For the use only of Registered Medical Practitioner or a Hospital or a Laboratory only Abridged Prescribing Information Ecosprin® AV Aspirin and Atorvastatin Capsules Composition: Each hard gelatin capsule contains Aspirin IP (75/150 mg) and Atorvastatin Calcium IP eq. to Atorvastatin (10/20/40 mg) Indications: For the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral vascular disease. Recommended Dosage: As directed by the physician. Method of Administration: Oral Adverse Reactions: Nasopharyngitis, allergic reactions, hyperglycemia, headache, flatulence, dyspepsia, nausea, diarrhea, myalgia, muscle spasms, joint swelling, back pain, and abnormal liver function test are most common adverse reactions associated with atorvastatin. Increased bleeding tendencies and dyspepsia are the most common adverse reactions associated with aspirin. Warnings and Precautions: Atorvastatin must be discontinued in cases of clinically significant elevation in creatinine kinase (CK) levels (>10 X ULN) or with a diagnosis of rhabdomyolysis. Aspirin must be avoided in patients with severe hepatic or renal impairment, menorrhagia, late pregnancy and during breastfeeding, and with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease, predisposing factors for rhabdomyolysis, risk of hemorrhagic stroke or increased CK levels (> 5 X ULN). Aspirin should be used with caution in patients with allergic diseases, hepatic or renal function impairment, dehydration, glucose-6-phosphate dehydrogenase deficiency, hypertension with active or history of stomach ulcer, and in the elderly who require prolonged therapy. Pregnancy - As a precautionary measure, it is preferable to avoid the use of atorvastatin during pregnancy. Breastfeeding - Atorvastatin should be discontinued during breastfeeding. Contraindications: Hypersensitivity to atorvastatin, salicylic acid compounds or prostaglandin synthetase inhibitors, or to any of the excipients. Atorvastatin is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal, during pregnancy, while breast-feeding and in women of child-bearing potential. Aspirin is contraindicated in patients with active or history of peptic ulceration and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages, haemorrhagic diathesis, coagulation disorders or concurrent anticoagulant therapy, gout, severe hepatic impairment, severe renal impairment or treated with the hepatitis C antivirals glecaprevir/pibrentasvir. For Additional Information/full prescribing information, please write to us: USV Private Limited, Arvind Vithal Gandhi Chowk, B.S.D Marg, Govandi, Mumbai - 400088 Updated on 20th March 2024.