PERODON 5 risedronate sodium 5mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

risedronate sodium hemipentahydrate

Available from:

Pharmacor Pty Ltd

INN (International Name):

Risedronate sodium hemipentahydrate

Authorization status:

Registered

Patient Information leaflet

PERODON
CONSUMER MEDICINE INFORMATION
Ver 1.1
Page 1 of 4
PERODON 5, 30 & 35
Risedronate Sodium (as hemipentahydrate)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers some
common
questions about PERODON.
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
PERODON
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
PERODON
IS
USED
FOR
PERODON
is
used
to
treat
bone
disease
and
belongs
to
a
group
of
medicines called bisphosphonates.
PERODON
works
directly
on
your
bones
to
make
them
stronger
and
therefore
less
likely
to
break
or
fracture.
PERODON 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
PERODON 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, height loss and a curve

Summary of Product characteristics

Product Information:
PERODON (Risedronate Sodium Tablets 5 mg, 30 mg & 35 mg)
Ver 1.1
Page 1 of 22
PRODUCT INFORMATION
PERODON 5 (5 MG RISEDRONATE SODIUM TABLETS)
PERODON 30 (30 MG RISEDRONATE SODIUM TABLETS)
PERODON 35 (35 MG RISEDRONATE SODIUM TABLETS)
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.
PERODON 5, 30 & 35 is available as tablets containing 5 mg, 30 mg & 35
mg risedronate sosium
as hemipentahydrate.
PERODON tablets contain following inactive ingredients:
Lactose, microcrystalline cellulose (PH
101 & PH 102), hydroxypropylcellulose, crospovidone, magnesium
stearate.
Each PERODON 5 tablet also contains Opadry Yellow 20C82695 (PI
ARTG-106484).
Each PERODON 30 tablet also contains hypromellose, macrogol 400 &
titanium dioxide.
Each PERODON 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
Product Information:
PERODON (Risedronate Sodium Tablets 5 mg, 30 mg & 35 mg)
Ver 1.1
Page 2 of 22
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
course of therapy. This data demonstrates that risedronate causes a
moderate red