Asprin And Extended-release Dipyridamole

1 INDICATIONS AND USAGE Aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. • Aspirin and extended-release dipyridamole capsules are a combination of aspirin and dipyridamole, antiplatelet agents, indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis ( 1 )

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: • Hypersensitivity [ see Contraindications (4.1) ] • Allergy [ see Contraindications (4.2) ] • Risk of Bleeding [ see Warnings and Precautions (5.1) ] • The most frequently reported adverse reactions (>10% and greater than placebo) were headache, dyspepsia, abdominal pain, nausea, and diarrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

5.4 Coronary Artery Disease Dipyridamole has a vasodilatory effect. Chest pain may be precipitated or aggravated in patients with underlying coronary artery disease who are receiving dipyridamole. For stroke or TIA patients for whom aspirin is indicated to prevent recurrent myocardial infarction (MI) or angina pectoris, the aspirin in this product may not provide adequate treatment for the cardiac indications.

5 WARNINGS AND PRECAUTIONS • Aspirin and extended-release dipyridamole capsules increase the risk of bleeding ( 5.1 ) • Avoid use in patients with severe hepatic or renal insufficiency ( 5.2 , 5.3 ) • Interrupt aspirin and extended-release dipyridamole capsules 48 hours before using intravenous dipyridamole or other adenosinergic agents for stress testing ( 5.6 , 7.1 ) 5.1 Risk of Bleeding Aspirin and extended-release dipyridamole capsules increase the risk of bleeding. Risk factors for bleeding include the use of other drugs that increase the risk of bleeding (e.g., anticoagulants, antiplatelet agents, heparin, anagrelide, fibrinolytic therapy, and chronic use of NSAIDs) [ see Drug Interaction (7.1) ]. 4 CONTRAINDICATIONS • Hypersensitivity to any product ingredients ( 4.1 ) • Patients with known allergy to NSAIDs ( 4.2 ) • Patients with the syndrome of asthma, rhinitis, and nasal polyps ( 4.2 ) 4.1 Hypersensitivity Aspirin and extended-release dipyridamole capsules are contraindicated in patients with known hypersensitivity to any of the product components.