Brilique 90 mg Orodispersible Tablets

Product Information *

  • Company:

    AstraZeneca Pharmaceuticals (Ireland) DAC
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 31 March 2021

File name

20210325 SPC IE MT Brilique-tablets 90mg ODT Trauma Risk CV 21 0015_1617200574.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)

[..]

4.4      Special warnings and precautions for use

Bleeding risk

[..]

  • 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.

[..]

4.8         Undesirable effects

[..]

Tabulated list of adverse reactions

[..]

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

SOC

Very common

 

Common

 

Uncommon

 

Not known

[..]

[..]

[..]

[..]

[..]

Nervous system disorders

 

Dizziness,
Syncope, Headache

Intracranial haemorrhagem

 

[..]

[..]

[..]

[..]

[..]

[..]

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

[..]

  1.       DATE OF REVISION OF THE TEXT

[..]

25th March 2021

Updated on 26 September 2019

File name

CLEAN-SPC-im-Brilique-tablets-90mg OD-HIT update CV 19 0019_1569512707.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-Brilique-tablets-90mg OD -HIT update CV 19 0016_1569512472.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
  • Change to MA holder contact details

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-ODT-90 mg TTP CV 19 0078_1560529158.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-ODT-90 mg TTP CV 19 0076_1560529213.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 ODT UIM CV 18 0126_1543413836.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_SmPC_Brilique_90 mg_ODT_UIM_CV_18 0122_1543413907.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 ODT UIM CV 18 0048_1533293055.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 SmPC Brilique 90 mg ODT UIM CV 18 0044_1533294906.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_SmPC_Brilique_90_mg_ODT_UIM_CV_18_0028.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 ODT UIM CV 18 0031.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 03 January 2018

File name

PIL_17385_828.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 January 2018

Reasons for updating

  • New SPC for new product

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