Actonel EC Combi D

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Risedronate sodium; Calcium carbonate; Colecalciferol

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

ACTONEL
®
 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 Actonel 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 Actonel 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 ACTONEL EC
COMBI D IS USED FOR
Actonel EC Combi D is used to treat
bone disease. Actonel EC Combi D
works directly on your bones to make
them stronger and therefore less
likely to break or fracture.
Actonel EC Combi D is a
combination medicine consisting of
risedronate sodium, calcium
carbonate and cholecalciferol
(Vitamin D3). Each week of therapy
includes:
One Actonel 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 Actonel EC
35mg Once-a-Week enteric-coated
tablets is called risedronate sodium
and belongs to a group of medicines
called bisphosphonates.
Actonel 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 needs to build
new bone.
The cholecalciferol (Vitamin D3)
contained in the sachet is an essential
nutrient required for calcium
absorption.
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
mu

Summary of Product characteristics

 
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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  

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DESCRIPTION 
Risedronate sodium is a fine, white
to off-white, odourless, crystalline powder.  It is solu