Zofran Zydis 4 mg oral lyophilisate

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Ondansetron

Fáanlegur frá:

Originalis B.V.

ATC númer:

A04AA; A04AA01

INN (Alþjóðlegt nafn):

Ondansetron

Skammtar:

4 milligram(s)

Lyfjaform:

Oral lyophilisate

Gerð lyfseðils:

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

Lækningarsvæði:

Serotonin (5HT3) antagonists; ondansetron

Leyfisdagur:

2018-12-21

Upplýsingar fylgiseðill

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, talk to your doctor, nurse or pharmacist before
taking Zofran Zydis.
WARNINGS AND PRECAUTIONS
Check with your doctor or pharmacist before taking Zofran Zydis if:
•
you have ever had heart problems
•
you have an uneven heart beat (arrhythmias)
•
you are allergic to medicines similar to ondansetron, such as
granisetron (known as ‘Kytril’)
•
you have liver problems
•
if you have a condition called phenylketonuria, which is an inability
to break down amino acids
•
you have a blockage in your gut
•
you have problems with the levels of salts in your blood, such as
potassium, sodium and magnesium.
If you are not sure if any of the above apply to you, talk to your

Vara einkenni

Health Products Regulatory Authority
21 December 2018
CRN008N0L
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 4 mg oral lyophilisate contains aspartame (E951), sodium methyl
parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate
(E217).
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 PA0896/036/007
5 PHARMACOLOGICAL PROPERTIES
As per PA0896/036/007
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Gelatin
Mannitol (E421)
Aspartame (E951)
Sodium methyl parahydroxybenzoate (E219)
Sodium propyl parahydroxybenzoate (E217)
Strawberry flavour (contains natural flavouring substances, artificial
flavouring
substances, propylene glycol (E1520))
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
21 December 2018
CRN008N0L
Page 2 of 2
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister and outer
carton of the product as marketed in the country of origin.
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.
Blisters of 10 Zofran Zydis oral lyophilisate dosage units.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE
MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF
THE
PRODUCT
DO NOT attempt to push Zofran Zydis through the lidding foil. PEEL
BACK the
lidding foil of one blister and GENTLY remove the Zofran Zydis. Place
the Zofran
Zydis on top of the tongue, where it will disperse within seconds,
then swallow.
Any unused product should be disposed of in accordance with local
requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER