Antifungal 2% - clotrimazole vaginal cream 30 g

Product Description

Vagisil antifungal cream based on clotrimazole, suitable for ages 12 and up.

Indications

VAGISIL ANTIFUNGAL is recommended for adults and adolescents aged 12 and up to relieve symptoms such as itching, abnormal vaginal discharge (leukorrhea), redness, and a feeling of swelling of the vaginal mucosa and glans, as well as burning during urination. These symptoms must be associated with vulvovaginal infections and balanitis caused by candidiasis, already diagnosed by a doctor.

Composition

Active ingredients

5 g of vaginal cream contain: Active ingredient: clotrimazole 100 mg. Excipients with known effects: cetostearyl alcohol 500 mg and benzyl alcohol 100 mg. For the full list of excipients.

Excipients

Sorbitan stearate, Polysorbate 60, Cetyl palmitate, Cetostearyl alcohol, Octyldodecanol, Benzyl alcohol, Purified water.

Directions for use and Dosage

Unless otherwise specified, follow the instructions on the product packaging.

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 reevaluated. Recurrent infections that recur within 2 months may be secondary to conditions such as diabetes or HIV infection that require thorough clinical investigations. It is preferable to start and stop treatment between menstrual periods. Tampons, vaginal douches, spermicides, or other vaginal products should not be used during treatment with VAGISIL ANTIFUNGAL. Abstinence from vaginal intercourse is recommended because the infection could be transmitted to the partner. Furthermore, to avoid reinfection, particularly in the presence of Candida vulvitis or balanitis, local treatment of the partner is recommended. During treatment with VAGISIL ANTIFUNGAL, the efficacy and safety of latex-based products, such as condoms and diaphragms, may be reduced. The use of topical products, especially if prolonged, may give rise to sensitization phenomena. In this case, it is necessary to discontinue treatment and adopt appropriate therapeutic measures. Avoid contact with eyes. Do not ingest. Important information about some of the excipients: This medicine contains cetostearyl alcohol: it may cause localized skin reactions (e.g., contact dermatitis). This medicinal product contains 100 mg benzyl alcohol per dose equivalent to 20 mg/g. Benzyl alcohol may cause allergic reactions and mild local irritation.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Undesirable effects

The adverse reactions in the table below are listed 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 estimated from the available data).

Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisation of the medicinal product is important. The use of this medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine.

Overdose

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

Pregnancy and breastfeeding

Pregnancy Available clinical data regarding the risk during pregnancy are limited. The administration of VAGISIL ANTIFUNGAL during pregnancy should be considered only 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 after topical administration and is unlikely to lead to systemic effects. Clotrimazole may cause serious side effects. be used during breastfeeding. Fertility: No studies on the effects of clotrimazole on fertility have been conducted in humans; however, animal studies have shown no effects on reproductive toxicity.

Format

30g tube with 6 disposable applicators