Zofran 8mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Ondansetron hydrochloride dihydrate

Inapatikana kutoka:

Novartis Pharmaceuticals UK Ltd

ATC kanuni:

A04AA01

INN (Jina la Kimataifa):

Ondansetron hydrochloride dihydrate

Kipimo:

8mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 04060000; GTIN: 5000123105182

Taarifa za kipeperushi

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Perigord
03 Aug 2022
1
300032512
LEAFLET_ZOFRAN_FCT_ALL_GB
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CM, DE, BAD OLDESLOE, ASPEN (IM)
Frutiger LT Pro
8 pt
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOFRAN
® TABLETS 4 MG AND 8 MG
ONDANSETRON (AS HYDROCHLORIDE DIHYDRATE)
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.
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

Tabia za bidhaa

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).
Excipient(s) 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 with "GX ET5" 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
Posology
Chemotherapy and radiotherapy induced nausea and vomiting (CINV and
RINV)
_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.
The recommended oral dose is 8mg 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
Zofran taken with 12
mg oral dexamethasone sodium phosphate, 1 to 2 hou