Keppra 100mgml oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levetiracetam

Available from:

UCB Pharma Ltd

ATC code:

N03AX14

INN (International Name):

Levetiracetam

Dosage:

100mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5024091711220 5015313013345 5015313013352

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KEPPRA 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 Keppra is and what it is used for
2.
What you need to know before you take Keppra
3.
How to take Keppra
4.
Possible side effects
5.
How to store Keppra
6.
Contents of the pack and other information
1.
WHAT KEPPRA IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Keppra 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

myoclonic seizures (short, shock-like jerks of a muscle or group of
muscles) in adults and
adolescents from 12 years of age with juvenile myoclonic epilepsy

primary generalised tonic-clonic seizures(major fits, including loss
of consciousness) in
adults and adolescents from 12 years of ag

Summary of Product characteristics

OBJECT 1
KEPPRA 100 MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 02-Jan-2017 | UCB Pharma
Limited
1. Name of the medicinal product
Keppra 100 mg/ml oral solution
2. Qualitative and quantitative composition
Each ml contains 100 mg levetiracetam
Excipients with known effect:
Each ml contains 2.7 mg of methyl parahydroxybenzoate (E218), 0.3 mg
of propyl parahydroxybenzoate
(E216) and 300 mg of maltitol liquid.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution.
Clear liquid.
4. Clinical particulars
4.1 Therapeutic indications
Keppra 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.
Keppra 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 up to 1,500 mg
twice daily. Dose changes can be made in 500 mg twice daily inc