Foznol 500 mg Chewable Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lanthanum carbonate hydrate

Available from:

Takeda Pharmaceuticals International AG Ireland Branch

ATC code:

V03AE; V03AE03

INN (International Name):

Lanthanum carbonate hydrate

Dosage:

500 milligram(s)

Pharmaceutical form:

Chewable tablet

Therapeutic area:

Drugs for treatment of hyperkalemia and hyperphosphatemia; lanthanum carbonate

Authorization status:

Marketed

Authorization date:

2005-06-17

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOZNOL 250 MG CHEWABLE TABLETS
FOZNOL 500 MG CHEWABLE TABLETS
FOZNOL 750 MG CHEWABLE TABLETS
FOZNOL 1000 MG CHEWABLE TABLETS
lanthanum
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Foznol is and what it is used for
2.
What you need to know before you take Foznol
3.
How to take Foznol
4.
Possible side effects
5.
How to store Foznol
6.
Contents of the pack and other information
1.
WHAT FOZNOL IS AND WHAT IT IS USED FOR
Foznol is used to lower the phosphate level in the blood of adult
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).
Foznol 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 Foznol cannot be
absorbed through the intestinal
wall.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOZNOL
DO NOT TAKE FOZNOL
•
if you are allergic to lanthanum carbonate hydrate or any of the other
ingredients of this
medicine (listed in section 6)
•
if you have too little phosphate in your blood (hypophosphataemia).
2
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Foznol if you know
that you have, or have had, any of
the following:
•
stomach or intestinal cancer
•
inflammatory bowel disease including ulcerative colitis or Crohn’s
disease
•
a

Summary of Product characteristics

Health Products Regulatory Authority
06 October 2023
CRN00D8S6
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Foznol 500 mg Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains lanthanum carbonate hydrate
corresponding to 500 mg lanthanum.
_Excipient with known effect:_
Chewable tablets also contain on average 1066 mg of dextrates,
containing glucose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
White, round, 18 mm, bevelled-edge flat tablets debossed with
‘S405/500’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Foznol is indicated in adult patients 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). Foznol is also indicated in adult
patients with chronic kidney disease not on dialysis with serum
phosphate levels ³1.78 mmol/L in whom a low phosphate diet
alone is insufficient to control serum phosphate levels.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Foznol is for oral administration.
The tablets must be chewed completely and not swallowed whole. To aid
with chewing the tablets may be crushed. Where
Foznol oral powder is available, it can replace chewable tablets in
patients who have difficulty chewing the tablets Foznol (see
section 4.4).
_Adults, including elderly (> 65 years)_
Foznol should be taken with or immediately after food, with the daily
dose divided between meals. Patients should adhere to
recommended diets in order to control phosphate and fluid intake.
Foznol is presented as a chewable tablet therefore avoiding
the need to take additional fluid. Serum phosphate levels should be
monitored and the dose of Foznol titrated every 2 to
3 weeks until an acceptable serum phosphate level is reached, with
regular monitoring thereafter.
Control of serum phosphate level has been demonstrated at doses
starting from 750 mg per day. The maximum dose studie