Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Dabigatran etexilate mesilate 172.95mg eqv Dabigatran etexilate
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
B01AE07
150.00mg
CAPSULE
Dabigatran etexilate mesilate 172.95mg eqv Dabigatran etexilate 150.00mg
ORAL
Prescription Only
Boehringer Ingelheim Pharma GmbH & Co. KG (Ingelheim/Rhein site)
ACTIVE
2011-03-31
PACKAGE LEAFLET: INFORMATION FOR THE USER PRADAXA ® 75 MG, HARD CAPSULES 110 MG, HARD CAPSULES 150 MG, HARD CAPSULES [dabigatran etexilate] ▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 PRADAXA is and what it is used for 2. What you need to know before you take PRADAXA 3. How to take PRADAXA 4. Possible side effects 5. How to store PRADAXA 6. Contents of the pack and other information 7. Marketing Authorisation Holder and Manufacturer 8. Product registration number 9. Date of revision 1. WHAT PRADAXA IS AND WHAT IT IS USED FOR PRADAXA contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body which is involved in blood clot formation. PRADAXA 75 mg is used in adults to: • prevent the formation of blood clots in the veins after knee or hip replacement surgery. PRADAXA 110 mg is used in adults to: • prevent the formation of blood clots in the veins after knee or hip replacement surgery. • prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor. • treat blood clots and to prevent blood clots from re-occurring in the veins o Read the complete document
1 PRADAXA ® Abcd 1. NAME OF THE MEDICINAL PRODUCT PRADAXA 75 mg hard capsules PRADAXA 110 mg hard capsules PRADAXA 150 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 75 mg or 110 mg or 150 mg of dabigatran etexilate (as mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 75 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose (HPMC) capsule with white opaque cap and white opaque body of size 2. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R75”. The colour of the imprint is black. 110 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose (HPMC) capsule with light blue opaque cap and light blue opaque body of size 1. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R110”. The colour of the imprint is black. 150 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose (HPMC) capsule with light blue opaque cap and white opaque body of size 0. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R150”. The colour of the imprint is black. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 75mg capsule: Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. 110mg capsule: Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. 150mg capsule: Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATI Read the complete document