Keppra 100 mg/ml oral solution
*Company:
UCB (Pharma) Ireland LimitedStatus:
No Recent UpdateLegal 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
Updated on 28 February 2023
File name
Keppra Oral Solution.pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 February 2023
File name
Keppra Oral Solution PIL.pdf
Reasons for updating
- New PIL for new product
Updated on 10 September 2021
File name
SPC OSL .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 .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.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.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 .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.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.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).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).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.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.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.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.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.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.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
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
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
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