APO-Alendronate Plus D3 70 mg/70 ug alendronic acid (as sodium) 70 mg and colecalciferol 70 microgram tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alendronate sodium,colecalciferol

Available from:

Apotex Pty Ltd

INN (International Name):

alendronate sodium,colecalciferol

Authorization status:

Registered

Patient Information leaflet

APO-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
This leaflet answers some common
questions about this medicine. It 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 this medicine
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 THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Alendronate Plus D3 tablets. It
contains the active ingredient
alendronate sodium and
colecalciferol (vitamin D3).
The alendronate in this medicine
belongs to a group of non-hormonal
medicines called bisphosphonates.
It is used to:
•
treat osteoporosis
•
provide additional vitamin D
Osteoporosis is a disease which
causes bones to become more porous,
gradually making them weaker, more
brittle and likely to break.
Osteoporosis is caused by changes in
the way bone is normally maintained.
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. 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.
Early on, osteoporosis usually has no
symptoms. However, if left untreated
it can result in broken bones, also
called fractures. Although fractures
usually cause pain, fractures of the
bones of the

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- ALENDRONATE PLUS D3 (ALENDRONATE SODIUM
AND COLECALCIFEROL (VITAMIN D
3
)) TABLETS
1
NAME OF THE MEDICINE
Alendronic acid (as alendronate sodium) and colecalciferol (vitamin
D3)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
EXCIPIENTS WITH KNOWN EFFECT
Mannitol
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
70 MG/70 ΜG TABLETS:
White to off-white biconvex, oval shaped tablet. Engraved “APO” on
one side, “A-D28” on the
other side.
70 MG/140 ΜG TABLETS:
White to off-white, rectangular, biconvex tablet. Engraved “APO”
on one side, “ALE-D56” on
the other side.
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alendronate Plus D3 (70 mg/70 µg &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 deviations below
the gender specific
mean for young adults; or
•
by the presence of osteoporotic fracture.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- ALENDRONATE PLUS D3 tablets are intended for oral administration.
DOSAGE
Alendronate Plus D3 (70 mg/70 µg or 70 mg/140 µg) must be taken at
least 30 minutes before
the first food, beverage or medication of the day, with plain water
only. Other beverages
(including mineral water), food and some medications, are likely to
reduce the absorption of
alendronate (see section 4.5 INTERACTIONS WITH OTHER MEDICINES AND
OTHER FORMS OF
INTERACTIONS).
Alendronate Plus D3 (70 mg/70 µg or 70 mg/140 µg) should only be
taken upon arising for the
day. To faci