Emizof 4 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ondansetron

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

A04AA; A04AA01

INN (International Name):

Ondansetron

Dosage:

4 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Serotonin (5HT3) antagonists; ondansetron

Authorization status:

Not marketed

Authorization date:

2006-09-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EMIZOF 4 MG FILM-COATED TABLETS
EMIZOF 8 MG FILM-COATED TABLETS
Ondansetron
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Emizof are and what they are used for
2.
What you need to know before you take Emizof
3.
How to take Emizof
4.
Possible Side effects
5.
How to store Emizof
6.
Contents of the pack and other information
1.
WHAT EMIZOF IS AND WHAT IT IS USED FOR
Ondansetron belongs to a group of medicines known as anti-emetics or
anti-sickness medicines.
Emizof is used for:
-
preventing nausea (feeling sick) and vomiting (being sick) caused by
chemotherapy or
radiotherapy treatment for cancer (in adults and children aged 6
months or over).
-
preventing nausea and vomiting after surgery (adults only).
Ask your doctor, nurse or pharmacist if you would like any further
explanation about these uses.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EMIZOF
DO NOT TAKE EMIZOF:
-
if you are allergic to ondansetron or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are allergic to anti-sickness medicines belonging to the group
selective serotonin (5-
HT
3
)-receptor antagonists (e.g. granisetron, dolasetron), because in such
a case you may also
be allergic to ondansetron.
-
if you are taking apomorphine (used to treat Parkinson’s disease).
If you are not sure, talk to your doctor, nurse or pharmacist before
taking Emizof.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before taking Emizof:
-
if you ha

Summary of Product characteristics

Health Products Regulatory Authority
10 March 2020
CRN009LQQ
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emizof 4 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 4mg ondansetron (as ondansetron
hydrochloride dihydrate).
Excipient with known effect:
Each tablet contains 84.5 mg of lactose monohydrate. For the full list
of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pale yellow, round, biconvex, film-coated tablets embossed with
identification marking “41” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults:
Emizof is indicated for the management of nausea and vomiting induced
by cytotoxic chemotherapy and radiotherapy, and for
the prevention and treatment of post-operative nausea and vomiting
(PONV).
For treatment of established PONV, administration by injection is
recommended.
Paediatric Population:
Emizof is indicated for the management of chemotherapy-induced nausea
and vomiting (CINV) in children aged ≥ 6 months.
No studies have been conducted on the use of orally administered
ondansetron in the prevention and treatment of PONV in
children aged ≥ 1 month, administration by IV injection is
recommended for this purpose.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING
_Adults_
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.
Emetogenic chemotherapy and radiotherapy
Emizof can be given either by oral or intravenous administration.
For oral administration: 8 mg taken 1-2 hours before treatment,
followed by 8 mg every 12 hours for a maximum of 5 days to
protect against delayed or prolonged emesis.
Highly emetogenic chemotherapy
The recommended oral dose is a single dose of up to 24 mg taken with
12 mg oral dexamethasone sodium phospha