Renagel 800mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Sevelamer

Commercializzato da:

Sanofi

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: 5030045000128

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RENAGEL 800 MG FILM-COATED TABLETS
sevelamer hydrochloride
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Renagel is and what it is used for
2. What you need to know before you take Renagel
3. How to take Renagel
4. Possible side effects
5. How to store Renagel
6. Contents of the pack and other information.
1.
WHAT RENAGEL IS AND WHAT IT IS USED FOR
Renagel contains sevelamer as the active ingredient. It binds
phosphate from food in the digestive tract
and so reduces serum phosphate levels in the blood.
Renagel is used to control the levels of phosphate in the blood of
adult kidney failure patients on
haemodialysis or peritoneal dialysis treatment.
Adult patients whose kidneys have failed and who are undergoing
haemodialysis or peritoneal dialysis
are not able to control the level of serum phosphate 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 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.
Renagel may be used with other medicines which include calcium or
vitamin D supplements to control
the development of renal bone disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENAGEL
DO NOT TAKE RENAGEL:
if you have low levels of phosphate in your blood (your doctor will

Scheda tecnica

OBJECT 1
RENAGEL 800 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 05-Sep-2016 | SANOFI
1. Name of the medicinal product
Renagel 800 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 800 mg sevelamer hydrochloride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet)
The off-white, oval tablets are imprinted with “Renagel 800“ on one
side.
4. Clinical particulars
4.1 Therapeutic indications
Renagel is indicated for the control of hyperphosphataemia in adult
patients receiving haemodialysis or
peritoneal dialysis. Renagel should be used within the context of a
multiple therapeutic approach, which
could include calcium supplements, 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 hydrochloride is 2.4 g or
4.8 g per day based on clinical
needs and serum phosphorus level. Renagel must be taken three times
per day with meals.
Serum phosphate level in patients not on phosphate
binders
Starting dose of Renagel 800 mg tablets
1.76 “ 2.42 mmol/L (5.5-7.5 mg/dl)
1 tablet, 3 times per day
> 2.42 mmol/L (>7.5 mg/dl)
2 tablets, 3 times per day
For patients previously on phosphate binders, Renagel should be given
on a gram for gram basis with
monitoring of serum phosphorus levels to ensure optimal daily doses.
_Titration and maintenance_
Serum phosphate levels should be closely monitored and the dose of
sevelamer hydrochloride titrated by
0.8 g three times per day (2.4 g/day) increments with the goal of
lowering serum phosphate to 1.76
mmol/L (5.5 mg/dl) or less. Serum phosphate should be tested every two
to three weeks until a stable
serum phosphate level is reached and on a regular basis thereafter.
The dose range may vary between 1 and 5 tablets of 800 mg per meal.
The average actual daily dose used
in the chronic phase of a one year clinical study was 7 gra