Foznol 1000mg Chewable Tablets

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

LANTHANUM

Disponible desde:

Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland

Código ATC:

V03AE03

Designación común internacional (DCI):

LANTHANUM

formulario farmacéutico:

CHEWABLE TABLET

Composición:

LANTHANUM 1000 milligram(s)

tipo de receta:

POM

Área terapéutica:

ALL OTHER THERAPEUTIC PRODUCTS

Estado de Autorización:

Authorised

Fecha de autorización:

2006-09-20

Información para el usuario

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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 has bonded to Foznol cannot be
absorbed through the
intestinal wall.
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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)
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

Ficha técnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Foznol 1000 mg chewable tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains lanthanum carbonate hydrate
corresponding to 1000 mg lanthanum.
Excipient(s) with known effect
Chewable tablets also contain on average 2132 mg of dextrates,
containing glucose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
White, round, 22mm, bevelled-edge flat tablets debossed with
‘S405/1000’ 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 3750 mg. Patients who
respond to lanthanum