Caeseva 800mg Film Coated Tablet

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Sevelamer carbonate

Available from:

DUOPHARMA (M) SDN. BHD.

INN (International Name):

Sevelamer carbonate

Units in package:

180 Tablets

Manufactured by:

Synthon Hispania S.L.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
CAESEVA 800MG FILM COATED TABLET
Sevelamer Carbonate (800mg)
WHAT IS IN THE LEAFLET
1.
What CAESEVA is used
for
2.
How CAESEVA works
3.
Before you use CAESEVA
4.
How to use CAESEVA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
CAESEVA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT CAESEVA IS USED FOR
CAESEVA is used for patients
who have kidneys that do not
work properly are not able to
control
the
level
of
serum
phosphorus in their blood. The
amount of phosphate then rises
(your
doctor
will
call
this
hyperphosphataemia).
Increased
levels
of
serum
phosphorus
can
lead
to
hard
deposits
in
your
body
called
calcification. These deposits is
can stiffen your blood vessels
and make it harder for blood to
be
pumped
around
the
body.
Increased serum phosphorus can
also lead to itchy skin, red eyes,
bone pain and fractures.
HOW CAESEVA WORKS
CAESEVA contains sevelamer
carbonate
as
the
active
ingredient. It binds phosphate
from food in the digestive tract
and
so
reduces
serum
phosphorus levels in the blood.
BEFORE YOU USE CAESEVA
-
_When you must not use it _
_ _
Do not use CAESEVA if:
•
you
are
allergic
to
the
sevelamer
carbonate
or
to
any of the other ingredients
of
this
medicine
(listed
in
Section 8 below).
-Signs of an allergic reaction
include: a rash, swallowing
or
breathing
problems,
swelling of your lips, face,
throat or tongue.
•
you
have
low
levels
of
phosphate
in
your
blood
(your doctor will check this
for you).
•
you have bowel obstruction.
-
_Before you start to use it _
You must tell you doctor if:
•
you
have
swallowing
problems
•
you
have
problems
with
motility
(movement)
in
your stomach and bowel
•
you
are
being
sick
frequently
•
you
have
active
inflammation of the bowel
•
you have undergone major
surgery on your stomach or
bowel
•
you
have
serious
inflammatory bowel disease
Additional treatments:
Due
to
either
your
kidney
condition
or
your
dialysis
treatment you may:

Summary of Product characteristics

Caeseva PI_20201207_V1.indd 1
07/12/2020 2:18 PM
CAESEVA FILM COATED TABLET 800MG
1.
NAME OF THE MEDICINAL PRODUCT
CAESEVA film coated tablet 800mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800 mg sevelamer carbonate. For the full list of
excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
Oval, white to off-white film coated tablets without scoring line. The
tablets are debossed with ‘SVL’ on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CAESEVA is indicated for the control of hyperphosphataemia in adult
patients receiving haemodialysis or peritoneal dialysis.
CAESEVA is also indicated for the control of hyperphosphataemia in
adult patients with chronic kidney disease (CKD) not on dialysis with
serum phosphorus ≥ 1.78 mmol/l.
CAESEVA should be used within the context of a multiple therapeutic
approach, which could include calcium supplement, 1,25-dihydroxy
Vitamin D3 or one of its
analogues to control
the development of renal bone disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Because of the rapid disintegration of the carbonate salt tablet and
its rapid reaction with the hydrochloric acid in the stomach, the
dosing of CAESEVA is anticipated to be similar to
that of the hydrochloride salt.
CAESEVA should be given three times a day with meals.
_Patients Not Taking a Phosphate Binder. _
The recommended starting dose of CAESEVA is 800 to 1600 mg, which can
be administered as one or two CAESEVA 800 mg Tablets,
with meals based on serum phosphorus level. Table 1 provides
recommended starting doses of CAESEVA for patients not taking a
phosphate binder.
TABLE 1. STARTING DOSE FOR PATIENTS NOT TAKING A PHOSPHATE BINDER
SERUM PHOSPHORUS
CAESEVA 800 MG
> 1.78 and < 2.42 mmol/L
1 tablet three times daily with meals
> 2.42 and < 2.91 mmol/L
2 tablets three times daily with meals
> 2.91 mmol/L
2 tablets three times daily with meals
_Patients Switching from Sevelamer Hydrochloride. _
For patients switching from sevelamer hydrochloride, sevelamer
carbonate sh