Ondran 4 mg film-coated tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Ondansetron

Verfügbar ab:

Pinewood Laboratories Ltd

ATC-Code:

A04AA; A04AA01

INN (Internationale Bezeichnung):

Ondansetron

Dosierung:

4 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

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

Therapiebereich:

Serotonin (5HT3) antagonists; ondansetron

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2005-12-22

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
ONDRAN 4 MG FILM-COATED TABLETS
ONDRAN 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, pharmacist or
nurse.
⎯
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 Ondran is and what it is used for
2.
What you need to know before you take Ondran
3.
How to take Ondran
4.
Possible side effects
5.
How to store Ondran
6.
Contents of the pack and other information
1. WHAT ONDRAN IS AND WHAT IT IS USED FOR
Ondran belongs to a group of medicines called anti-emetics. Ondran
inhibits the effect of the neuro-
transmitter serotonin in the brain. Serotonin causes nausea and
vomiting.
Ondran is used for
−
Preventing and treating nausea and vomiting induced by cytotoxic
chemotherapy (CINV) and
radiotherapy (adults and children aged ≥ 6 months).
−
Preventing and treating nausea and vomiting in patients following an
operation (PONV) (in adults
and children aged ≥ 1 month).
Your doctor may have prescribed Ondran for another use. Always follow
your doctor's advice.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONDRAN
DO NOT TAKE ONDRAN:
⎯
if you are allergic to ondansetron or any of the other ingredients of
this medicine (listed in section
6).
⎯
if you have previously experienced allergy to other medicines
belonging to the group of serotonin
antagonists (e.g. granisetron, dolasetron). If this is the case, it is
possible that you are also allergic
to ondansetron.
⎯
if you are taking apomorphine (used to treat Parkinson's disease).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharm

Fachinformation

Health Products Regulatory Authority
22 June 2022
CRN00CTKK
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ondran 4 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ondran 4 mg
Each film-coated tablet contains 4 mg ondansetron (as hydrochloride
dihydrate).
_Excipients with known effect _
Each film-coated tablet contains 84.50 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
4 mg: pale yellow, round, biconvex, film-coated tablet embossed with
"41" on one side, diameter 7.2 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
Management of nausea and vomiting induced by cytotoxic chemotherapy
and radiotherapy
Prevention and treatment of post-operative nausea and vomiting (PONV).
Paediatric population
Management of chemotherapy-induced nausea and vomiting (CINV) in
children aged ≥ 6 months.
Prevention and treatment of post-operative nausea and vomiting in
children aged ≥ 1 month.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For the different dose regimens appropriate strengths and formulations
are available.
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 route of administration and dose of
Ondansetron should be flexible and selected as shown
below.
_Emetogenic chemotherapy and radiotherapy_
For patients receiving emetogenic chemotherapy or radiotherapy
ondansetron can be given either by oral or intravenous
administration.
For most patients receiving emetogenic chemotherapy or radiotherapy,
ondansetron should initially be administered
intravenously immediately before treatment, followed by 8 mg orally
twelve hourly.
For oral administration: 8 mg 1-2 hours before treatment, followed by
8 mg orally 12 hours later.
To protect against delayed or prolonged emesis after the first 24
hours, oral treatment with ondansetron shou