Ondansetron 4mg orodispersible tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ondansetron

Available from:

Aristo Pharma 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: 4251575902336

Patient Information 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
This medicine contains Ondansetron, which belongs to a group
of medicines called anti-emetics which help to stop you feeling
or being sick.
Ondansetron is used to treat nausea (feeling sick) and vomiting
(being sick) caused by some medical treatments, such as
chemotherapy or radiotherapy for cancer (in adults and
children). It is also used to prevent nausea and vomiting in
patients following an operation (adults only).
2. What you need to know before you take
Ondansetron
Do not take Ondansetron
• if you are allergic to ondansetron, benzyl alcohol, sulphites or
any of the other ingredients of this medicine (listed in section 6
“Contents of the pack and other information”)
• if you are taking apomorphine (a medicine used to treat
Parkinson’s disease).
Do not give the tablets to children with a body surface area of
less than 0.6 m
2
or weighing up to 10 kg.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ondansetron
• if you are allergic to medicines (5-HT
3
antagonists) similar to
ondansetron
• if you are due to have surgery to the adenoids or tonsils
• if you have heart problems including irregular heartbeat
(arrhythmia)
• if you are taking certain medicines to treat depression and/or
anxiety (selective serotonin reuptake inhibitors [SSRIs] such as
fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram and
escitalopram or selective noradrenaline reuptake inhibitors
[SNRIs] such as venlafaxine or duloxetine)
• if you have digestive problems
• if you have liver problems, in which case your doctor will
possibly reduce your ondansetron dose
• if you have problems with salt levels in your blood (electrolyte
disorders), e.g. potassium and magnesium.
If you think any of the a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ondansetron 4 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
One orodispersible tablet contains 4 mg ondansetron.
Excipients with known effect:
Each orodispersible tablet contains 9.5 mg lactose (as lactose
monohydrate) and 3 mg
aspartame (E951).
This medicine contains up to 100 microgram benzyl alcohol in each
orodispersible tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orodispersible tablet.
_ _
White to off-white, round tablets debossed with ‘5’ on one side
and ‘E’ on the other
side with an embossed circular edge
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Ondansetron 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).
Paediatric population
Ondansetron is indicated for the management of chemotherapy-induced
nausea and vomiting
(CINV) in children aged
≥
6 months, and for the prevention and treatment of PONV in
children aged
≥
1 month.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Chemotherapy and radiotherapy induced nausea and vomiting
The emetogenic potential of cancer treatment varies according to the
doses and combinations
of chemotherapy and radiotherapy regimens used. Selection of the dose
and dosing regimen
must therefore be guided by the emetogenic potential.
_ _
_Adults_
The recommended oral dose is 8 mg, taken 1-2 hours prior to
chemotherapy or radiation,
followed by 8 mg orally every 12 hours over a maximum of 5 days.
In highly emetogenic chemotherapy, a single oral dose up to a maximum
of 24 mg
ondansetron can be given orally together with 12 mg
dexamethasone-21-dihydrogen
phosphate disodium salt or equivalent 1 to 2 hours prior to
chemotherapy. After the first
24 hours, ondansetron treatment can be continued orally for up to 5
days after a course of
treatment. The recommended dose is 8 mg twice daily.
For