Fycompa tablets

  • Name:

    Fycompa tablets

  • Company:
    info
  • Active Ingredients:

    Perampanel

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/05/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 5/5/2020

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Eisai Ltd

Eisai Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Fycompa 0.5 mg/ml oral suspension Active Ingredients Perampanel
Medicine Name Fycompa tablets Active Ingredients Perampanel
Medicine Name Gliadel Active Ingredients Carmustine
Medicine Name Halaven 0.44 mg/ml solution for injection Active Ingredients Eribulin mesylate
Medicine Name Inovelon Oral Suspension Active Ingredients Rufinamide
Medicine Name Inovelon Tablets Active Ingredients Rufinamide
Medicine Name Lenvima (lenvatinib) Active Ingredients Lenvatinib mesilate
Medicine Name Targretin Capsules Active Ingredients Bexarotene
Medicine Name Zebinix 200mg tablets Active Ingredients eslicarbazepine acetate
Medicine Name Zebinix 50 mg/ml Oral Suspension Active Ingredients eslicarbazepine acetate
Medicine Name Zebinix 800mg tablets Active Ingredients eslicarbazepine acetate
Medicine Name Zonegran capsules Active Ingredients Zonisamide
1 - 0 of 12 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 5 May 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 2: Raised liver enzymes added; Stevens-Johnson syndrome added as potential serious skin reaction; “oral” contraceptives – changed to “hormonal” contraceptives

Section 4: Stevens-Johnson syndrome added as potential serious skin reaction

Updated on 5 May 2020 SmPC

Reasons for updating

  • 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 - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Section 4.4: Addition of hepatotoxicity warning; Amendment of “oral” contraceptive to “hormonal” contraceptive; Addition of Stevens-Johnson syndrome as potential severe cutaneous adverse reaction.

Section 4.5: Amendment of “oral” contraceptive to “hormonal” contraceptive (interactions section)

Section 4.6: Amendment of “oral” contraceptive to “hormonal” contraceptive (section on women of childbearing potential and contraception)

Section 4.8: Addition of Stevens-Johnson syndrome as skin adverse reaction (frequency = not known)

Updated on 28 February 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 28 February 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

 

Documented changes

Sections of the SmPC

Changes/updates

Section 7

Marketing Authorisation Holder details have been updated:

Eisai GmbH

Lyoner Straße 36

60528 Frankfurt am Main

Germany

E-mail: medinfo_de@eisai.net

Section 10

The date of revision of text has been updated to 11/2018

 

Updated on 4 April 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 4 April 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Document Changes

Section of the SmPC

Changes / Updates

4.4     Special warnings and precautions for use

 

The following text has been added:

 

“Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS)

 

Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported (frequency unknown; see section 4.8) in association with perampanel treatment.

 

At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. Symptoms of DRESS include typically, although not exclusively, fever, rash associated with other organ system involvement, lymphadenopathy, liver function tests abnormalities and eosinophilia. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If signs and symptoms suggestive of these reactions appear, perampanel should be withdrawn immediately and an alternative treatment considered (as appropriate).”

 

 

4.8     Undesirable effects

 

 

The following text has been added:

 

 

“Post-marketing use

 

Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with perampanel treatment (see section 4.4).”

 

The text in bold has been added:

 

The following convention has been used for the classification of adverse reactions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), not known (cannot be estimated from the available data).

 

A “Not known” column has been added to the tabulated list of adverse reactions

 

System Organ Class  “Skin and subcutaneous tissue disorders” has been added to the tabulated list of adverse reactions, with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)*” included as an adverse reaction under the “Not known” column.

 

The following footnote has been added to the tabulated list of adverse reactions;

 

“See section  4.4”

 

Section 10 Date of Revision of the text

February 2018

Updated on 29 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 March 2018 PIL

Reasons for updating

  • 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 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 5 December 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details
  • Improved presentation of PIL

Updated on 11 May 2017 SmPC

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of black triangle

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

Free text change information supplied by the pharmaceutical company


Documented changes

Sections of the SPC

Changes/updates

 

 REMOVAL OF BLACK TRIANGLE

Section 9

Date of latest renewal: 6 April 2017

 

Section 10

 Date of Revision: April 2017

Updated on 11 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 9 May 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Removal of black triangle

Updated on 29 March 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Document Changes

 

Section of the SmPC

 

Changes / Updates

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

 

 

The following information has changed from:

 

Some anti‑epileptic drugs known as enzyme inducers (carbamazepine, phenytoin, oxcarbazepine) have been shown to increase perampanel clearance and consequently to decrease plasma concentrations of perampanel.

 

 

to:

 

 

Some anti‑epileptic drugs known as CYP450 3A enzyme inducers (carbamazepine, phenytoin, oxcarbazepine) have been shown to increase perampanel clearance and consequently to decrease plasma concentrations of perampanel. Conversely, withdrawal of a concomitant CYP450 3A enzyme inducer can be expected to increase plasma concentrations of perampanel and dose reduction may be required.

 

·         Section 5.1 Pharmacodynamic properties

 

 

The following paragraph in the clinical efficacy and safety section has changed from:

 

1.7 to 5.8% of the patients on perampanel in the clinical studies became seizure free during the 3 month maintenance period compared with 0%‑1.0% on placebo.  There are no data regarding the effects of withdrawal of concomitant anti-epileptic medicinal products to achieve monotherapy with perampanel

 

 

to:

 

1.7 to 5.8% of the patients on perampanel in the clinical studies became seizure free during the 3 month maintenance period compared with 0%‑1.0% on placebo

 

The following paragraph in Section 5.1 has also changed from:

 

Conversion to monotherapy

There are no data regarding the effects of withdrawal of concomitant anti-epileptic medicinal products to achieve monotherapy with perampanel.

 

to:

 

Conversion to monotherapy

In a retrospective study of clinical practice, 51 patients with epilepsy who received perampanel as adjunctive treatment converted to perampanel monotherapy. The majority of these patients had a history of partial onset seizures. Of these, 14 patients (27%) reverted to adjunctive therapy in the following months. Thirty four (34) patients were followed up for at least 6 months and, of these, 24 patients (71%) remained on perampanel monotherapy for at least 6 months. Ten (10) patients were followed up for at least 18 months and, of these, 3 patients (30%) remained on perampanel monotherapy for at least 18 months.

 

 

·         Section 8 Marketing Authorisation number(s)

 

The Marketing Authorsiation number has changed from:

 

EU/1/12/776/001-0023

 

to:

 

EU/1/12/776/001-023

 

·         Section 10 Date of Revision of the text

 

 

Feb-2017

Updated on 31 January 2017 SmPC

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

The date of the latest renewal of authorisation has been added to section 9 below:

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 23/07/2012

Date of latest renewal: 26 January 2017

The date of the revision of the text has also changed:

 

10.     DATE OF REVISION OF THE TEXT

 

01/2017

Updated on 30 December 2016 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

In addition to some formatting changes, the following sections of the Fycompa SmPC have been updated:

·         Section 5.1 Pharmacodynamic properties

·         Section 5.2 Pharmacokinetic properties

·         Section 10 DATE OF REVISION OF THE TEXT

 

The below summarises the changes to the Fycompa SmPC:

Section 5.1 Pharmacodynamic properties

The following statement has been added in the Cognitive function section:

In a placebo controlled study conducted in adolescent patients, no significant changes in cognition relative to placebo as measured by Cognitive Drug Research (CDR) System Global Cognition Score were observed for perampanel. In the open label extension, no significant changes were observed in global CDR system score after 52 weeks of perampanel treatment (see section 5.1 Paediatric population). 

In addition, the following information has been added under the paediatric population subheading of Section 5.1:

A 19-week, randomised, double-blind, placebo-controlled study with an open-label extension phase (Study 235) was performed to assess the short-term effects on cognition of Fycompa (target dose range of 8 to 12 mg once daily) as adjunctive therapy in 133 (Fycompa n=85, placebo n=48) adolescent patients, ages 12 to less than 18 years old, with inadequately controlled partial-onset seizures.  Cognitive function was assessed by the Cognitive Drug Research (CDR) System Global Cognition t-Score, which is a composite score derived from 5 domains testing Power of Attention, Continuity of Attention, Quality of Episodic Secondary Memory, Quality of Working Memory, and Speed of Memory.  The mean change (SD) from baseline to end of double-blind treatment (19 weeks) in CDR System Global Cognition t-Score was 1.1 (7.14) in the placebo group and (minus) –1.0 (8.86) in the perampanel group, with the difference between the treatment groups in LS means (95% CI) = (minus) ‑2.2 (‑5.2, 0.8). There was no statistically significant difference between the treatment groups (p = 0.145). CDR System Global Cognition t-Scores for placebo and perampanel were 41.2 (10.7) and 40.8 (13.0), respectively at the baseline. For patients with perampanel in the open label extension (n = 112), the mean change (SD) from baseline to end of open-label treatment (52 weeks) in CDR System Global Cognition t-Score was (minus) ‑1.0 (9.91). This was not statistically significant (p = 0.96).  After up to 52 weeks of treatment with perampanel (n = 114), no effect on bone growth was observed.  No effects on weight, height and sexual development were seen following up to 104 weeks of treatment (n = 114).

 

Section 5.2 Pharmacokinetic properties

The following information has changed from:

Paediatric population

In a population pharmacokinetic analysis of the adolescent patients in the Phase 3 clinical studies, there were no notable differences between this population and the overall population. 

to:

Paediatric population

In a population pharmacokinetic analysis of the adolescent patients pooled from the Phase 2 and 3 clinical studies, there were no notable differences between this population and the overall population. 

Section 10 DATE OF REVISION OF THE TEXT

October 2016

Updated on 17 November 2016 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 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

  • Section 4.2 Posology and method of administration

The following statement has been changed from:

Withdrawal
When withdrawing Fycompa, the dose should be gradually reduced (see section 4.4).

to:

Withdrawal
It is recommended that discontinuation be undertaken gradually to minimise the potential for rebound seizures. However, due to its long half-life and subsequent slow decline in plasma concentrations, perampanel can be discontinued abruptly if absolutely needed.

The following paragraph has also been changed from:

Method of administration
Fycompa should be taken as single oral dose at bedtime. It may be taken with or without food (see section 5.2). The tablet should be swallowed whole with a glass of water. It should not be chewed, crushed or split. The tablets cannot be split accurately as there is no break line. To ensure the patient receives the entire dose the tablets should be swallowed whole without chewing or crushing

to:

Method of administration
Fycompa should be taken as single oral dose at bedtime. It may be taken with or without food (see section 5.2). The tablet should be swallowed whole with a glass of water. It should not be chewed, crushed or split. The tablets cannot be split accurately as there is no break line.

  • Section 4.4 Special warnings and precautions for use

The following information has been removed from Section 4.4:

End of treatment
It is recommended that discontinuation be undertaken gradually to minimise the potential for rebound seizures (see section 4.2). However, due to its long half-life and subsequent slow decline in plasma concentrations, perampanel can be discontinued abruptly if absolutely needed.

Information moved to Section 4.2.

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

The following information has changed from:

Effect of cytochrome P450 inducers on perampanel pharmacokinetics
Strong inducers of cytochrome P450, such as rifampicin and hypericum, are expected to decrease perampanel concentrations. Felbamate has been shown to decrease the concentrations of some drugs and may also reduce perampanel concentrations. The potential for higher plasma concentrations of the reactive metabolites in presence of strong cytochrome P450 inducers could not be excluded.

to:

Effect of cytochrome P450 inducers on perampanel pharmacokinetics
Strong inducers of cytochrome P450, such as rifampicin and hypericum, are expected to decrease perampanel concentrations and the potential for higher plasma concentrations of reactive metabolites in their presence has not been excluded. Felbamate has been shown to decrease the concentrations of some medicinal products and may also reduce perampanel concentrations.

  • Section 4.8 Undesirable effects

The following has changed from:

Tabulated list of adverse reactions
In the table below, adverse reactions, which were identified based on review of the full Fycompa clinical studies safety database, are listed by System Organ Class and frequency. The initial review was done by considering all treatment emergent adverse events (TEAEs) in the double-blind Phase 3 epilepsy studies that occurred in ≥2% of patients in the total Fycompa group. The following were also considered: incidence rates higher than with placebo; severity, seriousness, and rates of discontinuation due to the events; analyses of exposure and dose-response; and consistency with Fycompa pharmacology. TEAEs that occurred in less frequency and met the same criteria as for the more frequent TEAEs were also considered. The following convention has been used for the classification of adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000).

The dose of 2 mg/day was not included in this assessment because it is not considered to be an effective dose, and the rates of TEAEs in that dose group were generally comparable to, or lower than, those in the placebo group.

to:

Tabulated list of adverse reactions

In the table below, adverse reactions, which were identified based on review of the full Fycompa clinical studies safety database, are listed by System Organ Class and frequency. The following convention has been used for the classification of adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).

  • Section 5.1 Pharmacodynamic properties

Formatting changes

  • Section 5.2 Pharmacokinetic properties

The Absorption section has changed from:

Absorption
Perampanel is readily absorbed after oral administration with no evidence of marked first-pass metabolism. Food does not affect the extent of absorption, but slows the rate of absorption. When administered with food, peak plasma concentrations are reduced and delayed by 2 hours compared with dosing in a fasted state.

To:

Absorption
Perampanel is readily absorbed after oral administration with no evidence of marked first-pass metabolism. Co-administration of perampanel tablets with a high fat meal had no impact on the peak plasma exposure (Cmax) or total exposure (AUC0-inf) of perampanel. The tmax was delayed by approximately 1 hour compared to that under fasted conditions

The wording in the ‘Elimination’ section of Section 5.2 has also changed from:

Following administration of a radiolabeled perampanel dose to 8 healthy elderly subjects, 30% of recovered radioactivity was found in the urine and 70% in the faeces.

to:

Following administration of a radiolabeled perampanel dose to either 8 healthy adults or elderly subjects, approximately 30% of recovered radioactivity was found in the urine and 70% in the faeces.

  • Section 6.6 Special precautions for disposal

The following has been added to Section 6.6:

Any unused medicinal product or waste material should be disposed of in accordance with local requirements

  • Section 10 Date of Revision of the text

November 2016

Updated on 5 October 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration

Updated on 1 March 2016 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Wording has been updated in section 4.8:

Paediatric population

Based on the clinical trial database of 196 adolescents exposed to perampanel from double-blind studies for partial onset seizures and primary generalized tonic-clonic seizures, the overall safety profile in adolescents was similar to that of adults, except for aggression, which was observed more frequently in adolescents than in adults.

Updated on 13 January 2016 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.5:
  • The sentence 'The potential for higher plasma concentrations of the reactive metabolites in presence of strong cytochrome P450 inducers could not be excluded' has been added to the subsection titled 'Effect of cytochrome P450 inducers on perampanel pharmacokinetics'

       

    • The sentence 'Strong inhibitors of other cytochrome P450 isoforms could potentially also increase perampanel concentrations' has been removed from the subsection titled 'Effect of cytochrome P450 inhibitors on perampanel pharmacokinetics' 

         

        Section 5.1: Typos corrected

        Section 5.2

        •  

          • The sentence 'However, the metabolism has not been completely elucidated and other pathways cannot be excluded' has been deleted from the subsection titled 'Biotransformation'

         

        Updated on 26 June 2015 PIL

        Reasons for updating

        • Change to, or new use for medicine
        • Change to date of revision

        Updated on 26 June 2015 SmPC

        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 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 10 - Date of revision of the text

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

        Free text change information supplied by the pharmaceutical company

        ·         Section 4.1 Therapeutic indications         

        Additional indication:

        Fycompa is indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy

        ·         Section 4.2 Posology and method of administration        

        Primary generalised tonic-clonic seizures dosing information added (see SPC)

         

        ·         Section 4.4 Special warnings and precautions for use      

         

        Sentence regarding responder rates with and without enzyme inducing anti-epileptic medicinal products moved to Section 5.1.   Sentence regarding no data for conversion to monotherapy moved to section 5.1

         

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

         

        Interaction data updated to include primary generalised tonic-clonic seizures Phase 3 study.  Influence of carbamazepine, oxcarbazepine , phenytoin and topiramate on Fycompa concentration adjusted (see table in Section 4.5)

        ·         Section 4.8 Undesirable effects

        Addition of information from primary generalised  tonic-clonic seizures clinical trial to summary of safety profile

                        Addition of 'suicidal ideation' and 'suicide attempt' to the table of adverse reactions under 'uncommon' (≥1/1,000 to <1/100)

        ·         Section 5.1 Pharmacodynamic properties            

        Addition of clinical efficacy and safety information from the primary generalised tonic-clonic seizures trial (Study 332). Multiple text inserts. Please see the SPC

                       

        ·         5.2 Pharmacokinetic properties

        Addition of information from a population pharmacokinetic analysis of patients with primary generalised tonic-clonic seizures

        Updated on 27 May 2015 SmPC

        Reasons for updating

        • Change to section 6.3 - Shelf life
        • Change to section 10 - Date of revision of the text

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

        Free text change information supplied by the pharmaceutical company

        In Section 6.3, shelf life extended from 4 years to 5 years for the 6mg, 8mg, 10mg and 12mg tablets
        In Section 10, date of revision of the text is 13 May 2015

        Updated on 29 September 2014 SmPC

        Reasons for updating

        • Change to section 6.3 - Shelf life
        • Change to section 10 - Date of revision of the text

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

        Free text change information supplied by the pharmaceutical company

        Section 6.3

        2 and 4 mg tablets - shelf life extended from 4 years to 5 years

        6, 8, 10 and 12 mg tablets - shelf life extended from 3 years to 4 years

        Updated on 27 November 2013 SmPC

        Reasons for updating

        • Addition of black triangle
        • Change to section 4.4 - Special warnings and precautions for use
        • Change to Section 4.8 – Undesirable effects - how to report a side effect
        • Change to section 10 - Date of revision of the text

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

        Free text change information supplied by the pharmaceutical company

        Section 4.4 (special warnings and precautions for use) - the warning regarding aggression has been expanded
        Section 4.8 (undesirable effects) - the phone number and fax number to report suspected adverse reactions has been updated

        Updated on 25 November 2013 PIL

        Reasons for updating

        • Change to warnings or special precautions for use
        • Change to date of revision
        • Addition of information on reporting a side effect.
        • Addition of black triangle

        Updated on 1 October 2013 PIL

        Reasons for updating

        • New PIL for new product
        • New PIL for medicines.ie

        Updated on 30 September 2013 SmPC

        Reasons for updating

        • New SPC for new product
        • New SPC for medicines.ie

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

        Free text change information supplied by the pharmaceutical company

        None provided