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Gilenya 0.5 mg hard capsules

*
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Fingolimod Hydrochloride

    *Additional information is available within the SPC or upon request to the company

  • Gilenya 0.5-1.png

Updated on 06 November 2024

File name

Gilenya_PIL Clean July 2024.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 18 May 2023

File name

Gilenya_REG SPC_PF23-0087_05. 2023_clean.pdf

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)

EDM Updated on 24 February 2023

File name

12404_Gilenya_RMPReminderCard_JUN22_LR9.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 24 February 2023

File name

12404_Gilenya_PregnancyReminderCard_JUN22_LR5.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 24 February 2023

File name

11781_Gilenya_PrescribersChecklist_JUN22_LR9.pdf

Reasons for updating

  • Add New Doc

Updated on 14 December 2022

File name

Gilenya-REGSPC_PF22-0237 _12.2022_Clean.pdf

Reasons for updating

  • 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 29 March 2022

File name

Gilenya_REG SPC_PF22-0069_22.03.2022_clean.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Updated on 04 August 2021

File name

Gilenya_REG PIL_PF21-0185_08.07.2021_clean.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

Updated on 04 August 2021

File name

Gilenya_REG SPC_PF21-0185_08.07.2021_clean.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

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

Updated on 21 December 2020

File name

Gilenya_REG SPC_PF20-0290_14.12.2020_clean.pdf

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)

Updated on 21 December 2020

File name

Gilenya_REG PIL_PF20-0290_14.12.2020_clean.pdf

Reasons for updating

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

Updated on 20 December 2019

File name

Gilenya PIL PF 19-0223 December 2019_Clean.pdf

Reasons for updating

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

Updated on 20 December 2019

File name

Gilenya REGSPC PF19-0223 December 2019_Clean.pdf

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)

Updated on 05 September 2019

File name

Gilenya PIL Sep 2019_Clean.pdf

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 05 September 2019

File name

Gilenya REGSPC PF19-0193 September 2019_Clean.pdf

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 08 February 2019

File name

Gilenya 2219697_R91_p4_LFT_X-4 RA approved 06.02.2019 TBI by 24.05.2019_IPHA.pdf

Reasons for updating

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

Updated on 22 January 2019

File name

Gilenya REGPIL 2215563_R91_p1_LFT_X-4 RA approved 18.09.2018 IPHA.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 17 January 2019

File name

Gilenya_0.25mg_0.5mg_HdCap REGSPC-Jan-19_Clean.pdf

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

File name

Gilenya_0.25mg_0.5mg_HdCap_REGSPC Dec 2018_Clean.pdf

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

File name

Gilenya 0.5mg Hard Caps REGSPC May 2018 _Clean.docx

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

File name

Gilenya 0.5 mg 2210167_R91_p1_LFT_X-4 RA approved 11.04.2018 IPHA TBI by 08.06.2018.pdf

Reasons for updating

  • Change to section 3 - dose and frequency

Updated on 17 January 2018

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

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 02 January 2018

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

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

File name

PIL_15126_562.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 February 2017

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 31 January 2017

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

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

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 01 February 2016

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

Reasons for updating

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

Updated on 26 November 2015

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 03 September 2015

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 18 June 2015

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 08 June 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 10 March 2015

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

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

Reasons for updating

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

Updated on 08 July 2014

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

Reasons for updating

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

Updated on 03 June 2014

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

Reasons for updating

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

Updated on 12 March 2014

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

Reasons for updating

  • Change to drug interactions

Updated on 08 January 2014

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

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

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

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

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

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

Reasons for updating

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

Updated on 02 August 2012

Reasons for updating

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

Updated on 05 July 2012

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 02 March 2012

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

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

Reasons for updating

  • New PIL for new product

Updated on 28 July 2011

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