Gynocanesten vaginal capsule 500 mg

Product Description

Gyno-Canesten is a clotrimazole-based antifungal useful for the treatment of vaginal candidiasis with a single application.

Indications

Gyno-Canesten single-dose is used for the treatment of infections of the vagina and external female genital organs, caused by microorganisms sensitive to clotrimazole such as fungi (usually Candida).

Dosage and method of use

• Adults and adolescents aged 16 years and over: one soft vaginal capsule inserted deeply into the vagina as a single dose in the evening. If there is no improvement after 7 days, the patient should consult a doctor.
• Adolescents aged 12-15 years: In patients under 16 years of age (post-menarche, i.e. after the first menstruation), the recommended dosage is the same as for adults. Safety and efficacy in girls under 12 years of age have not been established.

One vaginal soft capsule inserted deeply into the vagina as a single dose in the evening. The vaginal soft capsule should be inserted as deeply as possible into the vagina with the applicator included in the package. During pregnancy, the vaginal soft capsule should be inserted into the vagina with a finger, without the applicator, to avoid damage to the cervix. Treatment should not be administered during menstruation. Treatment should be finished before the onset of menstruation. The partner should undergo local treatment if he or she experiences symptoms such as itching, inflammation.

Composition

• active ingredient: 500 mg clotrimazole;
• excipients: gelatin, glycerol, purified water, titanium dioxide (E171), quinoline yellow (E104), sunset yellow (E110), lecithin (E322), medium chain triglycerides for the dried gelatin shell; white soft paraffin, liquid paraffin for filling material.

Contraindications

Hypersensitivity to clotrimazole or to any of the excipients.

Warnings

The patient should consult her doctor if:

• this is the first time she has had a vaginal infection;
• she has recurrent infections (at least four infections during the previous year);
• she has fever (> 38°C);
• she has pain in the lower part of the abdomen, back pain;
• she has foul-smelling vaginal discharge;
• she has nausea;
• she has vaginal bleeding and/or has simultaneous shoulder pain.

Tampons, douches, spermicides or other products for use Vaginal soft capsules should not be used concomitantly with this product. Sexual intercourse should be avoided during use, as the infection could be transmitted to the partner. The effectiveness and reliability of latex contraceptives such as condoms and diaphragms may be reduced. Vaginal soft capsules should not be swallowed.

Pregnancy and Breastfeeding

Data on the use of clotrimazole in pregnant women are limited. As a precaution, it is preferable to avoid the use of clotrimazole during the first trimester of pregnancy. The applicator should not be used during pregnancy. If treatment is considered necessary during pregnancy, it should be performed with clotrimazole vaginal soft capsules, as they can be inserted without an applicator. The birth canal should be kept clean, especially during the last 4-6 weeks of pregnancy. During local treatment, only minimal amounts of clotrimazole are absorbed into the bloodstream. As a precaution, it is recommended to discontinue breastfeeding during treatment. No human studies on the effects of clotrimazole on fertility have been conducted.

Interactions

The concomitant use of vaginally administered clotrimazole and orally administered tacrolimus 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 the 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 lead to increased plasma concentrations of tacrolimus. have an effect on the concentrations of drugs metabolized by the CYP3A4 isoenzyme 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 by the CYP2C9 is modest. Therefore, due to the very low absorption of clotrimazole after vaginal application, especially at a 500 mg dose, intravaginally applied clotrimazole is unlikely to result in clinically significant drug interactions.

Undesirable effects

The following adverse reactions have been identified during post-authorisation use of clotrimazole and the frequency is not known: reproductive system and breast disorders: desquamation of the genital area, feeling of discomfort, pelvic pain.

Format

Includes: 1 vaginal capsule and 1 applicator.