GYNO-CANESTEN SINGLE-DOSE 500 MG SOFT VAGINAL CAPSULE
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
Dosage Adults and adolescents aged 16 and over A soft vaginal 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. Teenagers of 12-15 years of age In adolescents under 16 years, Gyno-Canesten single-dose soft vaginal capsule should only be used after consultation with your doctor. When prescribed in this population (in post-menarche patients), the recommended posology is the same as for adults. Pediatric population The safety and efficacy in girls below 12 years of age have not been established. Method of administration A soft vaginal capsule inserted deep 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 soft vaginal capsule must be inserted into the vagina with a finger, without the applicator, to avoid injury to the uterine cervix. Treatment with Gyno-Canesten single-dose 500 mg vaginal soft capsule should not be used during the menstrual period. The treatment must be finished before the start of menstruation. The partner should undergo local treatment if they have symptoms such as itching, inflammation.
Hypersensitivity to clotrimazole or to any of the excipients listed in section 6.1.
| System and organ classification || Common (≥1 / 100 y || Uncommon (≥1 / 1000 a || Rare (≥1 / 10,000 y |
| Gastrointestinal disorders || ||abdominal pain || |
| Disorders of the immune system || || ||allergic reactions |
| Reproductive system and breast disorders ||burning ||Pruritus (itchy sensation) erythema / irritation ||edema rash of the skin vaginal haemorrhage |
The following adverse reactions have been identified during post-authorization 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 . Reproductive system and breast disorders: peeling of the genital area, feeling of discomfort, pelvic pain. Reporting of suspected adverse reactions
Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
The patient should contact her doctor if: · this is the first time she has a vaginal infection; Have recurrent infections, at least four infections in the previous year; Have a fever (≥ 38 ° C); Have pain in the lower abdomen, back pain; You have foul-smelling vaginal discharge; Have nausea; Have vaginal bleeding and / or have shoulder pain at the same time. Absorbents, 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, as the infection could be passed on to the partner. The effectiveness and reliability of latex contraceptives such as condoms and diaphragms can be reduced. The soft vaginal capsules should not be swallowed.
Pregnancy and breastfeeding
Pregnancy There are limited data on the use of clotrimazole in pregnant women. Animal studies do not indicate direct or indirect harmful effects in terms of reproductive toxicity (see section 5.3). 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 (see section 4.2). If the treatment is considered necessary during pregnancy, it should be done with vaginal soft capsules of clotrimazole as it is possible to insert them without an applicator. The birth canal should be kept clean especially during the last 4-6 weeks of pregnancy. Feeding time During local treatment only minimal amounts of clotrimazole are absorbed into the bloodstream, but since clinical studies have not defined the excretion of this drug in breast milk, it is recommended as a precaution to discontinue breastfeeding during treatment. Fertility No human studies on the effects of clotrimazole on fertility have been conducted. However, animal studies have shown no effect of the drug on fertility.
Expiration and retention
This medicinal product does not require any special storage conditions.
Interactions with other drugs
The concomitant use of vaginally administered clotrimazole and orally administered tacrolimus (FK-506, immunosuppressive drug) may lead to increased plasma concentrations of tacrolimus. The same happens with the immunosuppressive drug sirolimus. Therefore, patients taking tacrolimus or sirolimus should be closely monitored for overdose symptoms if necessary by determining their plasma concentrations. Clotrimazole is a moderate inhibitor of hepatic microsomal CYP3A4 isoenzyme, and a weak inhibitor of CYP2C9 isoenzyme. The 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 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 fraction of locally administered clotrimazole is absorbed into the systemic circulation, the effect of clotrimazole on the concentrations of drugs metabolised via the CYP2C9 isoenzyme is modest. Therefore, due to the very low absorption of clotrimazole after vaginal application especially a 500 mg dose, intravaginally applied clotrimazole is unlikely to result in clinically significant drug interactions.
There is no risk of acute intoxication as it is unlikely to occur after a single vaginal application of an overdose or after inadvertent oral ingestion. There is no specific antidote. The following adverse reactions have been reported during acute clotrimazole overdose: abdominal pain, pain in the upper abdomen, diarrhea, malaise, nausea and vomiting.
One vaginal soft capsule contains 500 mg of clotrimazole. For the full list of excipients, see section 6.1
Composition of the filling material: White soft paraffin Liquid paraffin Composition of the dried gelatin shell: Gelatin Glycerol Purified water Titanium dioxide (E171) Quinoline yellow (E104) Sunset yellow (E110) Lecithin (E322) Medium chain triglycerides