Ondansetron 8mg film-coated Tablet

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

ONDANSETRON HYDROCHLORIDE, DIHYDRATE

Prieinama:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

ATC kodas:

A04AA01

INN (Tarptautinis Pavadinimas):

ONDANSETRON HYDROCHLORIDE DIHYDRATE 8 mg

Vaisto forma:

FILM-COATED TABLET

Sudėtis:

ONDANSETRON HYDROCHLORIDE DIHYDRATE 8 mg

Recepto tipas:

POM

Gydymo sritis:

ANTIEMETICS AND ANTINAUSEANTS

Autorizacija statusas:

Withdrawn

Leidimo data:

2019-04-08

Pakuotės lapelis

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ONDANSETRON 4MG AND 8MG 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, please ask your doctor 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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What Ondansetron Tablets are and what they are used for
2.
What you need to know before you take Ondansetron Tablets
3.
How to take Ondansetron Tablets
4.
Possible side effects
5.
How to store Ondansetron Tablets
6.
Contents of the pack and other information
The name of your medicine is Ondansetron 4 mg Film-Coated Tablets and
8 mg Film-Coated
Tablets (also referred to as Ondansetron Tablets throughout this
leaflet).
1. WHAT ONDANSETRON TABLETS ARE AND WHAT THET ARE USED FOR
Ondansetron tablets contain a medicine called ondansetron. This
belongs to a group of medicines
called anti-emetics.
Ondansetron tablets are used for:
•
preventing nausea and vomiting caused by chemotherapy (in adults and
children) or
radiotherapy for cancer (adults only)
•
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 ONDANSETRON TABLETS
DO NOT TAKE ONDANSETRON TABLETS
•
If you are taking apomorphine (used to treat Parkinson’s disease).
•
If you are allergic (hypersensitive) to ondansetron or any of the
other ingredients in Ondansetron
tablets (listed in Section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before
taking Ondansetron tablets.
WARNINGS AND PRECAUTIONS
Talk to your do

Prekės savybės

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ondansetron 8mg Film-Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8mg of ondansetron (as hydrochloride dihydrate).
Excipient(s) with known effect
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 with ‘42’
embossed on one side.
_ _
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Adults
Ondansetron hydrochloride is indicated for the management of nausea
and vomiting induced
by cytotoxic chemotherapy and radiotherapy.
Ondansetron Hydrochloride is indicated for the prevention of
post-operative nausea and
vomiting (PONV). For treatment of established PONV, administration by
injection is
recommended.
_ _
Paediatric Population
Ondansetron hydrochloride 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
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING_ _
_ADULTS:_
The emetogenic potential of cancer treatment varies according to the
doses and combinations of
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chemotherapy and radiotherapy regimens used. The selection of dose
regimen should be
determined by the severity of the emetogenic challenge.
_Emetogenic chemotherapy and radiotherapy_
: Ondansetron hydrochloride can be given
either by rectal, oral (tablets or syrup), intravenous, or
intramuscular administration.
For oral administration: 8mg taken 1 to 2 hours before chemotherapy or
radiation treatment,
followed by 8 mg every 12 hours for a maximum of 5 days to protect
against delayed or
prolonged emesis.
For highly emetogenic chemotherapy: a single dose of up to 24 mg
ondansetron
hydrochloride taken with