Gynocanesten Clotrimazole 2% Antifungal Vaginal Cream 30g

WARNINGS
If the patient has fever (38 degrees C or higher), lower abdominal pain, back pain, foul-smelling vaginal discharge, nausea, vaginal bleeding and / or shoulder pain, she should consult a physician. The cream can reduce the efficacy and safety of latex-based products, such as condoms and diaphragms, when applied to the genital area (women: lips and areas adjacent to the vulva; men: foreskin and glans penis). The effect is temporary and occurs only 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 suitable therapeutic measures. Avoid contact with eyes. Do not swallow. The cream contains acetostearyl alcohol: it can cause local skin reactions (eg contact dermatitis).
PHARMACOTHERAPEUTIC CATEGORY
Gynecological antifectives and antiseptics, imidazole derivatives.
STORAGE
Vaginal cream: this medicine does not require any special storage conditions. Vaginal tablets: store at a temperature not exceeding 25 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients.
NAME
GYNO-CANESTEN
EXCIPIENTS
Vaginal cream: sorbitan stearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol, purified water. 100 mg vaginal tablets: lactose monohydrate, corn starch, magnesium stearate, colloidal anhydrous silica, calcium lactate pentahydrate, crospovidone, lactic acid, hypromellose, microcrystalline cellulose.
SIDE EFFECTS
The following adverse reactions were identified after the approval of clotrimazole. Since these reactions derive 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: peeling of the genital area, itching, rash, edema, erythema, discomfort, burning, irritation, pelvic pain, vaginal haemorrhage. Gastrointestinal disorders: abdominal pain. Report any suspected adverse reactions via the national reporting system.
PREGNANCY AND BREASTFEEDING
No human studies have been conducted on the effects of clotrimazole on fertility '; however, animal studies have shown no effect of the drug on fertility. There is a limited amount of data on the use of clotrimazole in pregnancy. Animal studies do not show any direct or indirect harmful effects in terms of reproductive toxicity. As a precautionary measure, the use of clotrimazole in the first trimester of pregnancy should be avoided. During pregnancy, treatment should be done with vaginal tablets, since they can be used without the applicator. Available pharmacodynamic / toxicological data in animals have demonstrated secretion of clotrimazole / metabolites in milk. Breastfeeding should be discontinued during treatment with clotrimazole.
INDICATIONS
Treatment of localized symptoms such as itching, leucorrhoea, redness and swelling of the vaginal mucosa, burning when passing urine if these symptoms are consequent to vulvovaginal infections caused by candida previously diagnosed by the doctor.
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 symptoms of overdose of tacrolimus or sirolimus, if necessary by determining plasma drug levels.
DOSAGE
The tablets or cream should be introduced as deeply as possible into the vagina in the evening and for this purpose the patient will have to assume the supine position with slightly bent legs. Treatment should be properly started and ended in the inter-menstrual period. Six symptoms persist for more than 7 days, it may be a disease that requires medical treatment. If necessary, the treatment can be repeated. However, recurring infections can indicate an underlying condition, such as diabetes or HIV infection. Six symptoms recur within 2 months the patient should see the doctor. 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 applicator. The product is intended for use by adults and adolescents over 12 years. Cremavaginal: unless otherwise prescribed, 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. If necessary, a second 3-day treatment can be carried out. Method of application: the applicator should be used only once and then thrown away in order to avoid possible reinfections. First pull the plunger out of the disposable applicator until it stops. Open the tube. Insert the disposable applicator into the latter and keep it firmly pressed. Fill the applicator by exerting a careful pressure on the tube. 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. Take out the applicator and then discard it. In case of Candida vulvitis or balanitis, treatment should continue for 1-2 weeks. Furthermore, it is advisable to apply the cream externally, on the perineal area up to the anal region. This is done by applying the stratosottile cream on site 2-3 times a day and making it penetrate with a light massage. In order to avoid reinfection, particularly in the presence of Candida spread or balanitis, the partner must be treated locally (glans penis and foreskin) at the same time. Vaginal tablets: one tablet in the evening for six consecutive days; alternatively you can 'implement the dosage of 2 tablets in the evening before bedtime, for 3 consecutive days. Method of application: after washing your hands thoroughly, introduce the vaginal tablet directly with your finger as deeply as possible into the vagina (the best way is with the patient lying on the back, with the 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 the cream externally, on the perineal area up to the anal region. This is done by applying the cream in a thin layer on site 2-3 times a day; It is also recommended, especially in the case of Candida vulvitis, the simultaneous local treatment of the partner (glans and foreskin) with the cream. For the tablets to dissolve completely it is necessary that the vagina has an adequate degree of humidity. Otherwise, undissolved fragments of the tablet may leak. 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 within one night, the use of vaginal cream should be considered.
ACTIVE PRINCIPLES
Vaginal cream: 5 g of vaginal cream contain clotrimazole 100 mg. 100 mg vaginal tablets: clotrimazole 100 mg.