资料单张
ACTONEL
®
EC COMBI
_risedronate sodium (enteric-coated) and calcium carbonate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Actonel 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 Actonel 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 ACTONEL EC
COMBI IS USED FOR
Actonel EC Combi is used to treat
bone disease and belongs to a group
of medicines called bisphosphonates.
Actonel EC Combi works directly on
your bones to make them stronger
and therefore less likely to break or
fracture.
Actonel EC Combi is a combination
medicine consisting of 7 tablets for
each week of therapy. Each week of
therapy includes:
One Actonel EC 35mg Once-a-Week
enteric-coated tablet (the small
yellow tablet) and 6 Calcium
Carbonate 1250mg tablets (the blue
tablets).
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 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 lose too
much bone then they become weaker
and are more likely to break.
Osteoporosis (brittle bone disease) is
a disease that causes bones to
become weaker. Weak bones break
(fracture) easily.
Many patients with osteoporosis have
no symptoms and may not even
know that they have osteoporosis.
However osteoporosis makes you
more likely to break bones when you
hav
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产品特点
_Actonel EC, Actonel EC Combi, Actonel _
_EC Combi D PI _
_#113742 v1.0 _
_Page 1 _
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
_Actonel EC, Actonel EC Combi, Actonel _
_EC Combi D PI _
_#113742 v1.0 _
_Page 2 _
DESCRIPTION
Risedronate sodium is a fine, white
to off-white, odourless, crystalline powder. It is solu
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