Risedronate Sanofi EC Combi
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
15-05-2024
Summary of Product characteristics
(SPC)
15-05-2024
Active ingredient:
Risedronate sodium; Calcium carbonate; Colecalciferol; cholecalciferol
Available from:
Sanofi-Aventis Australia Pty Ltd
Class:
Medicine Registered
Patient Information leaflet
risedronate-Sanofi-ec-combi-cmiv2
1
RISEDRONATE SANOFI 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 Sanofi
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
Sanofi 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
SANOFI EC COMBI IS
USED FOR
Risedronate Sanofi EC Combi is
used to treat bone disease and
belongs to a group of medicines
called bisphosphonates.
Risedronate Sanofi EC Combi works
directly on your bones to make them
stronger and therefore less likely to
break or fracture.
Risedronate Sanofi EC Combi is a
combination medicine consisting of 7
tablets for each week of therapy.
Each week of therapy includes:
One Risedronate Sanofi EC 35mg
Once-a-Week enteric-coated tablet
(the small yellow tablet) and 6
Calcium Carbonate 1250mg tablets
(the blue tablets).
Risedronate Sanofi 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 replace it. If you lo
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Summary of Product characteristics
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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
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