Levetiracetam 1g tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levetiracetam

Available from:

Accord Healthcare Ltd

ATC code:

N03AX14

INN (International Name):

Levetiracetam

Dosage:

1gram

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5060149316177

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM ACCORD 250 MG FILM-COATED TABLETS
LEVETIRACETAM ACCORD 500 MG FILM-COATED TABLETS
LEVETIRACETAM ACCORD 750 MG FILM-COATED TABLETS
LEVETIRACETAM ACCORD 1000 MG FILM-COATED TABLETS
LEVETIRACETAM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
TAKING THIS MEDICINEBECAUSE 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 sideeffects
not listed in this leaflet.See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Levetiracetam Accord is and what it is used for
2.
What you need to know before you take Levetiracetam Accord
3.
How to take Levetiracetam Accord
4.
Possible side effects
5.
How to store Levetiracetam Accord
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM ACCORD IS AND WHAT IT IS USED FOR
Levetiracetam Accord is an antiepileptic medicine (a medicine used to
treat seizures in epilepsy).
Levetiracetam Accord is used

on its own in adults and adolescents from 16 years of age with newly
diagnosed epilepsy, to treata
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 o

Summary of Product characteristics

OBJECT 1
LEVETIRACETAM ACCORD FILM-COATED TABLETS
Summary of Product Characteristics Updated 16-Dec-2016 | Accord
Healthcare Limited
1. Name of the medicinal product
Levetiracetam Accord 250 mg film-coated tablets
Levetiracetam Accord 500 mg film-coated tablets
Levetiracetam Accord 750 mg film-coated tablets
Levetiracetam Accord 1000 mg film-coated tablets
2. Qualitative and quantitative composition
Levetiracetam Accord 250 mg film-coated tablets
Each film-coated tablet contains 250 mg levetiracetam
Levetiracetam Accord 500 mg film-coated tablets
Each film-coated tablet contains 500 mg levetiracetam
Levetiracetam Accord 750 mg film-coated tablets
Each film-coated tablet contains 750 mg levetiracetam
Excipient with known effect:
Each film-coated tablet contains 0.013 mg of sunset yellow FCF (E110)
Levetiracetam Accord 1000 mg film-coated tablets
Each film-coated tablet contains 1000 mg levetiracetam
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
The tablet can be divided into equal halves
Levetiracetam Accord 250 mg film-coated tablets
White to off white, oval, biconvex, debossed 'L 64' and break line on
one side and plain on the other side
Levetiracetam Accord 500 mg film-coated tablets
Yellow coloured, oval, biconvex, debossed 'L 65' and break line on one
side and plain on the other side.
Levetiracetam Accord 750 mg film-coated tablets
Pink coloured, oval, biconvex, debossed 'L 66' and break line on one
side and plain on the other side.
Levetiracetam Accord 1000 mg film-coated tablets
White to off white, oval, biconvex, debossed 'L 67' and break line on
one side and plain on the other side.
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 genera