Sevelamer Hydrochloride Waymade 400 mg film-coated tablets

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Sevelamer hydrochloride

Disponibbli minn:

Waymade B.V.

Kodiċi ATC:

V03AE; V03AE02

INN (Isem Internazzjonali):

Sevelamer hydrochloride

Dożaġġ:

400 milligram(s)

Għamla farmaċewtika:

Film-coated tablet

Żona terapewtika:

Drugs for treatment of hyperkalemia and hyperphosphatemia; sevelamer

Data ta 'l-awtorizzazzjoni:

2020-01-24

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEVELAMER HYDROCHLORIDE WAYMADE 400 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 Sevelamer Hydrochloride Waymade is and what it is used for
2.
What you need to know before you take Sevelamer Hydrochloride Waymade
3.
How to take Sevelamer Hydrochloride Waymade
4.
Possible side effects
5.
How to store Sevelamer Hydrochloride Waymade
6.
Contents of the pack and other information
1.
WHAT SEVELAMER HYDROCHLORIDE WAYMADE IS AND WHAT IT IS USED FOR
Sevelamer Hydrochloride contains sevelamer as the active ingredient.
It binds phosphate from food in
the digestive tract and so reduces serum phosphate levels in the
blood.
Sevelamer Hydrochloride 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.
Sevelamer Hydrochloride may be used with other medicines which include
calcium or vitamin D
suppleme

Karatteristiċi tal-prodott

Health Products Regulatory Authority
03 November 2020
CRN009WGC
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sevelamer Hydrochloride Waymade 400 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg sevelamer hydrochloride.
Excipients with known effect:
This medicine contains 48 mg sorbitol in each tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White to off-white oval shape film coated tablet having approx. 15.50
x 8.00 mm dimension, debossed with 400 on one side
and debossed with SH on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sevelamer Hydrochloride is indicated for the control of
hyperphosphataemia in adult patients receiving haemodialysis or
peritoneal dialysis. Sevelamer Hydrochloride should be used within the
context of a multiple therapeutic approach, which could
include calcium supplements, 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 hydrochloride is 2.4 g, 3.6
g or 4.8 g per day based on clinical needs and serum
phosphorus level. Sevelamer Hydrochloride must be taken three times
per day with meals.
Serum phosphate level in patients not on phosphate binders
Starting dose of Sevelamer Hydrochloride Waymade 400 mg
tablets
1.76 – 2.42 mmol/L (5.5-7.5 mg/dl)
2 tablets, 3 times per day
2.42- 2.91 mmol/L (7.5-9 mg/dl)
3 tablets, 3 times per day
> 2.91 mmol/L
4 tablets, 3 times per day
For patients previously on phosphate binders, Sevelamer Hydrochloride
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 0.4 g or 0.8 g three
times per day (1.2 g/day or 2.4 g/day) increments with the goal of
lowering ser