ZOFRAN TABLET 8MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ONDANSETRON HYDROCHLORIDE DIHYDRATE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ONDANSETRON HYDROCHLORIDE DIHYDRATE

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

Aspen Bad Oldesloe GmbH

Risalah maklumat

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
ZOFRAN
™ TABLET
_ _
Ondansetron hydrochloride dihydrate (4mg, 8mg)
1
WHAT IS IN THIS LEAFLET
1.
What ZOFRAN is used for
2.
How ZOFRAN works
3.
Before you use ZOFRAN
4.
How to use ZOFRAN
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
ZOFRAN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ZOFRAN IS USED FOR
It is used to prevent and manage
nausea (feeling sick) and
vomiting (being sick), which can
occur:
•
during treatment for cancer
(chemotherapy or
radiotherapy)
•
after an operation
HOW ZOFRAN WORKS
Zofran belongs to a group of
medicines called anti-emetics.
Ondansetron is a 5HT
3
receptor
antagonist. It works by
inhibiting the 5HT
3
receptors on
neurons located in peripheral
and central nervous system of
the body.
BEFORE YOU USE ZOFRAN
-
_When you must not use it _
Do not take Zofran
•
if you are taking apomorphine
(used to treat Parkinson’s
disease, a movement disorder)
•
if you are allergic
(hypersensitive) to
ondansetron or any other
ingredients of Zofran
If you think this applies to you,
do not use Zofran until you have
checked with your doctor.
-
_Before you start to use it _
Before you use Zofran your
doctor needs to know:
•
if you are allergic to
medicines similar to Zofran,
such as medicines containing
_granisetron_
or
_palonosetron_
•
if you have ever had heart
problems, such as an irregular
heartbeat (arrhythmia)
•
if you have bowel problems
•
if you have liver disease, your
doctor may lower your dose of
Zofran
•
if you are taking other
medicines (interactions with
other medicinal products
including vaccines or
biologics)
Check with your doctor if you
think any of these may apply to
you.
_Pregnancy and breast-feeding _
Zofran is not recommended for
use during pregnancy.
•
Tell your doctor if you are
pregnant or planning to
become pregnant. Zofran may
harm your unborn baby.
•
If you do become pregnant
during treatment with Zofran,
tell your docto

Ciri produk

Novartis
Page 2
Malaysia Package Leaflet
10-Mar-2021
ZOFRAN™
ZOFRAN™
Serotonin (5HT
3
) antagonist
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
TABLETS:
Ondansetron tablets 4 mg: Yellow, oval, film-coated tablet engraved
with 'GX ET3’. Each
tablet contains ondansetron 4 mg as hydrochloride dihydrate.
Ondansetron tablets 8 mg: Yellow, oval, film-coated tablet engraved
with 'GX ET5'. Each tablet
contains ondansetron 8 mg as hydrochloride dihydrate.
ACTIVE SUBSTANCE
Ondansetron/Ondansetron hydrochloride dihydrate
EXCIPIENTS
Lactose
Microcrystalline cellulose
Pregelatinized maize starch
Magnesium stearate
Methyl hydroxypropyl cellulose
Titanium dioxide (E171)
Iron oxide (E172)
INDICATIONS
ADULTS
ZOFRAN oral formulations are indicated for the management of nausea
and vomiting
induced by cytotoxic chemotherapy and radiotherapy.
ZOFRAN is also indicated for the prevention of post-operative nausea
and vomiting.
PAEDIATRIC POPULATION
_ORAL FORMULATION: _
ZOFRAN is indicated for the management of nausea and vomiting induced
by cytotoxic
chemotherapy.
No studies have been conducted on the use of orally administered
ondansetron in the prevention
or treatment of post-operative nausea and vomiting.
Novartis
Page 3
Malaysia Package Leaflet
10-Mar-2021
ZOFRAN™
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING
(CINV AND RINV)
The emetogenic potential of cancer treatment varies according to the
doses and combinations
of chemotherapy and radiotherapy regimens used. The selection of dose
regimen should be
determined by the severity of the emetogenic challenge.
CINV AND RINV IN ADULTS
The recommended oral dose is 8 mg taken 1 to 2 hours before
chemotherapy or radiation
treatment, followed by 8 mg orally every 12 hours for a maximum of 5
days.
For highly emetogenic chemotherapy a single oral dose of up to 24 mg
ondansetron taken
together with 12 mg oral dexamethasone sodium phosphate, 1 to 2 hours
before chemotherapy,
may be used. After the first 24 hours, oral treatm