Fonat

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Alendronate sodium

Available from:

Alphapharm Pty Ltd

Class:

Medicine Registered

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.
It is also used to treat or prevent
osteoporosis in people who are
receiving corticosteroid medicines,
such as prednisone and
dexamethasone.
_HOW DOES FONAT WORK?_
Fonat belongs to a group of non-
hormonal medicines called
bisphosphonates.
In osteoporosis, 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.
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 c

Summary of Product characteristics

FONAT

_Alendronic acid _
PRODUCT INFORMATION 
NAME OF THE MEDICINE

Active ingredient: 
Alendronate sodium 
Chemical name:  
(4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate 
Structural formula: 

Empirical formula: 
C
4
H
12
NNaO
7
P
2
•3H
2
O 

Molecular weight: 
325.13 

CAS Registry no: 
121268-17-5

DESCRIPTION 
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.  
Alendronate  is  a  white,  crystalline,  non-hygroscopic  powder.  It  is  soluble  in  water,  very  slightly  soluble  in 
alcohol, and practically insoluble in chloroform. 
Each  tablet  of  Fonat  contains  91.37  mg  of  alendronate  sodium,  which  is  the  molar  equivalent  to  70  mg  of 
alendronic acid.  
In  addition  to  the  active  ingredient  alendronate  sodium,  each  Fonat  tablet  contains  the  following  inactive 
ingredients:  lactose  monohydrate,  microcrystalline  cellulose,  povidone  (K29-32),  croscarmellose  sodium  and 
magnesium stearate. 
PHARMACOLOGY 
PHARMACODYNAMIC  
Alendronate  is  a  bisphosphonate  that,  in  animal  studies,  localises  preferentially  to  sites  of  bone  resorption, 
specifically under osteoclasts, and inhibits osteoclastic bone resorption with no direct effect on bone formation. 
Since  bone  formation  and  bone  resorption  are  coupled,  bone  formation  is  also  reduced,  but  less  so  than 
resorption, leading to progressive gains in bone mass (see CLINICAL TRIALS). Following exposure to alendro