ALENDROBELL 10mg alendronic acid 10mg (as sodium alendronate anhydrous) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alendronate sodium, Quantity: 10.884 mg (Equivalent: alendronic acid, Qty 10 mg)

Available from:

Generic Health Pty Ltd

INN (International Name):

alendronate sodium

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: mannitol; croscarmellose sodium; purified talc; colloidal anhydrous silica; magnesium stearate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

*For the treatment of Osteoporosis. 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. * Treatment and prevention of glucocorticoid-induced osteoporosis in post menopausal women not receiving oestrogen and who are on long term corticosteroid therapy.

Product summary:

Visual Identification: White to off-white circular tablets, debossed with "A3" on one side and deep breakline on other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-07-25

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
ALENDROBELL
(ALENDRONATE SODIUM) UNCOATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Alendrobell (alendronate).
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
Alendrobell against the benefits
they expect it will have for you.
If you have any concerns about
using/taking this medicine, ask
your doctor or pharmacist.
Keep this leaflet with this
medicine.
You may need to read it again.
WHAT ALENDROBELL IS USED
FOR
Alendrobell is used to treat
osteoporosis.
This condition is caused by
changes in the way bone is
normally maintained.
_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 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.
_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.
Menopause occurs when the
ovaries virtually stop producing
the female hormone, oestrogen,
or are removed (which may
occur, for example, at the time
of a hysterectomy). At this time,
bone is removed faster than it is
formed, so bone loss occurs and
bones become weaker. The
earlier

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – ALENDROBELL
(ALENDRONATE SODIUM) UNCOATED TABLET
1
NAME OF THE MEDICINE
Alendronate sodium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Alendrobell 10 mg tablet contains alendronate sodium equivalent
to 10 mg alendronic acid.
Each Alendrobell 70 mg tablet contains alendronate sodium equivalent
to 70 mg alendronic acid.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Alendrobell 10 mg tablets are white to off-white tablets, debossed
with “A3” on one side and with a
deep breakline on other side.
Alendrobell 70 mg tablets are white to off-white circular tablets,
debossed with “A” on one side and “4”
on other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alendrobell
is
indicated
for
the
treatment
of
osteoporosis,
including
glucocorticoid-induced
osteoporosis (see SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION).
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.
Alendrobell is also indicated for the prevention of:
•
osteoporosis in postmenopausal women with low bone mass (at least 1
standard deviation below
the mean for young adults).
•
glucocorticoid-induced osteoporosis in those patients on long term
corticosteroid therapy (see
SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION for specific uses of
Alendrobell tablets)._ _
4.2 DOSE AND METHOD OF ADMINISTRATION
Alendrobell 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).
Alendrobell v4
Page 2 of 21
(alendronate sodium) uncoated tablet
Alendrobell should only be taken upon arising for the day. To
facilitate delivery to the stomach and