BONEFOS sodium clodronate 800mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium clodronate tetrahydrate

Available from:

Bayer Australia Ltd

INN (International Name):

sodium clodronate tetrahydrate

Authorization status:

Registered

Patient Information leaflet

1308 BONEFOS
®
Tablets and Capsules
1
BONEFOS

(BON·E·FOS)
_ _
_sodium clodronate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Bonefos.
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 Bonefos
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 BONEFOS IS
USED FOR
Certain cancers increase bone
breakdown and lead to an increased
amount of calcium circulating in
the bloodstream. This can result in
high calcium levels in the blood
(hypercalcaemia) or bone
destruction (osteolysis) which
increases your risk of bone
fractures and bone pain.
Bonefos works by stopping calcium
from coming out of your bones and
keeps your blood calcium at normal
levels (normocalcaemia). Bonefos
can be used to either bring your
blood calcium levels down to a
normal level (acute treatment) or to
keep it down at a normal level
(maintenance treatment).
Bonefos can also be used to treat
bone destruction due to breast
cancer and bone marrow cancer.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only
with a doctor’s prescription.
There is not enough information to
recommend the use of this
medicine for children.
BEFORE YOU TAKE
BONEFOS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE BONEFOS IF YOU HAVE
AN ALLERGY TO:
•
sodium clodronate, the active
ingredient in Bonefos
•
any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the

Summary of Product characteristics

1308 Bonefos PI
Page 1 of 11
PRODUCT INFORMATION
BONEFOS
® (SODIUM CLODRONATE)
NAME OF THE MEDICINE
BONEFOS contains sodium clodronate which is a bone metabolism
regulator.
CHEMICAL NAME
The chemical name of sodium clodronate tetrahydrate is disodium
(dichloromethylene)
bisphosphonate tetrahydrate.
STRUCTURAL FORMULA
DESCRIPTION
CHEMICAL PROPERTIES
_Sodium clodronate:_
A white to off-white, odourless powder which is freely soluble in
water,
slightly soluble in methanol, very slightly soluble in dehydrated
alcohol and insoluble in
toluene, acetone and diethylether.
_BONEFOS capsules 400 mg:_
One capsule contains 500 mg sodium clodronate tetrahydrate,
equivalent to 400 mg anhydrous sodium clodronate. Each capsule also
contains purified talc,
calcium stearate, colloidal anhydrous silica, lactose, gelatin,
purified water, iron oxide red,
iron oxide yellow, Tekprint SW-9008 black ink and titanium dioxide.
Each capsule contains
the equivalent of 64 mg sodium.
_BONEFOS tablets 800 mg:_
Each 800 mg tablet contains 1000 mg sodium clodronate
tetrahydrate, equivalent to 800 mg anhydrous sodium clodronate. Each
tablet also contains
croscarmellose sodium, microcrystalline cellulose, stearic acid,
magnesium stearate, colloidal
anhydrous silica and Opadry II complete film coating system 85F18422
white. Each tablet
contains the equivalent of 128 mg sodium.
1308 Bonefos PI
Page 2 of 11
PHARMACOLOGY
PHARMACODYNAMICS
Sodium clodronate belongs chemically to the bisphosphonate group,
which act primarily on
bone tissue. Its major pharmacological action is inhibition of bone
resorption.
The mechanism of sodium clodronate’s action lies in its protection
against the dissolution of
hydroxyapatite crystals and direct reduction of osteoclast activity.
There is some evidence that
sodium clodronate also has indirect effects on osteoclast activity by
inhibition of various
mediators. The selectivity of the direct effects most likely arises
from the strong affinity of
sodium clodronate for calcium phosphate and it will, therefore, be
distribu