Actonel

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

Risedronate sodium; Colecalciferol; Calcium carbonate

Commercializzato da:

Sanofi-Aventis Australia Pty Ltd

Classe:

Medicine Registered

Foglio illustrativo

ACTONEL
®

_risedronate sodium_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Actonel.
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 Actonel
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 ACTONEL IS USED
FOR
Actonel is used to treat bone disease
and belongs to a group of medicines
called bisphosphonates.
Actonel works directly on your bones
to make them stronger and therefore
less likely to break or fracture.
Actonel 5mg daily, 35mg Once-a-
Week and 150mg Once-a-Month
tablets are used to treat:
•
osteoporosis (brittle or fragile
bones that may fracture easily)
•
osteoporosis caused by taking
steroids
Actonel 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 curved back.
Osteoporosis is common in women
after the men

Scheda tecnica

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PRODUCT INFORMATION 
ACTONEL
®
, ACTONEL COMBI & ACTONEL COMBI D 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Risedronate 
Each Actonel tablet contains the equivalent of 5, 30, 35 or 150 mg
of risedronate sodium.  The 
empirical formula for risedronate sodium is C
7
H
10
NO
7
P
2
Na.  The chemical name of risedronate 
sodium is [1-hydroxy-2-(3- pyridinyl)ethylidene]bis(phosphonic acid)
monosodium salt.   
Calcium Carbonate Tablet 
Also contains 1250 mg calcium carbonate tablets.  Each calcium
tablet contains 1250 mg calcium 
carbonate, which is equivalent to 500 mg elemental calcium. 
Calcium Carbonate/Cholecalciferol Sachet 
Each sachet contains 2500 mg calcium carbonate and 22 
µg (880 IU) cholecalciferol, which is 
equivalent to 1000 mg elemental calcium and 22 
µg (880 IU) vitamin D3.  The terms cholecalciferol 
and vitamin D3 are equivalent.  The chemical name of
cholecalciferol is (5Z,7E)-9,10-
secocholesta-5,7,10(19)-trien-3β-ol. Molecular formula: C
27
H
44
O.  
CHEMICAL STRUCTURE 
The chemical structure of risedronate sodium is the following: 
Molecular Weight: 305.10 
The CAS registry number is 115436-72-1  
The chemical structure of cholecalciferol: 

Molecular Weight: 384.6 
The CAS registry number is 67-97-0  
DESCRIPTION 
Risedronate sodium is a fine, white to off-white, odourless,
crystalline powder.  It is soluble in water 
and in aqueous solutions and essentially insoluble in common organic
solvents.   
Calcium carbonate is a white powder, practically insoluble in water,
with a relative molecular 
weight of 100.1.   
Cholecalciferol is a secosterol that is a natural precursor of
the calcium-regulating hormone 
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calcitriol (1,25-dihydroxyvitamin). 
Risedronate 
Each Actonel tablet contains risedronate sodium (5, 30, 35 or 150
mg), lactose (5, 30 or 35 mg 
tablets only), crospovidone, magnesium stearate,
microcrystalline cellulose, hydro