RALOXIFENE AMNEAL raloxifene hydrochloride 60 mg tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

raloxifene hydrochloride

Dostupné s:

Amneal Pharma Australia Pty Ltd

INN (Mezinárodní Name):

Raloxifene hydrochloride

Stav Autorizace:

Registered

Informace pro uživatele

RALOXIFENE AMNEAL
_Raloxifene hydrochloride_
CONSUMER MEDICINE INFORMATION
Page 1 of 3
Raloxifene AMNEAL CMI v2.0
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
AMNEAL IS USED FOR
RALOXIFENE
AMNEAL
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
AMNEAL
mimics
some
of
the
beneficial
effects
of
oestrogen after menopause.
RALOXIFENE AMNEAL 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.
Your
doctor
may
have
prescribed
RALOXIFENE
AMNEAL
for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
RALOXIFENE
AMNEAL
HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
RALOXIFENE AMNEAL
TELL YOUR DOCTOR IF YOU HAVE ANY OF
THE FOLLOWING CONDITIONS OR IF YOU
HAVE EVER EXPERIENCED ANY OF THESE
CON

Charakteristika produktu

Raloxifene Amneal PI v3.0 Page 1 of 18
_Raloxifene AMNEAL tablets Product Information_
_ _
_ _
_Amneal Pharma Australia Pty Ltd_
_ _
RALOXIFENE AMNEAL
_ _
_(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 or practically
insoluble in water and in acetone. Each film coated tablet contains 60
mg raloxifene hydrochloride, which
is equivalent to 56 mg raloxifene free base. The tablets also contain
microcrystalline cellulose, povidone,
polysorbate
80,
crospovidone,
magnesium
stearate,
hypromellose,
macrogol
400,
citric
acid
monohydrate, and titanium dioxide.
Raloxifene Amneal PI v3.0 Page 2 of 18
PHARMACOLOGY
LONG-TERM POST-MENOPAUSAL HEALTH AND THE ROLE OF OESTROGEN
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.
Managing post-menopausal changes that are associated with decreased
oestrogen is a challeng