FOSRENOL CHEWABLE TABLETS 750MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

LANTHANUM CARBONATE HYDRATE

Boleh didapati daripada:

Takeda Malaysia Sdn Bhd

INN (Nama Antarabangsa):

LANTHANUM CARBONATE HYDRATE

Unit dalam pakej:

90Tablet Tablets

Dikeluarkan oleh:

HAMOL LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
FOSRENOL CHEWABLE TABLETS
LANTHANUM CARBONATE HYDRATE (250MG, 500MG, 750MG & 1000MG)
1
WHAT IS IN THIS LEAFLET:
1.
What Fosrenol is used for
2.
How Fosrenol works
3.
Before you use Fosrenol
4.
How to take Fosrenol
5.
While you are using Fosrenol
6.
Side effects
7.
Storage and Disposal of Fosrenol
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
WHAT FOSRENOL IS USED FOR
Fosrenol is used to lower the phosphate
level in the blood of patients with chronic
kidney disease.
Patients who have kidneys that do not
work properly are not able to control the
level of phosphate in the blood. The
amount of phosphate in the blood then
rises (your doctor may call this
hyperphosphataemia).
HOW FOSRENOL WORKS
Fosrenol is a medicine which reduces the
body's absorption of phosphate from food
by binding with it in your digestive tract.
Phosphate which has bonded to Fosrenol
cannot be absorbed through the intestinal
wall.
BEFORE YOU USE FOSRENOL
_When you must not use it _
Do not take Fosrenol:
•
if you are allergic (hypersensitive)
to lanthanum carbonate hydrate
or any of the other ingredients of
this medicine.
•
if you have too little phosphate in
your blood (hypophosphataemia).
_Before you start to use it _
If you know that you have or have had
any of the following conditions, you
should discuss this with your doctor
before using Fosrenol:
•
stomach ulcer;
•
inflammation of large intestine
and rectum (ulcerative colitis);
•
inflammation of the lining of the
digestive system (Crohn’s disease);
•
blockage of the bowel;
•
reduced liver or kidney function.
If you have previously had abdominal
surgery, or infection or inflammation of the
abdomen/bowel (peritonitis) inform your
doctor.
If you need to have an x-ray, please inform
your doctor that you are taking Fosrenol as it
may affect the results.
_Taking other medicines _
Tell your doctor or pharmacist if you are
taking, have recently taken, or might take
any other medicines.
Fo

Ciri produk

Fosrenol _
MultiS_210x400mm_
RB_449249_PilDrwg_A01
210x400mm
19/11/14
N/A V1
210 mm
400 mm
38 mm
38 mm
®
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains lanthanum carbonate hydrate
corresponding to 500 mg, 750 mg, 1000 mg lanthanum.
Excipient(s) with known effect
500mg Chewable tablets also contain on average 1066 mg
of dextrates, containing glucose. 750mg Chewable tablets also contain on
average 1599mg of dextrates, containing glucose. 1000mg Chewable tablets
also contain on average 2132 mg of dextrates, containing glucose.
For a full list of excipients, see “List of excipients”.
PHARMACEUTICAL FORM
Chewable tablet.
500 mg tablets: white, round, 18mm, bevelled-edge flat tablets debossed with
‘S405/500’ on one side. 750 mg tablets: white, round, 20mm, bevelled-edge flat
tablets debossed with ‘S405/750’ on one side. 1000 mg tablets: white, round,
22mm, bevelled-edge flat tablets debossed with ‘S405/1000’ on one side.
CLINICAL PARTICULARS
Therapeutic indications
Fosrenol is indicated as a phosphate binding agent for use in the control of
hyperphosphataemia in chronic renal failure patients on haemodialysis or\
continuous ambulatory peritoneal dialysis (CAPD) when calcium level is not
controlled and where hyperparathyroidism is present. Fosrenol is also indicated in
adult patients with chronic kidney disease not on dialysis with serum ph\
osphate
levels ≥1.78 mmol/L in whom a low phosphate diet alone is insufficient to control
serum phosphate levels.
Posology and method of administration
Fosrenol is for oral administration.
The tablets must be chewed completely and not swallowed whole. To aid
with chewing the tablets may be crushed. Fosrenol oral powder can be used in
patients who have difficulty chewing the tablets (see “Special warnings and
precautions for use”).
Adults, including elderly (> 65 years)
Fosrenol should be taken with or immediately after food, with the daily dose
divided between meals. Patients should adhere to recommended diets i