Risedronate Winthrop EC Combi

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

Calcium carbonate; Risedronate sodium; Colecalciferol; cholecalciferol

Disponible depuis:

Sanofi-Aventis Australia Pty Ltd

classe:

Medicine Registered

Notice patient

risedronate-winthrop-ec-combi-cmiv2 
1 
RISEDRONATE WINTHROP 
EC COMBI 
_risedronate sodium (enteric-coated) and calcium carbonate _
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Risedronate 
Winthrop EC Combi. 
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 
Winthrop EC Combi 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 
WINTHROP EC COMBI IS 
USED FOR 
Risedronate Winthrop EC Combi is 
used to treat bone disease and 
belongs to a group of medicines 
called bisphosphonates. 
Risedronate Winthrop EC Combi 
works directly on your bones to make 
them stronger and therefore less 
likely to break or fracture. 
Risedronate Winthrop EC Combi is a 
combination medicine consisting of 7 
tablets for each week of therapy.  
Each week of therapy includes: 
One Risedronate Winthrop EC 35mg 
Once-a-Week enteric-coated tablet 
(the small yellow tablet) and 6 
Calcium Carbonate 1250mg tablets 
(the blue tablets). 
Risedronate Winthrop EC 35mg 
Once-a-Week enteric-coated tablets 
are used to treat: 
  osteoporosis (brittle or fragile 
bones that may fracture easily) 
  osteoporosis caused by taking 
steroids 
The Calcium Carbonate tablets help 
to supply the calcium your body 
needs to build new 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 rep

Résumé des caractéristiques du produit

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PRODUCT INFORMATION 
RISEDRONATE WINTHROP EC, RISEDRONATE WINTHROP EC COMBI & 
RISEDRONATE WINTHROP EC COMBI D 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Risedronate 
Each Risedronate Winthrop 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 Winthrop 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 Winthrop 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, prac