LAMSEV 800 (Sevelamer Carbonate Tablets 800 mg)

Country: Малезија

Језик: Енглески

Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активни састојак:

Sevelamer carbonate

Доступно од:

SYNERRV SDN BHD

INN (Међународно име):

Sevelamer carbonate

Јединице у пакету:

30 Tablets; 180 Tablets

Произведен од:

Aurobindo Pharma Limited (Unit VII)

Информативни летак

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LAMSEV 800 (SEVELAMER CARBONATE TABLETS
800MG)
Sevelamer Carbonate 800mg
1
WHAT IS IN THIS LEAFLET
1.
What LAMSEV 800 is used for
2.
How LAMSEV 800 works
3.
Before you use LAMSEV 800
4.
How to use LAMSEV 800
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
LAMSEV 800
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT IS LAMSEV 800 USED FOR
LAMSEV 800 is used for patients
who have kidneys that do not work
properly or are not able to control the
level of serum phosphorus in their
blood. The amount of phosphate then
rises (your doctor will call this
hyperphosphatemia). 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.
HOW LAMSEV 800 WORKS
LAMSEV 800 contains sevelamer
carbonate as the active ingredient. It
binds to phosphate from food in the
digestive tract and so reduces serum
phosphorus levels in the blood.
BEFORE YOU USE LAMSEV 800
_-When you must not use it _
Do not use LAMSEV 800 if you
have low levels of phosphate in your
blood (your doctor will check this for
you) or bowel obstruction.
Do not use LAMSEV 800 if you are
allergic to sevelamer carbonate or to
any of the excipients used in this
product which is listed at the end of
this leaflet.
Signs of an allergic reaction include:
a rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue.
Do not use LAMSEV 800 if you
have bowel obstruction.
_-Before you start to use it _
Please check with your doctor before
taking LAMSEV 800 if:
•
You have swallowing
problems.
•
You have problems related
with motility (movement) in
your stomach and bowel.
•
You are being sick
frequently.
•
You have active
inflammation of the bowel.
•
You have undergone major
surgery

Карактеристике производа

1.
NAME OF THE DRUG PRODUCT
LAMSEV 800 (Sevelamer Carbonate Tablets 800 mg)
PHARMACEUTICAL DOSAGE FORM
Oral Film Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITIONS
Sevelamer Carbonate Tablets 800 mg
Each film-coated tablet contains 800 mg of Sevelamer Carbonate.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Product Description
White to off white, oval shaped, film-coated tablets, imprinted with
“J 75” on one side with edible
black ink and plain on other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
LAMSEV 800 is indicated for the control of hyperphosphatemia in adult
patients receiving
haemodialysis or peritoneal dialysis.
LAMSEV 800 is also indicated for the control of hyperphosphatemia in
adult patients with chronic
kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.
LAMSEV 800 should be used within the context of a multiple therapeutic
approach, which could
include calcium supplement, 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
Because of the rapid disintegration of the carbonate salt tablet and
its rapid reaction with the
hydrochloric acid in the stomach, the dosing of LAMSEV 800 is
anticipated to be similar to that of
the hydrochloride salt.
LAMSEV 800 should be given three times a day with meals.
_Patients Not Taking a Phosphate Binder:_
The recommended starting dose of LAMSEV 800 is 800
to 1600 mg, which can be administered as one or two LAMSEV 800 mg
Tablets, with meals based
on serum phosphorus level. Table 1 provides recommended starting doses
of LAMSEV 800 for
patients not taking a phosphate binder.
TABLE 1. STARTING DOSE FOR PATIENTS NOT TAKING A PHOSPHATE BINDER
SERUM PHOSPHORUS
LAMSEV 800
> 1.78 and < 2.42 mmol/L
1 tablet three times daily with meals
≥ 2.42 and < 2.91 mmol/L
2 tablets three times daily with meals
≥ 2.91 mmol/L
2 tablets three times daily with meals
_Patients _
_Switching _
_From _
_Sevelamer _
_Hydrochloride:_
For