Lovtelar 800 mg film-coated tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Sevelamer carbonate

Beszerezhető a:

Pharmathen S.A.

ATC-kód:

V03AE02

INN (nemzetközi neve):

Sevelamer carbonate

Gyógyszerészeti forma:

Film-coated tablet

Terápiás terület:

sevelamer

Engedélyezési státusz:

Not marketed

Engedély dátuma:

2023-03-31

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOVTELAR 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 you doctor. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lovtelar is and what it is used for
2.
What you need to know before you take Lovtelar
3.
How to take Lovtelar
4.
Possible side effects
5.
How to store Lovtelar
6.
Contents of the pack and other information
1. WHAT LOVTELAR IS AND WHAT IT IS USED FOR
Lovtelar contains sevelamer carbonate as the active substance. It
binds phosphate from food
in the digestive tract and so reduces serum phosphorus levels in the
blood.
This medicine 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.
This medicine 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 serum phosphorus can also lead to itchy skin, red eyes, bone
pain and fractures.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOVTE

Termékjellemzők

Health Products Regulatory Authority
31 March 2023
CRN00CLWH
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lovtelar 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).
White to off white, oval, biconvex film coated tablets of
approximately 21 mm in length,marked "C800" on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lovtelar is indicated for the control of hyperphosphataemia in adult
patients receiving haemodialysis or peritoneal dialysis.
Lovtelar is also indicated for the control of hyperphosphataemia in
adult patients with chronic kidney disease (CKD) not on
dialysis with serum phosphorus ≥ 1.78 mmol/L.
Lovtelar 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. Lovtelar 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, see section "Titration and maintenance"
For patients previously on phosphate binders (sevelamer hydrochloride
or calcium based), Lovtelar 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 acceptable serum
phosphorus level is reached, with regular monitoring
thereaf