Vimpat 50 mg, 100 mg, 150 mg, 200 mg film-coated tablets

  • Name:

    Vimpat 50 mg, 100 mg, 150 mg, 200 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    lacosamide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/09/19

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Summary of Product Characteristics last updated on medicines.ie: 9/9/2019

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UCB (Pharma) Ireland Limited

UCB (Pharma) Ireland Limited

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Medicine Name Keppra 1000 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 100mg/ml concentrate for solution for infusion Active Ingredients Levetiracetam
Medicine Name Keppra 250 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 500 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 750 mg film-coated tablets Active Ingredients Levetiracetam
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Medicine Name Tylex 30mg/500mg Hard Capsules Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name Tylex Effervescent Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name Vimpat 10 mg/ml solution for infusion Active Ingredients lacosamide
Medicine Name Vimpat 10 mg/ml syrup Active Ingredients lacosamide
Medicine Name Vimpat 50 mg, 100 mg, 150 mg, 200 mg film-coated tablets Active Ingredients lacosamide
Medicine Name Xyrem 500mg/ml oral solution Active Ingredients Sodium oxybate
Medicine Name Xyzal 0.5mg/ml oral solution Active Ingredients Levocetirizine dihydrochloride
Medicine Name Xyzal 5mg Tablets Active Ingredients Levocetirizine dihydrochloride
Medicine Name Xyzal 5mg/ml Oral Drops, Solution Active Ingredients Levocetirizine dihydrochloride
Medicine Name Zirtek Oral Solution Active Ingredients Cetirizine Dihydrochloride
Medicine Name Zirtek Plus Decongestant 5mg/120mg Prolonged Release Tablets Active Ingredients Cetirizine Dihydrochloride, Pseudoephedrine Hydrochloride
1 - 0 of 27 items.Total: Infinity pages

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 9 September 2019 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of 60 tablets package size in HDPE Bottle with a child resistant cap

Updated on 9 September 2019 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Addition of 60 tablets pack size in a HDPE bottle with a Child resistant Cap

Updated on 13 August 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 13 August 2019 SmPC

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 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 17 January 2018 SmPC

Reasons for updating

  • 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

$010.     DATE OF REVISION OF THE TEXT$0$0November 2017$0$0Detailedinformation on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/$0

Updated on 17 January 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 October 2017 SmPC

Reasons for 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)

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

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 10 October 2017 PIL

Reasons for updating

  • 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 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • 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
  • 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

Updated on 15 May 2017 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

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

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 15 May 2017 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation number

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 29 March 2017 SmPC

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 22 March 2017 PIL

Reasons for updating

  • Previous version of PIL reinstated

Updated on 22 March 2017 SmPC

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 SPC reinstated

Updated on 1 March 2017 SmPC

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 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 SmPC

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 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 28 September 2011 PIL

Reasons for updating

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

Updated on 22 September 2010 PIL

Reasons for updating

  • Change to date of revision

Updated on 16 September 2010 PIL

Reasons for updating

  • Change of manufacturer
  • Change to side-effects

Updated on 28 April 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 3 February 2009 PIL

Reasons for updating

  • New PIL for new product