Levetiracetam Brillpharma 100 mg/ml oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levetiracetam

Available from:

Brillpharma (Ireland) Limited

ATC code:

N03AX; N03AX14

INN (International Name):

Levetiracetam

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Therapeutic area:

Other antiepileptics; levetiracetam

Authorization status:

Not marketed

Authorization date:

2017-03-24

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM BRILLPHARMA 100 MG/ML ORAL SOLUTION
LEVETIRACETAM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 Levetiracetam Oral Solution is and what it is used for
2. What you need to know before you take Levetiracetam Oral Solution
3. How to take Levetiracetam Oral Solution
4. Possible side effects
5. How to store Levetiracetam Oral Solution
6. Contents of the pack and other information
1. WHAT LEVETIRACETAM ORAL SOLUTION IS AND WHAT IT IS USED FOR
The name of your medicine is Levetiracetam 100mg/ml Oral Solution and
is referred as
‘Levetiracetam Oral Solution’ throughout the leaflet.
Levetiracetam 100 mg/ml Oral Solution is an antiepileptic medicine (a
medicine used to
treat seizures in epilepsy).
Levetiracetam is used:
• on its own in adults and adolescents from 16 years of age with
newly diagnosed
epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition
where the patients
have repeated fits (seizures). Levetiracetam is used for the epilepsy
form in which the
fits initially affect only one side of the brain, but could thereafter
extend to larger areas
on
both
sides
of
the
brain
(partial
onset
seizure
with
or
without
secondary
generalisation). Levetiracetam has been given to you by your doctor to
reduce the
number of fits.
• as an add-on to other antiepileptic medicines to treat:
- partial onset seizures with or without generalisation in adults,
adolescents, children and
infants from one month of age

Summary of Product characteristics

Health Products Regulatory Authority
02 July 2021
CRN00CD72
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levetiracetam Brillpharma100 mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 100 mg Levetiracetam.
Excipients with known effect:
Each ml of solution contains 1.5 mg of methyl parahydroxybenzoate
(E218), 0.18 mg of propyl parahydroxybenzoate (E216)
and 300 mg of liquid maltitol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
A clear, colourless grape flavoured liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levetiracetam is indicated as monotherapy in the treatment of partial
onset seizures with or without secondary generalisation
in adults and adolescents from 16 years of age with newly diagnosed
epilepsy.
Levetiracetam is indicated as adjunctive therapy:

in the treatment of partial onset seizures with or without secondary
generalisation in adults, adolescents, children
and infants from 1 month of age with epilepsy.

in the treatment of myoclonic seizures in adults and adolescents from
12 years of age with Juvenile Myoclonic
Epilepsy.

in the treatment of primary generalised tonic-clonic seizures in
adults and adolescents from 12 years of age with
Idiopathic Generalised Epilepsy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Monotherapy for adults and adolescents from 16 years of age_
The recommended starting dose is 250 mg twice daily which should be
increased to an initial therapeutic dose of 500 mg twice
daily after two weeks. The dose can be further increased by 250 mg
twice daily every two weeks depending upon the clinical
response. The maximum dose is 1500 mg twice daily.
_Add-on therapy for adults (≥ 18 years) and adolescents (12 to 17
years) weighing 50 kg or more_
The initial therapeutic dose is 500 mg twice daily. This dose can be
started on the first day of treatment.
Depending upon the clinical response and tolerability, the daily dose
can be increased u