Infectious discharge caused by yeasts; vaginitis caused by fungi, usually Candida; superinfections due to clotrimazole-susceptible bacteria.

Posology Unless otherwise prescribed by a doctor the usual dose is: Canesten GYN 1-Day Treatment Vaginal Tablet: One vaginal tablet in the evening 1.3.1 1 2 Canesten GYN 6-Day Treatment Vaginal Tablets: One vaginal tablet in the evening on six consecutive days The vaginal tablets should be inserted deep into the vagina with the patient lying on her back with her legs slightly bent, if possible in the evening before bedtime. If necessary, the course of treatment can be repeated. However, recurrent infections may be a sign of an underlying disease requiring medical attention. Treatment should not be carried out during menstruation and should be completed before it begins. Generally the symptoms of vaginal mycosis (e.g. itching, discharge, burning sensation) abate significantly within the first four days of the start of treatment. If the symptoms do not disappear completely after treatment or worsen, consult your doctor. Canesten GYN 1-Day Treatment Vaginal Tablet: Symptoms may persist for several days after treatment. Note: The vaginal tablet may not dissolve completely if the vagina is dry. In this case it is advisable to apply the appropriate Canesten GYN 3-Day or 6-Day Treatment Vaginal Cream. The vaginal tablets should be used only under medical supervision in the following cases: - When the condition occurs for the first time - If the condition has occurred more than four times in the past 12 months. In the case of simultaneous infection of the labia and adjoining areas, local treatment with a clotrimazole cream for external application is indicated in addition to intravaginal treatment (combined therapy). The partner should also undergo local treatment if symptoms such as itching and inflammation are present. Tampons, vaginal douches, spermicides and other vaginal products should not be used during the treatment. In the case of vaginal infections and as long as this product is being used, sexual intercourse should be avoided, as the partner could become infected. During pregnancy, vaginal tablets should be used, which can be inserted into the vagina without an applicator.

In cases of fever (temperatures of 38°C or higher), abdominal pain, back pain, foul smelling vaginal discharge, nausea, vaginal bleeding with or without accompanying shoulder pain, the patient should consult a doctor. Note: If the vaginal tablets are used concurrently with latex products (e.g. condoms, diaphragms), the excipients (in particular stearates) may impair the function of those products and therefore adversely affect their reliability. The effect is temporary and occurs only during treatment. Keep out of the reach of children. Avoid contact with the eyes. Do not swallow.

Simultaneous use of vaginally administered clotrimazole and oral tacrolimus (FK-506 immunosuppressant) can result in increased plasma tacrolimus and sirolimus levels. Patients should therefore be monitored closely for symptoms of tacrolimus or sirolimus overdose, if necessary by determining the plasma concentration level of these drugs.

Data from a large number of exposed pregnant women (n = 5710) showed no adverse effects of clotrimazole on pregnancy or the health of the foetus/newborn. However, it is suspected that vaginally administered clotrimazole could be associated with an increased risk of spontaneous miscarriage in the first trimester of pregnancy. No further relevant epidemiological data are currently available. Animal studies have shown no direct or indirect harmful effects on pregnancy, embryonic/foetal development, birth or postnatal development (see section 5.3). Canesten GYN 1-6-Day Treatment Vaginal Tablet(s) can therefore be used during pregnancy, but only under medical supervision. Caution is advised if pregnant women are prescribed Canesten GYN 1-6-Day Treatment Vaginal Tablet(s) in the first trimester. Breast-feeding Systemic absorption is low after vaginal use (see section 5.2), so that use during breastfeeding does not pose a risk for the infant. Nevertheless, Canesten GYN 1-6-Day Treatment Vaginal Tablet(s) should be used during breast-feeding only under medical supervision. Fertility No studies on the influence of clotrimazole on fertility in humans are available. Animal studies have shown no effect of the substance on fertility.

Canesten GYN 1-6-Day Treatment Vaginal Tablet(s) have no influence or a negligible influence on the ability to drive and use machines

The incidence ratings on side effects are based on the following categories: Very common ≥ 1 / 10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 Very rare < 1 / 10,000 Unknown Frequency cannot be estimated from the available data. The following side effects of the use of clotrimazole were identified after marketing authorisation was granted. Because these reactions were voluntarily reported by patient groups of unknown size, it is not possible to estimate the frequency on the basis of the available data. Immune system disorders (incidence unknown): Allergic reactions (urticaria, hypotension, dyspnoea, syncope) Reproductive system and breast disorders (incidence unknown): Pruritus, burning, erythema, skin irritation, rash, peeling skin in genital area, oedema, malaise, pelvic pain, vaginal bleeding. Gastrointestinal disorders (incidence unknown): Abdominal pain Reporting suspected undesirable effects Reporting of suspected undesirable effects after marketing authorisation is granted is extremely important. It enables continuous monitoring of the risk-benefit ratio of a medicinal product. To report any side effect(s): National Pharmacovigilance and Drug Safety Center (NPC). Fax: + 966 - 11 - 205 - 7662. Call NPC at +966 - 11 - 2038222, Ext.: 2317 - 2356 - 2353 - 2354 - 2334 - 2340. Toll - free: 8002490000. E - mail: npc.drug@sfda.gov.sa. Website: www.sfda.gov.sa/npc

No acute risk of intoxication is thought to exist, since intoxication is unlikely after a single vaginal application or after a single application of an overdose on the skin (use on a large surface under conditions that favour absorption) or inadvertent ingestion. There is no specific antidote

1 Pharmacodynamic properties Pharmacotherapeutic group: Imidazole and triazole derivatives, topical antimycotic ATC code: D01 AC01

Mechanism of action Clotrimazole, the active substance in Canesten GYN Vaginal Tablets, acts as an inhibitor of ergosterol production in fungi, the inhibition of which results in disruption of the synthesis and function of the cytoplasm membrane of the fungal pathogen. Clotrimazole has a broad antimycotic spectrum of activity in vitro and in vivo that includes dermatophytes, yeast-like fungi, moulds and dimorphous fungi. Under suitable test conditions the MIC values for these fungal species is in the order of less than 0.062–8.0 µg/mL substrate. Clotrimazole acts primarily as a fungistatic or fungicide, depending on its concentration at the infection site. Its in vitro action is limited to proliferating fungal elements; fungal spores are poorly susceptible. In addition to its antimycotic activity, clotrimazole is also active against Gram-positive (streptococci / staphylococci / Gardnerella vaginalis) and Gram-negative (Bacteroides) microorganisms. Clotrimazole inhibits the proliferation of corynebacteria and Gram-positive cocci – except enterococci – in vitro at concentrations of 0.5–10 µg/mL substrate. The resistance situation of clotrimazole is favourable: primarily resistant variants of sensitive fungal species are very rare, and secondary resistance development of sensitive fungi has been observed under therapeutic conditions only in isolated cases.

Pharmacokinetic studies following dermal and vaginal application have shown that clotrimazole is only slightly absorbed (3-10 %). Because of the rapid conversion of absorbed clotrimazole in the liver to pharmacologically inactive metabolites, the resulting peak plasma concentrations after vaginal application of a 500 mg dose is < 10 ng/mL. This indicates that intravaginally applied clotrimazole does not lead to measurable systemic effects or adverse effects.

Based on conventional studies on safety pharmacology, toxicity after repeated doses, genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity, the preclinical data indicate no specific risks for humans. Local tolerance data: Neither skin nor eye irritations were observed in preclinical studies with clotrimazole. Clotrimazole was cytotoxic on in vitro corneal cells. By contrast, the clotrimazole-containing pharmaceutical forms were very well tolerated in clinical studies.

Calcium lactate pentahydrate crospovidone highly dispersed silicon dioxide lactose-monohydrate, magnesium stearate (Ph. Eur.), cornstarch, hypromellose, microcrystalline cellulose, lactic acid

Not applicable.

Canesten GYN 1-Day Treatment Vaginal Tablet: Store below 30°C. Canesten GYN 6-Day Treatment Vaginal Tablets: Store below 30°C.

Aluminium blister, applicator Canesten GYN 1-Day Treatment Vaginal Tablet: One vaginal tablet with applicator Canesten GYN 6-Day Treatment Vaginal Tablets: Six vaginal tablets with applicato

Do not dispose of the product in the drain (in the toilet or sink). Medicine that is no longer required can be disposed of in the household waste. These measures will help protect the environment.