Provera 5mg Tablets

Country: Malasía

Tungumál: enska

Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Virkt innihaldsefni:

MEDROXYPROGESTERONE ACETATE

Fáanlegur frá:

PFIZER (MALAYSIA) SDN. BHD.

INN (Alþjóðlegt nafn):

MEDROXYPROGESTERONE ACETATE

Einingar í pakka:

30 Tablet Tablets

Framleitt af:

Pfizer Italia S.r.l.

Upplýsingar fylgiseðill

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PROVERA
®
TABLET
Medroxyprogesterone acetate (5 mg, 10 mg)
PLD Title
: Medroxyprogesterone acetate (PROVERA)
PLD Date
: 10 January 2020
Country
: Malaysia
Reference Document
: Malaysia LPD dated 22 December 2017
Reason for Change
: To align with current effective LPD (dated 22 December 2017) and to
revise as per new template
: To update PRH address
: To update serial number
: PfLEET Number 2020-0057572 (S2): To address BOH comments
: To remove phone number for reporting side effects
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PROVERA
®
TABLET
Medroxyprogesterone acetate (5 mg, 10 mg)
1
WHAT IS IN THIS LEAFLET
1.
What PROVERA is used for
2.
How PROVERA works
3.
Before you use PROVERA
4.
How to use PROVERA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of PROVERA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT PROVERA IS USED FOR
PROVERA is used to:

Treat absence of menstrual period or to
treat abnormal bleeding due to
hormonal imbalance in the absence of
underlying condition, such as fibroids
or uterine cancer.

Prevent thickening of the inner lining
of the uterus (endometrial hyperplasia)
in postmenopausal women with a
uterus who use estrogen tablets.
HOW PROVERA WORKS
PROVERA tablets contain the active
substance medroxyprogesterone acetate,
which belong to a group of medicines
called ‘progestogens. Progestogens are
similar to the natural female hormone,
progesterone that helps to regulate
ovulation (the release of an egg from
ovary) and menstrual periods.
Progesterone also helps to prepare the
womb lining for pregnancy and shed the
lining each month when pregnancy does
not occur.
BEFORE YOU USE PROVERA
-
_When you must not use it_
Do not start taking PROVERA if you:
- have undiagnosed vaginal bleeding
- currently have or suspected to have
certain estrogen or progesterone
dependent cancers
- known, suspected, or history of

Vara einkenni

Pfizer confidential
Page 1 of 18
LPD Title
: Provera
LPD Date
: 03 July 2015
Country
: Malaysia
Reference
: USPI LAB-0144-6.0 (Revised May 2015)
1.
Reason for Change
: Section 4.5 Interaction with Other Medicinal products and
Other Forms of Interaction of the medroxyprogesterone acetate (MPA)
Core Data
Sheet is being updated to add information on the potential for
interaction between
MPA and inducers/inhibitors of cytochrome P450 enzymes. During
assessment of
the labeling supplement, the FDA have requested extensive additional
class-
labeling updates to the label
2.
To change the storage condition.
1. NAME OF THE MEDICINAL PRODUCT
PROVERA
®
medroxyprogesterone acetate tablets, USP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PROVERA tablet for oral administration contains 5 mg or 10 mg of
medroxyprogesterone acetate
.
Excipients:
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Tablets
PROVERA 5 MG: Pale blue, round, convex tablets scored on one side and
imprinted
“PROVERA 5” on the other side.
PROVERA 10 MG: White, round, convex tablets scored on one side and
imprinted
“PROVERA 10” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PROVERA tablets are indicated for the treatment of secondary
amenorrhea and abnormal
uterine bleeding due to hormonal imbalance in the absence of organic
pathology, such as
fibroids or uterine cancer. They are also indicated for use in the
prevention of
endometrial hyperplasia in non-hysterectomized postmenopausal women
who are
receiving daily oral conjugated estrogens 0.625 mg tablets.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
SECONDARY AMENORRHEA
Pfizer confidential
Page 2 of 18
PROVERA tablets may be given in dosages of 5 or 10 mg daily for 5 to
10 days. A dose
for inducing an optimum secretory transformation of an endometrium
that has been
adequately primed with either endogenous or exogenous estrogen is 10
mg of PROVERA
daily for 10 days. In cases of secondary amenorrhea, therapy may be
started at any time.
Progestin withdraw