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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 10 mg/ml syrup

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 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
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



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 to 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.

Section 6.3: After first opening amended from 4 weeks to 2 months.

Section 6.5: Addition of an oral syringe with an adaptor.

Updated on 30/03/2017 and displayed until 12/10/2017
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 23/03/2017 and displayed until 30/03/2017
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 the SPC reinstated
Updated on 01/03/2017 and displayed until 23/03/2017
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