Vimpat 10 mg/ml syrup *

  • Company:

    UCB (Pharma) Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, 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 22 July 2021

File name

ie-pil-vimpat-syr_1626958644.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

​​​​​​Addition of “Dyskinesia “ as Uncommon Adverse reaction, update to excipient wording for potassium content and change of local representative to United Kingdom (Northern Ireland).

Updated on 22 July 2021

File name

ie-spc-vimpat-syrup_1626958589.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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

​​​​​​Addition of “Dyskinesia “ as Uncommon Adverse reaction and update to excipient wording for potassium content

Updated on 02 December 2020

File name

Vimpat SYR EN PIL_1606923353.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • 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

Extension of the Vimpat indication as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients with idiopathic generalized epilepsy (IGE) aged 4 years and older

Updated on 02 December 2020

File name

Vimpat Syr EN SPC_1606923305.pdf

Reasons for 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Extension of the Vimpat indication as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients with idiopathic generalized epilepsy (IGE) aged 4 years and older

Updated on 09 September 2019

File name

ie-vimpat-spc-SYP-clean_1568035116.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to Excipients listed in section 2 and 6.1 of the SPC and warning listed in 4.4 of the SPC - Sorbitol, propylene glycol and sodium

Updated on 09 September 2019

File name

ie-vimpat-pil-SYP-clean_1568034670.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Free text change information supplied by the pharmaceutical company

Update to Excipients warning in section 2 of the package leaflet - Sorbitol, aspartame, sodium and propylene glycol

Updated on 13 August 2019

File name

PIL Syrup_1565693601.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects

Updated on 13 August 2019

File name

ie syrup SPC_1565693681.pdf

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

warning of cardiac arrhythmia 

Updated on 21 August 2018

File name

Vimpat 10 mg_ml syrup PIL_1534860952.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 21 August 2018

File name

Vimpat 1 mg_ml Syrup SPC_1534860983.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

update with paediatric additional data

Updated on 17 January 2018

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$02.       QUALITATIVE ANDQUANTITATIVE COMPOSITION$0$0 $0$0Eachml of syrup contains 10 mg lacosamide.$0$01 bottleof 200 ml contains 2,000 mg lacosamide.$0$01 bottle of 465 ml contains 4,650 mg lacosamide.$0$0 $0$0Excipients with known effect:$0$0Eachml of Vimpat syrup contains 187 mg sorbitol (E420), 2.60 mg sodiummethyl parahydroxybenzoate (E219), 0.032 mg aspartame (E951),and 1.42 mg sodium. $0$0 $0$0$0$0For the full list ofexcipients, see section 6.1.$0$0$0$06.5     Nature and contents of container$0$0 $0$0A 200 ml and 465 ml amber glassbottles with white polypropylene screw cap, a measuring cup and an oral syringewith an adaptor.$0$0Each graduation mark (5 ml) of the 30 mlmeasuring cup corresponds to 50 mg of lacosamide (for example 2 graduationmarks correspond to 100 mg). $0$0One full 10 ml oral syringecorresponds to 100 mg of lacosamide. The minimum extractable volume is1 ml which is 10 mg of lacosamide. As from the 1 ml graduationmark, each graduation corresponds to 0.25 ml which is 2.5 mg oflacosamide.$0$0$0$0Not all pack sizes may be marketed.$0$0$0$0$08.       MARKETING AUTHORISATION NUMBER(S) $0$0 $0$0$0$0EU/1/08/470/018-019$0$0$0$0$010.     DATE OF REVISION OF THE TEXT$0$0November 2017$0$0$0$0Detailedinformation on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/$0

Updated on 17 January 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 30 November 2017

File name

PIL_15278_554.pdf

Reasons for updating

  • New PIL for new product

Updated on 30 November 2017

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 12 October 2017

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 10 October 2017

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 30 March 2017

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 29 March 2017

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 23 March 2017

Reasons for updating

  • Previous version of SPC reinstated

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Previous version of the SPC reinstated

Updated on 22 March 2017

Reasons for updating

  • Previous version of PIL reinstated

Updated on 01 March 2017

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 28 February 2017

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 22 December 2016

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category:Product subject to medical prescription which may not be renewed (A)

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

Updated on 21 December 2016

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 25 July 2014

Reasons for updating

  • Change to side-effects

Updated on 10 January 2014

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation

Updated on 13 December 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 17 April 2012

Reasons for updating

  • Change to side-effects

Updated on 01 March 2012

Reasons for updating

  • New PIL for new product