FOSRENOL lanthanum 500mg (as lanthanum carbonate hydrate) chewable tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lanthanum carbonate hydrate, Quantity: 954 mg

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Name):

Lanthanum carbonate hydrate

Pharmaceutical form:

Tablet, chewable

Composition:

Excipient Ingredients: dextrates; silicon dioxide; magnesium stearate

Administration route:

Oral

Units in package:

45 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hyperphosphataemia in adults with chronic renal failure on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

Product summary:

Visual Identification: White to off white round, flat, bevel-edged tablet debossed on one side with S405 above 500. 18 mm diameter; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2005-11-08

Patient Information leaflet

FOSRENOL
®
_500 MG, 750 MG, 1000 MG CHEWABLE TABLETS_
_Lanthanum carbonate hydrate_
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 YOU START TO TAKE_
_FOSRENOL_
YOU MUST TELL YOUR DOCTOR IF:
•
you have reduced liver function.
It is possible that your liver will
not be able to "clean"
FOSRENOL from your body
adequately
•
you have a disease involving the
gastrointestinal tract
•
you have C

Summary of Product characteristics

FOSRENOL Tablets V2 CCDS V12.1
1
AUSTRALIAN PRODUCT INFORMATION
FOSRENOL
® (LANTHANUM CARBONATE HYDRATE) – CHEWABLE TABLETS
1
NAME OF THE MEDICINE
Lanthanum carbonate hydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FOSRENOL is presented as chewable tablets. Each tablet contains
lanthanum carbonate
hydrate corresponding to 500 mg, 750 mg or 1000 mg lanthanum.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablet, chewable
•
FOSRENOL 500 mg: White, round, bevel-edged flat tablets debossed with
‘S405/500’ on one side.
•
FOSRENOL 750 mg: White to off-white round, flat bevel-edged tablets
debossed on
one side with ‘S405’ above ‘750’.
•
FOSRENOL 1000 mg: White to off-white round, flat bevel-edged tablets
debossed on
one side with ‘S405’ above ‘1000’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Treatment of hyperphosphataemia in adults with chronic renal failure
on haemodialysis or
continuous ambulatory peritoneal dialysis (CAPD)
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION
Patients should adhere to recommended diets in order to control
phosphate and fluid intake.
FOSRENOL tablets must be chewed completely before swallowing. The
tablets may be
crushed as an aid to chewing. Intact tablets must not be swallowed
whole.
ADULTS, INCLUDING ELDERLY (>65 YEARS)
For patients taking FOSRENOL for the first time, the starting dose may
be determined
individually based on serum phosphate concentration as indicated in
the following table
(Table 1):
TABLE 1
PRE-TREATMENT SERUM PHOSPHATE LEVEL
RECOMMENDED INITIAL DAILY DOSE OF FOSRENOL
>1.8 and ≤2.4 mmol/L
750 mg
>2.4 and ≤2.9 mmol/L
1500 mg
>2.9 mmol/L
2250 mg
FOSRENOL Tablets V2 CCDS V12.1
2
FOSRENOL should be taken with or immediately after food, with the
daily dose divided
between meals, i.e. three times daily. Serum phosphate levels should
be monitored and the
dose of FOSRENOL titrated every 2-3 weeks until an acceptable serum
phosphate level is
reached, with regular monitoring thereafter.
Control of s