Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Warfarin sodium clathrate
Sun Pharmaceutical Industries Europe B.V.
B01AA; B01AA03
Warfarin sodium clathrate
2.5 milligram(s)
Tablet
Oral use
blisters containing 10, 20, 28, 30, 50, 56 or 100 tablets; bottles containing 100 tablets
Product subject to prescription which may be renewed (B)
Antithrombotic agent (Vitamin K Antagonist)
Vitamin K antagonists; warfarin
It is indicated for the prophylaxis of venous thrombosis and pulmonary embolism, and for use in the treatment of these conditions to prevent their extension and for the prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation.
Marketed
2007-10-26
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT WARFARIN TEVA 0.5 MG, 1 MG, 2 MG, 2.5 MG, 3 MG, 5 MG, 6 MG, 7.5 MG AND 10 MG TABLETS (WARFARIN SODIUM) 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 further questions, please ask your doctor or your 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. WHAT IS IN THIS LEAFLET: 1. What WARFARIN TEVA TABLETS are and what they are used for 2. What you need to know before you take WARFARIN TEVA TABLETS 3. How to take WARFARIN TEVA TABLETS 4. Possible side effects 5. How to store WARFARIN TEVA TABLETS 6. Contents of the pack and other Information 1. WHAT WARFARIN TEVA TABLETS ARE AND WHAT THEY ARE USED FOR Warfarin Teva Tablets contain an active substance called warfarin which belongs to a group of drugs called anticoagulants. They thin the blood and help prevent blood clots from forming in the heart and blood vessels. You may be given Warfarin Teva Tablets to prevent or treat problems with blood clots in the veins. You may also be given Warfarin Teva Tablets to prevent problems with blood clots in the heart, if your heartbeat is irregular and your heart valves are damaged. Warfarin Teva Tablets are not suitable for treating children. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE WARFARIN TEVA TABLETS DO NOT TAKE WARFARIN TEVA TABLETS - if you are allergic to warfarin or to any of the other ingredients in the tablets (listed in section 6) - if you are pregnant or you think that you may be pregnant - if you have just had a baby (within the last two days) - if you have had any bleeding problems including a stroke - if you have had major surgery less than three days ago or if you are due to have an op Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 15 January 2022 CRN00CQWJ Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Warfarin Teva 2.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains warfarin sodium clathrate equivalent to 2.5 mg warfarin sodium. Excipient with known effect: 196.5mg of lactose anhydrous. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Green, flat, capsule shaped, scored tablet with ‘WARFARIN’ on top of ‘TARO’ engraved on one side and ‘2½’ on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Warfarin is indicated in adults. Warfarin is indicated for the prophylaxis of venous thrombosis and pulmonary embolism, and for use in the treatment of these conditions to prevent their extension. Warfarin is indicated for the prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ The usual induction dose of warfarin is 10mg daily for 2 days, but this should be tailored to individual requirements. A baseline coagulation screen and liver function tests should be performed before initiating warfarin therapy. Subsequent daily doses should be adjusted according to the results of the prothrombin time, usually reported as the INR (international normalised ratio). The daily maintenance dose of warfarin is usually in the range 3 to 9mg, taken at the same time each day. The maintenance dose is omitted if the INR is excessively high. _Paediatric population_ The safety and efficacy of warfarin in children have not been established. _Elderly patients_ The elderly are generally more sensitive to the effects of warfarin and often require a smaller dose on a weight-for-weight basis than younger patients. In emergencies, anticoagulant therapy should be initiated with heparin and warfarin together. Where t Lesen Sie das vollständige Dokument