Candibene® (Clotrimazole) 200 mg, 3 vaginal tablets

Instruction for medical use


of Kandibene medicine ®

Trade name
of Kandibene®

International unlicensed


name Clotrimazolum Dosage Form
of the Tablet vaginal, 100 mg, 200 mg

Structure
One tablet soderzhitaktivny substance: Clotrimazolum of 100 mg, 200 mg,
excipients: lactoses monohydrate, starch corn prezhelatinizirovanny, adipic acid, Natrii hydrocarbonas, magnesium stearate, kopovidon (Kollidon VA 64), silicon colloidal anhydrous, polysorbate 80.

The description
White, biconvex, oblong tablets with an engraving of CL on one party (for a dosage of 100 mg).
White, biconvex, oblong tablets (for a dosage of 200 mg).

Pharmacotherapeutic group
of Antiseptics and antimicrobial drugs for treatment of gynecologic diseases. Imidazole derivatives.
The code of automatic telephone exchange G01AF02



the Pharmacological

Pharmacokinetics Pharmacokinetic Researches properties after vaginal use showed that only the minimum quantities of Clotrimazolum (less than 3-10% of a dose) are absorbed. The resulting peak concentration in plasma make less than 10 ng/ml, and do not cause the system effects or adverse effects which are subject to quantitative definition. Clotrimazolum is acquired in a liver in inactive hydroxyl derivatives, by means of oxidation and splitting of an imidazolny ring (deaminirovaniye, O-dealkylation), and removed, mainly, with bile.
The pharmacodynamics
of Kandibene® possesses fungistasis. Due to suppression of biosynthesis of the ergosterol which is a component of a cellular membrane of mushrooms the permeability of a membrane is broken. Besides, in fungistatic concentration of Kandibene® leads to toxic increase in concentration of peroxide of hydrogen that, promotes cellular death of mushrooms. Кандибене® possesses a broad spectrum of activity. It is active concerning dermatophytes, mold mushrooms, mushrooms of the sort Candida, dimorphous fungi. MIK for these types of fungi make less than 0.062 - 4 (-8) mkg/ml of substrate.
Кандибене® suppresses reproduction of Corynebacteria and gram-positive cocci, except enterococci, in concentration of 0.5 - 10 mkg/ml of substrate, and substance is trikhomonadotsidny at 100 mkg/ml.

Indications
- the genital infections caused by yeast-like mushrooms of the sort Candida and/or Trichomonos vaginalis (candidosis vulvovaginitis, trichomoniasis)
- the genital superinfections caused by the bacteria sensitive to Clotrimazolum

the Route of administration and doses
of Kandibene® enter in the evening into a vagina in a dorsal decubitus at slightly bent legs by means of the applicator as it is possible more deeply. Treatment is carried out by courses: daily enter on 1 vaginal tablet Kandibene® on 200 mg within 3 days or on 100 mg within 6 days. If necessary the course of treatment can be repeated. For ensuring successful treatment the use of Kandibene® is not stopped right after stopping of acute symptoms of a disease.

Side effects
Sometimes
- passing reddening, feeling of pricking and burning.





Contraindications
- hypersensitivity to Clotrimazolum or other components
- children's and teenage age up to 18 years

Medicinal interactions
At co-administration of the drug Kandibene® and:
- Amphotericinum B and other half-yen antibiotics the activity of the last

Special instructions decreases
prevention of urogenital reinfection requires simultaneous treatment of sexual partners.
In trichomoniasis for more successful treatment together with Kandibene® it is necessary to appoint other medicines possessing systemic action (for example, metronidazole inside).
It is necessary to avoid use of Kandibene® in the period of periods. Treatment in the period of periods is possible only at the expressed clinical symptomatology.
Pregnancy and the period of a lactation
the Issue of expediency of prescribing of drug at pregnancy has to be resolved individually after consultation of the doctor. In case of prescribing of drug of the pregnant woman she should be warned that at introduction of the vaginal tablets Kandibene® it is not necessary to use the applicator. The extra care should be shown at use of the drug Kandibene® in the I trimester of pregnancy.
Because of the minimum absorption of Kandibene® at external use, there is no risk when feeding by a breast.
Features of influence of medicine on ability to run the vehicle and potentially dangerous mechanisms
Are unknown

Overdose
Use of Kandibene® in the raised doses does not cause any certain reactions and states, life-threatening. In case of use of drug, symptoms are inside possible: anorexia, nausea, vomiting, gastralgias, an abnormal liver function, it is rare - drowsiness, hallucinations, a pollakiuria, skin allergic reactions.
Treatment: symptomatic. There is no specific antidote.

The form of release and packing
of the Tablet
place vaginal, 100 mg and 200 mg On 3 tablets in blister strip packaging
from a film of polyvinylchloride and
printing aluminum foil. 1 (for 200 mg) or 2 (for 100 mg) planimetric

packings together with the applicator and the instruction for medical use in the state and Russian languages put in a box of cardboard.


To Store storage conditions at a temperature not above 25 °C.
To store out of children's reach!


3 years
not to apply a period of storage after an expiration date!

Prescription status
Without prescription


MEDA Manufakchering GmbH Producer, Germany

the Owner of the registration certificate
ratiopharm GmbH, Germany
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of ratiopharm Kazakhstan LLP, 050023, Almaty, mdt Baganashyl, Syrgabekov St. 17, phone number: +7 (727) 269 69 92, 321 02 72, 321 02 73, Fax: +7 (727) 321 02 74, e-mail address: info@ratiopharm.kz