ALENDRONATE PLUS D3 CALCIUM ACTAVIS alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tablet and calcium 500 mg

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alendronate sodium,colecalciferol,Calcium carbonate,microcrystalline cellulose

Available from:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

alendronate sodium,colecalciferol,Calcium carbonate,microcrystalline cellulose

Patient Information leaflet

ALENDRONATE
PLUS
D3 CALCIUM ACTAVIS 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
Calcium
Actavis
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 Calcium Actavis 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
CALCIUM
ACTAVIS IS USED FOR
Alendronate
Plus
D3
Calcium
Actavis is a combination medicine
consisting of 4 once weekly tablets
of Alendronate D3 70 mg/ 140 µg
(5600 IU) together with 24 or 48
tablets of Calcium Actavis.
Alendronate
Plus
D3
Calcium
Actavis 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
disturbed,
with
bone
loss
occurring
at

Summary of Product characteristics

Product Information ALENDRONATE PLUS D3 CALCIUM ACTAVIS
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 Actavis 1 of 24
Product Information
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 Calcium Actavis is a composite pack containing
Alendronate D3 70 mg/140 µg
(Alendronic acid (as alendronate sodium) and colecalciferol [vitamin
D3]) in addition to Calcium Actavis
tablets (calcium carbonate).
Each tablet of Alendronate D3 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
colecalciferol equivalent to 5600 IU vitami