INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo MYCOHEXAL 1 (vaginal tablet)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

MYCOHEXAL 1 (vaginal tablet)

COMPOSITION
Each vaginal tablet contains 500 mg
clotrimazole.

PHARMACOLOGICAL CLASSIFICATION
A 20.2.2 Fungicides

PHARMACOLOGICAL ACTION
Clotrimazole has a fungicidal action on Candida species.

INDICATIONS
For the relief of vaginal itching, burning and discharge associated with recurrent vaginal yeast infections (vaginal candidiasis)

CONTRA INDICATIONS
Hypersensitivity to clotrimazole.

WARNINGS
Not for oral use
KEEP OUT OF REACH OF CHILDREN
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.
If there is no improvement in 3 days or if symptoms have not disappeared within 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, a fever or a foul smelling vaginal discharge before or during use of this medication.
If symptoms recur within 2 months, then consult a medical practitioner
If you are pregnant or think that 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 a skin rash or new irritation occurs, discontinue use.

DOSAGE AND DIRECTIONS FOR USE
1 vaginal tablet to be inserted, using the applicator, as high up into the vagina as possible as a single dose.
The easiest method of insertion is for the patient to lie on her back with the legs slightly drawn up.
If necessary a second follow up treatment may be administered.
MycoHexal 1 vaginal tablets should not be administered during menstruation.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
A mild burning sensation, vulval oedema, and less frequently, lower abdominal cramps, slight increase in urinary frequency or a skin rash have been reported.
Occassionally the sexual partner may experience penile or urethral discomfort.
Contact allergic dermatitis has been reported.

Use during pregnancy
MycoHexal 1 vaginal tablets should not be administered during the first three months of pregnancy.
During pregnancy the MycoHexal 1 vaginal tablet should be inserted without using the applicator.
The possibility of absorption of clotrimazole when administered vaginally cannot be excluded.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Gastro-intestinal disturbances and mental depression may occur following accidental oral ingestion.
Treatment is symptomatic and supportive.

IDENTIFICATION
White, oblong vaginal tablets.

PRESENTATION
Aluminium blister containing one vaginal tablet and an applicator.

STORAGE INSTRUCTIONS
Store below 25°C, in a dry place. Protect from light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
31/20.2.2/0650

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Hexal Pharma (SA)(PTY)LTD
Unit A
10 Fangio Road
Mahogany Ridge
Westmead
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT
February 1999

Updated on this site: February 2000

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