Keppra 100mg/ml concentrate for solution for infusion
*Company:
UCB (Pharma) Ireland LimitedStatus:
UpdatedLegal 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 16 October 2025
File name
spc - Keppra IV.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
4.6 Fertility, pregnancy and lactation
Pregnancy
A large amount of postmarketing data on pregnant women exposed to levetiracetam monotherapy (more than 1800, among which in more than 1500 exposure occurred during the 1st trimester) do not suggest an increase in the risk for major congenital malformations. Limited evidence is available on the neurodevelopment of children exposed to levetiracetam monotherapy in utero. Data from two observational population-based registry studies undertaken in largely the same dataset from the Nordic countries and including more than 1000 children born to women with epilepsy prenatally exposed to levetiracetam monotherapy do not suggest an increased risk of autism spectrum disorders or intellectual disability compared to children born to women with epilepsy not exposed to an antiepileptic drug in utero. The mean follow-up time of children in the levetiracetam group was shorter than for the group of children non exposed to any antiepileptic drug (e.g. 4.4 years vs 6.8 years in one of the studies).
Levetiracetam can be used during pregnancy, if after careful assessment it is considered clinically needed. In such case, the lowest effective dose is recommended.
Physiological changes during pregnancy may affect levetiracetam concentration. Decrease in levetiracetam plasma concentrations has been observed during pregnancy. This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy). Appropriate clinical management of pregnant women treated with levetiracetam should be ensured.
10. DATE OF REVISION OF THE TEXT
13 October 2025
Updated on 16 October 2025
File name
PIL - Keppra IV.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
2. What you need to know before you take Keppra
Warnings and precautions
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.
You should not stop your treatment without discussing this with your doctor.
A risk of birth defects for your unborn child cannot be completely excluded.
Two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, the available data regarding the impact of levetiracetam on neurodevelopment in children is limited.
Breast-feeding is not recommended during treatment.
Date of Revision October 2025
Updated on 01 July 2025
File name
keppra 100mgml concentrate for solution for infusion.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)
Updated on 01 July 2025
File name
pil IV.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 18 December 2024
File name
Keppra IV SPC.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 December 2024
File name
Keppra IV PIL.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 18 October 2024
File name
ie-spc-100mgml-conc for sol for infusion-keppra.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
Type II: CCDS Update - Levetiracetam CCDS v8.0 – Cat B: Additional information regarding Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS.
Updated on 18 October 2024
File name
ie-pil-100mgml-conc for sol for infusion-keppra.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Type II: CCDS Update - Levetiracetam CCDS v8.0 – Cat B: Additional information regarding Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS.
Updated on 01 March 2023
File name
Keppra Solution for Infusion.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 March 2023
File name
Keppra Injection PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 10 September 2021
File name
PIL IV.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 IV.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)
Free text change information supplied by the pharmaceutical company
Var II - CCDS.v.5.0 - Neuroleptic Malignant Syndrome
Updated on 27 July 2021
File name
IE SPC IV.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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
IA - Change of container closure (Removal of grey rubber stopper)
Updated on 13 January 2021
File name
PIL IV.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 – SmPC Section 4.2 - PIL section 3
Updated on 13 January 2021
File name
SPC IV.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)
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 IV.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Correction to the stated Manufacturer in section 6
Updated on 20 October 2020
File name
PIL IV.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 IV.pdf
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
Addition of warning and adverse reaction of QT Prolongation – Section 2 & 4
Updated on 31 July 2020
File name
pil IV ie .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 IV 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 October 2019
File name
ie spc iv 100 mgml.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)
Updated on 18 October 2019
File name
keppra pil i.v. injection.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 01 April 2019
File name
20190328-ie-pil-conc-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-conc-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-conc-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-conc-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 23 December 2016
File name
PIL_11237_598.pdf
Reasons for updating
- New PIL for new product
Updated on 23 December 2016
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
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 09 January 2014
Reasons for updating
- Change to side-effects
Updated on 10 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 of manufacturer
- Change to side-effects
Updated on 13 May 2011
Reasons for updating
- Change to MA holder contact details
Updated on 06 December 2010
Reasons for updating
- Change to improve clarity and readability
Updated on 06 April 2010
Reasons for updating
- Change to dosage and administration
Updated on 10 March 2009
Reasons for updating
- Change to warnings or special precautions for use
Updated on 18 February 2008
Reasons for updating
- Change of manufacturer
Updated on 09 August 2007
Reasons for updating
- Change of manufacturer
Updated on 05 February 2007
Reasons for updating
- Change to, or new use for medicine
Updated on 14 August 2006
Reasons for updating
- New PIL for new product
UCB (Pharma) Ireland Limited
 Ireland Limited.webp)
Address:
United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, IrelandMedical Information E-mail:
UCBCares.IE@ucb.comTelephone:
+ 353 14637395Medical Information Direct Line:
+353 1 463 2371