FOSRENOL

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

Lanthanum carbonate hydrate

Pieejams no:

Shire Australia Pty Ltd

Klase:

Medicine Registered

Lietošanas instrukcija

_Consumer Medicine Information _
_ _
_FOSRENOL_
_® _

FOSRENOL
®
LANTHANUM CARBONATE HYDRATE 
500 MG, 750 MG, 1000 MG 
CHEWABLE TABLETS 

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 

PLEASE READ THIS LEAFLET BEFORE YOU START 
TAKING FOSRENOL. 

This leaflet answers some common 
questions about FOSRENOL chewable 
tablets.  It does not contain all of the 
available information. 

This information is not intended to replace 
the advice of your health care professional. 

All medicines have risks and benefits.  Your 
doctor has weighed the risks of you taking 
FOSRENOL against the benefits they 
expect it will have for you.  IF YOU HAVE ANY 
CONCERNS ABOUT TAKING FOSRENOL, ASK 
YOUR DOCTOR OR PHARMACIST. 

KEEP THIS LEAFLET WITH THE MEDICINE.  You 
may need to read it again. 

WHAT FOSRENOL IS USED FOR 

Phosphorus is found in your body as 
“Phosphate” and is needed for building 
strong teeth and bones as well as keeping 
other parts of your body healthy.  When 
your kidneys fail to work properly, 
phosphate can build up in the blood. This 
build up of excess phosphate is called 
hyperphosphataemia. 

FOSRENOL is a phosphate binder and is 
used to lower the amount of phosphate in 
your body. It prevents the body from 
absorbing the phosphate from the food you 
eat. The phosphate in the food binds to 
FOSRENOL and is carried through the 
digestive tract to be eliminated in your stool. 

Fosrenol tablets are not addictive. 

Fosrenol tablets are only available on a 
doctor’s prescription. 

BEFORE YOU TAKE FOSRENOL 

FOSRENOL chewable tablets are not 
suitable for everyone. 
_ _
_WHEN YOU MUST NOT TAKE FOSRENOL_ 

DO NOT TAKE FOSRENOL IF: 
•  you are hypersensitive (allergic) to 
lanthanum carbonate hydrate or any of 
the other ingredients of FOSRENOL 
listed at the end of this leaflet. 
•  you have too little phosphate in your 
blood (hypophosphataemia). 

_BEFORE Y

Produkta apraksts

_Product Information _
_ _
_FOSRENOL_
_® _
PRODUCT INFORMATION 

FOSRENOL
®

500 MG, 750 MG AND 1000 MG CHEWABLE TABLETS 

NAME OF THE MEDICINE 

Lanthanum carbonate hydrate 
La
2
(CO
3
)
3
.xH
2
O = 457.85 (anhydrous), on average x = 4.5 moles of water. 
CAS Registry Number:  54451-24-0 

DESCRIPTION 

FOSRENOL (lanthanum carbonate hydrate) has been developed as a
dietary phosphate-
binding agent.  Phosphate absorption from the gastrointestinal
tract is effectively decreased by 
the formation of highly insoluble complexes that are largely unable to
pass through the wall of 
the gastrointestinal tract and are eliminated by excretion. 

FOSRENOL is presented as chewable tablets.  Each tablet contains
lanthanum carbonate 
hydrate corresponding to 500 mg, 750 mg or 1000 mg lanthanum.  The
tablets also contain 
the excipients dextrates, silicon dioxide and magnesium stearate.  

PHARMACOLOGY 

PHARMACODYNAMIC PROPERTIES 
FOSRENOL is indicated for the treatment of hyperphosphataemia.
 FOSRENOL contains 
lanthanum carbonate hydrate.  The activity of lanthanum carbonate
as a phosphate binder is 
dependent on the high affinity of lanthanum ions, which
are released from the carbonate salt in 
the acid environment of the upper gastrointestinal tract, for
dietary

phosphate.  Insoluble 
lanthanum phosphate is formed which reduces the absorption of
phosphate from the gastro-
intestinal tract.  

Several studies have shown that lanthanum can be used to control
hyperphosphataemia_ _
associated with chronic renal failure through dose titration and that
effect is maintained with 
long-term use.  A lower incidence of hypercalcaemia was reported
with FOSRENOL (0.4%) 
compared with calcium-based binders (20.2%) in comparative studies. 

Serum PTH concentrations may fluctuate depending on a patient’s
serum calcium, phosphate 
and vitamin D status.  FOSRENOL has not been shown to have
any direct effects on PTH 
secretion. 

PHAR