Brilique 90 mg film coated tablets *

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 12 October 2021

File name

20210929 SPC IE MT Brilique Tablets 90mg Sleep Apnoea & Paeds CV 21 0037_1634064395.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 13 September 2021

File name

20210902 SPC IE MT Brilique Tablets 90mg Sleep Apnoea CV 21 0031_1631531521.pdf

Reasons for updating

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

Inserted text; Deleted text

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4.4 Special warnings and precautions for use

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Central sleep apnoea

Central sleep apnoea including Cheyne-Stokes respiration has been reported in the post-marketing setting in patients taking ticagrelor. If central sleep apnoea is suspected, further clinical assessment should be considered.

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Updated on 13 September 2021

File name

20210902 Package Leaflet IE MT Brilique Tablets 90mg Sleep Apnoea CV 21 0034_1631531430.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Inserted text; Deleted text

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2. What you need to know before you take Brilique

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Warnings and precautions

Talk to your doctor or pharmacist before taking Brilique if:

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  • You develop irregular breathing patterns such as speeding up, slowing down or short pauses in breathing. Your doctor will decide if you need further evaluation.

Updated on 31 August 2021

File name

20210824 SPC IE MT Brilique Tablets 90mg Paediatric Update CV 21 0028_1630398295.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

4.2 Posology and method of administration

[..]

Paediatric population

The safety and efficacy of ticagrelor in children below the age of 18 years have not been established. There is no relevant use of ticagrelor in children with sickle cell disease (see sections 5.1 and 5.2). No data are available.

[..]

5.1 Pharmacodynamic properties

[..]

Paediatric population

In a randomised, double-blind, parallel-group Phase III study (HESTIA 3), 193 paediatric patients (ages 2 to less than 18 years) with sickle cell disease were randomised to receive either placebo or ticagrelor at doses of 15 mg to 45 mg twice daily depending on body weight. Ticagrelor resulted in a median platelet inhibition of 35% at pre-dose and 56% at 2 hours post-dose at steady state.

Compared to placebo, there was no treatment benefit of ticagrelor on the rate of vaso-occlusive crises.

[..]

5.2 Pharmacokinetic properties

[..]

Paediatric population

Limited data are available in children with sickle cell disease Ticagrelor has not been evaluated in a paediatric population (see sections 4.2 and 5.1).

In the HESTIA 3 study, patients aged 2 to less than 18 years weighing ≥ 12 to ≤ 24 kg, > 24 to ≤ 48 kg and > 48 kg, were administered ticagrelor as paediatric dispersible 15 mg tablets at doses of respectively 15, 30 and 45 mg twice daily. Based on population pharmacokinetic analysis, the mean AUC ranged from 1095 ng*h/mL to 1458 ng*h/mL and the mean Cmax ranged from 143 ng/mL to 206 ng/mL at steady state.

Updated on 31 March 2021

File name

20210325 SPC IE MT Brilique-tablets 90mg Trauma Risk CV 21 0014_1617199990.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 be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC (Inserted text)

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4.4      Special warnings and precautions for use

Bleeding risk

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  • Patients with a propensity to bleed (e.g. due to recent trauma, recent surgery, coagulation disorders, active or recent gastrointestinal bleeding) or who are at increased risk of trauma.

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4.8         Undesirable effects

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Tabulated list of adverse reactions

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Table 1 – Adverse reactions by frequency and system organ class (SOC)

SOC

Very common

 

Common

 

Uncommon

 

Not known

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Nervous system disorders

 

Dizziness,
Syncope, Headache

Intracranial haemorrhagem

 

[..]

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m i.e. spontaneous, procedure related or traumatic intracranial haemorrhage

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  1.       DATE OF REVISION OF THE TEXT

[..]

25th March 2021

Updated on 30 September 2019

File name

20190912-SPC-im-Brilique-tablets-90mg-HIT update CV 19 0018_1569848114.pdf

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

Addition of warning relating to interference with platelet function tests to diagnose heparin induced thrombocytopenia (HIT), update of HPRA adverse event reporting details, update to date of revision

Updated on 26 September 2019

File name

Package Leaflet-im-tagrisso-tablets-90mg -HIT update CV 19 0015_1569512294.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Blue = Addition

Red = Deletion

2.            What you need to know before you take Brilique

Warnings and Precautions

…..

If you are taking both Brilique and heparin:

  • Your doctor may require a sample of your blood for diagnostic tests if they suspect a rare platelet disorder caused by heparin. It is important that you inform your doctor that you are taking both Brilique and heparin, as Brilique may affect the diagnostic test.

 4.         Possible side effects

Reporting of side effects

UK

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

 

Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie  

e-mail: medsafety@hpra.ie

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

…..

6.            Contents of the pack and other information

Marketing Authorisation Holder and Manufacturer

…..

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom

AstraZeneca UK Ltd

Tel: + 44 1582 836 836

Ireland

AstraZeneca Pharmaceuticals (Ireland) DAC

Tel: + 353 1609 7100

Malta

Associated Drug Co. Ltd

Tel: + 356 2277 8000

This leaflet was last revised in September 2019.

Updated on 14 June 2019

File name

20190529-Package Leaflet-uim-Brilique-tablets-90 mg TTP CV 19 0080_1560528966.pdf

Reasons for updating

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

Updated on 14 June 2019

File name

20190529-SPC-uim-Brilique-tablets-60 90 mg TTP CV 19 0077_1560529015.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Section 4.5:       Addition of Thrombotic Thrombocytopenic Purpura wording.

Section 4.8:       Thrombotic Thrombocytopenic Purpura (unknown) side effect added to AE table.

Section 10:         date updated.

Additional minor editorial revisions were made throughout the SmPC.  

Updated on 28 November 2018

File name

2018-11-15 PIL Brilique 90 mg Tablets UIM CV 18 0125_1543413595.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 28 November 2018

File name

2018-11-15_cSmPC_Brilique_60_mg_and_90_mg_tablets_UIM_CV_18_0123_1543413679.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Section 2:           addition of sodium content wording.

Section 4.2:        deletion of wording for renal dialysis.

Section 4.4:        updated wording for bradycardia added.

Section 4.4:        Addition of ‘stroke’ for premature discontinuation.

Section 4.9:        wording for dialysis clarified.

Section 5.2:        haemodialysis wording added to the ‘Renal impairment’ subheading.

Section 10:         date updated.

Additional minor editorial revisions were made throughout the SmPC.  

Updated on 03 August 2018

File name

2018-07-26 PIL Brilique 90 mg Tablets UIM CV 18 0047_1533293021.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 03 August 2018

File name

2018-07-26 cSmPC Brilique 60 mg and 90 mg tablets UIM CV 18 0045_1533294744.pdf

Reasons for updating

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

Surgery

Change from 7 to 5 days where ticagrelor should be discontinued prior to surgery 

Section 10

Date of revision changed to 26th July 2018.

Updated on 29 May 2018

File name

2018-05-17_cSmPC_Brilique_60_mg_and_90_mg_tablets_UIM_CV_18_0027.docx

Reasons for updating

  • 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 5.3 - Preclinical safety data
  • 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          Editorial changes to placement of information on grapefruit juice. Addditional information relating to interaction between morphine and oral P2Y12 inhibitors, including ticagrelor and its active metabolite.

Section 4.8          Addition of comma and update UK ADR reporting details in line with latest version.

Section 5.3          Addition of comma.

Section 10           Updated date of revision.

Updated on 29 May 2018

File name

2018-05-17 PIL Brilique 90 mg Tablets UIM CV 18 0030.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 05 June 2017

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 4.5 - 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 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 – Addition of ‘twice daily’.
Section 4.2 – Replacement of ‘Brilique’ with ‘ticagrelor’ in subsection ‘History of myocardial infarction’
Section 4.3 – Deletion of ‘is contraindicated’
Section 4.4 – Replacement of ‘Brilique’ with ‘ticagrelor’ in subsection ‘Patients with prior ischaemic stroke’
Section 4.5 – Replacement of ‘effects’ with ‘reactions’ in subsection ‘Medicinal products metabolised by CYP3A4’
Section 4.8 – Editorial change to headings in Table 1.
Section 4.8 – Replacement of ‘Brilique’ with ‘ticagrelor’
Section 5.1 – Replacement of ‘Brilique’ with ‘ticagrelor’
Section 5.1 – Update to submission of results of studies relating to paediatric population
Section 6.6 – Deletion of ‘No special requirements’
Section 10 – Update to date of revision of text.

Updated on 05 June 2017

Reasons for updating

  • New SPC for new product

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

Updated on 31 May 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 31 May 2017

File name

PIL_15408_562.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 September 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4: updated to include information on platelet transfusion

Section 4.4: updated spelling of ‘ischaemic’

Section 4.9: updated to include information on platelet transfusion

Section 5.1: updated spelling of ‘ischaemic’ and minor editorial change

Section 10 : updated date of revision

Updated on 01 March 2016

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • 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 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

Section 1 – Addition of 60mg details.

Section 2 – Addition of 60mg details.

Section 3 – Addition of 60mg details.

Section 4.1 – Update indication to include history of myocardial infarction.

Section 4.2 – Update section to include history of myocardial infarction posology for 60mg strength. Update information about moderate hepatic impairment.

Section 4.3 – Remove moderate hepatic impairment as a contraindication.

Section 4.4 – Update to ‘Bleeding risk’ section. Addition of sections on ‘Patients with prior ischemic stroke’ and ‘Hepatic impairment’. Update to ‘Dyspnoea’ section. Update to ‘Uric acid increase’ section and addition of section of ‘Premature discontinuation’. Editorial changes to improve readability.

Section 4.5 – Amendment of ‘Brilique’ to ‘ticagrelor’ where relevant. Editorial changes to improve readability.

Section 4.6 – Amendment of ‘Brilique’ to ‘ticagrelor’ where relevant.

Section 4.7 – Addition of confusion to section.

Section 4.8 – Extensive update to section based on all available Brilique data. Amendment of ‘Brilique’ to ‘ticagrelor’ where relevant. Editorial changes to improve readability.

Section 4.9 – Amendment of ‘Brilique’ to ‘ticagrelor’ where relevant.

Section 5.1 – Addition of PEGASUS clinical safety and efficacy data. Editorial changes to improve readability.

Section 5.2 – Update to ‘Absorption’, ‘Hepatic impairment’ and ‘Ethnicity’ sections.

Section 6.1 – Addition of 60mg details. Editorial changes to improve readability.

Section 6.5 – Addition of 60mg details.

Section 6.6 – Addition of disposal information.

Section 8 – Addition of 60mg details.

Section 10 – Change to date of revision.

Updated on 29 February 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 30 July 2015

Reasons for updating

  • 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 4.7 - Effects on ability to drive and use machines
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • 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
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Section 1 – Change “film coated” to “film-coated”.

Section 2 – Change “film coated” to “film-coated”.

Section 4.1 – Editorial amendments.

Section 4.2 – Editorial amendments.

Section 4.3 – Remove reference to section 4.4.

Section 4.4 – Editorial amendments and remove repeated interaction information.

Section 4.5 – Editorial clarifications.

Section 4.6 – Change “Breast feeding” to “Breast-feeding”.

Section 4.7 – Clarification around effect on ability to drive and use machines.

Section 4.8 – Editorial amendments, amendment of Maltese ADR reporting address in line with updated Appendix V.

Section 4.9 – Editorial amendments.

Section 5.1 – Editorial amendments.

Section 5.2 – Editorial amendments.

Section 5.3 – Corrections to typographical errors.

Section 6.1 – Editorial amendments in line with QRD.

Section 7 – Correction to MAH address.

Section 9 – Addition of Date of Latest Renewal.
Section 10 – Update to date of revision

Updated on 29 July 2015

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to appearance of the medicine
  • Change to improve clarity and readability
  • Change of contraindications

Updated on 04 August 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 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 4.2 Addition of method of administration for crushed tablets

- Section 4.5 Removal of Dexamethasone as a CYP3A inducers
- Section 4.8 Update to new Irish agency details and minor editorial changes

- Section 5.1 Additional mechanism of action - adenosine pathway

- Section 5.2 Pharmacokinetic properties for crushed administration route

- Section 10 Revision date

Updated on 29 July 2014

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 29 November 2013

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

Section 4.5 – Interaction with other medicinal products and other forms of interaction: Added information on grapefruit juice

 

Section 4.7 – Effects on ability to drive and use machines: Added additional language regarding dizziness and confusion.

 

Section 4.8 - Undesirable effects: Added language about post-marketing experience to the Tabulated list of adverse reactions

Added a new footnote to Intracranial haemorrhage in Table 1 to list fatal intracranial bleedings have been reported during post-marketing.

Section 10 - Updated date of revision

Updated on 27 November 2013

Reasons for updating

  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 02 August 2013

Reasons for updating

  • 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Section 4.5 - PK data for Cyclosporine
Section 4.8 - Inclusion of adverse event reporting (ADR) process (this is standard wording that will apply to all products)
Section 5.2 - Clarification of renal impairment wording
Section 10 - Updated to date of revision
Various editorial changes

Updated on 30 July 2013

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 16 November 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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

Section 4.2

 

Changes in titles for Special Populations.

 

 

Section 4.3

 

Addition of excipient list reference.



Section 4.8

 

Addition of hypersensitivity into ADR table.

 

 

Section 10

 

Date of revision updated to 24th October 2012.

Updated on 13 November 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 11 July 2012

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 05 July 2012

Reasons for updating

  • New PIL for new product