Brilique 60 mg film-coated tablets
*Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 16 September 2024
File name
20240916 Package Leaflet IE MT Brilique FCT 60mg Remove NI details CV 24 0019.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 11 September 2024
File name
20240905 SPC IE MT Brilique FCT 60mg CDS Update DDI with Rosuvastatin CV 24 0016.pdf
Reasons for updating
- 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 be renewed (B)
Updated on 11 April 2024
File name
20240327 SPC IE MT Brilique Tablets 60mg CDS Update SAPT CV 24 0008.pdf
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 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
Update to section 4.2 Posology and method of administration to include the following text:
Discontinuation of ASA may be considered after 3 months in patients with ACS who have undergone a percutaneous coronary intervention (PCI) procedure and have an increased risk of bleeding. In that case, ticagrelor as single antiplatelet therapy should be continued for 9 months (see section 4.4).
Update of section 4.4 Special warnings and precautions for use to include the following text:
In two randomised controlled studies (TICO and TWILIGHT) in patients with ACS who have undergone a PCI procedure with a drug-eluting stent, discontinuing ASA after 3 months dual antiplatelet therapy with ticagrelor and ASA (DAPT), and continuing with ticagrelor as single antiplatelet therapy (SAPT) for 9 and 12 months, respectively, has been shown to decrease the risk of bleeding with no observed increase in risk of major adverse cardiovascular events (MACE) compared with continued DAPT. The decision to discontinue ASA after 3 months and continue with ticagrelor as single antiplatelet therapy for 9 months in patients with an increased risk of bleeding should be based on clinical judgment considering the risk of bleeding versus the risk of thrombotic events (see section 4.2).
Updated on 08 June 2023
File name
20230529 Package Leaflet IE MT Brilique Tablets 60mg Swedish Postcode Update CV 23 0023.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 January 2023
File name
20220303 SPC IE MT Brilique Tablets 60mg Bradyarrhythmia CDS update CV 22 0008.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 March 2022
File name
20220303 Package Leaflet IE MT Brilique Tablets 60mg Bradyarrhythmia CDS Update CV 22 0005.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Inserted text, Deleted text
[…]
4. Possible side effects
[…]
Not known (frequency cannot be estimated from the available data)
- Abnormally Low heart rate (usually lower than 60 beats per minute)
[…]
6. Contents of the pack and other information
[…]
This leaflet was last revised in 03/2022 12/2021
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Updated on 14 March 2022
File name
20220303 SPC IE MT Brilique Tablets 60mg Bradyarrhythmia CDS update CV 22 0008.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Inserted text, Deleted text
[…]
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
[…]
Brilique contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium‑free’.
For the full list of excipients, see section 6.1.
[…]
4. CLINICAL PARTICULARS
[…]
4.4 Special warnings and precautions for use
[…]
Patients at risk for bradycardic events
[…]
Bradyarrhythmic events and AV blocks have been reported in the post-marketing setting in patients taking ticagrelor (see section 4.8), primarily in patients with ACS, where cardiac ischemia and concomitant drugs reducing the heart rate or affecting cardiac conduction are potential confounders. The patient’s clinical condition and concomitant medication should be assessed as potential causes prior to adjusting treatment.
[…]
Sodium
Brilique contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium‑free’.
[…]
4.8 Undesirable effects
[…]
Table 1 – Adverse reactions by frequency and system organ class (SOC)
SOC |
Very common
|
Common
|
Uncommon
|
Not known |
Cardiac disorders |
|
|
|
Bradyarrhythmia, AV blockc |
[…]
10. DATE OF REVISION OF THE TEXT
03 March 2022 15 November 2021
Updated on 04 January 2022
File name
20211220 Package Leaflet IE MT Brilique Tablets 60mg UK Site Update CV 21 0055.pdf
Reasons for updating
- 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
[..]
6. Contents of the pack and other information
[..]
Marketing Authorisation Holder and Manufacturer
[..]
United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 836 |
|
This leaflet was last revised in 11/2021 12/2021
Updated on 24 November 2021
File name
20211115 SPC IE MT Brilique Tablets 60mg Interactions Update CV 21 0047.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
[..]
4.5 Interaction with other medicinal products and other forms of interaction
[..]
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.
[..]
4.8 Undesirable effects
[..]
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:
[..]
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
[..]
10. DATE OF REVISION OF THE TEXT
15 November 2021
Updated on 24 November 2021
File name
20211115 Package Leaflet IE MT Brilique Tablets 60mg Interactions Update CV 21 0050.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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1. What Brilique is and what it is used for
[..]
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)
[..]
4. Possible side effects
[..]
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.
[..]
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
[..]
6. Contents of the pack and other information
[..]
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
This leaflet was last revised in 09/2021 11/2021
Updated on 12 October 2021
File name
20210929 SPC IE MT Brilique Tablets 60mg Sleep Apnoea & Paeds CV 21 0036.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 60mg Sleep Apnoea CV 21 0030.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
[..]
4.4 Special warnings and precautions for use
[..]
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.
[..]
Updated on 13 September 2021
File name
20210902 Package Leaflet IE MT Brilique Tablets 60mg Sleep Apnoea CV 21 0033.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
[..]
2. What you need to know before you take Brilique
[..]
Warnings and precautions
Talk to your doctor or pharmacist before taking Brilique if:
[..]
- 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 60mg Paediatric Update CV 21 0027.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 60mg Trauma Risk CV 21 0013.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
[..]
- 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
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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, |
Intracranial haemorrhagem |
|
[..] |
[..] |
[..] |
[..] |
[..] |
[..]
m i.e. spontaneous, procedure related or traumatic intracranial haemorrhage
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- DATE OF REVISION OF THE TEXT
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25th March 2021
Updated on 30 September 2019
File name
20190912-SPC-im-Brilique-tablets-60mg-HIT update CV 19 0017.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-60mg -HIT update CV 19 0014.pdf
Reasons for updating
- Change to section 4 - possible side effects
- 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
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-60 mg TTP CV 19 0079.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.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 60 mg Tablets UIM CV 18 0124.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.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 60 mg Tablets UIM CV 18 0046.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.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 60 mg Tablets UIM CV 18 0029.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
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
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 – 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 31 May 2017
File name
PIL_16652_238.pdf
Reasons for updating
- New PIL for new product
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 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
- New PIL for new product
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 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 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 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 4.8 - 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 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 11 July 2012
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)