Risedronate Winthrop EC Combi D

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

Calcium carbonate; Risedronate sodium; Colecalciferol; cholecalciferol

Dostupné s:

Sanofi-Aventis Australia Pty Ltd

Třída:

Medicine Registered

Informace pro uživatele

risedronate-winthrop-ec-combi-d-cmiv2 
1 
RISEDRONATE WINTHROP 
EC COMBI D 
_risedronate sodium (enteric-coated), calcium carbonate,
cholecalciferol (Vitamin D3) _
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Risedronate 
Winthrop EC Combi D. 
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 D 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 D 
IS USED FOR 
Risedronate Winthrop EC Combi D 
is used to treat bone disease. 
Risedronate Winthrop EC Combi D 
works directly on your bones to make 
them stronger and therefore less 
likely to break or fracture. 
Risedronate Winthrop EC Combi D 
is a combination medicine consisting 
of risedronate sodium, calcium 
carbonate and cholecalciferol 
(Vitamin D3). Each week of therapy 
includes: 
One Risedronate Winthrop EC 35mg 
Once-a-Week enteric-coated tablet 
(the small yellow tablet) and 6 
sachets containing calcium carbonate 
2500mg and cholecalciferol 22mcg 
(Vitamin D3 880 IU). 
The active ingredient in Risedronate 
Winthrop EC 35mg Once-a-Week 
enteric-coated tablets is called 
risedronate sodium and belongs to a 
group of medicines called 
bisphosphonates. 
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 contained in 
the sachet helps to supply the 
calcium your body need

Charakteristika produktu

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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