Zofran Zydis 4 mg oral lyophilisate

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Ondansetron

Inapatikana kutoka:

Novartis Ireland Limited

ATC kanuni:

A04AA; A04AA01

INN (Jina la Kimataifa):

Ondansetron

Kipimo:

4 milligram(s)

Dawa fomu:

Oral lyophilisate

Dawa ya aina:

Product subject to prescription which may not be renewed (A)

Eneo la matibabu:

Serotonin (5HT3) antagonists; ondansetron

Idhini hali ya:

Marketed

Idhini ya tarehe:

1998-07-13

Taarifa za kipeperushi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOFRAN® ZYDIS 4 MG AND 8 MG ORAL LYOPHILISATE
ondansetron
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 signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1
What Zofran Zydis is and what it is used for
2
What you need to know before you take Zofran Zydis
3
How to take Zofran Zydis
4
Possible side effects
5
How to store Zofran Zydis
6
Contents of the pack and other information
1.
WHAT ZOFRAN ZYDIS IS AND WHAT IT IS USED FOR
Zofran Zydis contains a medicine called ondansetron. This belongs to a
group of medicines called
anti-emetics. Zofran Zydis is a special type of Zofran tablet that
dissolves very quickly when put on
top of the tongue.
Zofran Zydis is used for:
• preventing nausea and vomiting caused by chemotherapy or
radiotherapy for cancer in ADULTS
• preventing nausea and vomiting after surgery in ADULTS
• preventing nausea and vomiting caused by chemotherapy for cancer
in CHILDREN AND ADOLESCENTS
aged 6 months to 17 years
Ask your doctor, nurse or pharmacist if you would like any further
explanation about these uses.
Zofran Zydis should start to work within one or two hours of taking a
dose. You must talk to a doctor
if you do not feel better or if you feel worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOFRAN ZYDIS
DO NOT TAKE ZOFRAN ZYDIS IF:
•
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 Zydis
(listed in Section 6).
If you are not sure, t

Tabia za bidhaa

Health Products Regulatory Authority
17 June 2022
CRN00CV6M
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zofran Zydis 4 mg oral lyophilisate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Zofran Zydis oral lyophilisate contains ondansetron 4 mg
Excipients with known effect:
Each 4 mg Oral Lyophilisate contains
625 micrograms of aspartame (E951),
56 micrograms sodium methyl parahydroxybenzoate (E219)
6.9 micrograms of sodium propyl parahydroxybenzoate (E217).
0.031 mg Ethanol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral lyophilisate.
White round tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
Zofran Zydis is indicated for the management of nausea and vomiting
induced by cytotoxic chemotherapy and radiotherapy.
Zofran Zydis is also indicated for the prevention of post-operative
nausea and vomiting.
PAEDIATRIC POPULATION
Orally administered Zofran is indicated for the management of nausea
and vomiting induced by cytotoxic chemotherapy in
children and adolescents aged from 6 months to 17 years.
No studies have been conducted in children on the use of orally
administered Zofran in the prevention or treatment of
post-operative nausea and vomiting; IV injection may be recommended
for this purpose.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Zofran is also available for parenteral and rectal use to allow the
route of administration and dosing to be flexible.
Place the Zofran Zydis on top of the tongue, where it will disperse
within seconds, then swallow.
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV AND
RINV):
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.
_CINV AND RINV IN ADULTS:_
The recommended oral dose is 8mg taken 1-2 hours before chemotherapy
or radiation treatment, followed by 8mg orally
every 12 hours for a maximum of 5 days.
H