SEVELAMER LUPIN sevelamer carbonate 800 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sevelamer carbonate, Quantity: 800 mg

Available from:

Dr Reddys Laboratories Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: silicon dioxide; hyprolose; crospovidone; mannitol; zinc stearate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid; purified talc; xanthan gum; polyvinyl alcohol; lecithin

Administration route:

Oral

Units in package:

270, 180, 30 (Starter pack)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SEVELAMER LUPIN is indicated for the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.

Product summary:

Visual Identification: White to off-white, oval, film coated tablets plain on one side and imprinted 'R789' on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2018-11-09

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
SEVELAMER LUPIN
(SEVELAMER CARBONATE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Sevelamer Lupin.
It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Sevelamer Lupin against the
benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET. You may
need to read it again.
WHAT SEVELAMER LUPIN IS
USED FOR
Sevelamer Lupin contains the
active substance sevelamer
carbonate and is used to treat
hyperphosphatemia, a condition
caused by too much dietary
phosphorus being retained in
your body due to a diseased
kidney.
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.
Sevelamer Lupin helps to
remove excess phosphorus that
has built up in your body by
binding the phosphorus that is in
the food that you eat.
Your doctor, however, may have
prescribed Sevelamer Lupin for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY IT
HAS BEEN PRESCRIBED FOR YOU.
This medicine is only available
with a doctor's prescription.
BEFORE YOU TAKE
SEVELAMER LUPIN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SEVELAMER LUPIN
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
sevelamer carbonate (the
active ingredient);
•
any of the ingredients listed
at the end of this leaflet;
•
any other similar medicine,
such as sevelamer
hydrochloride.
Symptoms that may indicate an
allergic reaction include:
•
shortness of breath;
•
wheezing or difficulty
breathing;
•
swelling of the face, lips,
tongue or other parts of the
body;
•
rash, itching or hives on the
skin.
Tell your doctor if you are
experiencing any of the above
symptoms.
DO NOT TAKE SEVELAMER LUPIN

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – SEVELAMER LUPIN
(SEVELAMER CARBONATE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Sevelamer carbonate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 800 mg of sevelamer carbonate on an
anhydrous basis.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Sevelamer Lupin tablets are white to off-white, oval, film-coated
tablets imprinted with “R789” on one
side and are blank on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sevelamer Lupin is indicated for the management of hyperphosphataemia
in adult patients with stage 4
and 5 chronic kidney disease.
4.2 DOSE AND METHOD OF ADMINISTRATION
Sevelamer Lupin is available as tablets.
Note that powder for oral suspension can be available from other
brand/s.
It is recommended to continue monitoring serum phosphorus levels in
patients when switching between
sevelamer carbonate tablets and powder.
Sevelamer Lupin should be taken in conjunction with a prescribed diet
for the management of
hyperphosphatemia.
Sevelamer Lupin 800 mg tablets must be taken three times per day with
meals at a dosage based on
individual patient requirements to control phosphate levels. Tablets
should be swallowed intact and
should not be crushed, chewed, or broken into pieces prior to
administration. Patients should swallow
the tablets whole with water.
STARTING DOSE
The recommended starting dose of sevelamer carbonate is 2.4 to 4.8 g
per day based on clinical needs
and phosphorus level (TABLE 1). Sevelamer carbonate must be taken
three times per day with meals.
TABLE 1: STARTING DOSE FOR PATIENTS NOT TAKING A PHOSPHATE BINDER
SERUM PHOSPHORUS
TOTAL DAILY DOSE TAKEN OVER THREE MEALS PER DAY
> 1.78 and < 2.42 mmol/L
2.4 g
≥ 2.42
4.8 g
For patients previously on calcium based phosphate binders, TABLE 2
below provides guidance on
switching to sevelamer carbonate. Serum phosphorus levels should be
monitored to ensure optimal
daily doses.
TABLE 2: STARTING DOSE FOR PATIENTS SW