Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Acetylsalicylic acid
Rowex Ltd
B01AC; B01AC06
Acetylsalicylic acid
75 milligram(s)
Gastro-resistant tablet
Oral use
Pack sizes of 10, 20, 28, 30, 50, 56, 60, 90, 100 gastro-resistant tablets
Product subject to prescription which may be renewed (B)
Actavis Ltd, Balkanpharma Dupnitsa AD, Actavis hf
Antithrombotic agents: platelet aggregation inhibitors excl. heparin
Platelet aggregation inhibitors excl. heparin; acetylsalicylic acid
It is used for: Secondary prevention of myocardial infarction, prevention of cardiovascular morbidity in patients suffering from stable angina pectoris, history of unstable angina pectoris, except during the acute phase, prevention of graft occlusion after Coronary Artery Bypass Grafting (CABG), coronary angioplasty, except during the acute phase, secondary prevention of transient ischaemic attacks (TIA) and ischaemic cerebrovascular accidents (CVA), provided intracerebral haemorrhages have been ruled out.
Authorised
2015-05-08
PACKAGE LEAFLET: INFORMATION FOR THE USER ASPIRIN ROWEX 75 MG GASTRO-RESISTANT TABLETS Acetylsalicylic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Aspirin Rowex is and what it is used for 2. What you need to know before you take Aspirin Rowex 3. How to take Aspirin Rowex 4. Possible side effects 5. How to store Aspirin Rowex 6. Contents of the pack and other information 1. WHAT ASPIRIN ROWEX IS AND WHAT IT IS USED FOR Aspirin Rowex contains acetylsalicylic acid, which in low doses belong to a group of medicines called anti- platelet agents. Platelets are tiny cells in the blood that cause the blood to clot and are involved in thrombosis. When a blood clot occurs in an artery it stops the blood flowing and cuts off the oxygen supply. When this happens in the heart it can cause a heart attack or angina; in the brain it can cause a stroke. Aspirin Rowex can only be used as a preventive treatment. It is taken to reduce the risk of blood clots forming and thereby prevent further: - heart attacks - strokes - cardiovascular problems in patients who suffer from stable or unstable angina (a type of chest pain). Aspirin Rowex is also used to prevent the formation of blood clots after certain types of heart surgery in order to widen or to unblock the blood vessels. This medicinal product is not recommended for emergencies. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN ROWEX DO NOT TAKE ASPIRIN ROWEX IF YOU - are allergic to acetylsalicylic acid or any of the other ingredients of this medicine ( Pročitajte cijeli dokument
Health Products Regulatory Authority 21 November 2019 CRN0090CM Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aspirin Rowex 75mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 75 mg acetylsalicylic acid. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. Oval, white, biconvex film-coated tablet, 9.2 x 5.2 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aspirin Rowex is restricted to secondary prevention with chronic treatment: Secondary prevention of myocardial infarction. Prevention of cardiovascular morbidity in patients suffering from stable angina pectoris. History of unstable angina pectoris, except during the acute phase. Prevention of graft occlusion after Coronary Artery Bypass Grafting (CABG). Coronary angioplasty, except during the acute phase. Secondary prevention of transient ischaemic attacks (TIA) and ischaemic cerebrovascular accidents (CVA), provided intracerebral haemorrhages have been ruled out. Aspirin Rowex is not recommended in emergency situations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ _Secondary prevention of myocardial infarction:_ The recommended dose is 75-150 mg once daily. _Prevention of cardiovascular morbidity in patients suffering from stable angina pectoris:_ The recommended dose is 75-150 mg once daily. _History of unstable angina pectoris, except during the acute phase:_ The recommended dose is 75-150 mg once daily. _Prevention of graft occlusion after CABG (Coronary Artery Bypass Grafting):_ The recommended dose is 75-150 mg once daily. _Coronary angioplasty, except during the acute phase:_ The recommended dose is 75-150 mg once daily. _Secondary prevention of TIA (transient ischaemic attacks) and ischaemic cerebrovascular accidents (CVA), provided intracerebral _ _haemorrhages have been ruled out:_ The recommended dose is 75-300 mg once daily. Health Products Regulatory Authority 21 Novembe Pročitajte cijeli dokument