Keppra 1000 mg film-coated tablets

  • Name:

    Keppra 1000 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Levetiracetam

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/10/19

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Summary of Product Characteristics last updated on medicines.ie: 18/10/2019

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UCB (Pharma) Ireland Limited

UCB (Pharma) Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Briviact 10 mg/ml solution for injection/infusion Active Ingredients Brivaracetam
Medicine Name Briviact 10mg/ml oral solution Active Ingredients Brivaracetam
Medicine Name Briviact film-coated tablets Active Ingredients Brivaracetam
Medicine Name Cimzia 200 mg solution for injection in pre-filled pen Active Ingredients Certolizumab Pegol
Medicine Name Cimzia 200 mg solution for injection in pre-filled syringe Active Ingredients Certolizumab Pegol
Medicine Name Keppra 100 mg/ml oral solution Active Ingredients Levetiracetam
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
Medicine Name Neupro 1mg/24hr and 3 mg/24 hTransdermal Patch Active Ingredients Rotigotine
Medicine Name Neupro 2mg/24hr Transdermal Patch Active Ingredients Rotigotine
Medicine Name Neupro 4 mg/24hr, 6 mg/24hr, 8 mg/24hr Transdermal Patch Active Ingredients Rotigotine
Medicine Name Tylex 30mg/500mg Hard Capsules 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 Allergy Relief 10 mg film-coated tablets (OTC) Active Ingredients Cetirizine 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 26 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 18 October 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.4 of the SPC the following has been added:

 

Abnormal and aggressive behaviours

Levetiracetam may cause psychotic symptoms and behavioural abnormalities including irritability and aggressiveness. Patients treated with levetiracetam should be monitored for developing psychiatric signs suggesting important mood and/or personality changes. If such behaviours are noticed, treatment adaptation or gradual discontinuation should be considered. If discontinuation is considered, please refer to section 4.2.

 

Updated on 18 October 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

In section 4 of the leaflet the following has been added:

 

Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:

  • Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour.

 

 

Updated on 1 April 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 29 March 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 13 March 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 13 March 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Pregnancy wording update, dysgeusia, pregnancy malformation update and gait disturbance

Updated on 8 May 2017 PIL

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

-        Section 6.3 Shelf Life (clarification / editorial / wording changes –  actual shelf life not changed).

-        Section 6.6 Special precautions for disposal and other handling (includes substantial changes to Instructions for reconstituting Actilyse).

-        Section 10 (Revision date updated).  The date of revision of the text has updated to align with the RMS approval dated 25Apr17.

Updated on 2 January 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 23 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 March 2015 PIL

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 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Further to receipt of renewal approval, the following are updated:


Sections 1, 2 and 7 (with minor typographical changes)

Sections 3 (re appearance), 4.2, 4.3, 4.4, 4.6, 4.8, 4.9, 5.1, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6 and 9 (with significant changes)

Section 10 (revision date updated from August 2013 to March 2015) 

Updated on 1 November 2013 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.3 Contraindications

This section has been updated to include warnings for latex and gentamicin.

This section has been updated to include additional anticoagulation statements.

 

Section 4.4 Special Warnings and Precautions for Use

This section has been updated to include warnings for latex and gentamicin.

This section has been updated to include additional anticoagulation statements.

 

Section 6.6 Special Precautions for Disposal and Other Handling

The section header has been updated to now read Special precautions for disposal and other handling i.e. … of a used medicinal product or waste materials derived from such medicinal product and … of the product have been deleted.


Section 10 Date of Revision of the Text

The date has been updated from October 2011 to August 2013.

Updated on 16 April 2012 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.1 Therapeutic Indications

The final paragraph (regarding fibrinolytic treatment of acute ischaemic stroke) has had text both added to and deleted from.  The text … as early as possible …,

… 4.5 …, … after … and all that after … imaging techniques … is new.

 

Section 4.2 Posology and Method of Administration

The Acute ischaemic stroke sub-heading of this section has had both text added to and deleted from. 

 

The text … only …, … under the responsibility and follow-up of …, … trained and experienced …, and … neurovascular … is new in the first paragraph.

 

The text … as early as possible …, … 4.5 … and the complete final sentence of the third paragraph is new.

 

Section 4.3 Contraindications

The second paragraph of this section has been added as new text.

 

The first bullet point of the Additional contraindications in acute ischaemic stroke sub-heading has been amended.  The text … 4.5 …, … symptoms for which the …, … time … and … and could potentially be more than 4.5 hours ago (see section 5.1) has been added.

 

A new sub-heading entitled Use in elderly patients, together with corresponding text, has been added.

 

Section 4.4 Special Warnings and Precautions for Use

A new first paragraph has been added to this section.

 

The sub-heading Additional special warnings and precautions in acute ischaemic stroke has had both text added to and deleted from.  The text … only …, … under the responsibility and follow-up of a … and … neurovascular … has been added.

 

A new third bullet point has been added to the Special warnings/conditions with a decreased benefit/risk ratio sub-heading.

 

A new penultimate paragraph (regarding data available from ECASS III) has been added to this section.

 

Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

The text … active substances which interfere with … has replaced the text … other agents inhibiting … in the second paragraph of this section.

 

Section 4.8 Undesirable Effects

The first paragraph of this section (regarding adverse reactions frequency and system organ class) has had text both added to and deleted from.

 

The text … and without any relevant increase in overall mortality and severe disability combined, i.e. mRS of 5 and 6 … has been added to the common category of the Haemorrhage sub-heading.

 

The text … ear haemorrhage … has been added to the uncommon category of the Haemorrhage sub-heading.

 

Section 4.9 Overdose

The text … severe bleeding results, the infusion of fresh frozen plasma or fresh blood is recommended and if necessary, synthetic antifibryinolytics may be administered … has been added to the first paragraph of this section.

 

Section 5.1 Pharmacodynamic Properties

The text … iv… and … s.c… has been replaced with the text … intravenous … and … subcutaneous … in the fourth paragraph of this section.

 

The Acute stroke sub-heading of this section has had both text added to and deleted from, including the addition of a new second paragraph regarding the ECASS III trial and the addition of a new third paragraph regarding the safety and efficacy of Actilyse for acute ischaemic stroke treatment.

 

Section 6.6 Special Precautions for Disposal and Other Handling

Minor editorial changes have been made to this section.

 

Section 10 Date of Revision of the Text

The date has been amended from November 2009 to October 2011.

Updated on 11 May 2010 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 2 Qualitative and Quantitative Composition

The text Active ingredient: has been deleted as the first paragraph of this section.

 

Section 4.3 Contraindications

A new second paragraph for this section has been inserted i.e. paragraph commencing with the text: Additional contraindications in acute myocardial infarction, …

 

Section 4.4 Special Warnings and Precautions for Use

A new first paragraph for this section has been inserted i.e. paragraph commencing with the text: Special warnings and precautions in acute myocardial infarction, …

 

The word oedama has been corrected to spell oedema in the first sentence of the last paragraph of this section i.e. the one entitled Other special warnings.


Section 4.8 Undesirable Effects

The first paragraph of this section has been completely reworded i.e. the one regarding adverse reactions according to frequency and system organ class.  Text has both been deleted from and added to this paragraph.

 

The word arrythmias has been corrected to spell arrhythmias in the very common paragraph of the Cardiac disorders heading of this section.

 

Section 5.1 Pharmacodynamic Properties

A new third paragraph has been added to this section i.e. one commencing with the text: Due to its relative fibrin-specificity alteplase at a dose of 100 mg leads to a modest decrease …

 

This paragraph was originally the first paragraph in section 5.2 (Pharmacokinetic Properties) and has moved location.  No changes to the text itself have taken place.

 

Section 5.2 Pharmacokinetic Properties

What was originally the first paragraph of this section has been deleted and moved to section 5.1 (Pharmacodynamic Properties) where it has become the third paragraph of this section.

 

Section 6.3 Shelf-Life

The text 10 mg, 20 mg and 50 mg pack sizes has been added to now come before the text 3 years.

 

Section 6.4 Special Precautions for Storage

The text Do not store above 25ºC has been relocated to become the second sentence of the second paragraph of this section.

 

The text For 10 mg, 20 mg and 50 mg pack sizes: has been added as the first sentence of the second paragraph of this section.

 

Section 6.5 Nature and Contents of Container

The text For the 10 mg. 20 mg and 50 mg pack sizes, t has been added to and the capital T of the word the deleted from the beginning of the first sentence under the Solvent heading of this section. 

 

The words injection and have been added to the first sentences of each strength pack size details in this section.

 

Section 6.6 Special Precautions for Disposal and Other Handling

A new fourth paragraph has been added to this section i.e. one commencing with the text When reconstituting the product from the respective amount of powder and solvent, …

 

Section 10 Date of Revision of the Text

The date March 2007 has been replaced with the date April 2010.

Updated on 6 February 2009 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 7 December 2007 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Correction of error in Section 4.8 Undesirable effects

Updated on 2 August 2007 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Changes to section 4.2 - Posology and method of administration, Change to section 4.3 – Contraindications, Change to section 4.4 – Special warnings and special 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 details:

Section 4.2 Posology and method of administration.

The section on adjunctive therapy has been updated to incorporate current recommendations.  It now states “Antithrombotic adjunctive therapy is recommended according to the current international guidelines for the management of patients with ST-elevation myocardial infarction”

 

Section 4.3 Contraindications

Acitylase is contraindicated in cases where there is a high risk of haemorrhage in a number of situations; this now includes patients with a “significant bleeding disorder at present or within the past 6 months”.

An additional contraindication for use in acute myocardial infarction and acute pulmonary embolism was any history of stroke.  This has now been changed to include

“any known history of haemorrhagic stroke or stroke of unknown origin”

and “any known history of ischaemic stroke if transient ischaemic attack in the preceding 6 months, except current acute ischaemic stroke in the last 3 hours”.

 

Section 4.4 Special warnings and special precautions for use

This section now notes that the concomitant use of GPIIb/IIIa antagonists increases the risk of bleeding.

 

Section 4.5 Interaction with other medicinal products and other forms of interaction

This section now notes that the concomitant use of GPIIb/IIIa antagonists increases the risk of bleeding.

 

Section 4.8 – Undesirable effects

Corrections in the frequency classification of some undesirable effects.  The following effects have been reclassified from uncommon to common:

Respiratory tract haemorrhage (such as pharyngeal haemorrhage, epistaxis, haemoptysis)

Gastrointestinal haemorrhage (such as gastric haemorrhage, gastric ulcer haemorrhage, haemorrhage rectum, haematemesis, melaena, mouth haemorrhage)

 

As with other thrombolytic agents some cardiac disorders have been reported as sequelae of myocardial infarction and / or thrombolytic treatment. Reperfusion arrythmias are now classified as a very common undesirable effect.

 

Gastrointestinal disorders: Nausea and vomiting have been reclassified from a rare to a common undesirable effect.

 

The following effect has been added

Injury and poisoning and procedural complications:

rare:     fat embolism (cholesterol crystal embolisation), which may lead to corresponding consequences in the organs concerned

Updated on 14 February 2006 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Updated on 19 May 2005 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 20 August 2003 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 25 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie