Abbreviated Prescribing Information
Brilinta

Presentation: Ticagrelor 90mg / 60mg film-coated tablet. Indication: Co-administered with acetylsalicylic acid (ASA), for prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS); or a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event. Dosage and administration: Should be taken with 75-150mg ASA daily, unless specifically contraindicated. For ACS patients, initiated with a single 180mg loading dose and then continued at 90mg twice daily for 12 months unless discontinuation is clinically indicated. In ACS patients who have undergone a percutaneous coronary intervention (PCI) procedure and have an increased risk of bleeding, discontinuation of ASA after 3 months may be considered, and ticagrelor as single antiplatelet therapy (SAPT) should be continued for 9 months. For patients with a history of MI of at least one year and a high risk of an atherothrombotic event, when extended treatment is required, 60mg twice daily recommended. Treatment may be started without interruption as continuation therapy after the initial one-year treatment with 90 mg or other adenosine diphosphate (ADP) receptor inhibitor therapy in ACS patients with a high risk of an atherothrombotic event. Treatment can also be initiated up to 2 years from the MI, or within one year after stopping previous ADP receptor inhibitor treatment. Contraindications: Hypersensitivity to active substance or to any of its excipients; Active pathological bleeding; History of intracranial haemorrhage; Severe hepatic impairment; Co-administration with strong CYP3A4 inhibitors e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir. Precautions and Interactions: Trauma; Surgery; Prior ischaemic stroke; Risk for bradycardic events; Dyspnoea; Central sleep apnoea; Hepatic impairment; Thrombotic thrombocytopenic purpura; Heparin induced thrombocytopenia; Children (< 18 years); Premature treatment discontinuation; Co-administration with potent CYP3A inducers e.g. rifampicin, phenytoin, carbamazepine and phenobarbital; Co-administration with CYP3A4 substrates with narrow therapeutic indices i.e. cisapride and ergot alkaloids; Co-administration of simvastatin or lovastatin ≥40mg; Co-administration of high dose ASA (>300mg); Medicinal products metabolised by CYP3A4; Cyclosporine; Rosuvastatin; SSRIs e.g. paroxetine, sertraline and citalopram; morphine; Pregnancy; Breast-feeding. Undesirable effects: Very common: Blood disorder bleedings (bruise, spontaneous haematoma, haemorrhagic diathesis), hyperuricaemia, dyspnoea. Common: gout/gouty arthritis, dizziness, syncope, headache, vertigo, hypotension, respiratory system bleedings (epistaxis, haemoptysis), gastrointestinal haemorrhage (gingival bleeding, rectal bleeding, gastric ulcer haemorrhage), diarrhoea, nausea, dyspepsia, constipation, subcutaneous or dermal bleeding (ecchymosis, skin haemorrhage, petechiae), rash, pruritus, urinary tract bleeding (haematuria, cystitis haemorrhage), blood creatinine increased, post procedural haemorrhage, traumatic bleedings (contusion, traumatic haematoma, traumatic haemorrhage). Not known: thrombotic thrombocytopenic purpura, bradyarrhythmia, AV block. Full local prescribing information is available upon request. API.HK.BRIL90.0724.BRIL60.0724 

HK-12456 06/11/2025