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Logo GYNOSPOR VAGINAL CREAM

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

GYNOSPOR VAGINAL CREAM

COMPOSITION:
Each gram contains:
Miconazole Nitrate         20 mg
Preservative:
Benzoic acid 0,2% m/m
Anti-oxidant:
Butylated hydroxyanisole BP 0,0052% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 18.6 Medicines acting on the genito-urinary system. Vaginal preparations.

PHARMACOLOGICAL ACTION:
Miconazole nitrate is a synthetic 1-phenethylimidazole derivative. In vitro, low concentrations of miconazole nitrate are fungistatic against all Phycomycetes, Ascomycetes and Adelomycetes tested (e.g. Saprolegnia, Candida, Cryptococcus, Aspergillus, Dermatophytes, Phialophora, Sporotrichum) and fungicidal against Trichophyton mentagrophytes, Trichophyton rubrum, Epidermophyton floccosum, Trichophyton interdigitale and Micosporum canis.
Thus GYNOSPOR VAGINAL CREAM is a broad-spectrum antifungal agent.
Miconazole nitrate also possesses some antimicrobial activity against gram positive bacilli and cocci.

PHARMACOKINETICS:
Systemic absorption after intravaginal administration is limited.

INDICATIONS:
For the relief of vaginal itching, burning and discharge associated with recurrent vaginal yeast infections.

CONTRA-INDICATIONS:
Contra-indicated in individuals who have shown hypersensitivity to miconazole nitrate and other ingredients in the cream.

WARNINGS:
Use only if you have the same symptoms as previously diagnosed (by a medical practitioner) for a vaginal yeast infection. These symptoms may include itching and burning of the vagina and are sometimes accompanied by a white vaginal discharge.
Consult your medical practitioner if you are not certain about the symptoms or if there is no improvement after 3 days of using GYNOSPOR VAGINAL CREAM. Symptoms should disappear after 7 days treatment.
In addition, should you experience abdominal pain, fever or foul smelling vaginal discharge, before or during use of GYNOSPOR VAGINAL CREAM then consult your medical practitioner.
If symptoms reoccur within 2 months then consult your medical practitioner.
Do not use GYNOSPOR VAGINAL CREAM when you are pregnant, or think you are pregnant or are breast-feeding, without consulting your medical practitioner.
Do not use in girls under 12 years of age without consulting your medical practitioner.
Discontinue use if skin rash or new irritation occurs.

DOSAGE AND DIRECTIONS FOR USE:
GYNOSPOR VAGINAL CREAM is supplied with an applicator which delivers a dose of 5 g of cream (100 mg miconazole nitrate).
One applicator full should be applied intravaginally for 6 (or 7) consecutive nights even during menstruation and even if symptoms disappear, ie. giving a dose of (±)5 g nocturnally.
A second course may be completed if the patient is not mycologically cured after the first course.
The applicator is filled by screwing it into the GYNOSPOR VAGINAL CREAM tube after having removed the cap and breaking the seal. The base of the tube is then depressed until the applicator is full.
Insert the full applicator deep into the vagina and depress the piston completely, emptying the contents of the applicator.
After each application, the applicator must be washed thoroughly and stored in a clean, dry place.
The patient must complete the full course of treatment in spite of symptomatic relief, which may well occur within the first few days. Continue using even if menstruation begins. The same daily dose of 5 g is applicable for all age groups.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects such as local irritation, pruritis, burning sensation, especially at the start of treatment have been reported. In addition, some patients have experienced pelvic cramping, hives and skin rashes.
Should an allergic reaction occur then discontinue treatment and consult your Medical Practitioner.
Caution should be exercised when prescribing GYNOSPOR VAGINAL CREAM to pregnant and lactating women. The cream should only be used during the first trimester and only if, in the medical practitioner s opinion, the potential benefits outweigh the possible risks.

INTERACTIONS:
Avoid contact of latex products such as contraceptive diaphragms or condoms with GYNOSPOR VAGINAL CREAM as the rubber might be damaged.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Poisoning or overdosage is unlikely to occur owing to the very limited extent to which miconazole nitrate is absorbed. If it does present, treatment should be symptomatic. In the event of accidental ingestion of large quantities, gastric emptying may be appropriate.

IDENTIFICATION:
Smooth, white, homogeneous, odourless cream.

PRESENTATION:
GYNOSPOR VAGINAL CREAM is supplied in an aluminium tube of 40 g, together with an applicator for intravaginal application.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
S/18.6/85

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Garec (Pty) Ltd
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
2 November 1989

GYN1.1P07/03
Code No.: 022934
        2003G
        P585/1

Updated on this site: October 2003
Source: Pharmaceutical Industry

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