Keppra 100 mg/ml oral solution *

  • Company:

    UCB (Pharma) Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 10 September 2021

File name

PIL OSL_1631273292.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Var II - CCDS.v.5.0 - Neuroleptic Malignant Syndrome

Updated on 10 September 2021

File name

SPC OSL _1631273263.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Var II - CCDS.v.5.0 - Neuroleptic Malignant Syndrome

Updated on 17 March 2021

File name

SPC OSL _1615989508.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 13 January 2021

File name

PIL OSL_1610504594.pdf

Reasons for updating

  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

Update to recommend the same dosing for monotherapy and adjunctive therapy – PIL section 3

Updated on 13 January 2021

File name

PIL OSL_1610504531.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to recommend the same dosing for monotherapy and adjunctive therapy – SmPC Section 4.2

Updated on 20 October 2020

File name

PIL OSL_1603184372.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Addition of warning and adverse reaction of QT Prolongation – Section 2 & 4

Updated on 20 October 2020

File name

SPC OSL _1603184327.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of warning and adverse reaction of QT Prolongation – Section 4.4 & 4.8

Updated on 31 July 2020

File name

pil OSL_1596188926.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Addition of the warning and ADR on “Worsening Seizures”

Updated on 31 July 2020

File name

spc OSL ie_1596188896.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of the warning and ADR on “Worsening Seizures”

Updated on 18 February 2020

File name

1.1 IE PIL - Keppra 100mg_ml Oral Solution (Clean)_1582041990.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 4 - How to Report a Side Effect

Addition of "HPRA Pharmacovigilance Website: www.hpra.ie"

Section 6 - Manufacturer

Addition of "Or UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium"

Section 6 - Date of Revision

Addition of "January 2020"

Updated on 18 February 2020

File name

2.1 IE SPC - Keppra 100mg_ml Oral Solution (Clean)_1582041617.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to Section 4.8 - Undesireable Effects (reporting of suspected adverse reactions)

Addition of "HPRA Pharmacovigilance Website: www.hpra.ie"

Change to Section 10 - Date of revision of text

Addition of "January 2020"

Updated on 18 October 2019

File name

ie spc oral solution 100 mg ml_1571398054.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.4 of the SPC the following has been added:

 

Abnormal and aggressive behaviours

Levetiracetam may cause psychotic symptoms and behavioural abnormalities including irritability and aggressiveness. Patients treated with levetiracetam should be monitored for developing psychiatric signs suggesting important mood and/or personality changes. If such behaviours are noticed, treatment adaptation or gradual discontinuation should be considered. If discontinuation is considered, please refer to section 4.2.

 

Updated on 18 October 2019

File name

ie keppra pil oral solution_1571397022.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

In section 4 of the leaflet the following has been added:

 

Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:

  • Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour.

 

 

Updated on 01 April 2019

File name

20190328-ie-pil-osl-en-approved-current_1553866800.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 29 March 2019

File name

20190328-ie-spc-osl-en-approved-current_1553866821.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 13 March 2019

File name

20180426-ema-ie-pil-osl-h277-en-approved-current_1552474445.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 13 March 2019

File name

20180426-ema-ie-spc-sol-h277-en-approved-current_1552474544.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Pregnancy wording update, dysgeusia, pregnancy malformation update and gait disturbance

Updated on 02 January 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 02 January 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.4: addition of warnings regarding Acute Kidney injury and blood cell counts


Change to section 4.8: addtion of Acute Kidney injury and blood cell counts as adverse reactions within the tabulated list of advers reacions

Change to section 10: date of revision

Updated on 23 December 2016

File name

PIL_9349_661.pdf

Reasons for updating

  • New PIL for new product

Updated on 23 December 2016

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 08 September 2015

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Oral Solution

Throughout:
Replacement of Keppra with Levetiracetam.

4.2 Posology and method of administration
Addition of details for instruction on discontinuation.
Additional details for use of the oral solution for doses under 250mg.

4.4 Special warnings and precautions for use
Removal of details for instruction on discontinuation.
Removal of statement for lack of safety and efficacy information for use in infants.

4.5 Interaction with other medicinal products and other forms of interaction
Addition of details of interaction with Methotrexate.
Removal of statement relating to excretion by active tubular secretion.
Removal of statement that no data exists for interaction with antacids.

4.6 Fertility, pregnancy and lactation
Removal of “As with other antiepileptic medicinal products” clause from pregnancy warning

4.7 Effects on ability to drive and use machines
Driving warning upgraded to ‘minor or moderate influence…”

4.8 Undesirable effects
Editorial change to re-arrange the order of the opening paragraph.
Addition of the statement: “Adverse reactions are presented in the order of decreasing seriousness and their…”
Addition of:
• Hypersensitivity
Reordering of statement for coadminitration with topiramate.
Addition of post approval study data for infants.

5.1 Pharmacodynamic properties
Mechanism of action updated.
Infant data added.

5.3 Preclinical safety data
Fetal updated to foetal
Removal of Environmental Risk Assessment (ERA).

6.1 List of excipients
Opadry reference removed

10. DATE OF REVISION OF THE TEXT
Date of revision updated

Updated on 07 September 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 24 March 2014

Reasons for updating

  • Change to side-effects

Updated on 28 January 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

To add 'hyponatremia' as new ADR 

Updated on 09 January 2014

Reasons for updating

  • Change to side-effects

Updated on 20 December 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.8     Undesirable effects

Immune system disorders

Rare: Drug reaction with eosinophilia and systemic symptoms (DRESS)

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via IMB and MHRA websites (refer to SmPC)

Updated on 04 September 2013

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.5     Interaction with other medicinal products and other forms of interaction

Laxatives

There have been isolated reports of decreased levetiracetam efficacy when the osmotic laxative macrogol has been concomitantly administered with oral levetiracetam. Therefore, macrogol should not be taken orally for one hour before and for one hour after taking levetiracetam.

 

 

4.6     Fertility, pregnancy and lactation

Pregnancy

Postmarketing data from several prospective pregnancy registries have documented outcomes in over 1000 women exposed to levetiracetam monotherapy during the first trimester of pregnancy. Overall, these data do not suggest a substantial increase in the risk for major congenital malformations, although a teratogenic risk cannot be completely excluded. Therapy with multiple antiepileptic medicinal products is associated with a higher risk of congenital malformations than monotherapy and therefore monotherapy should be considered. Studies in animals have shown reproductive toxicity (see section 5.3).

Keppra is not recommended during pregnancy and in women of childbearing potential not using contraception unless clinically necessary.

 

4.8     Undesirable effects

Blood and lymphatic system disorders

Rare: agranulocytosis

Updated on 19 September 2012

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

New SPC for individual product

Updated on 23 August 2012

Reasons for updating

  • Change to side-effects

Updated on 16 December 2011

Reasons for updating

  • Correction of spelling/typing errors

Updated on 28 November 2011

Reasons for updating

  • Change to side-effects

Updated on 19 October 2011

Reasons for updating

  • Change to side-effects
  • Change to dosage and administration

Updated on 13 May 2011

Reasons for updating

  • Change to further information section
  • Change to MA holder contact details

Updated on 29 October 2010

Reasons for updating

  • Change to side-effects

Updated on 16 September 2010

Reasons for updating

  • Change to side-effects

Updated on 06 April 2010

Reasons for updating

  • Change to dosage and administration
  • Introduction of new pack/pack size

Updated on 10 March 2009

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 21 June 2008

Reasons for updating

  • Change of manufacturer

Updated on 28 November 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 09 August 2007

Reasons for updating

  • Change of manufacturer

Updated on 06 February 2007

Reasons for updating

  • Change to, or new use for medicine

Updated on 14 July 2006

Reasons for updating

  • Change to, or new use for medicine

Updated on 19 July 2005

Reasons for updating

  • Change to further information section

Updated on 19 January 2005

Reasons for updating

  • New PIL for new product