Brilique 90 mg Orodispersible Tablets *
Pharmacy Only: Prescription

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 24 November 2021

File name

20211115 SPC IE MT Brilique Tablets 90mg ODT Interactions Update CV 21 0049_1637776485.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 - 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

Inserted text

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4.5         Interaction with other medicinal products and other forms of interaction

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Rosuvastatin

Ticagrelor might affect renal excretion of rosuvastatin, increasing the risk for rosuvastatin accumulation. Although the exact mechanism is not known, in some cases, concomitant use of ticagrelor and rosuvastatin led to renal function decrease, increased CPK level and rhabdomyolysis.

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4.8         Undesirable effects

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Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

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United Kingdom (Northern Ireland)

Yellow Card Scheme

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

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10.      DATE OF REVISION OF THE TEXT

15 November 2021

 

Updated on 24 November 2021

File name

20211115 Package Leaflet IE MT Brilique Tablets 90mg ODT Interactions Update CV 21 0052_1637775531.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • 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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Other medicines and Brilique

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Brilique can affect the way some medicines work and some medicines can have an effect on Brilique.

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • rosuvastatin (a medicine to treat high cholesterol)

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4.       Possible side effects

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Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

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United Kingdom (Northern Ireland)

Yellow Card Scheme

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

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6.       Contents of the pack and other information

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

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United Kingdom

AstraZeneca UK Ltd

Tel: +44 1582 836 836

This leaflet was last revised in 09/2021 11/2021

Updated on 12 October 2021

File name

20210929 SPC IE MT Brilique Tablets 90mg ODT Sleep Apnoea & Paeds CV 21 0038_1634064433.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 ODT Sleep Apnoea CV 21 0032_1631531670.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 ODT Sleep Apnoea CV 21 0035_1631531598.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 ODT Paediatric Update CV 21 0029_1630398405.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

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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.

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5.1 Pharmacodynamic properties

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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.

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5.2 Pharmacokinetic properties

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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 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)

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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

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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

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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

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6.            Contents of the pack and other information

Marketing Authorisation Holder and Manufacturer

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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)