Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Pharma Dynamics (Pty) Ltd
10,0 mg
TABLET
EACH TABLET CONTAINS RIVAROXABAN 10,0 mg
Registered
_APPLICANT/PHCR: Innovata Pharmaceuticals (Pty) Ltd _ _PRODUCT PROPRIETARY NAME: RIVAR 10, _ _DOSAGE FORM & STRENGTH: Film-coated Tablets, Rivaroxaban 10 mg _ CTD, Module 1 Approved PIL : 29 MARCH 2022 Page 1 of 12 PATIENT INFORMATION LEAFLET SCHEDULING STATUS S4 PRODUCT NAME, STRENGTH AND PHARMACEUTICAL FORM RIVAR 10, (FILM COATED TABLETS) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING RIVAR 10 • Keep this leaflet. You may need to read it again • If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider. • RIVAR 10 has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours 1. WHAT RIVAR 10 IS AND WHAT IT IS USED FOR: • RIVAR 10 belong to a group of medicines called antithrombotic medicines. It works by blocking a blood clotting factor (Factor Xa) and thus reduces the tendency of the blood to clot. • RIVAR 10 prevents blood clots in the veins after a hip or knee replacement operation. Your doctor has prescribed this medicine for you because after an operation you are at an increased risk of getting blood clots. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE RIVAR 10 _APPLICANT/PHCR: Innovata Pharmaceuticals (Pty) Ltd _ _PRODUCT PROPRIETARY NAME: RIVAR 10, _ _DOSAGE FORM & STRENGTH: Film-coated Tablets, Rivaroxaban 10 mg _ CTD, Module 1 Approved PIL : 29 MARCH 2022 Page 2 of 12 • If you are allergic (hypersensitive) to rivaroxaban or to any ingredients of RIVAR 10, (listed in section 6) • If you have a bleeding disorder that you have inherited or bleeding excessively • If you have a disease or condition in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes) • If you are taking medicines to prevent blood clotting (e.g. warfarin or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arter Read the complete document
_APPLICANT/PHCR: Innovata Pharmaceuticals (Pty) Ltd _ _PRODUCT PROPRIETARY NAME: RIVAR 10, _ _DOSAGE FORM & STRENGTH: Film-coated Tablets, Rivaroxaban 10 mg,_ _ _ _ _ _ CTD, Module 1_ Date of PI: 29 MARCH 2022 Page 1 of 27 SCHEDULING STATUS 1. NAME OF MEDICINE: RIVAR 10, (FILM COATED TABLETS) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each RIVAR 10 film-coated tablet contains rivaroxaban 10 mg. Contains sugar (lactose - 21.0 mg per 10 mg tablet) For the full list of excipients, see SECTION 6.1 3. PHARMACEUTICAL FORM Film coated tablets RIVAR 10 round pink, biconvex film coated tablets, debossed with “L” on one side and “10” on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RIVAR 10 film-coated tablets are indicated for the prevention of venous thromboembolism (VTE) in patients undergoing major orthopaedic surgery of the lower limbs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY RECOMMENDED DOSE AND FREQUENCY OF ADMINISTRATION The recommended dose is one RIVAR 10 tablet once daily for the prevention of venous thromboembolism (VTE) in major orthopaedic surgery. S4 _APPLICANT/PHCR: Innovata Pharmaceuticals (Pty) Ltd _ _PRODUCT PROPRIETARY NAME: RIVAR 10, _ _DOSAGE FORM & STRENGTH: Film-coated Tablets, Rivaroxaban 10 mg,_ _ _ _ _ _ CTD, Module 1_ Date of PI: 29 MARCH 2022 Page 2 of 27 The initial dose should be taken within 6 - 10 hours after surgery provided that haemostasis has been established. If a dose is missed the patient should take RIVAR 10 immediately and continue on the following day with the once daily intake as before. DURATION OF TREATMENT The duration of treatment depends on the type of major orthopaedic surgery. After major hip surgery patients should be treated for 5 weeks. After major knee surgery patients should be treated for 2 weeks. SPECIAL POPULATIONS Elderly Population No dose adjustment is required for these patient populations. Hepatic Impairment RIVAR 10 is contra-indicated in patients with significant hepatic disease which is associated with coagulopathy lea Read the complete document