Zofran 8mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ondansetron hydrochloride dihydrate

Available from:

Sigma Pharmaceuticals 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

ZOFRAN
® 4 MG TABLETS
ZOFRAN
® 8 MG TABLETS
(ondansetron hydrochloride dihydrate)
PATIENT INFORMATION LEAFLET
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 about your illness or your medicine,
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 symptoms are the same as
yours.
-
If any of the side effects get serious, or if you notice any side
effects not
listed in this leaflet, please tell 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 Zofran 4mg Tablets or Zofran 8mg Tablets
but will be referred to as Zofran tablets throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Zofran tablets are and what they are used for
2. What you need to know before you take Zofran tablets
3. How to take Zofran tablets
4. Possible side effects
5. How to store Zofran tablets
6. Contents of the pack and other information
1. WHAT ZOFRAN TABLETS ARE AND WHAT THEY ARE USED FOR
Zofran tablets contain a medicine called ondansetron. This belongs to
a
group of medicines called anti-emetics.
Zofran 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 ZOFRAN
TABLETS
DO NOT TAKE ZOFRAN TABLETS IF:
-
you are taking apomorphine (used to treat Parkinson’s disease)
-
you are allergic (hypersensitive) to ondansetron or any of the other
ingredients in Zofran tablets (listed in Section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before
taking
Zofran tablets.
WARNINGS AND PRECAUTION

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zofran Tablets 8 mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ondansetron 8 mg (as hydrochloride dihydrate).
Excipients with known effect: Contains Lactose (anhydrous) 163.75 mg
(see
section 4.4).
For the full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Film coated tablet.
Yellow, oval, film coated tablet engraved "GXET5" on one face and
plain on
the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults: _
Zofran tablets are indicated for the management of nausea and vomiting
induced by cytotoxic chemotherapy and radiotherapy.
Zofran 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: _
Zofran 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
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:_ Zofran can be given either
by rectal,
oral (tablets or syrup), intravenous or intramuscular administration.
For oral administration: 8mg taken1 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
Zofran taken with
12 mg oral dexamethasone sodium phosphate, 1 to 2 hours before
chemotherapy, may
be used.