FONAT alendronic acid 70mg 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)

Available from:

Alphapharm Pty Ltd

INN (International Name):

alendronate sodium

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: povidone; croscarmellose sodium; lactose monohydrate; magnesium stearate; microcrystalline cellulose

Administration route:

Oral

Units in package:

4 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Fonat is indicated for the treatment of: Osteoporosis, including glucocorticoid-induced osteoporosis. Fonat is indicated for the prevention of Glucocorticoid-induced osteoporosis in those patients on long term corticosteroid therapy (see Clinical Trials, Glucorticoid-Induced Osteoporosis). Prior to treatment, osteoporosis must be confirmed by: - the finding of low bone mass of at least 2 standard deviations below the mean for young adults (gender specific), or by: - the presence of osteoporotic fracture.

Product summary:

Visual Identification: white normal bi-convex tablet 9.5mm in diameter, embossed "AD70" on one side and "G" on the reverse.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2008-10-15

Patient Information leaflet

FONAT
_contains the active ingredient alendronic acid_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fonat.
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 benefits and
risks. Your doctor has weighed the
risks of you taking Fonat against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT FONAT IS USED FOR
Fonat is used to treat osteoporosis.
This condition is caused by changes
in the way bone is normally
maintained.
_HOW DOES FONAT WORK?_
Fonat belongs to a group of non-
hormonal medicines called
bisphosphonates.
Fonat works by slowing down the
process of old bone being removed,
which allows the bone-forming cells
time to rebuild normal bone. Fonat
not only helps prevent the loss of
bone but actually helps to rebuild
bone and makes bone less likely to
fracture. Thus, Fonat prevents or
reverses the progression of
osteoporosis.
Fonat starts working on the bone
cells immediately, but measurable
effects on bone mass may not be seen
for several months or more.
_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. 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
fa

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
FONAT
_(ALENDRONATE SODIUM) TABLET_
_ _
1
NAME OF THE MEDICINE
Alendronate sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bisphosphonates are synthetic analogs of pyrophosphate that bind to
the hydroxyapatite found in bone. Fonat
contains alendronate sodium which is a bisphosphonate that acts as a
potent, specific inhibitor of osteoclast-
mediated bone resorption.
Each tablet contains 91.37 mg of alendronate sodium as the active
ingredient. This is the molar equivalent to
70 mg of alendronic acid.
Excipients with known effect: contains sugars (as lactose)
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Fonat 70 mg white normal concave tablets are embossed "AD70" on one
side and "G" on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fonat is indicated for the treatment of:
Osteoporosis*, including glucocorticoid-induced osteoporosis
Fonat is indicated for the prevention of:
Glucocorticoid-induced osteoporosis in those patients on long term
corticosteroid therapy (Section 5.1
PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS - Glucocorticoid –
Induced
Osteoporosis)
*Prior to treatment, osteoporosis must be confirmed by:
the finding of low bone mass of at least 2 standard deviations below
the mean for young adults (gender
specific), or by
the presence of osteoporotic fracture.
4.2
DOSE AND METHOD OF ADMINISTRATION
Alendronate 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).
Fonat should only be taken upon rising for the day. To facilitate
delivery to the stomach and thus reduce the
potential for oesophageal irritation, alendronate should only be
swallowed upon arising for the day with a full
glass of water and patients should not lie down for at least 30
minutes