Acris

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

Risedronate sodium; Risedronate sodium hemipentahydrate

Disponible depuis:

Alphapharm Pty Ltd

classe:

Medicine Registered

Notice patient

ACRIS
®
; ACRIS
®
 ONCE-
A-MONTH

_contains the active ingredient risedronate sodium_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ACRIS.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking ACRIS against
the benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ACRIS IS USED
FOR
ACRIS is used for bone disease and
belongs to a group of medicines
called bisphosphonates. It is used to
treat:
•
osteoporosis (brittle or fragile
bones that may fracture easily)
•
osteoporosis caused by taking
steroids.
_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.
ACRIS works by helping to:
•
slow down the process of
removing old bone. This allows
the bone-forming cells time to
rebuild normal bone.
•
maintaining and increasing bone
density by rebuilding bone mass.
•
reverse the progression of
osteoporosis.
_OSTEOPOROSIS_
Osteoporosis (brittle bone disease) is
a disease that causes bones to
become less dense, gradually making
them weaker, more brittle and
consequently, more likely to break.
Broken bones may result from injury
or falls. Breaks may occur in normal,
everyday activity, such as lifting, or
from minor injury that would not
usually fracture normal bone.
Fractures usually occur at the hip,
spine or wrist, although can occur in
any bone of the body.
Osteoporosis can also cause back
pain, height loss and a curvature of
the spine.
Many patients with osteoporosis ha

Résumé des caractéristiques du produit

ACRIS
®

ACRIS
®
 ONCE-A-MONTH 
_Risedronate sodium _
PRODUCT INFORMATION 
NAME OF THE MEDICINE 
Active ingredient: 
Risedronate sodium hemipentahydrate 
Chemical name: 
[1-hydroxy-2-(3- pyridinyl)ethylidene]bis(phosphonic acid) monosodium 
salt.hemipentahydrate 
Structural formula: 

Molecular formula: 
C
7
H
10
NO
7
P
2
Na.2.5H
2
O   

Molecular weight: 
350.13 

CAS Registry no.: 
329003-65-8 
DESCRIPTION

Risedronate  sodium  (as  hemipentahydrate)  is  a  fine,  white  to  off-white,  odourless,  crystalline  powder.    It  is 
soluble in water and essentially insoluble in common organic
solvents.  
ACRIS tablets contain 35 mg risedronate sodium (as hemipentahydrate) and the following inactive ingredients: 
Mannitol,  microcrystalline  cellulose,  crospovidone,  silicon  dioxide,  magnesium  stearate,  Opadry  II  complete 
film  coating  system  40L97490  beige  (ARTG  No.  107225)  and  Opadry  complete  film  coating  system  YS-1-
7006 clear (ARTG No. 12789). 
ACRIS  Once-a-Month  contains  150  mg  risedronate sodium  and  the  following  inactive  ingredients:  Mannitol, 
microcrystalline  cellulose,  crospovidone,  colloidal  anhydrous  silica,  magnesium  stearate,  Opadry  II  complete 
film coating system 40C10881 Blue (ARTG No. 108066).  
PHARMACOLOGY

ACRIS risedronate sodium tablets are currently available as a 35
mg or 150 mg tablet. 

ACRIS and ACRIS ONCE-A-MONTH 
– Product Information

2 

PHARMACODYNAMICS 
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  ant