Expiration date: 03/2025

Structure and Composition: 

Vaginal Tablets. 1 tablet contains clotrimazole 500 mg

Excipients: lactose, starch, sodium carboxymethyl starch purified talc magnesium stearate, silica colloidal methyl parahydroxybenzoate (methylparaben) propyl parahydroxybenzoate (propylparaben)

in a strip 1 pcs., complete with an applicator in the paper cartons 1 set.

Description pharmaceutical form:

White, oblong, biconvex tablet, with one end rounded, the other - with a bevelled edge. On one side of the tablet - engraving «G».

Pharmacokinetics:

When administered intravaginal clotrimazole absorption - 3-10% of the administered dose. High concentrations in the vaginal secretions and low blood stored for 48-72 hours. The liver is rapidly metabolized to inactive metabolites.

Description of the pharmacological actions:

Antifungal effect of active principle - clotrimazole (imidazole derivative) is connected with the violation of the synthesis of ergosterol, a component of the cell membrane of fungi that alters the permeability of the membrane and causes a subsequent cell lysis. In low concentrations fungistatic effect, in large - fungicide, not only in proliferating cells. The fungicidal concentrations interacts with mitochondrial and peroxidase enzymes, thereby increasing the concentration of hydrogen peroxide to toxic levels, which also contributes to the destruction of the fungus cells.

It is effective against dermatophytes, yeast and molds, as well as multi-colored depriving the pathogen (Pityriasis versicolor) and the pathogen erythrasma. Has antimicrobial activity against Gram-positive (staphylococci, streptococci) and Gram-negative bacteria (Bacteroides, Gardnerella vaginalis), as well as against Trichomonas vaginalis.

Indications:

• Genital infections caused by yeast fungi of the genus Candida and / or Trichomonas vaginalis (vulvovaginal candidiasis, trichomoniasis)
  
• genital superinfection caused by microorganisms sensitive to clotrimazole
  
• reorganization of the birth canal before delivery.
  

Contraindications:

• Hypersensitivity to clotrimazole or excipients
  
• I trimester of pregnancy
  
• menstruating.
  

Carefully:

during breastfeeding.

Application of pregnancy and breastfeeding:

In clinical and experimental studies, it was found that the use of the drug during pregnancy or breast-feeding has a negative impact on the health of the woman or the fetus (child). However, the question of the advisability of the appointment of the drug should be decided individually after consulting a doctor.

Side effect:

Itching, burning and swelling of the vaginal mucosa, vaginal discharge, headache, gastralgia, frequent urination, intercurrent cystitis, burning sensation in the penis in sexual partner, pain during sexual intercourse.

Drug Interactions:

Vaginal administration of clotrimazole reduces the activity of amphotericin B, and other polyene antibiotics. While the use of clotrimazole Nystatin activity may decrease.

Dosage and administration:

Locally. Introduced vaginally, deep in the "supine" with slightly bent legs. At 500 mg once daily (evening). Repeated treatment is possible after consulting a doctor.

For the rehabilitation of the birth canal is recommended that a single administration of 1 tablet.

Overdose:

Use of the drug in high doses does not cause any reactions and conditions, life-threatening.

Symptoms (in the event of an unintended use of the drug inside): anorexia, nausea, vomiting, gastralgia, liver dysfunction, rarely - drowsiness, hallucinations, pollakiuria, skin allergic reactions.

Treatment: the appointment of activated charcoal, if necessary - symptomatic therapy is no specific antidote.

Special instructions:

simultaneous treatment of sexual partners is necessary to prevent urogenital reinfection.

If trichomoniasis for more successful treatment in conjunction with Candide should use other drugs that have systemic effects (eg metronidazole orally).

When simultaneous infection of the labia and the surrounding areas (candida vulvitis) should be further carried out by local drug treatment Candid cream.

During pregnancy, vaginal tablets treatment should be carried out without an applicator.

Patients with hepatic insufficiency should periodically monitor liver function.

When you see signs of hypersensitivity or irritation of the treatment is stopped.

If there is no effect for 4 weeks should confirm the diagnosis.