Sevelamer Carbonate Rowex 800 mg film-coated tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Sevelamer carbonate

Предлага се от:

Rowex Ltd

АТС код:

V03AE; V03AE02

INN (Международно Name):

Sevelamer carbonate

дозиране:

800 milligram(s)

Лекарствена форма:

Film-coated tablet

Вид предписание :

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

Терапевтична област:

Drugs for treatment of hyperkalemia and hyperphosphatemia; sevelamer

Статус Оторизация:

Marketed

Дата Оторизация:

2015-02-20

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEVELAMER CARBONATE ROWEX 800MG 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 any 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 you doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sevelamer carbonate Rowex is and what it is used for
2.
What you need to know before you take Sevelamer carbonate Rowex
3.
How to take Sevelamer carbonate Rowex
4.
Possible side effects
5.
How to store Sevelamer carbonate Rowex
6.
Contents of the pack and other information
1.
WHAT SEVELAMER CARBONATE ROWEX IS AND WHAT IT IS USED FOR
Sevelamer carbonate Rowex 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 Rowex 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 Rowex
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 pu

Данни за продукта

Health Products Regulatory Authority
23 December 2019
CRN0099YV
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sevelamer Carbonate Rowex 800 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated 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 (20 mm x 7 mm) without
scoring line. The tablets are debossed with ‘SVL’ on one
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sevelamer Carbonate Rowex is indicated for the control of
hyperphosphataemia in adult patients receiving haemodialysis or
peritoneal dialysis.
Sevelamer Carbonate Rowex 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 Rowex should be used within the context of a
multiple therapeutic approach, which could include
calcium supplement, 1,25-dihydroxy Vitamin D
3
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 Rowex 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 as per instructions
For patients previously on phosphate binders (sevelamer hydrochloride
or calcium based), Sevelamer Carbonate Rowex 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 th