GYNO-PEVARYL DEPOT VAGINAL SUPPOSITORY 150 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ECONAZOLE NITRATE

Available from:

JOHNSON & JOHNSON PTE. LTD.

ATC code:

G01AF05

Dosage:

150 mg

Pharmaceutical form:

SUPPOSITORY

Composition:

ECONAZOLE NITRATE 150 mg

Administration route:

VAGINAL

Prescription type:

Pharmacy Only

Manufactured by:

Xian-Janssen Pharmaceutical Ltd.,

Authorization status:

ACTIVE

Authorization date:

1989-06-05

Patient Information leaflet

NAME OF THE MEDICINAL PRODUCT 
Gyno Pevaryl Ovules 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
150mg Ovules: 1 ovule contains 150.0mg econazole nitrate. 
150mg Depot Ovules: 1 ovule contains 150mg micronized econazole
nitrate. 

PHARMACEUTICAL FORM 
Ovules of 150mg; 150mg Depot Ovules. 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
Gyno  Pevaryl  Ovules  is  indicated  for  the  treatment  of  vulvovaginal  mycoses  and 
mycotic balanitis. 

POSOLOGY AND METHOD OF ADMINISTRATION 
ADULT FEMALES 
_150 mg Ovules: _One ovule is inserted high into the vagina once daily at bedtime for 
three consecutive days. This is best done in the reclining position. In event of relapse, 
or if the culture examination one week after treatment is positive, a second round of 
treatment should be undertaken.  
_150  mg  Depot  Ovules:  _One  depot  ovule  is  inserted  high  into  the  vagina  in  the 
morning and one in the evening. This is best done in
the reclining position.  

CHILDREN (2 TO 16 YEARS OLD)  
The safety and effectiveness in children has not been
established. 

ELDERLY  
Data  are  insufficient  regarding  the  use  of  Gyno  Pevaryl  Ovules  in  the  elderly  (>65 
years old).  

CONTRAINDICATIONS 
Hypersensitivity to any component of the product.  

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 
The  concurrent  use  of  latex  condoms  or  diaphragms  with  vaginal  anti-infective 
preparations may decrease the effectiveness of rubber contraceptive agents. Therefore 
products  such  as  Gyno  Pevaryl  ovules  should  not  be  used  concurrently  with  a 
diaphragm or latex condom. Patients using spermicidal contraceptives should consult 
their  physician  since  any  local  vaginal  treatment  may  inactivate  the  spermi

Summary of Product characteristics

PRODUCT NAME
GYNO-PEVARYL
®
OVULES
GYNO-PEVARYL
®
DEPOT OVULES
DOSAGE FORMS AND STRENGTHS
_150mg Ovules_: 1 ovule contains 150.0 mg econazole nitrate
_150mg Depot Ovules_: 1 ovule contains 150 mg micronized econazole
nitrate
_Not all presentations may be available locally. _
For excipients, see _List of Excipients_.
CLINICAL INFORMATION
INDICATIONS
GYNO-PEVARYL
®
is
indicated
for
the
treatment
of
vulvovaginal
mycoses
and
mycotic
balanitis.
DOSAGE AND ADMINISTRATION
DOSAGE
_ADULT FEMALES _
_150 mg Ovules: _ One ovule is inserted high into the vagina once
daily at bedtime for three
consecutive days. This is best done in the reclining position. In
event of relapse, or if the culture
examination one week after treatment is positive, a second round of
treatment should be
undertaken.
_150 mg Depot Ovules: _One depot ovule is inserted high into the
vagina in the morning and one in
the evening. This is best done in the reclining position.
SPECIAL POPULATIONS
_PEDIATRICS (2 TO 16 YEARS OLD) _
The safety and effectiveness in children has not been established.
_ELDERLY (OLDER THAN 65 YEARS OLD) _
Data are insufficient regarding the use of GYNO-PEVARYL
®
in the elderly (>65 years old).
CONTRAINDICATIONS
GYNO-PEVARYL
®
is contraindicated in individuals who have shown hypersensitivity to
any of
its ingredients.
WARNINGS AND PRECAUTIONS
For intravaginal use only. GYNO-PEVARYL
®
is not for ophthalmic or oral use.
The concurrent use of latex condoms or diaphragms with vaginal
anti-infective preparations may
decrease the effectiveness of rubber contraceptive agents. Therefore
products such as GYNO-
PEVARYL
®
should not be used concurrently with a diaphragm or latex condom.
Patients using
spermicidal contraceptives should consult their physician since any
local vaginal treatment may
inactivate the spermicidal contraceptive.
GYNO-PEVARYL
®
should not be used in conjunction with other internal or external
treatment
of the genitalia.
If marked irritation or sensitivity occurs, the treatment should be
discontinued.
Patients wit