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Logo GYNEZOL (vaginal cream)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

GYNEZOL (vaginal cream)

COMPOSITION:
Each 1 g of cream contains:       
Clotrimazole        10 mg
Preservative: Nipastat 0,275% m/m
  Biopure 0,3% m/m

PHARMACOLOGICAL CLASSIFICATION:
A: 20.2.2 Fungicides

PHARMACOLOGICAL ACTION:
Gynezol
is a broad spectrum antimycotic with fungicidal properties.

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

CONTRA-INDICATIONS:
Possible hypersensitivity to clotrimazole
The possibility of absorption of clotrimazole when administered vaginally cannot be excluded. Safety in pregnancy has not been established.

WARNINGS:
i) 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.
ii) If there is an 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 yeast.
iii) Consult a medical practitioner if you have abdominal pain, fever or a foul-smelling vaginal discharge or during use of this medication.
iv) If symptoms recur within 2 months, consult a medical practitioner.
v) 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.
vi) Do not use in girls under 12 years of age, except on the advice of a medical practitioner.
vii) If skin rash or new irritation occurs, discontinue use.

DOSAGE AND DIRECTIONS FOR USE:
Not intended for oral administration.
Fill enclosed vaginal applicator to the top (i.e. 5 g Gynezol vaginal cream). Insert deeply into the vagina every night on retiring for six consecutive days. This is best achieved when lying on the back with the legs pulled in a little towards the body. If individual cases should require it, two applications of 5 g vaginal cream can be used daily, i.e., once in the morning and once in the evening, for 6-12 days. The treatment should be continued even during menstruation and even if symptoms disappear.
For the prevention of re-infection the partner should be treated locally with Gynezol cream at the same time. This preparation does not stain the underwear.

DIRECTIONS FOR USING THE APPLICATOR:
PREPARATION OF THE APPLICATOR:
1. Wash your hands thoroughly
2. Screw the open end of one of the applicators over the opening of the tube of cream. The plunger of the applicator should be pushed right in at this stage.
3. Gently squeeze the bottom of the tube so that the cream fills the applicator to the top, pushing the plunger out to almost its full extent.
4. Unscrew the tube of cream and replace its cap
INSERTING THE APPLICATOR:
5. Carefully insert the end of the applicator as deeply as possible into the vagina (making sure plunger does not fall out). This is best achieved when lying on the back with the legs pulled in a little towards the body.
6. Slowly push the plunger with the forefinger until it stops.
7. Remove the applicator from the vagina and discard it.
The surplus cream can be used to treat any inflammation of the vulva (outer vaginal area) and nearby areas. The cream should be applied thinly and rubbed in gently 2-3 times a day. Follow your doctor’s instructions.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Local reactions including irritation and burning may occur. Contact allergic dermatitis have been reported. Gynezol vaginal cream should only be administered to pregnant women under medical supervision, especially during early stages of pregnancy.
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:
A soft, white cream

PRESENTATION:
Tube of 50 g with single or 6 vaginal applicators

STORAGE INSTRUCTIONS:
Store below 25ºC in a dry place
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
28/20.2.2/0418

NAME AND BUSINESS ADDRESS OF APPLICANT:
GULF DRUG COMPANY (PTY) LTD
22 BURNSIDE DRIVE
OLD MILL INDUSTRIAL PARK
MOUNT EDGECOMBE
4300

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
2 November 1993

New addition to this site: July 2010
Source: Pharmaceutical Industry

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