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GYNO CANESTEN SINGLE-DOSE OFFER

GYNO CANESTEN SINGLE-DOSE OFFER

043850015
12 Items
Features:


Indicated in case of candida infections.


Single single dose to be taken in the evening.


Deductible over-the-counter drug.


Can also be used during pregnancy.


















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043850015
12 Items

GYNO CANESTEN SINGLE-DOSE OFFER



































TECHNICAL SHEET RCP DRUGS FROM DATABASE



Gyno canesten single-dose vaginal capsule is the new concentrated formulation to be used in case of candida infections. Thanks to its single-dose formulation, a single administration to be carried out in the evening is sufficient. In case of infections, it is advisable to implement proper hygiene and treatment of the infection also for the partner. It is advisable to deepen for more information, using the form below.



MEDICINAL NAME



































































































































































Gyno Canesten single-dose capsule 500 mg soft vaginal capsule.



































































































































































QUALITATIVE AND QUANTITATIVE COMPOSITION





















One vaginal soft capsule contains 500 mg of clotrimazole.

For the full list of excipients, see below.





















PHARMACEUTICAL FORM















































































Soft vaginal capsule

Drop-shaped soft vaginal capsule with yellow opaque gelatin shell containing a homogeneous suspension.















































































THERAPEUTIC INDICATIONS





































































































































































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 ADMINISTRATION













































































































































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.



CONTRAINDICATIONS



















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



















WARNINGS AND PRECAUTIONS FOR USE















The patient should contact the doctor if:

this is the first time you have had a vaginal infection;

have recurrent infections, at least four infections in the previous year;

has fever (≥ 38 ° C);

have pain in the lower abdomen, back pain;

you have foul-smelling vaginal discharge;

has nausea;

have vaginal bleeding and / or have shoulder pain at the same time.

Absorbents, vaginal douches, spermicides or other products for vaginal use should not be used in conjunction with this product.

During the use of Gyno-Canesten single-dose 500 mg vaginal soft capsule, sexual intercourse should be avoided, as the infection could be transmitted 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.















INTERACTIONS

















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. 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 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 after vaginal application especially a 500 mg dose, intravaginally applied clotrimazole is unlikely to result in clinically significant drug interactions.









FERTILITY, 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.



























































































































EFFECTS ON THE ABILITY TO DRIVE VEHICLES



































































































































































Gyno-Canesten single-dose 500 mg vaginal soft capsule does not affect the ability to drive or use machines.

































SIDE EFFECTS









































































































































































































































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


Itching (itchy feeling)


erythema / irritation


edema


skin rash


vaginal bleeding




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. 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 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 www.agenziafarmaco.gov.it/it/responsabili.



































































































OVERDOSE





































































































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.





































































































LIST OF EXCIPIENTS

















Composition of the filling material:

White soft paraffin

Liquid paraffin

Composition of the dried gelatin shell:

Jelly

Glycerol

Purified water

Titanium dioxide (E171)

Quinoline yellow (E104)

Sunset Yellow (E110)

Lecithin (E322)

Medium-chain triglycerides

















STORAGE



































































































































































This medicinal product does not require any special storage conditions.





































































































































































MARKETING AUTHORIZATION HOLDER

































































































































Bayer Spa Viale Certosa 130, 20156 Milan Italy



































































































































AUTHORIZATION NUMBER - MINSAN















043850015 - "500 mg soft vaginal capsule" 1 capsule in PVC / PVdC / PVC blister.

















































043850015
12 Items

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