CANESTEN (clotrimazole)
 
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->Canestan (clotrimazole) 1 of 35g 6 day cream  NZ$ 25, 3 of 35g 6 day cream  NZ$ 61
 
COMPOSITION:
Each vaginal tablet contains clotrimazole 500 mg
10 g Cream contains clotrimazole 100 mg and benzyl alcohol 1% m/m (as preservative)

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.2 Fungicides

PHARMACOLOGICAL ACTION:
Clotrimazole is a broad spectrum antimycotic and has a fungicidal action on Candida species.

INDICATIONS:
Vaginal Tablet:
For the relief of vaginal itching, burning and discharge associated with recurrent vaginal yeast infections (vaginal candidiasis). Vaginitis due to Candida species.
Topical Cream
Infections of the labia and adjacent areas as well as inflammation of the glans and prepuce of the sexual partner caused by yeast fungi (Candidal vulvitis and Candidal balanitis)

CONTRA-INDICATIONS:
Vaginal Tablet: Possible hypersensitivity to clotrimazole.
Topical Cream: Possible hypersensitivity to clotrimazole and cetostearyl alcohol.

WARNINGS:
(Vaginal Tablet)
Not for oral use.

Use only if you have already had a vaginal yeast infection diagnosed by a medical practitioner and you have the same symptoms now, otherwise consult your doctor. These symptoms include itching and burning of the vagina and sometimes a white discharge. For the treatment of vaginal candidiasis in first-time sufferers the condition must be diagnosed by a medical practitioner, and the use of CANESTEN Vaginal Tablet be prescribed by the medical practitioner.

If there is no improvement in 3 days or if symptoms have not disappeared in 7 days, then consult a medical practitioner as not all vaginal infections are caused by yeasts.

Consult a medical practitioner if you have abdominal pain, fever or a foul-smelling vaginal discharge before or during the use of this medication.

If symptoms recur within 2 months, consult a medical practitioner.

If you are pregnant or think you may be pregnant or are nursing, do not use this medication except on the advice of a medical practitioner.

Do not use in girls under 12 years of age, except on the advice of a medical practitioner.

If skin rash or new irritation occurs, discontinue use.


DOSAGE AND DIRECTIONS FOR USE:
Vaginal Tablet
In general, a single dose treatment will be sufficient for Candida vaginitis. Unless otherwise prescribed by the doctor, the CANESTEN 1 Vaginal Tablet should be inserted, preferably at night into the vagina as deeply as possible (see instructions for use of applicator). This is best achieved when lying back with the legs slightly drawn up. However, the tablet may also be inserted by the doctor after the examination. If necessary a second treatment may be carried out.
If is recommended that the treatment should be timed so as to avoid the menstrual period. For prevention of re-infection the partner should be treated locally with CANESTEN Cream at the same time.
Topical Cream (Candida vulvitis/Candida balanitis)
CANESTEN Cream (Duopak) is applied thinly to the affected areas (external genital organs to the anus in women; glans to the prepuce in men) 2-3 times a day and rubbed in. The normal period of treatment is 1-2 weeks. A small amount of cream is usually sufficient for an area about the size of a palm. Successful treatment demands that CANESTEN be applied correctly and over a sufficiently long period of time.
Topical treatment of fungal infections should be continued for approximately 2 weeks after the disappearance of all symptoms despite a rapid, subjective improvement, in order to prevent relapse.
Use during pregnancy:
CANESTEN 1 Vaginal tablet should not be administered to pregnant women during the first trimester except on the advice of a medical practitioner. During pregnancy the CANESTEN 1 Vaginal Tablet 500 mg should be inserted without using an applicator.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Vaginal tablet: Local reactions including irritation and burning may occur. Contact allergic dermatitis has been reported. In the case of systemic absorption, lower abdominal cramps, increase in urinary frequency or skin rash may occur.
Topical Cream: Not intended for opthalmic use. Local reactions including skin irritation and burning may occur. Contact allergic dermatitis has been reported. In cases of systemic absorption, lower abdominal cramps, increase in urinary frequency or skin rash may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side effects and special precautions. In case of accidental ingestion, gastro-intestinal disturbances and central nervous system depression may occur. Treatment is symptomatic and supportive.

IDENTIFICATION:
Vaginal Tablet: Nearly white to slightly yellowish oblong vaginal tablet with the word 'Bayer' on one side and MU on the other side.
Topical Cream: A white cream

PRESENTATION:
Cardboard pack containing one vaginal tablet of 500 mg, sealed in aluminium foil, an applicator and a 10 g collapsible aluminium tube of topical cream.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep out of reach of children.


® = Registered trade mark of Bayer, Germany

Prior to application remove the tablet from the aluminium foil (as illustrated).
{illustrated}
Directions for using the Applicator:

Pull out plunger A until it stops. Place the vaginal tablet into the applicator B.

Insert applicator containing the tablet carefully and as deeply as possible into the vagina (preferably lying on your back).


Important notice
Pregnant women should follow the instructions of their doctor strictly. During pregnancy insertion should be done without using the applicator.

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