Product Description
Clotidal is a vaginal cream intended for topical intravaginal use.
Composition
INCI / Ingredients:
Active substance: Clotrimazole. Each 1 g of vaginal cream contains 10 mg of clotrimazole.
Excipients: cetyl palmitate, octyldodecanol, polysorbate 60, sorbitan stearate, benzyl alcohol, cetearyl alcohol, purified water.
Dosage and Administration
Intravaginal use.
Clotidal should be administered once daily, preferably at bedtime, for 6 consecutive days.
For topical treatment of balanitis (inflammation of the glans penis) in the sexual partner, the recommended duration of treatment is 1 to 2 weeks.
This medicinal product should be used exactly as described in the package leaflet or as directed by a physician or pharmacist. Adults and adolescents over 16 years of age may use the product.
If symptoms do not improve after 3 days of treatment, worsen, or persist after 7 days, medical consultation is required.
Method of administration:
-
Fully extend the plunger of the applicator until resistance is felt.
-
Open the tube and attach the applicator.
-
While holding both parts together, fill the applicator by gently squeezing the tube.
-
Detach the applicator.
-
Insert the applicator as deeply into the vagina as possible (preferably in a lying position with slightly bent legs) and depress the plunger until the applicator is completely emptied.
-
Remove and dispose of the applicator.
-
Wash hands before and after application.
Treatment should be completed in full, even if symptoms resolve earlier.
Mechanism of Action
Clotidal is an over-the-counter antifungal medicinal product. Clotrimazole exhibits fungistatic and fungicidal activity against Candida species, addressing both the cause of the infection and its associated symptoms such as pruritus, burning, and abnormal discharge.
Indications
Local treatment of:
-
Vulvovaginal candidiasis (vaginitis, vulvitis) caused by Candida spp.
-
Candidal balanitis in sexual partners.
Contraindications
Do not use if:
-
The patient is hypersensitive to clotrimazole or any of the excipients.
-
The patient is under 16 years of age.
-
The patient is menstruating (do not use during menstrual bleeding).
Adverse Reactions
As with all medicinal products, adverse reactions may occur, although not everyone will experience them.
Seek medical assistance immediately if signs of hypersensitivity occur (e.g., syncope, hypotension, dyspnea, swelling, urticaria).
Other possible adverse reactions include:
-
Peeling of the genital skin
-
Pruritus
-
Rash
-
Erythema
-
Burning or irritation
-
Pelvic pain
-
Vaginal bleeding
-
Abdominal pain
Warnings and Precautions
Topical use of Clotidal on genital areas (intravaginally in women, on foreskin/glans in men) may reduce the effectiveness and safety of latex products, including condoms and vaginal diaphragms. Additional contraceptive methods are recommended during treatment.
Interactions with Other Medicinal Products
Inform the doctor of all medicines currently or recently used.
Clotidal may interact with:
-
Oral forms of tacrolimus or sirolimus (possible increase in systemic exposure).
-
Amphotericin B and other polyene antimycotics (e.g., nystatin, natamycin) — reduced efficacy.
-
Potent topical corticosteroids — may diminish clotrimazole activity.
Pregnancy and Breastfeeding
-
Treatment during pregnancy is not recommended unless advised by a physician.
-
Breastfeeding should be discontinued during therapy with Clotidal.
-
No data are available regarding effects on fertility.
Effects on Ability to Drive and Use Machines
Clotidal has no or negligible influence on the ability to drive or operate machinery.
