Fosamax Plus 70 mg/140 ug alendronic acid 70 mg (as alendronate sodium) and colecalciferol 140 micrograms tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alendronate sodium, Quantity: 91.37 mg (Equivalent: alendronic acid, Qty 70 mg); colecalciferol, Quantity: 0.1387 mg

Available from:

ORGANON PHARMA PTY LTD

INN (International Name):

alendronate sodium

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; lactose; croscarmellose sodium; purified water; Gelatin; aluminium starch octenylsuccinate; aluminium sodium silicate; sucrose; medium chain triglycerides

Administration route:

Oral

Units in package:

4 Tablets, 1 Tablet

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The treatment of osteoporosis in select patients where vitamin D supplementation is recommended.

Product summary:

Visual Identification: White to off-white, modified rectangular shaped tablet with code "270" on one side and a bone shape on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-05-14

Patient Information leaflet

FOSAMAX PLUS™
ONCE WEEKLY
_Alendronate sodium/colecalciferol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FOSAMAX 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 FOSAMAX
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 FOSAMAX PLUS
IS USED FOR
FOSAMAX 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 co

Summary of Product characteristics

FOSAMAX PLUS PI
Page 1 of 27
S-WPC-MK0217-MF-052015, S-WPC-MK0217A-T-052015
[Organon] Proprietary
AUSTRALIAN PRODUCT INFORMATION-
FOSAMAX PLUS
™ (ALENDRONATE SODIUM/COLECALCIFEROL)
1
NAME OF THE MEDICINE
FOSAMAX PLUS tablets contain alendronate sodium and colecalciferol
(vitamin D
3
).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alendronate is a white, crystalline, nonhygroscopic powder. It is
soluble in water, very slightly
soluble in alcohol, and practically insoluble in chloroform.
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 tablet of FOSAMAX PLUS 70 mg/70 μg contains 91.4 mg of
alendronate sodium, which
is the molar equivalent to 70 mg of alendronic acid, and 70 μg of
colecalciferol equivalent to
2800 IU vitamin D.
Each tablet of FOSAMAX PLUS 70 mg/140 μg contains 91.4 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.
List of excipients with known effect: lactose, sucrose
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
FOSAMAX PLUS (alendronate sodium/colecalciferol) 70 mg/ 70 µg Once
Weekly Tablet,
providing 2800 IU vitamin D
3
. White to off-white, modified capsule-shaped tablet with the
outline of a bone image on one side and 710 on the other._ _
FOSAMAX PLUS (alendronate sodium/colecalciferol) 70 mg/ 140 µg, once
weekly tablet,
providing 5600 IU vitamin D
3
. White to off-white, modified rectangle-shaped tablet with "270"
on one side and a bone image on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FOSAMAX PLUS Once Weekly tablet and FOSAMAX PLUS 70 mg/140_ _µg are
indicated for
the treatment of:
•
Osteoporosis* in select patients where vitamin D supplementation is
recommended
* Prior to treatment, osteoporosis must be confirmed by:
•
the finding of low bone mass of at least 2 standard deviat