Keppra 100mg/ml concentrate for solution for infusion

*
Pharmacy Only: Prescription
  • Company:

    UCB (Pharma) Ireland Limited
  • Status:

    Updated
  • 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

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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

UCB (Pharma) Ireland Limited