Canesten Vaginal Tablet

Canesten Vaginal Tablet

clotrimazole

Manufacturer:

Bayer

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Clotrimazole.
Description
Each 500-mg vaginal tablet also contains inert excipients 1.5-g, respectively.
Clotrimazole is bis-phenyl-(2-chloro-phenyl)-1-imidazolyl-methane.
Canesten vaginal tablet is colourless, odourless and does not stain the underwear.
Action
Canesten has reliable action on dermatophytes, yeasts and other fungi. It is also effective against gram-positive microorganisms (Streptococci/Staphylococci).
Indications/Uses
500-mg Tablet: Treatment of infectious vaginal therapy.
Vaginitis caused by fungi, mostly Candida.
Superinfections caused by clotrimazole-sensitive bacteria.
Dosage/Direction for Use
500-mg Tablet: A single-dose treatment is generally sufficient for vaginitis, especially when it has been caused by fungi. Unless otherwise prescribed by the physician, Canesten Vaginal Tablet should be inserted, preferably at night, into the vagina as deeply as possible (see Directions for Using Applicator under Cautions). This is best achieved when lying back with the legs slightly drawn up. However, the tablet may also be inserted by the physician himself after examination.
If necessary, a 2nd treatment may be carried out.
It is recommended that the treatment should be timed so as to avoid the menstrual period and be finished before the onset of menstruation.
In cases of concomitant vulvitis or Candida balanitis of the sexual partner and in order to prevent reinfection, both partners should undergo additional topical treatment with Canesten cream.
If symptoms persist for >7 days, the patient may have a medical condition that requires treatment by a physician.
Avoidance of vaginal intercourse is recommended while using Canesten Vaginal Tablet because the infection could be transferred to the partner, and the effectiveness and safety of latex products eg, condoms and diaphragms may be reduced.
Tolerability: Canesten is practically not absorbed in the vaginal skin.
No systemic effects are therefore, to be expected, since local tolerability is generally good.
Contraindications
Hypersensitivity to clotrimazole or to any other component of Canesten Vaginal Tablet.
Special Precautions
If the patient has a fever (≥38°C), lower abdominal pain, back pain, foul-smelling vaginal discharge, nausea, vaginal haemorrhage, and/or associated shoulder pain, the patient should consult a physician.
Avoid contact with eyes and do not swallow.
Use in pregnancy: Experimental and clinical investigations indicates that Canesten does not have any harmful effects on the mother and child when administered during pregnancy.
Sanitation of the birth canal should be ensured particularly during the last 4-6 weeks of pregnancy.
During pregnancy, Canesten Vaginal Tablet should be inserted without using an applicator.
Administration during the 1st trimester of pregnancy should be used with clear indication.
Use In Pregnancy & Lactation
Use in pregnancy: Experimental and clinical investigations indicates that Canesten does not have any harmful effects on the mother and child when administered during pregnancy.
Sanitation of the birth canal should be ensured particularly during the last 4-6 weeks of pregnancy.
During pregnancy, Canesten Vaginal Tablet should be inserted without using an applicator.
Administration during the 1st trimester of pregnancy should be used with clear indication.
Adverse Reactions
Immune System Disorders: Allergic reactions (syncope, hypotension, dyspnea, urticaria).
Reproductive System and Breast Disorders: Genital peeling, pruritis, rash, edema, erythema, discomfort, burning, irritation, pelvic pain and vaginal haemorrhage.
Gastrointestinal Disorders: Abdominal pain.
Drug Interactions
Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels and similarly with sirolimus. Patients should be thoroughly monitored for symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.
Caution For Usage
Instructions for Use and Handling: Directions for Using the Applicator: Pull out plunger until it stops.
Place a vaginal tablet into applicator.
Carefully insert the applicator containing the tablet as deeply as possible into the vagina. This is best achieved when lying on the back.
Push plunger carefully until it stops, thereby depositing the tablet into the vagina. Remove the applicator.
Storage
Do not store above 30°C.
ATC Classification
G01AF02 - clotrimazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
Presentation/Packing
Vag tab (white to pale yellow, biconvex with 1 rounded end) 500 mg x 1's.
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