Rivaroxaban-BP

Rivaroxabanum

Each film-coated tablet of Rivaroxaban-BP 20 mg contains rivaroxaban 20 mg. Excipient with known effect: lactose 43.6 mg (as monohydrate).

Each film-coated tablet of Rivaroxaban-BP 15 mg contains rivaroxaban 15 mg. Excipient with known effect: lactose 48.6 mg (as monohydrate).

Each film-coated tablet of Rivaroxaban-BP 10 mg contains rivaroxaban 10 mg. Excipient with known effect: lactose 53.6 mg (as monohydrate).

Indication: Rivaroxaban-BP 15 mg and 20 mg: In adults, prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients). In children and adolescents, treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in children and adolescents aged less than 18 years and weighing 30 kg or more, after at least 5 days of initial parenteral anticoagulant treatment.

Rivaroxaban-BP 10 mg: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. − Active, clinically significant bleeding. − Lesion or condition considered to be at significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent ophthalmic, cerebral or spinal surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. − Concomitant treatment with any other anticoagulants, e.g. unfractionated heparin, low molecular weight heparin (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban, etc.) except in specific circumstances of switching anticoagulant therapy (see section 4.2) or when unfractionated heparin is given at doses necessary to maintain patency of a central venous or arterial catheter (see section 4.5). − Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including cirrhotic patients with Child Pugh B and C (see section 5.2). − Pregnancy and breast-feeding (see section 4.6).

Clinical surveillance in line with anticoagulant practice is recommended throughout the treatment period. Haemorrhage risk. As with other anticoagulants, patients taking Rivaroxaban-BP should be closely monitored for signs of bleeding. It is recommended to be used with caution in conditions with an increased risk of haemorrhage. Rivaroxaban-BP administration should be discontinued if severe haemorrhage occurs (see section 4.9). In clinical studies, mucosal bleeding (e.g. epistaxis, gingival, gastrointestinal, genitourinary, including abnormal vaginal bleeding or increased menstrual bleeding) and anaemia were observed more frequently during long-term rivaroxaban treatment compared with VKA treatment. Therefore, in addition to adequate clinical surveillance […]