Ondansetron 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ondansetron hydrochloride dihydrate

Available from:

Bristol Laboratories Ltd

ATC code:

A04AA01

INN (International Name):

Ondansetron hydrochloride dihydrate

Dosage:

4mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5060013941467

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
Ondansetron belongs to a group of medicines
called anti-emetics, drugs against feeling sick
(nausea) or being sick (vomiting).
This medicine is used for:
• preventing nausea (feeling sick) and vomiting
(being sick) caused by chemotherapy (in adults
and children) or radiotherapy for cancer
(adults only),
• preventing nausea and vomiting after surgery
(adults only).
DO NOT TAKE ONDANSETRON
• if you are taking apomorphine, a medicine
used to treat Parkinson's disease,
• if 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 or pharmacist before taking
Ondansetron:
• if you have ever had heart problems (e.g.
congestive heart failure which causes
shortness of breath and swollen ankles),
• if you have an uneven heart beat (arrhythmias),
• if you are allergic to medicines similar to
ondansetron, such as granisetron or
palonosetron,
• if you have liver problems,
• if you suffer from any blockage in your gut or
if you have severe constipation,
• if your blood levels of potassium or
magnesium are reduced,
• if you are having your tonsils out.
OTHER MEDICINES AND ONDANSETRON
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines that you buy
without a prescription and herbal medicines.
This is because Ondansetron 4 mg / 8 mg
Film-coated Tablets can affect the way some
medicines work. Also some other medicines can
affect the way Ondansetron 4 mg / 8 mg
Film-coated Tablets works.
In particular, tell your doctor or pharmacist:
• if you are taking phenytoin, carbamazepine
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
(used to treat epilepsy or other illnesses), or
rifampicin (used to treat c

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ondansetron 4 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains ondansetron hydrochloride dihydrate
equivalent to 4 mg ondansetron.
Excipients with known effect:
Each film-coated tablet contains 74.25 mg of lactose (as anhydrous and
as
monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, oval shaped, plain on both sides
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
(PONV).
For treatment of established PONV, administration by injection is
recommended.
Paediatric population:
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 (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 to 24 mg
ondansetron
tablet taken with 12 mg oral dexamethasone sodium phosphate, 1 to 2
hours
before chemotherapy, may be used.
To protect against delayed or prolonged emesis