Sevelamer 800mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Sevelamer

Commercializzato da:

Zentiva

Codice ATC:

V03AE02

INN (Nome Internazionale):

Sevelamer

Dosaggio:

800mg

Forma farmaceutica:

Tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 09050202; GTIN: 5000283657699

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEVELAMER CARBONATE ZENTIVA 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 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 Zentiva is and what it is used for
2. What you need to know before you take Sevelamer carbonate Zentiva
3. How to take Sevelamer carbonate Zentiva
4. Possible side effects
5. How to store Sevelamer carbonate Zentiva
6. Contents of the pack and other information
1.
WHAT SEVELAMER CARBONATE ZENTIVA IS AND WHAT IT IS USED FOR
Sevelamer carbonate Zentiva 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 Zentiva 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 Zentiva 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 is can stiffen your blood vessels and make it harder
for blood t

Scheda tecnica

OBJECT 1
SEVELAMER CARBONATE ZENTIVA 800 MG FILM COATED
TABLETS
Summary of Product Characteristics Updated 09-Oct-2017 | Zentiva
1. Name of the medicinal product
Sevelamer carbonate Zentiva 800 mg film-coated tablets
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 (tablet).
The white to off-white tablets are imprinted with “SC800” on one
side.
4. Clinical particulars
4.1 Therapeutic indications
Sevelamer carbonate Zentiva is indicated for the control of
hyperphosphataemia in adult patients
receiving haemodialysis or peritoneal dialysis.
Sevelamer carbonate Zentiva 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 Zentiva 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 Zentiva 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 Zentiva 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 dose of sevelamer
carbonate titrated by 0.8 g three
times per day (2.4 g/day) increments every 2-4 weeks until an
acce