Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
dabigatran etexilate mesilate, Quantity: 172.95 mg (Equivalent: dabigatran etexilate, Qty 150 mg)
Boehringer Ingelheim Pty Ltd
dabigatran etexilate mesilate
Capsule, hard
Excipient Ingredients: dimeticone 350; purified talc; hyprolose; purified water; indigo carmine; hypromellose; carrageenan; Acacia; potassium chloride; titanium dioxide; tartaric acid; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
10s, 60s
(S4) Prescription Only Medicine
Prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). (see Section 4.2 Dose and Method of Administration for details of treatment duration). Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults.
Visual Identification: Oblong capsule with light blue opaque cap and white opaque body. The cap is printed in black with the BI company symbol and the body with 'R150'.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2011-04-29
PRADAXA ® _CAPSULES_ _dabigatran etexilate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pradaxa. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor or from www.medicines.org.au and may contain important information about the medicine and its use of which you should be aware. KEEP THIS INFORMATION WITH THE MEDICINE. You may need to read it again. WHAT PRADAXA IS USED FOR Pradaxa contains the active substance dabigatran etexilate (as dabigatran etexilate mesilate). After oral use, dabigatran etexilate is rapidly converted in the body to its active form dabigatran. It belongs to a group of medicines called anticoagulants. Some people refer to anticoagulant medicines as "blood thinners". Dabigatran works by inhibiting a specific protein in the blood, called thrombin. Thrombin contributes to the formation of blood clots. Dabigatran prevents the formation of blood clots. Pradaxa has been prescribed to you for one of the following uses: • to prevent the formation of blood clots in the veins after knee or hip replacement surgery in adults • to reduce the risk of brain (stroke) and/or other body vessel obstruction by blood clot formation in adults with an abnormal heart beat rhythm called non-valvular atrial fibrillation • to treat blood clots in the veins of your legs and lungs and to prevent blood clots from re- occurring in the veins of your legs and/or lungs. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Read the complete document
PRADAXA PI0122-28 1 AUSTRALIAN PRODUCT INFORMATION – PRADAXA ® (DABIGATRAN ETEXILATE) CAPSULE 1 NAME OF THE MEDICINE dabigatran etexilate (as dabigatran etexilate mesilate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PRADAXA are hard capsules for oral administration. PRADAXA 75 mg hard capsules contain 75 mg dabigatran etexilate. PRADAXA 110 mg hard capsules contain 110 mg dabigatran etexilate. PRADAXA 150 mg hard capsules contain 150 mg dabigatran etexilate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Capsules 75 mg: Imprinted hypromellose capsules with white opaque cap and body of size 2 filled with yellowish pellets. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with R75. Capsules 110mg: Imprinted hypromellose capsules with light blue opaque cap and body of size 1 filled with yellowish pellets. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with R110. Capsules 150 mg: Imprinted hypromellose capsules with light blue opaque cap and white opaque body of size 0 filled with yellowish pellets. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with R150. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). (see Section 4.2 Dose and Method of Administration for details of treatment duration). Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults. 4.2 DOSE AND METHOD OF ADMINISTRATION PRADAXA capsules can be taken with or without food. PRADAXA should be swallowed whole with a full glass of water, to facilitate delivery to the stomach. The capsule should not be chewed, broken, or opened as this may increase the ris Read the complete document