CAVSAMIR (Sevelamer Carbonate Tablets 800mg)

Country: Malaysia

Language: English

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

Active ingredient:

Sevelamer carbonate

Available from:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (International Name):

Sevelamer carbonate

Units in package:

270 Tablets; 30 Tablets

Manufactured by:

DR. REDDY'S LABORATORIES LIMITED

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ CAVSAMIR
Sevelamer carbonate Tablets 800 mg
1
WHAT IS IN THIS LEAFLET
1.
What Cavsamir is used for
2.
How Cavsamir works
3.
Before you use Cavsamir
4.
How to use Cavsamir
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Cavsamir
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT CAVSAMIR IS USED FOR
Cavsamir is used for patients who have
kidneys that do not work properly are not
able to control the level of serum
phosphorus 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 is 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 CAVSAMIR WORKS
Cavsamir 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.
BEFORE YOU USE CAVSAMIR
_-When you must not use it _
Do not take Cavsamir if:
•
You are allergic (hypersensitive) to
sevelamer carbonate or to any of the
other ingredients of this medicine (listed
in Section 8 below).
-Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or
tongue
•
You have low levels of phosphate in
your blood (your doctor will check this
for you)
•
You have bowel obstruction.
_-Before you start to use it_
Check with your doctor before taking
Cavsamir 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
on your stomach or bowel
•
You have severe constipation.
_Additional treatments: _
Due to either your kidney condition

Summary of Product characteristics

ARTWORK APPROVAL FORM
UNIT: FTO-HO
DEPARTMENT: Packaging Development
PAGE: 1 of 2
Component: Leaflet
Product Name: CAVSAMIR
Strength: 800 mg
Counts: NA
Market / Customer: Malaysia
Material Code: 150086414
Supersedes:150086020
REFERENCE SOP NO.
SOP-GLOB-PG-0002
LEGACY DOCUMENT NO.
FTCPD033/A02
Any Comments:
Approval from
CMS / Marketing / Country Manager /
Country Regulatory / Customer
enclosed (tick as applicable)
Dimensions: (WxH) 170 x 380 mm
PANTONE CODES
Version No: 00
WI-GLOB-PG-0002-2.0
BLACK C
(W) 170 mm
Dimensions: (WxH) 170 x 380 mm
Folding: 30 x 30 mm
30 mm
30 mm
30 mm
CAVSAMIR
150086414
CAVSAMIR
150086414
62 mm
For paediatric patients the oral suspension should be administered, as
tablet formulations are not appropriate for this population.
F)
ROUTE OF ADMINISTRATION
For oral use.
Tablets should be swallowed intact and should not be crushed, chewed,
or broken into pieces prior to administration.
G)
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
•
Hypophosphataemia
•
Bowel obstruction.
H)
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Sevelamer is currently not recommended for use in adult patients with
chronic kidney disease not on dialysis with serum phosphorus < 1.78
mmol/l.
Caution should be exercised when Sevelamer is used in patients with
the following disorders:
•
Dysphagia
•
swallowing disorders
•
Severe gastrointestinal motility disorders including untreated or
severe constipation or major gastrointestinal tract surgery. Use with
caution in patients with
these gastrointestinal disorders. Monitor serum chemistries:
Bicarbonate and chloride levels should be monitored.
Reductions in Vitamins A, D, E, K (clotting factors) and Folic Acid
Levels: Patients with CKD may develop low levels of fat-soluble
vitamins A, D, E and K,
depending on dietary intake and the severity of their disease. It
cannot be excluded that Sevelamer can bind fat-soluble vitamins
contained in ingested food. In
patients not taking supplemental vitamins but on sevelamer, serum
vitam