REDDYMAX PLUS D-CAL alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tablet and calcium 500 mg tablet composit

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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

REDDYMAX
PLUS
D-
CAL 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
Reddymax
Plus
D-Cal
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
Reddymax
Plus
D-Cal
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
REDDYMAX
PLUS
D-CAL IS USED FOR
Reddymax
Plus
D-Cal
is
a
combination medicine consisting of 4
once weekly tablets of Alendronate
Plus
D3
-
DRLA
70
mg/
140
µg
(5600
IU)
together
with
24
or
48
tablets of ReddyCal.
Reddymax Plus D-Cal 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 a slightly faster rate than
it can be replaced. In women, after
menopause, hormonal chang

Summary of Product characteristics

Product Information
REDDYMAX PLUS D-CAL
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.
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.
ReddyMax Plus D-Cal 1 of 24
Product Information
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.
ReddyMax Plus D-Cal is a composite pack containing Alendronate Plus D3
- DRLA 70 mg/140 µg
(Alendronic acid (as alendronate sodium) and colecalciferol [vitamin
D3]) in addition to ReddyCal tablets
(calcium carbonate).
Each tablet of Alendronate Plus D3 - DRLA 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 vitamin D. The tablets also contain the f