INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
GYNO-TROSYD VAGINAL CREAM

        20 mg per gram Tioconazole
        GYNO-TROSYD^®
        Vaginal Cream

SCHEDULING STATUS:
Schedule 2

PROPRIETARY NAMES
(and dosage forms):

GYNO-TROSYD VAGINAL CREAM

COMPOSITION:
Each gram of Gyno-Trosyd Vaginal Cream contains 20 mg tioconazole, with 1% m/m benzyl alcohol.

PHARMACOLOGICAL CLASSIFICATION:
A.18.6 Vaginal Preparations.

PHARMACOLOGICAL ACTION:
Tioconazole is a synthetic broad spectrum antifungal agent.

INDICATIONS:
Gyno-Trosyd Vaginal Cream is indicated for the relief of vaginal itching, burning and discharge associated with recurrent vaginal yeast infections (Vaginal candidiasis).

CONTRA-INDICATIONS:
Gyno-Trosyd is contra-indicated in individuals who have been shown to be hypersensitive to imidazole antifungal agents or to any of the components of the cream or tablets. Safety in pregnancy has not been established.

WARNINGS:
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 seven 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 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 a new irritation occurs, discontinue use.

DOSAGE AND DIRECTIONS FOR USE:
Gyno-Trosyd Vaginal Cream (5g) should be applied once daily on retiring at night, using the applicator supplied (see enclosed patient leaflet).
In cases of vaginal candidiasis with scant discharge the cream formulation should be used in preference to the tablets.
The duration of treatment required is usually 3 to 6 days even during menstruation or if symptoms disappear. A repeat course may be effective in patients who are improved but not cured by the initial course.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Symptoms of local irritation have been reported by some patients during use. They are usually seen early during the course of treatment and are transient and mild. However, if a sensitivity reaction develops with the use of Gyno-Trosyd, treatment should be discontinued and appropriate therapy instituted.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The treatment of sensitivity reactions is symptomatic.

IDENTIFICATION:
Gyno-Trosyd Vaginal Cream: A smooth, white to off-white cream.

PRESENTATION:
Gyno-Trosyd Vaginal Cream: Aluminium tubes each containing 20g.

STORAGE INSTRUCTIONS:
Store below 30°C, Keep out of reach of children. Do not freeze.

REGISTRATION NUMBERS:
Gyno-Trosyd Vaginal Cream: Q/18.6/56

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pfizer Laboratories (Pty) Ltd
102 Rivonia Road
SANDTON 2199

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
3 June 1996

Updated on this site: February 2000
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