Renagel

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sevelamer hydrochloride 800mg;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Sevelamer hydrochloride 800 mg

Dosage:

800 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Sevelamer hydrochloride 800mg   Excipient: Colloidal silicon dioxide Purified water Stearic acid

Units in package:

Bottle, plastic, HDPE - 30 tablets, Sample pack, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Genzyme Ltd

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE - 30 tablets, Sample pack - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Bottle, plastic, HDPE - 180 tablets - 180 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture

Authorization date:

2004-04-21

Patient Information leaflet

RENAGEL
®
1
RENAGEL
®
_Sevelamer hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Renagel. It does not
contain all the available information.
It does not take the place of talking to
your doctor or a trained health care
professional.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Renagel
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 WITH THE MEDICINE.
You may need to read it again.
WHAT RENAGEL IS USED
FOR
The name of your medicine is
Renagel. It contains the active
ingredient called sevelamer
hydrochloride.
Renagel is used to treat
hyperphosphataemia, a condition
caused by too much dietary
phosphorus being retained in your
body due to a diseased kidney.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
_HOW IT WORKS _
Renagel belongs to a class of
medicines that are called ion
exchange resins.
Renagel helps to remove excess
phosphorus that has built up in your
body by binding the phosphorus that
is in the food that you eat.
BEFORE YOU USE
RENAGEL
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE RENAGEL IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
sevelamer hydrochloride
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
skin rash, itching or hives
DO NOT TAKE RENAGEL IF YOU HAVE:
•
hypophosphatemia, a condition
where you do not have enough
phosphorus in your body
•
have a bowel obstruction
DO NOT TAKE RENAGEL IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
DO NOT TAKE RENAGEL AFTER THE
EXPIRY DATE (EXP) PRINTED ON THE
PACK HAS PASSED.
IF YOU TAKE THIS MEDICINE AFTER THE
EXPIRY DATE IT MAY HAVE NO EFFECT AT
ALL, OR WORSE, AN UNEXPECTED

Summary of Product characteristics

renagel-ccdsv05-ccdsv06-dsv18-20jun22
Page 1 NEW ZEALAND DATA SHEET
1
RENAGEL 800 MG FILM COATED TABLETS
Renagel 800 mg film coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Renagel 800 mg tablets contain 800 mg sevelamer hydrochloride.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Film coated tablets.
Renagel tablets are oval film coated tablets imprinted with "Renagel
800" for the 800 mg tablet on
one side and blank on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Renagel 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
DOSE
_STARTING DOSE _
The recommended starting dose for patients not taking a phosphate
binder is 800 to 1600 mg
(Table 1), which can be administered as one to two Renagel 800 mg
tablets with each meal based
on serum phosphorus level.
renagel-ccdsv05-ccdsv06-dsv18-20jun22
Page 2
TABLE 1 - STARTING DOSE FOR PATIENTS NOT TAKING A PHOSPHATE BINDER
SERUM PHOSPHORUS
RENAGEL 800 MG TABLETS
> 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
When patients are converting from a calcium based phosphate binder,
Renagel should be given in
equivalent doses on a (mg to mg) weight basis compared to the
patient’s previous calcium based
phosphate binder (Table 2). Serum phosphorus levels should be closely
monitored and the dose
of Renagel adjusted accordingly with the goal of lowering serum
phosphorus. Serum phosphorus
should be tested every 2 to 3 weeks until a stable serum phosphorus
level is reached, and on a
regular basis thereafter.
TABLE 2 - STARTING DOSE FOR PATIENTS SWITCHING FROM CALCIUM ACETATE TO
RENAGEL
CALCIUM ACETATE 667 MG
(TABLETS PER MEAL)
RENAGEL 800 MG
(TABLETS PER MEAL)
1 tablet
1 tablet
2 tablets
2 tablets
3 tablets
3 tablets
_DOSE TITRATION FOR ALL PATIENTS TAKING RENAGEL _
The dosage should be gra