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UCB (Pharma) Ireland Limited

United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
Telephone: + 353 14637395
Medical Information Direct Line: +353 1 463 2371
Medical Information e-mail: UCBCares.IE@ucb.com
Summary of Product Characteristics last updated on medicines.ie: 12/10/2017
SPC Vimpat 50 mg, 100 mg, 150 mg, 200 mg film-coated tablets

When a pharmaceutical company changes an SPC or PIL, 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 12/10/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
Date of revision of text on the SPC:   14-Sep-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



The individual SmPCs for the 50mg, 100mg, 150mg and 200mg film-coated tablet strengths have been replaced with one combined SmPC.

Sections 1, 2, 3, 6.1, 6.5 and 8: updated to include information relating to all 4 strengths (combine the SmPC for the 50mg to include the 100mg, 150mg and 200mg filim-coated tablet strengths).

Section 4.1: updated to add the indication for use in adolescents and children from 4 years of age.

Section 4.2: updated to add information relating to paediatric population and information relating to missed dose.

Section 4.4: updated to add information relating to paediatric population.

Section 4.6: update to Breastfeeding section (risk to newborns/infants).

Section 4.8: updated to add “convulsion” and add information relating to paediatric population.

Section 5.1: updated to add information relating to paediatric population.

Section 5.2: updated to add information relating to paediatric population.

Section 5.3: updated to add information relating to paediatric population.

Updated on 15/05/2017 and displayed until 12/10/2017
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
Date of revision of text on the SPC:   03-May-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



 

 

Addition of new pack-sizes: 28in PVC/PVDC blister  and 14x1  in PVC/PVDC perforated unit dose blisters

Updated on 29/03/2017 and displayed until 15/05/2017
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   24-Mar-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

In section 4.2 (Posology and method of administration)
Hepatic impairment
A maximum dose of 300 mg/day is recommended for patients with mild to moderate hepatic impairment.
[..] Lacosamide should be administered to patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks. The dose may need to be adjusted while carefully observing disease activity and potential side effects in the patient.

In section 4.8 (Undesirable effects)Hepatic enzyme increased” has been added as Uncommon adverse reaction

In section 4.9 (Overdose) the text has been updated as follow:
Symptoms
Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated with CNS and gastrointestinal system.
• The types of adverse reactions experienced by patients exposed to doses above 400 mg up to 800 mg were not clinically different from those of patients administered recommended doses of lacosamide.
• Reactions reported after an intake of more than 800 mg are dizziness, nausea, vomiting, seizures (generalized tonic-clonic seizures, status epilepticus). Cardiac conduction disorders, shock and coma have also been observed. Fatalities have been reported in patients following an intake of acute single overdose of several grams of lacosamide.
Updated on 22/03/2017 and displayed until 29/03/2017
Reasons for adding or updating:
  • Previous version of SPC reinstated
Date of revision of text on the SPC:   12-Dec-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Previous version of SPC reinstated
Updated on 01/03/2017 and displayed until 22/03/2017
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   23-Feb-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

In section 4.2 (Posology and method of administration)
Hepatic impairment
A maximum dose of 300 mg/day is recommended for patients with mild to moderate hepatic impairment.
[..] Lacosamide should be administered to patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks. The dose may need to be adjusted while carefully observing disease activity and potential side effects in the patient.

In section 4.8 (Undesirable effects)Hepatic enzyme increased” has been added as Uncommon adverse reaction.

In section 4.9 (Overdose)
the text has been updated as follow:
Symptoms
Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated with CNS and gastrointestinal system.
• The types of adverse reactions experienced by patients exposed to doses above 400 mg up to 800 mg were not clinically different from those of patients administered recommended doses of lacosamide.
• Reactions reported after an intake of more than 800 mg are dizziness, nausea, vomiting, seizures (generalized tonic-clonic seizures, status epilepticus). Cardiac conduction disorders, shock and coma have also been observed. Fatalities have been reported in patients following an intake of acute single overdose of several grams of lacosamide
Updated on 22/12/2016 and displayed until 01/03/2017
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Change to section 4.1 - Addition of monotherapy inidication
Change to section 4.2 - Posology regarding the new indication
Change to section 4.4 - Special warnings and precaution fo use (cardiac rhythm and conduction)
Change to section 4.5 - Interaction with other with other medicinal products (eslcarbezine)
Change to section 4.8 - Undesiderable side effects
Change to section 5.1 - Pharmacodynamic properties (clinical efficacy and safety in monotherapy)
Change to section 5.2 - Pharmacokinetic properties (editiorial change)
Change to section 10 - Date of revision

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Active Ingredients

 
   lacosamide