DRONALEN PLUS 70 mg/140 microgram alendronic acid 70 mg (as alendronate sodium) and colecalciferol 140 micrograms tablet blister

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

alendronate sodium,colecalciferol

Доступно од:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (Међународно име):

alendronate sodium,colecalciferol

Статус ауторизације:

Registered

Информативни летак

DRONALEN PLUS
®
_Alendronate sodium/colecalciferol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DRONALEN PLUS.
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 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 IS USED FOR
DRONALEN PLUS is used to treat
osteoporosis and to provide
additional vitamin D.
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.
_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 thinner
and weaker, and therefore are more
likely to break.
_OSTEOPOROSIS_
"Osteo" means bone, and "porosis"
means something that has holes in it,
like a sponge. Therefore,
osteoporosis is a disease which
causes bones to become more porous,
gradually making them weaker, more
brittle and likely to break.
Osteoporosis is common in

Карактеристике производа

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