Sevelamer Carbonate 800 mg film coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Sevelamer carbonate

Tilgjengelig fra:

Generics (UK) Limited

ATC-kode:

V03AE; V03AE02

INN (International Name):

Sevelamer carbonate

Dosering :

800 milligram(s)

Legemiddelform:

Film-coated tablet

Administreringsrute:

oral administration

Enheter i pakken:

180, 200 or 210 tablets per bottle

Resept typen:

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

Produsert av:

Synthon Hispania SL

Terapeutisk gruppe:

Treatment of hyperkalaemia and hyperphosphataemia

Terapeutisk område:

Drugs for treatment of hyperkalemia and hyperphosphatemia; sevelamer

Indikasjoner:

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.

Autorisasjon status:

Marketed

Autorisasjon dato:

2015-11-19

Informasjon til brukeren

PACKAGE LEAFLET
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 ser

Preparatomtale

Health Products Regulatory Authority
24 October 2018
CRN008L8M
Page 1 of 12
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.
Health Products Regulatory Authority
24 October 2018
CRN008L8M
Page 2 of 12
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 as per instructions
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 Mainten