Ondansetron 8mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ondansetron hydrochloride dihydrate

Available from:

Waymade Healthcare Plc

ATC code:

A04AA01

INN (International Name):

Ondansetron hydrochloride dihydrate

Dosage:

8mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000

Patient Information leaflet

Product:
Ondansetron 4mg & 8mg Tablets
Item Code:
P1412T
Size:
240 x 400 mm
Min. Point size:
9pt
O. Artwork:
06/04/20
Proof No.
2
Amendment Date:
07/04/20
Process Black
Keyline - Does not print
Colours Used
ONDANSETRON 4MG AND 8MG TABLETS
Ondansetron hydrochloride dihydrate
PACKAGE LEAFLET: INFORMATION FOR THE USER
•
you have a blockage in your gut
•
you have problems with the levels of salts in your blood, such as
potassium, sodium and magnesium.
•
you have liver problems
•
you have an uneven heart beat (arrhythmias)
•
you are allergic to medicines similar to ondansetron, such as
granisetron (known as 'Kytril') or palonosetron.
OTHER MEDICINES AND ONDANSETRON TABLETS
Tell your doctor, nurse 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
can affect the way some medicines work. Also some other medicines can
affect the way Ondansetron works.
The liver function for persons under 18 years of age taking
Ondansetron
Tablets should be regularly checked.
There are known interaction between the following medications and
Ondansetron therefore there use with Ondansetron Tablets is not
recommended.
If you are not sure if any of the above apply to you, talk to your
doctor,
nurse or pharmacist before taking Ondansetron Tablets
•
rifampicm used to treat infections such as tuberculosis (TB), it
lowers
the concentration of ondansetron,
CHILDREN AND ADOLESCENTS
•
carbamazepine or phenytoin used to treat epilepsy, as it lowers the
concentration of ondansetron,
•
antibiotics such as erythromycin and antifungals such as ketoconazole
•
anti-arrhythmic medicines used to treat an uneven heartbeat, as
ondansetron prevents medication from working,
•
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, PHARMACIST OR
NURSE.THL

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ondansetron 8 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ondansetron 8 mg (as the hydrochloride
dihydrate).
Excipient: Lactose monohydrate.
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet (Tablet).
Ondansetron 8 mg Tablets are white, circular, biconvex film-coated
tablets
with a breakline on one side, plain on the other. The breakline is
only to
facilitate breaking if necessary for ease of swallowing and not to
divide into
equal doses
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ADULTS: _
_ _
Ondansetron is indicated for the management of nausea and vomiting
induced
by cytotoxic chemotherapy and radiotherapy.
Ondansetron is indicated for the prevention and treatment 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, and for the
prevention and treatment of PONV in children aged
≥
1 month, administration
by injection is recommended
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. The route of administration and dose of ondansetron should
be
flexible in the range of 8-32mg a day and selected as shown below.
_Emetogenic Chemotherapy and Radiotherapy_: Ondansetron can be given
either
by rectal, oral (tablets or syrup), intravenous or intramuscular
administration,
using either Ondansetron 4 mg and 8 mg Tablets or other
commercially-available
ondansetron presentations.
For oral administration: 8mg 1-2 hours before chemotherapy or
radiation
treatme