ALENDRONATE PLUS D3 and CALCIUM SANDOZ alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tablet and calcium 500
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
alendronate sodium,calcium carbonate,colecalciferol,microcrystalline cellulose
Available from:
Dr Reddys Laboratories Australia Pty Ltd
INN (International Name):
alendronate sodium,colecalciferol,Calcium carbonate,microcrystalline cellulose
Authorization status:
Registered
Patient Information leaflet
ALENDRONATE PLUS
D3 AND CALCIUM
SANDOZ 70 MG/ 140 ΜG
_Contains the active ingredient alendronate sodium/colecalciferol and
calcium carbonate _
CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
ALENDRONATE PLUS D3 AND
CALCIUM SANDOZ 70 mg/ 140
µg. It is particularly important that
you read the sections “When to take
it” and “How to take it” before you
take this medicine. This leaflet does
not contain all the available
information.
It does not take the place of talking to
your doctor and pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
ALENDRONATE PLUS D3 AND
CALCIUM SANDOZ against the
benefits they expect it will 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 ALENDRONATE
PLUS D3 AND
CALCIUM SANDOZ IS
USED FOR
ALENDRONATE PLUS D3 AND
CALCIUM SANDOZ is a
combination medicine consisting of
4 once weekly tablets of
ALENDRONATE PLUS D3
SANDOZ 70 mg/ 140 µg (5600 IU)
together with 24 or 48 tablets of
Calcium Sandoz.
ALENDRONATE PLUS D3 AND
CALCIUM SANDOZ is used to treat
osteoporosis and to provide
additional vitamin D and additional
calcium.
Osteoporosis is caused by changes in
the way bone is normally maintained.
Vitamin D is an essential nutrient
required for calcium absorption and
healthy bones. Calcium is an
essential mineral, necessary to
maintain the bone structure in the
body.
_UNDERSTANDING BONE _
Bone is a living, growing tissue.
Throughout life, our bodies are
breaking down old bone and
rebuilding new bone in a continuous
cycle. Until our late 20s, while bones
are still developing, we gain bone by
building more than we lose. From
then until about age 35 the process is
usually in balance, so that the amount
of bone lost is about equal to the
amount that is replaced. This
balanced process keeps your skeleton
healthy and strong. After about age
35 this balance is disturbe
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Summary of Product characteristics
Product Information Version-2.0 ALENDRONATE PLUS D3 AND CALCIUM SANDOZ
COMPOSITE PACK
NAME OF THE MEDICINE
Alendronic sodium and colecalciferol, and, calcium carbonate composite
pack.
ALENDRONATE SODIUM
Chemical Name:
(4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt
trihydrate.
Structural Formula:
CAS Number:
121268-17-5
Molecular Formula:
C
4
H
12
NNaO
7
P
2
•3H
2
O
Molecular Weight:
325.12
COLECALCIFEROL
Chemical Name:
colecalciferol(5_Z_,7_E_)-9,10-secocholesta-5,7,10(19)-trien-3β-ol.
colecalciferol
Structural Formula:
CAS Number:
67-97-0
Molecular Formula:
C
27
H
44
O
Molecular Weight:
384.6
CALCIUM CARBONATE
Calcium carbonate is described chemically as carbonic acid calcium
salt (1:1). The empirical formula of
calcium carbonate is CaCO
3
and its molecular weight is 100.09. The CAS Registry Number is
471-34-1.
Alendronate Plus D3 and Calcium Sandoz 1 of 24
Product Information Version-2.0
DESCRIPTION
Alendronate sodium is a bisphosphonate that acts as a potent, specific
inhibitor of osteoclast- mediated
bone
resorption.
Bisphosphonates
are
synthetic
analogs
of
pyrophosphate
that
bind
to
the
hydroxyapatite found in bone.
Alendronate sodium is a white or almost white, crystalline powder. It
is soluble in water, very slightly
soluble in methanol, practically insoluble in methylene chloride.
Colecalciferol (vitamin D
3
) is a secosterol that is the natural precursor of the
calcium-regulating hormone
calcitriol (1,25-dihydroxyvitamin D
3
).
Colecalciferol is a white to almost white crystalline powder.
Colecalciferol is practically insoluble in
water, free soluble in alcohol, soluble in fatty oils.
Alendronate Plus D3 and Calcium Sandoz is a composite pack containing
Alendronate plus D3 Sandoz
70 mg/140 µg (Alendronic acid (as alendronate sodium) and
colecalciferol [vitamin D3]) in addition to
Calcium Sandoz (calcium carbonate).
Each tablet of Alendronate plus D3 Sandoz 70 mg/140 µg contains 91.37
mg of alendronate sodium,
which is the molar equivalent to 70 mg of alendronic acid, and 140 µg
of
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