pregnancy, treatment should be performed with vaginal tablets, as they can be used without the applicator (see section 4.2). Lactation Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk (see section 5.3). Breastfeeding should be discontinued during treatment with clotrimazole.

Expiration and 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

Interactions with other drugs

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 closely monitored for symptoms of tacrolimus or sirolimus overdose, if necessary by determination of drug plasma levels.

Overdose

No risk of acute intoxication is anticipated since it is unlikely to occur following single vaginal or topical application of an overdose (application over a large area under conditions favorable for absorption) or inadvertent oral intake. There is no specific antidote.

Active principles

GYNO-CANESTEN 2% vaginal cream 5 g of vaginal cream contain: Active ingredient: clotrimazole 100 mg Excipient with known effect: cetostearyl alcohol GYNO-CANESTEN 100 mg vaginal tablets One vaginal tablet contains: Active ingredient: clotrimazole 100 mg For the complete 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