Gynocanesten Vaginal Cream 2% 30g with 6 disposable applicators

Localized symptoms such as itching, leucorrhoea, redness and swelling of the vaginal mucosa and other symptoms are consequent to vulvovaginal infections.

1. Therapeutic indications
Gynocanesten Vaginal Cream is used in the treatment of localized symptoms such as itching, leucorrhoea, redness and swelling of the vaginal mucosa, burning when passing urine when these symptoms are consequent to previously diagnosed vulvovaginal infections caused by candida.

2. Dosage and method of use
Gynocanesten Vaginal 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.

If 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. If symptoms recur within 2 months, 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. Vaginal cream: 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.

The applicator should be used only once and then thrown away in order to avoid possible reinfection. First of all, extract the piston from the disposable applicator until it stops; open the tube; insert the disposable applicator in 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 the case of Candida vulvitis or balanitis, treatment should continue for 1-2 weeks. 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 2-3 times a day and making it penetrate with a light massage. In order to avoid reinfection, especially in the presence of Candida vulvitis or balanitis, the partner must be treated locally (glans penis and foreskin) at the same time.

3. Contraindications
> Hypersensitivity to the active substance or to any of the excipients.

4. Pregnancy and breastfeeding
> Pregnancy
No human studies have been conducted on the effects of clotrimazole on fertility '; however, animal studies have not shown any 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.

> Breastfeeding
Available pharmacodynamic / toxicological data in animals have demonstrated secretion of clotrimazole / metabolites in milk. Breastfeeding should be discontinued during treatment with clotrimazole.

5. Expiration and retention
Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store at a temperature not exceeding 25 ° C.

6. 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 drug 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 drug in cream contains cetostearyl alcohol: it can cause local skin reactions (eg contact dermatitis).

7. Composition
Active ingredient: clotrimazole 100 mg
Excipients: Sorbitan stearate, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol, purified water.

Gynocanesten Vaginal Cream 2% 30g