FOZNOL 1000 Milligram Oral Powder

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

LANTHANUM CARBONATE HYDRATE

Tillgänglig från:

Shire Pharmaceutical Contracts Ltd

ATC-kod:

V03AE03

INN (International namn):

LANTHANUM CARBONATE HYDRATE

Dos:

1000 Milligram

Läkemedelsform:

Oral Powder

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

Drugs for treatment of hyperkalemia and hyperphosphatemia

Bemyndigande status:

Authorised

Tillstånd datum:

2012-05-11

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOZNOL 750 MG ORAL POWDER
FOZNOL 1000 MG ORAL POWDER
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 is 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’s
disease

abdominal surgery, or infection or inflammation of the abdomen/bowel
(perit

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Foznol 1000 mg Oral Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 1000 mg lanthanum (as lanthanum carbonate
hydrate).
_Excipient(s) with known effect:_
Each sachet also contains 855.6 mg dextrates, containing glucose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Powder.
White to off-white powder.
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.
Foznol oral powder is intended to be mixed with a small quantity of
soft food (e.g. applesauce or other similar food
product) and consumed immediately (within 15 minutes). The sachet must
not be opened until ready to use. Once
mixed with food, Foznol oral powder must not be stored for future use.
Foznol oral powder is insoluble and must not be
dissolved in liquid for administration.
_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 an oral powder
intended to be mixed with soft food, 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 level is reached,
with regular monitoring thereafter. Dose titration may be performed
with the chewable tablet presentation as these are
available in a number of strengths allowing for smaller inc