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UCB Pharma Limited
208 Bath Road, Slough, Berkshire, SL1 3WE
Telephone: +44 (0)1753 534 655
Medical Information Direct Line: +44 (0)1753 447 690
Medical Information e-mail: Medicalinformationuk@ucb.com
Customer Care direct line: +44 (0) 1773 510123

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 07/11/2011
SPC Keppra 250,500,750 and 1000 mg film-coated Tablets, 100 mg/ml oral solution and 100 mg/ml concentrate for solution for infusion

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 07/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   25-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update of SmPC section 4.8 Adverse effects as per the QRD template.  Adverse effects frequencies reordered.
Updated on 28/07/2011 and displayed until 07/11/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   29-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Minor changes to various sections.

Section 4.1: amendment to the table detailing dosage adjustments for infants and adolescents weighing less than 50 kg with impaired renal function.

Section 4.8: additional side-effects with unknown frequency: choreoathetosis and dyskinesia.
Updated on 26/10/2010 and displayed until 28/07/2011
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   30-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Updated shelf-life and in-use shelf-life for Oral Solution presentation
Updated on 23/07/2010 and displayed until 26/10/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   06-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.8 - additional adverse effects:
Post-marketing experience: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme and alopecia: in several alopecia cases, recovery was observed when levetiracetam was discontinued.
Updated on 21/09/2009 and displayed until 23/07/2010
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
All changes are related to including in the indication for adjunctive therapy for partial onset seizures with or without secondary generalisation in  infants from 1 month of age with epilepsy.
Updated on 16/02/2009 and displayed until 21/09/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition to section 4.4:  Approval of class variation regarding antiepileptic medicines and the monitoring of patients for suicide, suicidal ideation and behaviour.
Updated on 11/08/2008 and displayed until 16/02/2009
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   25-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.6 - further details on the clinical management of therapy during pregnancy and if breast-feeding.
Updated on 01/05/2008 and displayed until 11/08/2008
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   15-Nov-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.2: Additional clarificaton of pharmacokinetic information as shown in bold.

Levetiracetam is a highly soluble and permeable compound. The pharmacokinetic profile is linear with low intra- and inter-subject variability. There is no modification of the clearance after repeated administration. The time independent pharmacokinetic profile of levetiracetam was also confirmed following 1500 mg intravenous infusion for 4 days with b.i.d. dosing.  


In vitro, levetiracetam and its primary metabolite have been shown not to inhibit the major human liver cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C8/9/10, 2C19, 2D6, 2E1 and 1A2), glucuronyl transferase (UGT1A1 AND UGTIA6) and epoxide hydroxylase activities. In addition, levetiracetam does not affect the in vitro glucuronidation of valproic acid.

 

In human hepatocytes in culture, levetiracetam had little or no effect on CYP1A2, SULT1E1 or UGT1A1.  Levetiracetam caused mild induction of CYP2B6 and CYP3A4.  The in vitro data and in vivo interaction data on oral contraceptives, digoxin and warfarin indicate that no significant enzyme induction is expected in vivo. Therefore, the interaction of Keppra with other substances, or vice versa, is unlikely.

 
Updated on 06/11/2007 and displayed until 01/05/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   10/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Additional equation for CLcr - adjustment to body surface area (BSA).
Section 4.4 - Addtional warning that patients should be advised to immediately report symptoms of depression and/or suicidal ideation to their prescribing physicians.
Section 5.2 - Addition of pharmacokinetics in children aged 4-12 years after IV administration.
Section 6.2 - Solution for infusion - product must not be mixed with other medicinal products excep those mentioned in section 6.6.
 
Updated on 04/09/2007 and displayed until 06/11/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of MAH name to UCB Pharma SA.
Updated on 17/01/2007 and displayed until 04/09/2007
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1- Addition of indication for primary generalised tonic-clonic seizures in patients with Idiopathic Generalised Epilepsy.
Section 4.8 - Clarification of emotional lability  - mood swings.  Addition of side effects from post marketing experience: paraesthesia, pancreatitis, weight loss, leukopenia, neutropenia, pancytopenia (with bone marrow suppression identified in some of the cases), hepatic failure, hepatitis, liver function tests abnormal.
 
Updated on 15/01/2007 and displayed until 17/01/2007
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of indication: primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Side effects: Clarification of emotional lability - mood swings.
 
Updated on 18/08/2006 and displayed until 15/01/2007
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - addition of excipient colouring agent E110 for 750 mg tablets.
 
Section 6.5 - 200 tablet pack size.
Updated on 16/08/2006 and displayed until 18/08/2006
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.1 Addition of monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients of 16 years of age.
 
4.1 Starting and maintenance dose instructions.
 
4.8 Additions of AEs - balance disorders, disturbance in attention, memory impairment, weight increase, vision blurred, myalgia, nasopharangitis, eczema,pruritis, thrombocytopenia.
Promotion of AEs from post marketing experience to common - aggression & irritability
 
5.3 Removal of sentene concerning carcinogenicity.
 
10. Change of date of partial revision of text  to August 2006.
Updated on 05/06/2006 and displayed until 16/08/2006
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   01/06/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of Black Triangle.
Updated on 10/05/2006 and displayed until 05/06/2006
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   27/04/06
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2: Addition of new indication as follows:  Keppra is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
 
Section 4.2: Presentation of formula for calculation of Creatinine Clearance completed.
 
Section 4.8: Insertion of missing brackets.
 
Section 9: Date of first authorisation and renewal amended to reflect the date the first licences for the tablet formulations were granted and renewed.
 
Section 10: Revised date of revision
Updated on 21/04/2006 and displayed until 10/05/2006
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
Updated on 26/09/2005 and displayed until 21/04/2006
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 22/09/2005 and displayed until 26/09/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 10/06/2005 and displayed until 22/09/2005
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  levetiracetam