Premia Continuous

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

Medroxyprogesterone acetate; Oestrogens - conjugated

Հասանելի է:

Pfizer Australia Pty Ltd

Դաս:

Medicine Registered

Տեղեկատվական թերթիկ

PREMIA
®
 2.5
CONTINUOUS & PREMIA 5
CONTINUOUS

_Conjugated Oestrogens and Medroxyprogesterone acetate Tablets_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about Premia
Continuous Tablets. It does not
contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Premia
Continuous against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Your doctor and pharmacist have
more information.
KEEP THIS LEAFLET WITH THE MEDICINE
You may need to read it again.
WHAT PREMIA
CONTINUOUS IS USED
FOR
Premia Continuous is a type of
treatment called hormone
replacement therapy (HRT) and
contains the hormones conjugated
oestrogens and medroxyprogesterone
acetate (MPA).
Premia Continuous helps to relieve
the discomfort many women feel
during and after menopause,
including symptoms such as "hot
flushes", sweating and vaginal
dryness. It also helps to prevent
thinning of the bones (osteoporosis),
which can cause fractures, in some
women. Premia Continuous is used
by women who still have a uterus
(womb).
If your doctor thinks you will need to
take HRT for a long time, including
for the prevention of osteoporosis, he
or she will have considered the
benefits and risks of other treatments
before prescribing Premia
Continuous for you.
_HOW IT WORKS_
Menopause occurs naturally in
women usually between the ages of
45 and 55. During menopause, your
body produces less oestrogen than it
did beforehand. This can cause
symptoms such as, "hot flushes",
which are like sudden, intense
feelings of heat and sweating
throughout the body. Some women
also have problems with dryness of
the vagina causing discomfort during
or after sexual intercourse. Some
women develop osteoporosis during
or after menopause. This is a
thinning of the bones that makes
them weaker and more li

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PREMIA

 2.5 Continuous and PREMIA

 5 Continuous 
PRODUCT INFORMATION 

WARNING 
OESTROGENS  AND  PROGESTOGENS  SHOULD  NOT  BE  USED  FOR  THE  PREVENTION  OF  CARDIOVASCULAR 
DISEASE OR DEMENTIA (SEE CLINCAL TRIALS AND PRECAUTIONS, _CARDIOVASCULAR
RISK_ 
AND _DEMENTIA_). 
THE  OESTROGEN  PLUS  PROGESTOGEN  SUBSTUDY  OF  THE  WOMEN’S  HEALTH  INITIATIVE  (WHI) 
REPORTED  INCREASED  RISKS  OF  MYOCARDIAL  INFARCTION,  STROKE,  INVASIVE  BREAST  CANCER, 
PULMONARY EMBOLI, AND DEEP VEIN THROMBOSIS IN POSTMENOPAUSAL WOMEN (50 TO 79 YEARS 
OF  AGE)  DURING  5.6  YEARS  OF  TREATMENT  WITH  CONJUGATED  OESTROGENS  (CE  0.625  MG) 
COMBINED WITH MEDROXYPROGESTERONE ACETATE (MPA 2.5 MG) PER DAY RELATIVE TO PLACEBO 
(SEE  CLINICAL  TRIALS  AND  PRECAUTIONS,  _CARDIOVASCULAR  RISK  _AND  _MALIGNANT _
_NEOPLASMS, _BREAST CANCER). 
THE  OESTROGEN-ALONE  SUBSTUDY  OF THE WHI REPORTED INCREASED RISKS OF STROKE AND DEEP 
VEIN  THROMBOSIS  IN  POSTMENOPAUSAL  WOMEN  (50  TO  79  YEARS  OF  AGE)  DURING  7.1  YEARS  OF 
TREATMENT  WITH  CONJUGATED  OESTROGENS  (0.625  MG)  PER  DAY  RELATIVE  TO  PLACEBO  (SEE 
CLINICAL TRIALS AND PRECAUTIONS, _CARDIOVASCULAR RISK_). 
THE WOMEN’S HEALTH INITIATIVE MEMORY STUDY (WHIMS), A SUBSTUDY OF WHI, REPORTED 
AN INCREASED RISK OF DEVELOPING PROBABLE DEMENTIA IN POSTMENOPAUSAL WOMEN 65 YEARS 
OF AGE OR OLDER DURING 4 YEARS OF TREATMENT WITH CE 0.625 MG COMBINED WITH MPA 2.5 
MG AND DURING 5.2 YEARS OF TREATMENT WITH CE 0.625 MG ALONE, RELATIVE TO PLACEBO.  IT IS 
UNKNOWN  WHETHER  THIS  FINDING  APPLIES  TO  YOUNGER  POSTMENOPAUSAL  WOMEN  (SEE 
CLINICAL TRIALS AND PRECAUTIONS, _DEMENTIA _AND _U