Risedronate Sanofi EC

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

Risedronate sodium; Calcium carbonate; Colecalciferol; cholecalciferol

Dostępny od:

Sanofi-Aventis Australia Pty Ltd

Klasa:

Medicine Registered

Ulotka dla pacjenta

Actonel-ec-cmiv2-oct11 
1 
RISEDRONATE SANOFI 
®

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 Risedronate Sanofi 
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 Risedronate 
Sanofi 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 RISEDRONATE 
SANOFI EC IS USED FOR 
Risedronate Sanofi EC is used to 
treat bone disease and belongs to a 
group of medicines called 
bisphosphonates. 
Risedronate Sanofi EC works 
directly on your bones to make them 
stronger and therefore less likely to 
break or fracture. 
Risedronate Sanofi 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

Charakterystyka produktu

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PRODUCT INFORMATION 
RISEDRONATE SANOFI EC, RISEDRONATE SANOFI EC COMBI
& RISEDRONATE 
SANOFI EC COMBI D 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Risedronate 
Each Risedronate Sanofi 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 
Risedronate Sanofi
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 
Risedronate Sanofi 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  
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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 ins