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

Logo MYCOSTATIN VAGINAL CREAM

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form)

MYCOSTATIN VAGINAL CREAM

COMPOSITION
MYCOSTATIN VAGINAL CREAM contains 100 000 units
nystatin per 4 g, preserved with methylparaben 0,24% m/m and propylparaben 0,024% m/m.

PHARMACOLOGICAL CLASSIFICATION
Category A 18.6 Vaginal preparations.

PHARMACOLOGICAL ACTION
Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeast and yeast-like fungi.
Nystatin exhibits no appreciable activity against bacteria, protozoa or viruses.

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

CONTRA-INDICATIONS
Patients with a history of hypersensitivity to any component.

WARNINGS TO PATIENT
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 new irritation occurs, discontinue use.

DOSAGE AND DIRECTIONS FOR USE
MYCOSTATIN VAGINAL CREAM: Insert one or two applicatorfuls daily, high into the vagina by means of the applicator.
Repeat on 7 consecutive nights even during menstruation and even if symptoms disappear (See enclosed detailed instructions for inserting and care of the applicator).

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Nystatin is well tolerated even with prolonged therapy. Vaginal irritation and sensitization (including: burning and pruritis) have been reported. If local sensitization develops treatment should be discontinued.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Treatment of overdosage should be symptomatic and supportive.

IDENTIFICATION
MYCOSTATIN VAGINAL CREAM: Between off-white and slightly yellow cream.

PRESENTATION
MYCOSTATIN VAGINAL CREAM: Package of 60 g containing a vaginal applicator designed to deliver a 4 g dose.

STORAGE INSTRUCTIONS
Store at room temperature not exceeding 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS
MYCOSTATIN VAGINAL CREAM; E/18.6/126

NAME AND BUSINESS ADDRESS OF APPLICANT
BRISTOL-MYERS SQUIBB (PTY) LTD*
47 Van Buuren Road,
Bedfordview.
2008

DATE OF PUBLICATION OF THIS PACKAGE INSERT
June 1994

* Authorised user of the TM MYCOSTATIN

Updated on this site: November 2005
Source: Pharmaceutical Industry

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