GYNO-CANESTEN SINGLE-DOSE 1 CAPSULA SOFT VAGINAL 500MG

NAME:
GYNO-CANESTEN SINGLE-DOSE 500 MG SOFT VAGINAL CAPSULE

PHARMACOTHERAPEUTIC CATEGORY:
Gynecological anti-infectives and antiseptics, imidazole derivatives.

ACTIVE PRINCIPLES:
500 mg of clotrimazole.

EXCIPIENTS:
Composition of the filling material: white soft paraffin, liquid paraffin.
Composition of the dried gelatin shell: gelatin, glycerol, purified water, titanium dioxide (E171), chi noline yellow (E104), sunset yellow (E110), lecithin (E322), medium chain triglycerides.

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

CONTRAINDICATIONS / SECONDAR EFFECT:
Hypersensitivity 'to clotrimazole or to any of the excipients.

DOSAGE:
Adults and adolescents aged 16 years 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 see a doctor.
Teenagers of 12-15 years of age.
In adolescents under 16 years (in post-menarche patients), the recommended posology is the same as for adults.
The safety and efficacy in girls less than 12 years of age have not been established.
A soft vaginal capsule inserted deep into the vagina as a single dose in the evening.
The soft vaginal 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.
The treatment should not be carried out 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.

STORAGE:
This medicinal product does not require any special storage conditions.

WARNINGS:
The patient should contact the doctor if: it is the first time that she has a vaginal infection; have recurrent infections, at least four infections in the previous year; has fever (> = 38 degrees C); have lower abdominal pain, back pain; to foul-smelling vaginal discharge; has nausea; have vaginal bleeding and / or have pain in the shoulders at the same time.
Absorbents, vaginal douches, spermicides or other products for vaginal use should not be used in conjunction with this product.
During use, sexual intercourse should be avoided, because the infection could be transmitted to the partner.
The efficacy and reliability of latex contraceptives such as condoms and diaphragms can be reduced.
The soft vaginal capsules should not be swallowed.

INTERACTIONS:
The concomitant use of vaginally administered clotrimazole and orally administered tacrolimus may lead to increased plasma concentrations of tacrolimus.
The same happens with the immunosuppressive drug sirolimus.
Therefore, patients taking ta crolimus 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 affect the concentrations of drugs metabolised via the CYP3A4 isoenzyme in particular, potentially increasing the plasma concentrations of these drugs when used. at the same time.
Since the effect on the CYP2C9 isoenzyme is small, and only a small fraction 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 clotrim azole following vaginal application especially a 500 mg dose, intravaginally applied clotrimazole is unlikely to result in clinically significant drug interactions.

SIDE EFFECTS:
System Organ Class: common (> = 1/100 to <1/10); not common (> = 1/1000 to <1/100); rare (> = 1 / 10,000 to <1/1000).
Gastrointestinal disorders; uncommon: abdominal pain.
Disorders of the immune system; rare: allergic reactions: reproductive system and breast disorders.
Common: burning; uncommon: pruritus (itching sensation) erythema / irritation; rare: skin rash edema and vaginal bleeding.
The following adverse reactions have been identified during post-authorization use of clotrimazole and the frequency is: not known.
Reproductive system and breast disorders: peeling of the genital area, feeling of discomfort, pelvic pain.

PREGNANCY AND BREASTFEEDING:
There are limited data on the use of clotrimazole in pregnant women.
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 the treatment is considered necessary during pregnancy, it should be carried out with soft vaginal 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.
During local treatment only minimal amounts of clotrimazole are absorbed into the bloodstream.
It is recommended as a precaution to stop breastfeeding during treatment.
No human studies have been conducted on the effects of clotrimazole on fertility.