Zofran Zydis 4 mg oral lyophilisate

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Ondansetron

Доступна з:

PCO Manufacturing Ltd.

Код атс:

A04AA01

ІПН (Міжнародна Ім'я):

Ondansetron

Дозування:

4 milligram(s)

Фармацевтична форма:

Oral lyophilisate

Терапевтична области:

ondansetron

Дата Авторизація:

2019-05-31

інформаційний буклет

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

Характеристики продукта

Health Products Regulatory Authority
06 December 2023
CRN00DZ5Q
Page 1 of 2
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 4 mg ondansetron.
Excipient(s) with known effect: Each 4mg Oral Lyophilisate contains
aspartame (E951), sodium methyl parahydroxybenzoate
(E219) and sodium propyl parahydroxybenzoate (E217) and 0.0015 mg of
ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral lyophilisate
_Product imported from Spain:_
White round oral lyophilisate.
4 CLINICAL PARTICULARS
As per PA0711/327/005
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Zofran Zydis 4 mg tablet contains less than 0.0015 mg of alcohol
(ethanol) in each 4 mg Oral lyophilisate tablet which is
equivalent to 0.1 % w/w.
The amount in one tablet of this medicine is equivalent to less than 1
ml of beer or 1 ml of wine. The small amount of alcohol
in this medicine will not have any noticeable effects.
5 PHARMACOLOGICAL PROPERTIES
As per PA0711/327/005
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Gelatin
Mannitol (E421)
Aspartame (E951)
Sodium methyl parahydroxybenzoate (E219)
Sodium propyl parahydroxybenzoate (E217)
Strawberry flavour. The strawberry flavour has the following
composition: artificial flavouring substances, natural flavouring
substances and propylene glycol (E1520)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister and outer package of the product on the market in
the country of origin.
Health Products Regulatory Authority
06 December 2023
CRN00DZ5Q
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C
Store in the original package in order to protect from light and
moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Double foil blister packs contained in an outer cardboard carton.
Blisters of 10 Zofran Zydis oral lyophilisate dosage units.
6.6 SPECIAL PRECAUTIONS