Ondansetron 4 mg/5 ml syrup

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Ondansetron

Tilgjengelig fra:

Syri Pharma Limited t/a Thame Laboratories

ATC-kode:

A04AA; A04AA01

INN (International Name):

Ondansetron

Dosering :

4 mg/5ml

Legemiddelform:

Syrup

Terapeutisk område:

Serotonin (5HT3) antagonists; ondansetron

Autorisasjon status:

Marketed

Autorisasjon dato:

2018-08-17

Informasjon til brukeren

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ONDANSETRON 4MG/5ML SYRUP
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, nurse or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Ondansetron 4mg/5ml Syrup but it will be
referred as
Ondansetron throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Ondansetron is and what it is used for
2.
What you need to know before you take Ondansetron
3.
How to take Ondansetron
4.
Possible side effects
5.
How to store Ondansetron
6.
Contents of the pack and other information
1.
WHAT ONDANSETRON IS AND WHAT IT IS USED FOR
Ondansetron contains the active substance ondansetron hydrochloride
dihydrate. This belongs
to a group of medicines called anti-emetics.
Ondansetron is used for:

preventing nausea and vomiting caused by chemotherapy or radiotherapy
for cancer in
ADULTS

preventing nausea and vomiting after surgery in
ADULTS

preventing nausea and vomiting caused by chemotherapy for cancer in
CHILDREN AND
ADOLESCENTS
aged 6 months to 17 years
Ask your doctor, nurse or pharmacist if you would like any further
explanation about these
uses.
Ondansetron should start to work within one or two hours of taking a
dose. You must talk to
a doctor if you do not feel better or if you feel worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONDANSETRON
DO NOT TAKE ONDANSETRON IF:

you are taking apomorphine (used to treat Parkinson's Disease)

you are allergic (hypersensitive) to Ondansetron
or any of the other ingredients of this
medicine (listed in section 6). Signs of an allergic reactio

Preparatomtale

Health Products Regulatory Authority
29 August 2022
CRN00D0PY
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ondansetron 4 mg/5 ml syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml syrup contains 4mg ondansetron (as ondansetron hydrochloride
dihydrate).
Excipients with known effect:
Each 5ml syrup contains 2100mg of Sorbitol (E420), 6mg of sodium
benzoate (E211) and 14.1mg propylene glycol (E1520).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
Clear, colourless syrup with strawberry flavour
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
Management of nausea and vomiting induced by cytotoxic chemotherapy
and radiotherapy.
Prevention of post-operative nausea and vomiting.
PAEDIATRIC POPULATION
Management of chemotherapy-induced nausea and vomiting in children
aged ≥6 months.
No studies have been conducted in children on the use of orally
administered ondansetron in the prevention or treatment of
post-operative nausea and vomiting in children aged ≥ 1 month; IV
injection may be recommended for this purpose.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 (10 ml, i.e., two 5 ml spoonfuls)
1-2 hours before treatment, followed by 8 mg (10 ml, i.e.,
two 5 ml spoonfuls) orally 12 hours later.
Highly emetogenic chemotherapy:
For patients receiving highly emetogenic chemotherapy a single oral
dose of up to 24 mg (30 ml, i.e., six 5 ml spoonfuls)
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 treatment with ondansetron should
be continued for up to 5 days and rectal treatment