DRONALEN PLUS D-CAL alendronic acid 70mg/colecalciferol 140 microgram tablet and 1250mg calcium carbonate tablet composite pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alendronate sodium,calcium carbonate,colecalciferol

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

alendronate sodium,colecalciferol,Calcium carbonate

Authorization status:

Registered

Patient Information leaflet

DRONALEN PLUS D-CAL®
_Alendronate sodium/colecalciferol and calcium carbonate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DRONALEN PLUS
D-Cal. 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 or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking DRONALEN
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 DRONALEN
PLUS D-CAL IS USED
FOR
DRONALEN PLUS D-Cal is a
combination medicine consisting of 4
once weekly tablets of DRONALEN
PLUS 70mg/140 micrograms (5600
IU) together with 48 tablets of
BoneCal
®
.
DRONALEN 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
changes cause bone loss at an even
faster rate. When bone loss is
excessive, bones can become

Summary of Product characteristics

DRONALEN/DRONALEN PLUS/DRONALEN PLUS D-CAL PI
S-WPC-MK0217A-T-052015
1
PRODUCT INFORMATION
DRONALEN PLUS
®
(ALENDRONATE SODIUM/COLECALCIFEROL)
TABLETS
DRONALEN PLUS D-CAL
®
(ALENDRONATE SODIUM/COLECALCIFEROL/CALCIUM)
TABLETS
DRONALEN PLUS tablets contain alendronate sodium and colecalciferol
(vitamin D
3
).
DRONALEN PLUS D-Cal is a combination pack containing DRONALEN PLUS
(alendronate sodium and
colecalciferol [vitamin D3]) in addition to BoneCal® tablets (calcium
carbonate).
Alendronate
sodium
is
described
chemically
as:
(4-amino-1-hydroxybutylidene)
bisphosphonic
acid
monosodium salt trihydrate.
The empirical formula is C
4
H
12
NNaO
7
P
2
•3H
2
O. The formula weight is 325.12. The CAS Registry
Number is 121268-17-5. The structural formula is:
Colecalciferol
The chemical name of colecalciferol is
(3β,5_Z_,7_E_)-9,10-secocholesta-5,7,10(19)-trien-3-ol. The empirical
formula of colecalciferol is C
27
H
44
O and its molecular weight is 384.6. The CAS Registry Number is 67-
97-0. The structural formula is:
CH
2
H
HO
CH
3
H
H
CH
3
H
CH
3
H
3
C
® Registered Trademark of Merck Sharp & Dohme Corp., a subsidiary of
Merck & Co., Inc., Whitehouse Station, NJ, USA
TM Trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck &
Co., Inc., Whitehouse Station, NJ, USA
DRONALEN/DRONALEN PLUS/DRONALEN PLUS D-CAL PI
S-WPC-MK0217A-T-052015
2
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.
Alendronate is a white, crystalline, nonhygroscopic powder. It is
soluble in water, very slightly soluble in
alcohol, and practically insoluble in chloroform.
Colecalciferol (vitamin D
3
) is a secosterol that is the natural precurs