Foznol 1000mg Chewable Tablets

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

LANTHANUM

제공처:

Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 D02 HW68, Ireland

ATC 코드:

V03AE03

INN (International Name):

LANTHANUM 1000 mg

약제 형태:

CHEWABLE TABLET

구성:

LANTHANUM 1000 mg

처방전 유형:

POM

치료 영역:

ALL OTHER THERAPEUTIC PRODUCTS

승인 상태:

Authorised

승인 날짜:

2006-09-20

환자 정보 전단

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 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 in section 6).
•
if you have too little phosphate in your blood (hypophosphataemia)
PAGE 2 OF 6
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
d

제품 특성 요약

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
N
AME OF THE
M
EDICINAL
P
RODUCT
Foznol 1000 mg chewable tablets.
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each chewable tablet contains lanthanum carbonate hydrate
corresponding to 1000 mg lanthanum.
Excipient 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.
P
HARMACEUTICAL
F
ORM
Chewable tablet.
White, round, 22-mm, bevelled-edge flat tablets debossed with
‘S405/1000’ on one side.
4.
C
LINICAL
P
ARTICULARS
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. Where Foznol 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) _
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 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
pat