GYNOCANESTEN MONO * 1CPSVAG500MG
Treatment of infections of the vagina and external female genital organs caused by microorganisms sensitive to clotrimazole such as fungi (usuallyCandida).
Dosage and method of use
Dosage Adults and adolescents aged 16 and overA 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. The treatment can be repeated. However, recurring infections can indicate the presence of an underlying disease. The patient should consult a physician if symptoms occur repeatedly.Teenagers of 12-15 years of ageIn 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 populationThe safety and efficacy in girls below 12 years of age have not been established.Method of administrationThe soft vaginal capsule should be inserted as deeply as possible into the vagina with the applicator included in the package, 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 injury to the uterine cervix.
Hypersensitivity to clotrimazole or to any of the excipients listed in section 6.1.
The frequencies shown in the table below come from clinical studies of clotrimazole in formulations for vaginal use.
| System and organ classification || Common (≥1 / 100 y || Uncommon (≥1 / 1000 y || Rare (≥1 / 10,000 y |
| Gastrointestinal disorders || ||abdominal pain || |
| Disorders of the immune system || || ||allergic reactions |
| Skin and subcutaneous tissue disorders || || ||rash |
| Reproductive system and breast disorders ||vulvovaginal burning sensation ||vulvovaginal itching vulvovaginal erythema ||vaginal bleeding |
| General disorders and administration site conditions || ||irritation at the application site ||edema |
In addition, 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. 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 reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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.
The patient should contact her doctor in case of: • first vaginal infection; • vaginal infection during the first trimester of pregnancy; • recurrent infections ie more than two infections during the previous six months; • fever (≥ 38 ° C); • pain in the lower abdomen, back pain; • foul-smelling vaginal discharge; • nausea; • vaginal bleeding and / or shoulder pain at the same time. Treatment with Gyno-Canesten single-dose 500 mg vaginal soft capsule should not be used during the menstrual period. Treatment must be finished before menstruation begins. Absorbents, 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, as the infection could be passed on to the partner. The partner should also undergo local treatment if they have symptoms such as itching and inflammation. Treating the partner can help prevent reinfection. 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
PregnancyClinical data in pregnant women are limited, animal studies do not indicate direct or indirect harmful effects in terms of 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.Feeding timeThere are no data on the excretion of clotrimazole in breast milk. However, systemic absorption is minimal after administration and systemic effects are unlikely. Clotrimazole can be used during breastfeeding.FertilityNo human studies have been conducted on the effects of clotrimazole on fertility. However, animal studies have shown no effect of the drug on fertility.
Expiry 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 the hepatic microsomal isoenzyme CYP3A4, and a weak inhibitor of the CYP2C9 isoenzyme. 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 part of the 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 following 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.