Fosrenol 750 mg Tuggtablett

מדינה: שוודיה

שפה: שוודית

מקור: Läkemedelsverket (Medical Products Agency)

מרכיב פעיל:

lantan(III)karbonattetrahydrat

זמין מ:

Paranova Läkemedel AB

קוד ATC:

V03AE03

INN (שם בינלאומי):

lanthanum(III)karbonattetrahydrat

כמות:

750 mg

טופס פרצבטיות:

Tuggtablett

הרכב:

lantan(III)karbonattetrahydrat 1431 mg Aktiv substans; dextrat, hydratiserat Hjälpämne

סוג מרשם:

Receptbelagt

leaflet_short:

Förpacknings: Burk, 90 (6 x 15) tabletter

מצב אישור:

Avregistrerad

תאריך אישור:

2017-07-12

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOSRENOL 250 MG CHEWABLE TABLETS
FOSRENOL 500 MG CHEWABLE TABLETS
FOSRENOL 750 MG CHEWABLE TABLETS
FOSRENOL 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 Fosrenol is and what it is used for
2.
What you need to know before you take Fosrenol
3.
How to take Fosrenol
4.
Possible side effects
5.
How to store Fosrenol
6.
Contents of the pack and other information
1.
WHAT FOSRENOL IS AND WHAT IT IS USED FOR
Fosrenol 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).
Fosrenol 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 Fosrenol cannot
be absorbed through the
intestinal wall.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSRENOL
DO NOT TAKE FOSRENOL
-
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 Fosrenol if you know
that you have, or have had, any
of the following:
-
stomach or intestinal cancer
-
inflammatory bowel disease including ulcerative colitis or Cro

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1.
N
AME OF THE
M
EDICINAL
P
RODUCT
Fosrenol 750 mg chewable tablets.
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each chewable tablet contains lanthanum carbonate hydrate
corresponding to 750 mg lanthanum.
Excipient(s) with known effect
Chewable tablets also contain on average 1599 mg of dextrates,
containing glucose.
For the full list of excipients, see section 6.1.
3.
P
HARMACEUTICAL
F
ORM
Chewable tablet.
White, round, 20-mm, bevelled-edge flat tablets debossed with
‘S405/750’ on one side.
4.
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fosrenol 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). Fosrenol 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
Fosrenol is for oral administration.
The tablets must be chewed completely and not swallowed whole. To aid
with chewing the tablets
may be crushed. Where Fosrenol oral powder is available, it can
replace chewable tablets in patients
who have difficulty chewing the tablets (see section 4.4).
_Adults, including elderly (>65 years)_
Fosrenol 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. Fosrenol
is presented as a chewable tablet therefore avoiding the need to take
additional fluid. Serum phosphate
levels should be monitored and the dose of Fosrenol titrated every 2
to 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
pati