FOSAMAX ONCE WEEKLY alendronic acid 70mg (as sodium) tablet blister pack (New dosage regimen 16/4/03)

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

alendronate sodium

Mevcut itibaren:

Merck Sharp & Dohme (Australia) Pty Ltd

Yetkilendirme durumu:

Registered

Bilgilendirme broşürü

FOSAMAX
® ONCE
WEEKLY
_Alendronate sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FOSAMAX Once
Weekly. 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 FOSAMAX
Once Weekly 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 FOSAMAX ONCE
WEEKLY IS USED FOR
FOSAMAX Once Weekly is used to
treat osteoporosis.
This condition is caused by changes
in the way bone is normally
maintained.
_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
postmenopausal women. The
menopause occurs when the ovaries
virtually stop producing the female
hormone,

Ürün özellikleri

1
FOSAMAX/FOSAMAX PLUS/FOSAMAX PLUS D-CAL PI
S-WPC-MK0217-MF-052015, S-WPC-MK0217A-T-052015
PRODUCT INFORMATION
FOSAMAX

(ALENDRONATE SODIUM)
TABLETS
FOSAMAX PLUS
TM
(ALENDRONATE SODIUM/COLECALCIFEROL)
FOSAMAX PLUS D-CAL ®
(ALENDRONATE SODIUM/COLECALCIFEROL/CALCIUM)
FOSAMAX tablets contain alendronate sodium.
FOSAMAX PLUS tablets contain alendronate sodium and colecalciferol
(vitamin D
3
).
FOSAMAX PLUS D-Cal is a combination pack containing FOSAMAX 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.
2
FOSAMAX/FOSAMAX PLUS/FOSAMAX PLUS D-CAL PI
S-WPC-MK0217-MF-052015, S-WPC-MK0217A-T-052015
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 pr