Gilenya Capsules

  • Name:

    Gilenya Capsules

  • Company:
    info
  • Active Ingredients:

    fingolimod hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/09/19

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Summary of Product Characteristics last updated on medicines.ie: 5/9/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Novartis Ireland Limited

Novartis Ireland Limited

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1 - 0 of 116 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 September 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - duration of treatment
  • Change to section 4 - possible side effects

Updated on 5 September 2019 SmPC

Reasons for updating

  • 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

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

Updated on 8 February 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 22 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 17 January 2019 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

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

Updated on 12 December 2018 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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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 6.3 - 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)

Updated on 21 May 2018 SmPC

Reasons for updating

  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Address change-BREXIT

Updated on 26 April 2018 PIL

Reasons for updating

  • Change to section 3 - dose and frequency

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 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

In Section 4.4, Information on Return of disease activity (rebound) has been added

Updated on 2 January 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.3 - Contraindications

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

Free text change information supplied by the pharmaceutical company

4.3 Contraindications

Different heart problems have been added under contraindications

4.4       Special warnings and precautions for use

Information on the Immunosuppressive effects of Gilenya has been added

Information on Cutaneous neoplasms has been added

4.8        Undesirable effects

Kaposi’s sarcoma has been changed from a “Not known” to a “very rare” side effect

Updated on 24 May 2017 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 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Update to Section 4.4   Special warnings and precautions for use, typographical changes (ivabradine no longer listed as a calcium channel blocker)

Update to Section 4.5   Interaction with other medicinal products and other forms of interaction (ivabradine no longer listed as a calcium channel blocker)

Update to Section 4.6    Fertility, pregnancy and lactation update concerning information for use of Gilenya during pregnancy

Update to Section 5.3   Preclinical safety data update concerning information for use of Gilenya during pregnancy

Updated on 21 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 February 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 31 January 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use

Additional information has been added on cryptococcal meningitis and PML

 

Section 4.8     Undesirable effects

Description of cryptococcal meningitis has been changed from an isolated case to cases

Updated on 14 December 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

The following side effects have been added:

Kaposi’s sarcoma

Thrombocytopenia





Updated on 19 May 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 1 February 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

In Section 4.4     Special warnings and precautions for use information on Progressive multifocal leukoencephalopathy (PML) has been added

In Section  4.8    Undesirable effects PML has been added as an adverse reactions with frequency “not known”

In Section 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION the renewal date has been added.

Updated on 12 January 2016 PIL

Reasons for updating

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

Updated on 26 November 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

In Section 4.1 Therapeutic indications, Active disease indication has been added

 

In Section 4.3 Contraindications, “except for patients with cutaneous basal cell carcinoma” has been removed

 

In Section 4.4 Special warnings and precautions for use, information has been added on the following

Very rare cases of T-wave inversion have been reported in patients treated with fingolimod

opportunistic infections

Basal cell carcinoma

 

In Section 4.8     Undesirable effects, the following side effects have been added with given frequencies:

Common:            Basal cell carcinoma

Rare:     Lymphoma

Not known:        Peripheral oedema

Not known***:

Hypersensitivity reactions, including rash, urticaria and angioedema upon treatment initiation

 

Very rare***:

T-wave inversion

Uncommon***:

Nausea

 

In the post-marketing setting, cases of infections with opportunistic pathogens, such as viral (e.g. varicella zoster virus [VZV], John Cunningham virus [JCV] causing Progressive Multifocal Leukoencephalopathy, herpes simplex virus [HSV]), fungal (e.g. cryptococci including cryptococcal meningitis) or bacterial (e.g. atypical mycobacterium), have been reported (see section 4.4).

 

Updated on 3 September 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 18 June 2015 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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

In Section 4.4 Special warnings and precautions for use

The following information has been added: Isolated cases of cryptococcal meningitis (a fungal infection) have been reported in the post-marketing setting

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

Teriflunomide has been added to this Section. Caution should be taken when switching from this product to Gilenya.

In section 4.8 Undesirable effects

Cryptococcal infections has been added as a side effect with unknown frequency

Updated on 8 June 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 10 March 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company



7.       MARKETING AUTHORISATION HOLDER address has been changed.

Updated on 25 September 2014 SmPC

Reasons for updating

  • 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

Sections 5.1 and 5.2 have been updated

Updated on 22 September 2014 PIL

Reasons for updating

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

Updated on 8 July 2014 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects

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 to include "............despite treatment with one disease modifying therapy"

Change to Section 4.8 to include "hypersensitivity " and "rash" as unknown side effects

Updated on 11 June 2014 PIL

Reasons for updating

  • Change of active ingredient
  • Change to warnings or special precautions for use

Updated on 3 June 2014 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 - how to report a side effect
  • 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

Section 4.2 has been updated in relation to Neutropenia and Cytopenia (Switching therapy to Gilenya)
Section 4.4 Infection: VZV and concomittant use of corticosteroids, upgrade of PRES from ADR to warnings and precautions.Changes in frequencies of ADR in line with update of Section 4.8
Section 4.5 Interaction with other medicinal products and other forms of Interaction - concomitant use with corticosteroids (connected to VZV)
Section 4.8 Revised ADR profile (table and related text) based on pooled analysis from D2301/D2309
Section 5.2- to amend the information related to the enzymes involved in the metabolic pathway of fingolimod
Section 6.5 - to include the new pack size of 98 capsules
Section 10- Date of revision of the text

Updated on 13 March 2014 PIL

Reasons for updating

  • Addition of information on reporting a side effect.
  • Addition of black triangle

Updated on 12 March 2014 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 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

Sections 4.4 and Sections 4.5 have been updated to include reference to warning on co-administration with potent CYP450 inducers in addition to an update to Section 4.8 to include mention of fatal cases of disseminated herpes infection with 0.5mg dose.

Updated on 17 February 2014 PIL

Reasons for updating

  • Change to drug interactions

Updated on 8 January 2014 SmPC

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Inclusion of warning - 2 rare case of Hemophagocytic Syndrome (HPS)

Updated on 15 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
  • 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

    Insertion of the black triangle.
Update to Section 4.8 to specify the periodicity of CBC assessments  ; at month 3 and atleast yearly thereafter.
Update of Section 10 to state October 2013 for Date of Revision.

Updated on 23 July 2013 SmPC

Reasons for updating

  • 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 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 of existing warning on bradycardia in Section 4.4. Update of lymphoma in Section 4.8.

Updated on 24 April 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to dosage and administration
  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 12 March 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

In Section 2 "a" has been changed to "the" full list of excipients, see section 6.1.
Posology in Section 4.2 has been updated in relation to first dose monitoring......
Section 4.4 has been updated to include information on treatment discontinuation and first dose monitoring....
Section 5.1 has been updated

Updated on 16 January 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage

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 4.8 of the SPC to include information on PRES.
Change to Section 6.4 of the SPC to update the storage conditions from 30 degrees to 25 degrees celsius

Updated on 31 August 2012 PIL

Reasons for updating

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

Updated on 2 August 2012 PIL

Reasons for updating

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

Updated on 5 July 2012 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Following approval of a Type II variation by the EMA, the SPC for Gilenya has been updated.

Updated on 2 March 2012 SmPC

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

Sections 4.4 and 4.8 have been updated in relation to the information on liver monitoring - the frequency of liver monitoring has been increased.

Updated on 28 October 2011 SmPC

Reasons for updating

  • Introduction of new pack/pack size

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

Free text change information supplied by the pharmaceutical company

Additional pack size of 28 capsules was approved.

Updated on 30 August 2011 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 July 2011 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided