Foznol 1000mg oral powder

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

LANTHANUM

Pieejams no:

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

ATĶ kods:

V03AE03

SNN (starptautisko nepatentēto nosaukumu):

LANTHANUM 1000 mg

Zāļu forma:

ORAL POWDER

Kompozīcija:

LANTHANUM 1000 mg

Receptes veids:

POM

Ārstniecības joma:

ALL OTHER THERAPEUTIC PRODUCTS

Autorizācija statuss:

Withdrawn

Autorizācija datums:

2012-06-06

Lietošanas instrukcija

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
(peri

Produkta apraksts

Page 1 of 9
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 allow