Terry White Chemists Alendronate Plus D3 70 mg/140 ug alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tablet
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
22-06-2016
Summary of Product characteristics
(SPC)
22-06-2016
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
alendronate sodium,colecalciferol
Available from:
Apotex Pty Ltd
INN (International Name):
alendronate sodium,colecalciferol
Patient Information leaflet
TERRY WHITE CHEMISTS
ALENDRONATE PLUS D3
TABLETS
_Contains the active ingredient alendronate acid (as alendronate
sodium) and colecalciferol (vitamin D3)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about Alendronate Plus
D3. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is Terry
White Chemists Alendronate Plus D3
tablets. It contains the active
ingredient alendronate sodium and
colecalciferol (vitamin D3).
It is used to:
•
treat osteoporosis
•
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 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 r
Read the complete document
Summary of Product characteristics
Product Information – Australia
Terry White Chemists Alendronate Plus D3 tablets
Page 1
TERRY WHITE CHEMISTS ALENDRONATE PLUS D3 TABLETS
NAME OF THE MEDICINE
Alendronate acid (as alendronate sodium) and colecalciferol (vitamin D
3
)
ALENDRONATE SODIUM
Chemical Name:
(4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt
trihydrate.
Structural Formula:
Molecular Formula:
C
4
H
12
NNaO
7
P
2
•3H
2
O
Molecular Weight:
325.12
CAS Registry Number:
121268-17-5
COLECALCIFEROL (VITAMIN D
3
)
Chemical Name:
(3β,5_Z_,7_E_)-9,10-secocholesta-5,7,10(19)-trien-3-ol
Structural Formula:
Molecular Formula:
C
27
H
44
O
Molecular Weight:
384.6
CAS Registry Number:
67-97-0.
DESCRIPTION
Alendronate sodium is a bisphosphonate that acts as a potent, specific
inhibitor of osteoclast-mediated
bone resorption. Bisphosphonates are synthetic analogues of
pyrophosphate that bind to the
hydroxyapatite found in bone.
Alendronate is a white, crystalline, non-hygroscopic powder. It is
soluble in water, very slightly soluble
in alcohol and practically insoluble in chloroform.
Product Information – Australia
Terry White Chemists Alendronate Plus D3 tablets
Page 2
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, crystalline, odourless powder.
Colecalciferol is practically insoluble in water,
freely soluble in usual organic solvents and slightly soluble in
vegetable oils.
Each 70 mg/70 μg tablet contains 91.37 mg alendronate sodium
(equivalent to 70 mg alendronic acid)
and 70 μg colecalciferol (2800 IU vitamin D
3
) as the active ingredients. Each 70 mg/140 μg tablet
contains 91.37 mg alendronate sodium (equivalent to 70 mg alendronic
acid) and 140 μg colecalciferol
(5600 IU vitamin D
3
) as the active ingredients. In addition, each tablet contains the
following inactive
ingredients:
microcrystalline
cellulose,
mannitol,
colloidal
anhydrous
silica,
magnesium
stearate,
hypromellose and butylated hydrox
Read the complete document
