RISEDRONATE AN risedronate sodium 35mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
risedronate sodium hemipentahydrate
Available from:
Amneal Pharma Australia Pty Ltd
INN (International Name):
Risedronate sodium hemipentahydrate
Authorization status:
Registered
Patient Information leaflet
Risedronate AN CMI v 2.0
Page 1 of 4
RISEDRONATE AN
Risedronate Sodium (as hemipentahydrate)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
RISEDRONATE AN.
It does not contain all 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
RISEDRONATE
AN
against
the
benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT RISEDRONATE AN
IS USED FOR
RISEDRONATE
AN
is
used
to
treat bone disease and belongs to
a
group
of
medicines
called
bisphosphonates.
RISEDRONATE AN works directly
on
your
bones
to
make
them
stronger and therefore less likely
to break or fracture.
RISEDRONATE AN 5mg daily &
35mg Once-a- Week tablets are
used to treat:
osteoporosis (brittle or fragile
bones that may fracture easily)
osteoporosis caused by taking
steroids
RISEDRONATE AN 30mg tablets
are used to treat:
Paget's disease of the bone.
These conditions are caused by
changes
in
the
way
bone
is
normally maintained.
_ _
_UNDERSTANDING BONE_
Bone is a living tissue consisting
of
calcium
and
other
minerals.
Throughout
life,
old
bone
is
constantly
broken
down
and
replaced with new bone. After the
age of 35, bone loss may occur
faster than your body can replace
it. If you lose too much bone then
they
become
weaker
and
are
more likely to break.
_OSTEOPOROSIS _
Osteoporosis
(brittle
bone
disease) is a disease that causes
bones to become weaker. Weak
bones break (fracture) easily.
Many
patients
with
osteoporosis
have no symptoms and may not
even
know
that
they
have
osteoporosis.
However
osteoporosis
makes
you
more
likely to break bones when
you
have a fall or bump. The spine, hip
and wrist are the most likely bones
to break, although this can happen
to
any
bone
in
your
body.
Osteoporosis can also cause back
pain,
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Summary of Product characteristics
_Risedronate AN tablets Product Information _
_ _
_ _
_ Amneal Pharma Australia Pty Ltd _
Risedronate AN PI v 2.0
Page 1
RISEDRONATE AN
_ _
_(RISEDRONATE SODIUM TABLETS) _
_ _
PRODUCT INFORMATION
_ _
NAME OF THE MEDICINE
Risedronate Sodium Hemipentahydrate
CHEMICAL NAME: [1-hydroxy-2-(3-pyridinyl)-ethylidene]Bisphosphonic
acid monosodium salt,
hemipentahydrate
MOLECULAR FORMULA: C
7
H
10
NO
7
P
2
Na.2.5 H
2
O
MOLECULAR WEIGHT: 350.13
CAS REGISTRY NUMBER: _[329003-65-8]_
DESCRIPTION
Risedronate sodium hemipentahydrate is a white to off-white powder. It
is soluble in water and
insoluble in common organic solvents.
RISEDRONATE AN is available as tablets containing 5 mg, 30 mg & 35 mg
risedronate sodium
as
hemipentahydrate.
RISEDRONATE
AN
tablets
contain
following
inactive
ingredients:
Lactose,
microcrystalline
cellulose (PH
101 & PH 102), hydroxypropylcellulose, crospovidone, magnesium
stearate.
Each RISEDRONATE AN 5 tablet also contains Opadry Yellow 20C82695 (PI
ARTG-106484). Each
RISEDRONATE AN 30 tablet also contains hypromellose, macrogol 400 &
titanium dioxide. Each
RISEDRONATE AN 35 tablet also contains Opadry Brown 20C86893 (PI
ARTG-106485).
PHARMACOLOGY
Risedronate is a potent pyridinyl bisphosphonate that binds to bone
hydroxyapatite and inhibits
osteoclast-mediated
bone
resorption.
Risedronate
is
a
third
generation
bisphosphonate.
In
preclinical
studies
risedronate
demonstrated
potent
anti-osteoclast
and
anti-resorptive
activity,
increasing bone mass and biomechanical strength dose-dependently. The
activity of risedronate was
confirmed by bone marker measurements during pharmacodynamic and
clinical studies. With
risedronate 5 mg daily, decreases in biochemical markers of bone
turnover were observed within 1
month of treatment and reached a maximum decrease in 3-6 months,
remaining stable during the
_Risedronate AN tablets Product Information _
_ _
_ _
_ Amneal Pharma Australia Pty Ltd _
Risedronate AN PI v 2.0
Page 2
course of therapy. This data demonstrates that risedronate causes a
moderate reduction in
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