Zarontin 250mg/5ml Syrup

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Ethosuximide

Tilgjengelig fra:

Originalis B.V.

ATC-kode:

N03AD01

INN (International Name):

Ethosuximide

Legemiddelform:

Syrup

Terapeutisk område:

ethosuximide

Autorisasjon dato:

2024-01-05

Informasjon til brukeren

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, ask your doctor 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 or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Zarontin is and what it is used for
2.
What you need to know before you take Zarontin
3.
How to take Zarontin
4.
Possible side effects
5.
How to store Zarontin
6.
Contents of the pack and other information
1.
What Zarontin is and what it is used for
Zarontin contains the active substance ethosuximide which is one of a
group of
medicines called anti-epileptic drugs; these medicines are used to
treat epilepsy.
Zarontin can be used for the treatment of absence seizures (a form of
epilepsy) in
adults, elderly and children and may be taken with other
anti-epileptic drugs.
You should consult your doctor if you are unsure why you have been
given
Zarontin 250 mg/5ml Syrup, if you do not feel better or if you feel
worse.
2.
What you need to know before you take Zarontin Do not take Zarontin:
•
if you are allergic to ethosuximide, or any of the other ingredients
in
this medicine (listed in section 6).
Warnings and precautions
Serious skin reactions including Stevens-Johnson syndrome and drug
reaction
with eosinophilia and systemic symptoms (DRESS) have been reported in
association with Zarontin treatment. Stop using Zarontin and seek
medical
attention immediately if you notice any of the symptoms described in
section 4.
These symptoms often occur within 28 days of starting this medicine,
but can
happen later.
Talk to your doctor or pharmacist before taking Zarontin if you suffer
from or have
suffered in the past from any of the following conditions

Preparatomtale

Health Products Regulatory Authority
09 January 2024
CRN00DWQW
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zarontin 250mg/5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 250 mg ethosuximide.
Excipients with known effect:
Each 5 ml contains 3 g sucrose, 5 mg glucose, 12 mg sodium benzoate
(E211) and 42 mg propylene glycol (E1520).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
_Product imported from Belgium. _
A clear, slightly yellowish to slightly pinkish, dye-free, raspberry
flavoured syrup.
4 CLINICAL PARTICULARS
As per PA22644/005/001
5 PHARMACOLOGICAL PROPERTIES
As per PA22644/005/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium citrate
Sodium benzoate (E211)
Saccharin sodium
Sucrose
Glycerol
Raspberry flavour including (contains glucose and propylene glycol (E
1520))
Citric acid monohydrate
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the bottle and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C
Health Products Regulatory Authority
09 January 2024
CRN00DWQW
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Amber glass bottle with child-resistant cap. Each unit contains 200 ml
and is placed in folding carton with a measuring cup
graduated 15 ml.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Originalis B.V.
Joop Geesinkweg 901
1114 AB Amsterdam-Duivendrecht
Netherlands
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA2306/031/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 5
th
January 2024
10 DATE OF REVISION OF THE TEXT