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

Logo GYNO-PEVARYL® 50 Ovule
GYNO-PEVARYL® 150 Ovule
GYNO-PEVARYL® DEPOT Ovule

SCHEDULING STATUS
Schedule 1

PROPRIETARY NAME
(and dosage form)

GYNO-PEVARYL® 50 Ovule
GYNO-PEVARYL® 150 Ovule
GYNO-PEVARYL® DEPOT Ovule

COMPOSITION
GYNO-PEVARYL ovules contain as active ingredient 50 mg or 150 mg
econazole nitrate.
GYNO-PEVARYL DEPOT ovule contains 150 mg micronised econazole nitrate.

PHARMACOLOGICAL CLASSIFICATION
A 18.6 Vaginal preparations

PHARMACOLOGICAL ACTION
Econazole is a broad spectrum antimycotic with fungicidal properties.
The active substance of GYNO-PEVARYL DEPOT spreads over the vaginal epithelium where it forms a gel layer serving as an econazole depot. The antimycotic effect is thus ensured for several days.

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

CONTRA-INDICATIONS
Hypersensitivity to econazole nitrate

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 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, 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
GYNO-PEVARYL 50:
Unless otherwise prescribed by the physician, during a period of two weeks introduce one vaginal ovule of GYNO-PEVARYL 50 deeply into the vagina, preferably while assuming a supine position, just before retiring at night.
The treatment must be continued even during menstruation and even after the disappearance of subjective complaints (itching, discharge).
GYNO-PEVARYL 150:
Unless otherwise prescribed by the physician, introduce one GYNO-PEVARYL '150' ovule deep into the vagina preferably while assuming the supine position, just before retiring at night. The ovules are to be introduced on three consecutive nights even during menstruation and even if symptoms disappear.
GYNO-PEVARYL DEPOT:
Unless otherwise prescribed by the physician, introduce oneGYNO-PEVARYL DEPOT Ovule deep into the vagina, preferably while assuming the supine position, just before retiring at night.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Local reactions including burning and irritation may occur. Contact dermatitis has been reported.
The use of this product should be avoided during the first trimester of pregnancy, since the safety in this regard has not been established.
The possibility of absorption of econazole when administered vaginally cannot be excluded.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Accidental ingestion can lead to nausea and vomiting which should be treated symptomatically.

IDENTIFICATION
GYNO-PEVARYL 50 and 150:
Yellowish to creamy-white ovule with a fat-like odour.
GYNO-PEVARYL DEPOT:
A yellowish to creamy-white ovule.

PRESENTATION
GYNO-PEVARYL 50:
Carton boxes containing 15 ovules of 50 mg each.
GYNO-PEVARYL 150:
Carton boxes containing 3 ovules of 150 mg each.
GYNO-PEVARYL DEPOT:
Carton box containing one GYNO-PEVARYL DEPOT 150 mg ovule in a strip pack.

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

REGISTRATION NUMBER
GYNO-PEVARYL 50: H/18.6/167
GYNO-PEVARYL 150: J/18.6/176
GYNO-PEVARYL DEPOT: R/18.6/179

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN-CILAG logo
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 1980/11122/07)
15th Road
HALFWAY HOUSE
1685
www.janssencilag.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT
16 August 1995

024362 2003E        Pro-Print

Updated on this site: March 2004
Source: Pharmaceutical Industry

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