PROVERA TABLET 5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Medroxyprogesterone acetate (milled)

Available from:

PFIZER PRIVATE LIMITED

ATC code:

G03DA02

Dosage:

5 mg

Pharmaceutical form:

TABLET

Composition:

Medroxyprogesterone acetate (milled) 5 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Pfizer Italia S.r.l.

Authorization status:

ACTIVE

Authorization date:

1998-12-03

Patient Information leaflet

PROVERA
TABLE OF CONTENT
_Please click on either of the following links to access the required
information: _
_ _
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page
1
of
10
1.
TRADE NAME(S) OF THE MEDICINAL PRODUCT
PROVERA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg or 10 mg of medroxyprogesterone acetate.
3.
PHARMACEUTICAL FORM
Tablets
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into
equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
_GYNECOLOGY _
Medroxyprogesterone acetate (MPA) tablets are indicated for:
•
Treatment of secondary amenorrhea.
•
Treatment of abnormal uterine bleeding due to hormonal imbalance in
the absence
of organic pathology, such as fibroids or uterine cancer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_GYNECOLOGY _
Use of combined estrogen/progestin therapy should be limited to the
lowest effective
dose and shortest duration consistent with treatment goals and risks
for the individual
woman, and should be periodically evaluated (see
SECTION 4.4. SPECIAL WARNINGS AND
PRECAUTIONS FOR USE
).
Periodic check-ups are recommended of a frequency and nature adapted
to the
individual woman (see
SECTION 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
Unless there is a previous diagnosis of endometriosis, it is not
recommended to add a
progestin in a woman without an intact uterus.
SECONDARY AMENORRHEA
– MPA may be given in dosages of 5 mg to 10 mg daily for
5 to 10 days. A dose of inducing an optimum secretory transformation
of an
endometrium that has been adequately primed with either endogenous or
exogenous
estrogen is 10 mg of MPA daily for 10 days. In cases of secondary
amenorrhea, therapy
may be started at any time. Progestin withdrawal bleeding usually
occurs within three to
seven days after discontinuing MPA therapy.
Page
2
of
10
ABNORMAL UTERINE BLEEDING DUE TO HORMONAL IMBALANCE IN THE ABSENCE OF
ORGANIC PATHOLOGY
– Beginning on the calculated 16
th
or 21
st
day of the menstrual
cycle, 5 to 10 mg of

Summary of Product characteristics

Page 1 of 11
1.
TRADE NAME(S) OF THE MEDICINAL PRODUCT
PROVERA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg or 10 mg of medroxyprogesterone acetate.
3.
PHARMACEUTICAL FORM
Tablets
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
GYNECOLOGY
Medroxyprogesterone acetate (MPA) tablets are indicated for:

Treatment of secondary amenorrhea.

Treatment of abnormal uterine bleeding due to hormonal imbalance in
the
absence of organic pathology, such as fibroids or uterine cancer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
GYNECOLOGY
Use of combined estrogen/progestin therapy should be limited to the
lowest
effective dose and shortest duration consistent with treatment goals
and risks for the
individual woman, and should be periodically evaluated (see SECTION
4.4. SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
Periodic check-ups are recommended of a frequency and nature adapted
to the
individual woman (see SECTION 4.4. SPECIAL WARNINGS AND PRECAUTIONS
FOR USE).
Unless there is a previous diagnosis of endometriosis, it is not
recommended to add
a progestin in a woman without an intact uterus.
SECONDARY AMENORRHEA – MPA may be given in dosages of 5 mg to 10 mg
daily
for 5 to 10 days. A dose of inducing an optimum secretory
transformation of an
endometrium that has been adequately primed with either endogenous or
exogenous
Page 2 of 11
estrogen is 10 mg of MPA daily for 10 days. In cases of secondary
amenorrhea,
therapy may be started at any time. Progestin withdrawal bleeding
usually occurs
within three to seven days after discontinuing MPA therapy.
ABNORMAL UTERINE BLEEDING DUE TO HORMONAL IMBALANCE IN THE ABSENCE OF
ORGANIC PATHOLOGY – Beginning on the calculated 16
th
or 21
st
day of the menstrual
cycle, 5 to 10 mg of MPA may be given daily for 5 to 10 days. To
produce an
optimum secretory transformation of an endometrium that has been
adequately
primed with either endogenous or exogenous