Ondansetron 4mg orodispersible tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ondansetron

Available from:

Zentiva Pharma UK Ltd

ATC code:

A04AA01

INN (International Name):

Ondansetron

Dosage:

4mg

Pharmaceutical form:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 7311921243173

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Ondansetron
4mg and 8mg Orodispersible 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, nurse or
pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet
1. What Ondansetron Orodispersible Tablets are and what they
are used for
2. What you need to know before you take Ondansetron
Orodispersible Tablets
3. How to take Ondansetron Orodispersible Tablets
4. Possible side effects
5. How to store Ondansetron Orodispersible Tablets
6. Contents of the pack and other information
1. What Ondansetron Orodispersible Tablets are and what
they are used for
Ondansetron Orodispersible Tablets contain a medicine called
ondansetron. This belongs to a group of medicines called
anti-emetics. Ondansetron Orodispersible Tablets are a special
type of tablets that dissolves very quickly when put on top of the
tongue.
Ondansetron Orodispersible 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
Orodispersible Tablets
Do not take Ondansetron Orodispersible Tablets if:
•
you are taking apomorphine (used to treat Parkinson’s disease),
•
you are allergic to ondansetron or any of the other ingredients of
this medicine (listed in Section 6).
Warnings and precautions
Talk to your doctor, nurse or pharmacist

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ondansetron 4mg Orodispersible Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains ondansetron 4mg.
Excipient with known effect
Each orodispersible tablet contains 3mg aspartame.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablets.
Round, white to off-white, flat, bevelled edged, tablets plain on both
the surfaces,
having strawberry odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults: _
Ondansetron orodispersible tablets are indicated for the management of
nausea and
vomiting induced by cytotoxic chemotherapy and radiotherapy.
Ondansetron orodispersible tablets are indicated for the prevention of
post-operative
nausea and vomiting (PONV).
For treatment of established PONV, administration by injection is
recommended.
_Paediatric Population:_
_ _
Ondansetron 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:_ Ondansetron can be given
either by
rectal, oral (as orodispersible tablet, tablets or syrup) intravenous
or intramuscular
administration.
For oral administration: 8 mg 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