Presentation: Each 1 ml of the oral suspension contains 5 mg rivaroxaban.

Indications: Rivaroxaban 5 mg/ml Oral Suspension is intended for: Adults: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with nonvalvular 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. Paediatrics: Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 30 kg after at least 5 days of initial parenteral anticoagulation treatment.

Dosage and administration: Please see the full Summary of Product Characteristics (SmPC) for a summary of posology per indication. Prevention of VTE in Adults Undergoing Elective Hip or Knee Replacement: Recommended dose: 10 mg rivaroxaban (2 ml suspension) orally once daily, with water, (with or without food), starting 6–10 hours after surgery if haemostasis is established. Duration depends on the individual risk of the patient, but the recommended durations are 5 weeks for major hip surgery, and 2 weeks for major knee surgery. Treatment and Prevention of VTE Recurrence in Children and Adolescents (<18 years): Initiate after at least 5 days of parenteral anticoagulation. Dose to be taken with food and is based on body weight: 30–50 kg: 15 mg (3ml suspension) once daily (max dose); ≥50 kg: 20 mg (4ml suspension) once daily (max dose); <30 kg: See paediatric SmPC. Treatment duration: Minimum 3 months; up to 12 months if clinically needed. Body weight should be monitored regularly, with dose adjustments made solely based on weight changes to maintain a therapeutic dose. No data support dose reduction after 6 months in children. Continued treatment beyond 3 months should be individually assessed, balancing thrombosis risk against bleeding risk. Missed dose: Take as soon as possible on the same day. Do not double dose. Prevention of Stroke and Systemic Embolism in Adults: Recommended dose: 20 mg (4ml suspension) once daily with food. Continue long-term if benefits outweigh bleeding risk. Missed dose: Take immediately, continue with next dose the following day. Do not double dose. Treatment of DVT/PE and Prevention of Recurrence in Adults: Initial treatment: 15 mg (3ml suspension) twice daily for 21 days, followed by 20 mg (4ml suspension) once daily thereafter. Missed dose during twice daily phase: Take both doses same day (30 mg total), continue regular schedule next day. Missed dose during once daily phase: Take immediately, continue with next dose the following day. Do not double dose. Extended prevention (after ≥6 months): 10 mg (2ml) or 20 mg (4ml) once daily, based on individual risk. For conversions to, or from, other anticoagulants please consult full SmPC. Rivaroxaban 5 mg/ml Oral Suspension is taken by mouth using a graduated oral syringe. 15 mg (3 ml) and 20 mg (4 ml) doses must be taken with food; 10 mg (2 ml) can be taken with water, with or without food. The suspension is ready-to-use and can be administered directly into the mouth, followed by water. It may also be given via gastric tube after confirming correct placement and flushing with water. If the patient spits out or vomits the dose within 30 minutes, re-administer. If vomiting occurs after 30 minutes, do not repeat the dose - continue as scheduled. Shake the bottle for 5 seconds before each use and ensure the correct dose is drawn.

Special Populations: Renal Impairment – Adults: Use with caution in severe renal impairment (CrCl 15–29 ml/min); plasma concentrations may increase. Not recommended if CrCl <15 ml/min. VTE prevention (hip/knee surgery): No dose adjustment for mild/moderate impairment (CrCl ≥30 ml/min). Non-valvular AF: Mild (CrCl 50–80 ml/min): No adjustment. Moderate/severe (CrCl 15–49 ml/min): Use 15 mg (3 ml) once daily. DVT/PE treatment & prevention: Mild: No adjustment. Moderate/severe: 15 mg (3 ml) twice daily for 3 weeks, then consider 15 mg (3 ml) once daily instead of 20 mg (4 ml) based on bleeding risk. Recommendation based on PK modelling, not clinical data. When 10 mg (2 ml) once daily is the standard dose: No adjustment needed. Renal Impairment - Paediatrics: Mild (GFR 50–80 ml/min/1.73 m²): No adjustment. Moderate/severe (GFR <50 ml/min/1.73 m²): Not recommended (no data). Hepatic Impairment: Contraindicated in patients with hepatic disease and coagulopathy, including Child Pugh B and C. No data for paediatrics. Elderly: No adjustment required. Bleeding risk increases with age. Body Weight: Adults: No adjustment. Paediatrics: Dose based on weight. Gender: No adjustment required. Cardioversion:
Can be initiated or continued. For TEE-guided procedures in anticoagulant-naïve patients, start ≥4 hours prior. Ensure compliance before cardioversion; follow guideline recommendations. AF Patients Undergoing PCI: Limited experience with reduced doses (15 mg or 10 mg once daily) alongside a P2Y12 inhibitor for up to 12 months in moderate renal impairment (CrCl 30–49 ml/min). Paediatric Use - Other Indications: Not recommended outside VTE treatment/prevention. No data for other uses in <18 years.

Contraindications: Hypersensitivity to rivaroxaban or any excipients, active clinically significant bleeding, conditions posing a high risk of major bleeding (e.g., current or recent gastrointestinal ulcers, high-risk malignant neoplasms, recent brain or spinal injury, recent brain, spinal, or eye surgery, recent intracranial bleeding, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal/intracerebral vascular abnormalities), use of other anticoagulants (e.g., UFH, LMWHs, fondaparinux, warfarin, dabigatran, apixaban) except during therapy transitions or when UFH is used to keep a central catheter open, liver disease with coagulopathy and bleeding risk including cirrhosis classified as Child-Pugh B or C, pregnancy and breastfeeding.

Special warnings and precautions: Clinical surveillance in line with anticoagulation practice is recommended during treatment. Haemorrhagic Risk: Monitor for bleeding signs. Discontinue if severe bleeding occurs. Mucosal bleeding and anaemia were more frequent versus VKA. Consider lab tests to detect occult bleeding. Monitor high-risk patients closely. After surgery, examine wounds and monitor haemoglobin. Monitoring Rivaroxaban Levels: Routine monitoring not required, but anti-factor Xa assay may be useful in overdose or emergency situations. Paediatric Population: Limited data in children with CNS infections. Evaluate bleeding risk carefully. Renal Impairment: Use with caution if creatinine clearance is 15–29 ml/min; not recommended if <15 ml/min. In children with GFR <50 ml/min/1.73m², not recommended. Drug Interactions: Avoid use with strong CYP3A4/P-gp inhibitors. Caution with NSAIDs, ASA, SSRIs/SNRIs. Consider GI protection in at-risk patients. Other Haemorrhagic Risk Factors: Not recommended in patients with high bleeding risk, such as: bleeding disorders, severe uncontrolled hypertension, GI diseases prone to bleeding, vascular retinopathy, bronchiectasis or pulmonary bleeding history. Cancer Patients: Balance thrombosis and bleeding risks. Avoid use in high-risk bleeding cancers, especially GI or GU tumours. Prosthetic Valves: Not recommended in patients with prosthetic valves or post-TAVR. Antiphospholipid Syndrome: Not recommended for patients with APS, especially triple positive. Hip Fracture Surgery: Not studied in this population. Haemodynamically Unstable PE: Not suitable as a heparin alternative in unstable PE or where thrombolysis/pulmonary embolectomy is needed. PCI with Stent Placement: Limited safety data in AF patients undergoing PCI. No data for those with prior stroke or TIA. Spinal/Epidural Anaesthesia or Puncture: Risk of spinal haematoma. Monitor for neurological signs. Delay rivaroxaban if traumatic puncture. Consider PK for catheter timing. Wait 18–26 hrs after last dose before catheter removal; restart 6 hrs post-removal. Surgical Procedures: Discontinue at least 24 hrs before surgery. Resume once haemostasis is established. Elderly: Bleeding risk increases with age. Dermatological Reactions: Discontinue if severe skin reactions (e.g., SJS/TEN, DRESS) occur, especially early in treatment. Excipients: Propylene glycol: 37 mg/ml, Sodium: <1 mmol per max dose (essentially sodium-free), Sodium benzoate: 2.5 mg/ml, Maltitol: avoid in hereditary fructose intolerance, Sorbitol: 50 mg/ml; avoid in HFI.

Drug Interactions: CYP3A4 and P-gp Inhibitors: Co-administration with ketoconazole (400 mg) or ritonavir (600 mg) increases rivaroxaban AUC by 2.6/2.5-fold and C_max by 1.7/1.6-fold, raising bleeding risk. Rivaroxaban should not be used with azole-antimycotics or HIV protease inhibitors. Clarithromycin (500 mg) causes a 1.5-fold increase in AUC and 1.4-fold increase in C_max; likely not clinically relevant in most patients but may be significant in high-risk patients. Erythromycin (500 mg) causes a 1.3-fold increase in AUC and C_max, with higher increases in patients with renal impairment (1.8/2.0-fold). Fluconazole (400 mg) causes a 1.4-fold increase in AUC and 1.3-fold in C_max; not clinically relevant for most but significant in high-risk patients. Dronedarone should be avoided due to limited data. Anticoagulants: Co-administration with enoxaparin (40 mg) shows an additive anti-factor Xa effect without clotting test changes. Increased bleeding risk when combined with other anticoagulants. NSAIDs/Platelet Aggregation Inhibitors: Co-administration with naproxen (500 mg) and rivaroxaban (15 mg) does not affect bleeding time, but may be significant in some patients. No relevant interaction with acetylsalicylic acid (500 mg). Clopidogrel (300 mg loading dose followed by 75 mg maintenance dose) shows increased bleeding time in some patients without affecting platelet aggregation. SSRIs/SNRIs: Increased bleeding risk when used with rivaroxaban due to effects on platelets; higher rates of bleeding observed in clinical trials. Warfarin: Switching between rivaroxaban (20 mg) and warfarin (INR 2.0-3.0) causes a significant increase in prothrombin time/INR. Monitoring with anti-factor Xa activity or PiCT is recommended during the conversion period. CYP3A4 Inducers: Co-administration with rifampicin (strong CYP3A4 inducer) decreases rivaroxaban AUC by 50%, reducing its effects. Other strong CYP3A4 inducers (e.g., phenytoin, carbamazepine) should be avoided unless closely monitored for thrombosis signs. Other Concomitant Therapies: No significant interaction with midazolam, digoxin, atorvastatin, or omeprazole. Rivaroxaban does not affect CYP3A4. No relevant interaction with food at a 10 mg dose. Laboratory Parameters: Clotting tests (PT, aPTT, HepTest) are affected by rivaroxaban’s mode of action.

Fertility, pregnancy and lactation: Pregnancy: Rivaroxaban is contraindicated during pregnancy due to potential reproductive toxicity, bleeding risks, and placental transfer. Safety and efficacy have not been established. Women of childbearing potential should avoid pregnancy during treatment. Breast-feeding: Rivaroxaban is contraindicated during breast-feeding as it is secreted into milk. A decision should be made to discontinue either breast-feeding or therapy. Fertility: No specific studies on fertility have been conducted in humans. Animal studies showed no effects on male or female fertility.

Effects on ability to drive/use machines: Rivaroxaban has minor influence on the ability to drive or use machines. However, patients experiencing syncope (uncommon) or dizziness (common) should avoid driving or operating machinery.
Undesirable effects: Please consult the SmPC for a full list of adverse reactions. Anaemia (including respective laboratory parameters), thrombocytosis (including platelet count increased), thrombocytopenia, allergic reaction, dermatitis allergic, angioedema and allergic oedema, anaphylactic reactions including anaphylactic shock, dizziness, headache, cerebral and intracranial haemorrhage, syncope, eye haemorrhage (including conjunctival haemorrhage, tachycardia, hypotension, haematoma, epistaxis, haemoptysis, eosinophilic pneumonia, gingival bleeding, gastrointestinal tract haemorrhage (including rectal haemorrhage), gastrointestinal and abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting, dry mouth, increase in transaminases, hepatic impairment, increased bilirubin, increased blood alkaline phosphatase, increased GGT, jaundice, bilirubin conjugated increased (with or without concomitant increase of ALT), cholestasis, hepatitis (including hepatocellular injury), pruritus (including uncommon cases of generalised pruritus), rash, ecchymosis, cutaneous and subcutaneous haemorrhage, urticaria, Stevens-Johnson syndrome/Toxic Epidermal Necrolysis, DRESS syndrome, pain in extremity, haemarthrosis, muscle haemorrhage, compartment syndrome secondary to a bleeding, urogenital tract haemorrhage (including haematuria and menorrhagia²), renal impairment (including blood creatinine increased, blood urea increased), renal failure/acute renal failure secondary to a bleeding sufficient to cause hypoperfusion, anticoagulant-related nephropathy, fever, peripheral oedema, decreased general strength and energy (including fatigue and asthenia), feeling unwell (including malaise), localised oedema, increased LDH, increased lipase, increased amylase, postprocedural haemorrhage (including postoperative anaemia and wound haemorrhage), contusion, wound secretion, vascular pseudoaneurysm.

Pack sizes and UK list price: 200ml bottle: £78.50 (PL 17780/1232)

Legal category: POM.

Marketing Authorisation Holder: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom

Date of Preparation: April 2025 Ref: 000748367

Rivaroxaban 5 mg /ml Oral Suspension Prescribing Information. Prescribers should consult the SmPC before prescribing.