Sevelamer Carbonate 800 mg film coated tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Sevelamer carbonate

Διαθέσιμο από:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Φαρμακολογική κατηγορία (ATC):

V03AE; V03AE02

INN (Διεθνής Όνομα):

Sevelamer carbonate

Δοσολογία:

800 milligram(s)

Φαρμακοτεχνική μορφή:

Film-coated tablet

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Θεραπευτική περιοχή:

Drugs for treatment of hyperkalemia and hyperphosphatemia; sevelamer

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2015-11-19

Φύλλο οδηγιών χρήσης

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEVELAMER CARBONATE 800 MG FILM-COATED TABLETS
sevelamer carbonate
_ _
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 further questions, ask your doctor or your 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. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sevelamer Carbonate is and what it is used for
2.
What you need to know before you take Sevelamer Carbonate
3.
How to take Sevelamer Carbonate
4.
Possible side effects
5.
How to store Sevelamer Carbonate
6.
Contents of the pack and other information
1.
WHAT SEVELAMER CARBONATE IS AND WHAT IT IS USED FOR
Sevelamer Carbonate 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.
Sevelamer Carbonate is used to control hyperphosphataemia (high blood
phosphate levels) in:
•
adult patients on dialysis (a blood clearance technique). It can be
used in patients undergoing
haemodialysis (using a blood filtration machine) or peritoneal
dialysis (where fluid is pumped
into the abdomen and an internal body membrane filters the blood);
•
patients with chronic (long-term) kidney disease who are not on
dialysis and have a serum
(blood) phosphorus level equal to or above 1.78 mmol/l.
Sevelamer Carbonate should be used with other treatments such as
calcium supplements and vitamin
D to prevent the development of bone disease.
Increased levels of serum phosphorus can lead to hard deposits in your
body called calcification.
These deposits can stiffen your blood vessels and make it harder for
blood to be pumped around the
body. Increased serum p

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
06 February 2020
CRN0097T4
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sevelamer Carbonate 800 mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800 mg sevelamer carbonate.
Excipients with known effect: each film-coated tablet contains 286.25
mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Oval, white to off-white film-coated tablets (approximately 20 mm long
and 7 mm wide) without scoring line. The tablets are
debossed with ‘SVL’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sevelamer Carbonate is indicated for the control of hyperphosphataemia
in adult patients receiving haemodialysis or
peritoneal dialysis.
Sevelamer Carbonate is also indicated for the control of
hyperphosphataemia in adult patients with chronic kidney disease not
on dialysis with serum phosphorus ≥ 1.78 mmol/l.
Sevelamer Carbonate 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
Posology
_Starting dose_
The recommended starting dose of sevelamer carbonate is 2.4 g or 4.8 g
per day based on clinical needs and serum
phosphorus level. Sevelamer Carbonate must be taken three times per
day with meals.
Serum phosphorus level in patients
Total daily dose of sevelamer carbonate to be taken over 3 meals per
day
1.78 – 2.42 mmol/l (5.5 – 7.5 mg/dl)
2.4 g*
> 2.42 mmol/l (> 7.5 mg/dl)
4.8 g*
*Plus subsequent titrating, see section "Titration and Maintenance"
For patients previously on phosphate binders (sevelamer hydrochloride
or calcium based), Sevelamer Carbonate should be
given on a gram for gram basis with monitoring of serum phosphorus
levels to ensure optimal daily doses.
_Titration and Maintenance_
Serum phosphorus levels must be monitored and the