Vimpat 10 mg/ml syrup
- Name:
Vimpat 10 mg/ml syrup
- Company:
UCB (Pharma) Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/12/20
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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 2 December 2020 PIL
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 2 December 2020 SPC
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 9 September 2019 SPC
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 9 September 2019 PIL
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 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
Updated on 13 August 2019 SPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 21 August 2018 SPC
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 17 January 2018 SPC
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
Updated on 30 November 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 30 November 2017 PIL
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 SPC
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 PIL
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 SPC
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
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 PIL
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 SPC
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
Updated on 22 March 2017 PIL
Reasons for updating
- Previous version of PIL reinstated
Updated on 1 March 2017 SPC
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
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 PIL
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 SPC
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 PIL
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 PIL
Reasons for updating
- Change to side-effects
Updated on 10 January 2014 PIL
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 17 April 2012 PIL
Reasons for updating
- Change to side-effects
Updated on 1 March 2012 PIL
Reasons for updating
- New PIL for new product