Gyno‑Canesten 500 mg 1 soft vaginal capsule

Gyno‑Canesten 500 mg 1 vaginal soft capsule is an antifungal for vaginal use specifically formulated for the treatment of vaginal candida infections (vaginal candidiasis). Thanks to its active ingredient, clotrimazole , it acts effectively against the main agents responsible for vaginal fungal infections , rapidly alleviating symptoms such as vaginal itching, burning and vaginal discharge . The single-dose soft capsule formulation guarantees simple, discreet and comfortable application, ideal for those looking for a practical and fast solution.

Gyno‑Canesten 500 mg is produced by Bayer , a leading pharmaceutical company, and is indicated for the local treatment of female genital infections caused by fungi sensitive to clotrimazole. The included applicator facilitates the insertion of the capsule directly into the vagina, ensuring optimal distribution of the active ingredient. This over-the-counter medicine is particularly suitable for those who want a targeted and rapid treatment of disorders related to vaginal candidiasis , such as irritation, redness and intimate discomfort.

Gyno-Canesten 500 mg vaginal soft capsule is a reliable choice for the symptomatic treatment of vaginal infections , providing relief from the first applications and helping to restore female intimate well-being. Thanks to its effectiveness and practicality, it is one of the most popular solutions for the treatment of vaginal candidiasis infections .

ACTIVE INGREDIENTS

Active ingredients contained in Gyno‑Canesten 500 mg 1 vaginal soft capsule - What is the active ingredient in Gyno‑Canesten 500 mg 1 vaginal soft capsule?

One vaginal soft capsule contains 500 mg clotrimazole. For a full list of excipients, see section 6.1

EXCIPIENTS

Composition of Gyno‑Canesten 500 mg 1 vaginal soft capsule - What does Gyno‑Canesten 500 mg 1 vaginal soft capsule contain?

Composition of filling material: White soft paraffin; Liquid paraffin. Composition of dried gelatin shell: Gelatin; Glycerol; Purified water; Titanium dioxide (E171); Quinoline yellow (E104); Sunset yellow (E110); Lecithin (E322); Medium chain triglycerides.

DIRECTIONS

Therapeutic indications Gyno‑Canesten 500 mg 1 vaginal soft capsule - Why is Gyno‑Canesten 500 mg 1 vaginal soft capsule used? What is it used for?

Treatment of infections of the vagina and external female genital organs caused by microorganisms sensitive to clotrimazole such as fungi (usually Candida ).

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Gyno‑Canesten 500 mg 1 vaginal soft capsule - When should Gyno‑Canesten 500 mg 1 vaginal soft capsule not be used?

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

DOSAGE

Quantity and method of taking Gyno‑Canesten 500 mg 1 vaginal soft capsule - How to take Gyno‑Canesten 500 mg 1 vaginal soft capsule?

Dosage Adults and adolescents aged 16 years and over One vaginal soft capsule inserted deep into the vagina as a single dose in the evening. If there is no improvement after 7 days, the patient should consult a doctor. Treatment may be repeated. However, recurrent infections may indicate the presence of an underlying disease. The patient should consult a doctor if symptoms occur repeatedly. Adolescents aged 12-15 years In adolescents under 16 years, Gyno-Canesten single-dose vaginal soft capsule should be used only after consulting a doctor. If prescribed in this population (in post-menarche patients), the recommended dosage is the same as for adults. Paediatric population Safety and efficacy in girls under 12 years of age have not been established. Method of administration The vaginal soft capsule should be inserted as deeply as possible into the vagina with the applicator included in the pack, preferably in a lying position, in the evening before bed. During pregnancy, the soft vaginal capsule must be inserted into the vagina with a finger, without the applicator, to avoid damage to the cervix.

CONSERVATION

Storage Gyno‑Canesten 500 mg 1 vaginal soft capsule - How should Gyno‑Canesten 500 mg 1 vaginal soft capsule be stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Gyno‑Canesten 500 mg 1 vaginal soft capsule - It is important to know that Gyno‑Canesten 500 mg 1 vaginal soft capsule:

The patient should contact her doctor in case of: • first vaginal infection; • vaginal infection during the first trimester of pregnancy; • recurrent infections i.e. more than two infections during the previous six months; • fever (≥ 38 °C); • lower abdominal pain, back pain; • foul-smelling vaginal discharge; • nausea; • vaginal bleeding and/or simultaneous shoulder pain. Treatment with Gyno-Canesten single-dose 500 mg vaginal soft capsule should not be carried out during menstruation. Treatment should be finished before the onset of menstruation. Tampons, vaginal douches, spermicides or other products for vaginal use should not be used in conjunction with this product. Sexual intercourse should be avoided while using Gyno-Canesten single-dose 500 mg vaginal soft capsule, because the infection could be transmitted to the partner. The partner should also undergo local treatment if he or she presents symptoms such as itching and inflammation. Treatment of the partner may help prevent reinfection. The effectiveness and reliability of latex contraceptives such as condoms and diaphragms may be reduced. Vaginal softgels should not be swallowed.

INTERACTIONS

Interactions Gyno‑Canesten 500 mg 1 vaginal soft capsule - Which medicines or foods can modify the effect of Gyno‑Canesten 500 mg 1 vaginal soft capsule?

Concomitant use of vaginally administered clotrimazole and orally administered tacrolimus (FK-506, immunosuppressant) may lead to increased plasma concentrations of tacrolimus. The same occurs with the immunosuppressant sirolimus. Therefore, patients taking tacrolimus or sirolimus should be carefully monitored for symptoms of overdose if necessary by determining their respective plasma concentrations. Clotrimazole is a moderate inhibitor of the hepatic microsomal isoenzyme CYP3A4, and a weak inhibitor of the isoenzyme CYP2C9. 3-10% of the local vaginal dose of clotrimazole is absorbed into the systemic circulation, which may have an effect on the concentrations of drugs metabolised via the isoenzyme CYP3A4 in particular, potentially increasing the plasma concentrations of these drugs when used concomitantly. Since the effect on the CYP2C9 isoenzyme is small, and only a small portion of locally administered clotrimazole is absorbed into the systemic circulation, the effect of clotrimazole on the concentrations of drugs metabolized via the CYP2C9 isoenzyme is modest. Therefore, due to the very low absorption of clotrimazole after vaginal application especially of a 500 mg dose, intravaginally applied clotrimazole is unlikely to result in clinically significant drug interactions.

SIDE EFFECTS

Like all medicines, Gyno‑Canesten 500 mg 1 vaginal soft capsule can cause side effects - What are the side effects of Gyno‑Canesten 500 mg 1 vaginal soft capsule?

The frequencies reported in the table below come from clinical studies on clotrimazole in formulations for vaginal use.

Classification by systems and organs	Common (≥1/100 to < 1/10)	Uncommon (≥1/1000 to < 1/100)	Rare (≥1/10,000 to < 1/1000)
Gastrointestinal disorders		abdominal pain
Immune system disorders			allergic reactions
Skin and subcutaneous tissue disorders			rash
Reproductive system and breast disorders	vulvovaginal burning sensation	vulvovaginal pruritus vulvovaginal erythema	vaginal bleeding
Systemic disorders and conditions related to the administration site		irritation at the application site	edema

In addition, the following adverse reactions have been identified during post-authorisation use of clotrimazole: Since these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency, i.e. the frequency is: not known. Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity. Vascular disorders: syncope, hypotension. Respiratory, thoracic and mediastinal disorders: dyspnoea. Gastrointestinal disorders: nausea. Skin and subcutaneous tissue disorders: urticaria. Reproductive system and breast disorders: vaginal exfoliation, vaginal discharge, vulvovaginal discomfort, vulvovaginal pain. General disorders and administration site conditions: pain. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Gyno‑Canesten 500 mg 1 vaginal soft capsule - What are the risks of Gyno‑Canesten 500 mg 1 vaginal soft capsule in case of overdose?

There is no risk of acute intoxication as it is unlikely to occur after a single vaginal application of an excessive dose or after inadvertent oral ingestion. There is no specific antidote. The following adverse reactions have been reported during acute clotrimazole overdose: abdominal pain, upper abdominal pain, diarrhea, malaise, nausea and vomiting.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Gyno-Canesten 500 mg 1 vaginal soft capsule.

Pregnancy Clinical data in pregnant women are limited, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Clotrimazole can be used during pregnancy. However, during the first trimester of pregnancy, it is recommended to start treatment only under medical supervision. During pregnancy, clotrimazole vaginal soft capsules should be inserted without an applicator (see section 4.2). The birth canal should be kept clean especially during the last 4-6 weeks of pregnancy. Breast-feeding There are no data on the excretion of clotrimazole in breast milk. However, systemic absorption is minimal after administration and systemic effects are unlikely to occur. Clotrimazole can be used during breast-feeding. Fertility No studies on the effects of clotrimazole on fertility have been conducted in humans. However, animal studies have not shown any effect of the drug on fertility.

DRIVING AND USE OF MACHINERY

Taking Gyno‑Canesten 500 mg 1 vaginal soft capsule before driving or using machines - Does Gyno‑Canesten 500 mg 1 vaginal soft capsule affect driving or using machines?

Gyno-Canesten single dose 500 mg vaginal soft capsule does not alter the ability to drive vehicles or use machinery.