FOZNOL 250 Milligram Tablets Chewable

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LANTHANUM CARBONATE HYDRATE

Available from:

Shire Pharmaceutical Contracts Ltd

ATC code:

V03AE03

INN (International Name):

LANTHANUM CARBONATE HYDRATE

Dosage:

250 Milligram

Pharmaceutical form:

Tablets Chewable

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Drugs for treatment of hyperkalemia and hyperphosphatemia

Authorization status:

Authorised

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 drug which reduces the body's absorption of phosphate from
food by binding with it in
your digestive tract. Phosphate which have 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

ab

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Foznol 250 mg Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains lanthanum carbonate hydrate
corresponding to 250 mg lanthanum.
_Excipient(s) with known effect:_
Each chewable tablet also contains 533.2 mg dextrates, containing
glucose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
White, round, 13 mm, bevelled-edge flat tablets debossed with
‘S405/250’ 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
1.78 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.
Foznol oral powder can be used in patients who have difficulty chewing
the tablets (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 2-3 weeks until an acceptable serum phosphate
levels 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
studied in clinical trials, in a limited number of patients, is 3750mg
Patients who respond to lanthanum therapy,
usually achieve accepta