Risedronate Sanofi-Aventis Combi D
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
30-04-2024
Summary of Product characteristics
(SPC)
30-04-2024
Active ingredient:
Risedronate sodium; Calcium carbonate; Colecalciferol; cholecalciferol
Available from:
Sanofi-Aventis Australia Pty Ltd
Class:
Medicine Registered
Patient Information leaflet
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Risedronate sanofi-aventis
Combi D
_RISEDRONATE SODIUM, CALCIUM CARBONATE, CHOLECALCIFEROL (VITAMIN
D3) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Risedronate sanofi-
aventis 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 sanofi-aventis
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
SANOFI-AVENTIS COMBI D
IS USED FOR
Risedronate sanofi-aventis Combi D is
used to treat bone disease. Risedronate
sanofi-aventis Combi D works directly
on your bones to make them stronger
and therefore less likely to break or
fracture.
Risedronate sanofi-aventis Combi D is
a combination medicine consisting of
risedronate sodium, calcium carbonate
and cholecalciferol (Vitamin D3).
Each week of therapy includes:
One Risedronate sanofi-aventis 35mg
Once-a-Week tablet (the small light-
orange tablet) and 6 sachets containing
calcium carbonate 2500mg and
cholecalciferol 22mcg (Vitamin D3
880 IU).
The active ingredient in Risedronate
sanofi-aventis 35mg tablets is called
risedronate sodium and belongs to a
group of medicines called
bisphosphonates.
Risedronate sanofi-aventis 35mg
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 you
Read the complete document
Summary of Product characteristics
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PRODUCT INFORMATION
RISEDRONATE SANOFI-AVENTIS
®
, RISEDRONATE SANOFI-AVENTIS COMBI &
RISEDRONATE SANOFI-AVENTIS COMBI D
NAME OF THE MEDICINE
NON-PROPRIETARY NAME
Risedronate
Each Risedronate sanofi-aventis tablet contains the equivalent of
5, 30, 35 or 75, or 150 mg of
risedronate sodium. 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
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
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: 305.10
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
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 insoluble
in water, with a relative molecular
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weight of 100.1.
Cholecalciferol is a secosterol that is a natural precursor
of the calcium-regulating hormone
calcitriol (1,25-dihydroxy
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