RALOXIFENE AN Raloxifene hydrochloride 60 mg tablets, blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-02-2015
Summary of Product characteristics
(SPC)
24-02-2015
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
Raloxifene hydrochloride
Available from:
Amneal Pharma Australia Pty Ltd
INN (International Name):
Raloxifene hydrochloride
Patient Information leaflet
RALOXIFENE AN
1
RALOXIFENE AN
_Raloxifene hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
you with answers to some common
questions about this medicine. It
does not contain all the available
information and does not take the
place of talking with your doctor.
All medicines have risks and
benefits. Your doctor has more
information about this medicine than
is contained in this leaflet. Also,
your doctor has had the benefit of
taking a full and detailed history
from you and is in the best position
to make an expert judgement to meet
your individual needs.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT RALOXIFENE
AN IS USED FOR
RALOXIFENE AN belongs to a
group of non-hormonal medicines
called Selective Estrogen Receptor
Modulators (SERMs). When a
woman reaches menopause, the level
of the female sex hormone,
oestrogen, goes down.
RALOXIFENE AN mimics some of
the beneficial effects of oestrogen
after menopause.
RALOXIFENE AN is used to
prevent and treat osteoporosis in
women after menopause.
Osteoporosis causes your bones to
become thin and fragile - it is
especially common in women after
menopause. While osteoporosis may
have no symptoms at first, it makes
your bones more likely to break,
especially in your spine, hips and
wrists. Osteoporosis may also cause
back pain, loss of height and a curved
back.
Fractures may occur during normal,
everyday activity, such as lifting, or
from minor injury that would not
ordinarily fracture normal bone.
RALOXIFENE AN is also used to
reduce the risk of invasive breast
cancer in women with osteoporosis
after menopause and reduce the
risk of invasive breast cancer in
women at high risk of invasive
breast cancer after menopause.
Breast cancer is invasive when it has
spread outside the milk duct or
milk-making glands and has grown
into normal tissue inside the breast.
Invasive cancers can spread cancer to
other parts
Read the complete document
Summary of Product characteristics
_ _
_ _
_Raloxifene AN tablets Product Information _
_ _
_ Amneal Pharma Australia Pty Ltd _
Raloxifene AN PI V1.0 Page 1 of 21
RALOXIFENE AN
_ _
_(RALOXIFENE HYDROCHLORIDE TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Raloxifene
hydrochloride.
Chemically
raloxifene
hydrochloride
is
methanone,
[6‐hydroxy‐2‐(4‐
hydroxyphenyl)benzo[b]thien‐3‐yl]‐[4‐[2‐(1‐
piperidinyl)ethoxy]phenyl]‐,hydrochloride
and
its
empirical formula is C
28
H
27
NO
4
S•HCl
which corresponds to a molecular weight of 510.05.
The CAS number for raloxifene HCl is 82640‐04‐8.
The CAS number for raloxifene free base is
84449‐90‐1.
DESCRIPTION
Raloxifene hydrochloride is an off‐white to pale‐yellow solid that
is very slightly soluble in water. Each film
coated tablet contains 60 mg raloxifene hydrochloride, which is
equivalent to 56 mg raloxifene free base.
The tablets also contain povidone, polysorbate 80, glycine,
crospovidone, microcrystalline cellulose,
colloidal anhydrous silica, magnesium stearate and Opadry White
12B580000 (ARTG 108743).
PHARMACOLOGY
LONG‐TERM POST‐MENOPAUSAL HEALTH AND THE ROLE OF OESTROGEN
_ _
_ _
_Raloxifene AN tablets Product Information _
_ _
_ Amneal Pharma Australia Pty Ltd _
Raloxifene AN PI V1.0 Page 2 of 21
Oestrogen exerts agonistic effects on a number of bodily tissues. For
example, oestrogen affects the
structure and integrity of bone.
Decreases
in
oestrogen
levels
after
oophorectomy
or
menopause
lead
to
increases
in
bone
resorption, accelerated bone loss and increased risk of fracture. Bone
is initially lost rapidly because
the compensatory increase in bone formation is inadequate to offset
resorptive losses. This
imbalance between resorption and formation is related to loss of
oestrogen, and may also involve
age‐related
impairment
of
osteoblasts
or
their
precursors.
Vertebral
fractures
are
the
most
common type of osteoporotic fracture in post‐menopausal women. These
fractures are associated
with substantial morbidity and impairment in quality of life.
Managi
Read the complete document
