Actonel EC

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

Risedronate sodium; Calcium carbonate; Colecalciferol

Commercializzato da:

Sanofi-Aventis Australia Pty Ltd

Classe:

Medicine Registered

Foglio illustrativo

ACTONEL
®
 EC

_35MG ONCE-A-WEEK ENTERIC-COATED TABLETS_
_risedronate sodium_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Actonel EC (enteric-
coated tablets).
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 EC
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 EC IS
USED FOR
Actonel EC is used to treat bone
disease and belongs to a group of
medicines called bisphosphonates.
Actonel EC works directly on your
bones to make them stronger and
therefore less likely to break or
fracture.
Actonel EC 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.
_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 menopause (change of life)
and is also more likely to occur in
women who have reached the
menopause early. Osteoporosis can
a

Scheda tecnica

 
_Actonel EC, Actonel EC Combi, Actonel _
_EC Combi D PI  _
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PRODUCT INFORMATION 
ACTONEL EC, ACTONEL EC COMBI & ACTONEL EC COMBI D 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Risedronate 
Each Actonel EC enteric-coated tablet contains the equivalent of 35 mg of anhydrous risedronate 
sodium in the form of the hemi-pentahydrate with small amounts of monohydrate.  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 
Actonel EC Combi 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 
Actonel  EC  Combi  D  also  contains  calcium  carbonate/cholecalciferol  sachets.    Each  sachet 
contains  2500  mg  calcium  carbonate  and  22  g  (880  IU)  cholecalciferol,  which  is  equivalent  to 
1000 mg elemental calcium and 22  g (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 
Anhydrous: 305.10 
Hemi-pentahydrate: 350.13 
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  

_Actonel EC, Actonel EC Combi, Actonel _
_EC Combi D PI  _
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DESCRIPTION 
Risedronate sodium is a fine, white
to off-white, odourless, crystalline powder.  It is solu