Brilique 90 mg film coated tablets
- Name:
Brilique 90 mg film coated tablets
- Company:
AstraZeneca Pharmaceuticals (Ireland) DAC
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/09/19
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AstraZeneca Pharmaceuticals (Ireland) DAC
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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 30 September 2019 SPC
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 PIL
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 June 2019 SPC
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 PIL
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 SPC
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 3 August 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 3 August 2018 SPC
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 SPC
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 PIL
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 5 June 2017 SPC
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 – 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 5 June 2017 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 31 May 2017 PIL
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 28 September 2016 SPC
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 1 March 2016 SPC
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 PIL
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 SPC
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 PIL
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 4 August 2014 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- Change to information about driving or using machinery
- Change to date of revision
Updated on 2 August 2013 SPC
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 4.8 - 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 PIL
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 SPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
Updated on 11 July 2012 SPC
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
Updated on 5 July 2012 PIL
Reasons for updating
- New PIL for new product