AURO-RALOXIFENE 60 raloxifene hydrochloride 60 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

raloxifene hydrochloride, Quantity: 60 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Raloxifene hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: povidone; magnesium stearate; citric acid monohydrate; macrogol 400; polysorbate 80; titanium dioxide; hypromellose; microcrystalline cellulose; crospovidone

Administration route:

Oral

Units in package:

30, 100 (hospital pack)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Raloxifene is indicated for the prevention and treatment of osteoporosis in post-menopausal women.

Product summary:

Visual Identification: White to off-white, elliptical, film-coated tablets debossed with 'X' on one side and '57' on other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-09-26

Patient Information leaflet

AURO-RALOXIFENE
CONSUMER MEDICINE INFORMATION
Ver 1.1
Page 1 of 3
AURO-RALOXIFENE 60
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 AURO-RALOXIFENE
IS USED FOR
AURO-RALOXIFENE 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.
AURO-
RALOXIFENE mimics some of the
beneficial
effects of
oestrogen after
menopause.
AURO-RALOXIFENE 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
AURO-RALOXIFENE for
another
reason.
ASK YOUR DOCTOR IF
YOU HAVE ANY
QUESTIONS
ABOUT
WHY
AURO-
RALOXIFENE
HAS
BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
AURO-RALOXIFENE
TELL YOUR DOCTOR IF YOU HAVE ANY OF
THE FOLLOWING CONDITIONS OR IF
YOU
HAVE EVER EXPERIENCED AN

Summary of Product characteristics

Product Information:
AURO-RALOXIFENE (Raloxifene Hydrochloride Tablets 60 mg)
Ver 1.1
Page 1 of 17
PRODUCT INFORMATION
AURO-RALOXIFENE 60 (60 MG RALOXIFENE HYDROCHLORIDE TABLETS)
NAME OF THE MEDICINE
The active ingredient in AURO-RALOXIFENE tablets is raloxifene
hydrochloride.
CHEMICAL NAME: methanone,
[6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-
piperidinyl)ethoxy]phenyl], hydrochloride
MOLECULAR FORMULA: C
28
H
27
NO
4
S•HCl
MOLECULAR WEIGHT: 510.05
The CAS number for raloxifene hydrochloride 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 AURO-RALOXIFENE film coated tablet contains 60 mg raloxifene
hydrochloride, which is
equivalent to 56 mg raloxifene free base.
AURO-RALOXIFENE tablets contain following inactive ingredients:
microcrystalline cellulose,
povidone,
polysorbate 80,
crospovidone,
magnesium stearate,
hypromellose,
macrogol
400
,
citric
acid monohydrate & titanium dioxide.
PHARMACOLOGY
LONGTERM 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
Product Information:
AURO-RALOXIFENE (Raloxifene Hydrochloride Tablets 60 mg)
Ver 1.1
Page 2 of 17
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-me