Warfarin Sodium Oral Suspension Abbreviated Prescribing Information

Abbreviated Prescribing Information: Warfarin Sodium 1mg/1ml Oral Suspension. Consult Summary of Product Characteristics before prescribing. Presentation: A white to off white suspension, each 1ml of suspension contains Warfarin Sodium 1mg. Therapeutic Indications: Prophylaxis of systemic embolism in patients with rheumatic heart disease and atrial fibrillation. Prophylaxis after insertion of prosthetic heart valves. Prophylaxis of venous thrombosis and pulmonary embolism and for use in the treatment of these conditions to prevent their extension. Posology and Method of Administration: For oral administration only. Adults: Between 3mg and 10mg per day. Concomitant therapy with heparin should be discontinued for at least six hours before the first control test is carried out. Elderly: dosage may need to be lowered. Paediatric population: Warfarin 1mg/ml Oral Suspension is not recommended for use in children. Contra-indications: Hypersensitivity to the active substance or to any of the excipients, haemorrhagic stroke and clinically significant bleeding, use within 72 hours of surgery with risk of severe bleeding, use within 48 hours postpartum, pregnancy (first and third trimesters), fibrinolytic drugs, drugs where interactions lead to a significantly increased risk of bleeding, and any physical condition in which the risk of haemorrhage might be greater than the potential clinical benefits. Special Warnings and Precautions for use: Most adverse events reported with warfarin are a result of over anticoagulation. If this preparation replaces or is replaced by another warfarin product, the patient should be monitored closely in the period immediately following the change. Monitoring: Regular depending on risk. Thrombophilia: Patients with protein C or S deficiency are at risk of developing skin necrosis when starting warfarin treatment. There is a risk of haemorrhage with warfarin treatment. Haemorrhage can indicate an overdose of warfarin has been taken. Warfarin treatment should be re-started 2–14 days following ischaemic stroke, depending on the size of the infarct and blood pressure. Minor surgical procedures with low risk of bleeding can be performed in general with an INR of <2.5. Where there is a risk of severe bleeding, warfarin should be stopped 3-5 days prior to surgery. Where it is necessary to continue anticoagulation the INR should be reduced to <2.5 and heparin therapy should be started. If surgery is required and warfarin cannot be stopped 3 days beforehand, anticoagulation should be reversed with low-dose vitamin K. The timing for re-instating warfarin therapy depends on the risk of post-operative haemorrhage. In most instances warfarin treatment can be re- started as soon as the patient has an oral intake. In most cases warfarin need not be stopped before routine dental surgery. Calciphylaxis has been reported. Patients with history of peptic ulcers should be reviewed regularly. Any change to medication, including self-medication with OTC products, warrants increased monitoring of the INR. The rate of warfarin metabolism depends on thyroid status; patients with hyper- or hypo-thyroidism should be closely monitored on starting warfarin therapy. The following may exaggerate the effect of warfarin and necessitate a reduction of dosage: loss of weight, acute illness, cessation of smoking. The following may reduce the effect of warfarin and require the dosage to be increased: weight gain, diarrhoea, vomiting. Acquired or inherited warfarin resistance should be suspected if larger than usual daily doses of warfarin are required to achieve the desired anticoagulant effect. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice: Not applicable. Legal Category: POM. The reported adverse reactions are fever, hypersensitivity, cerebral subdural haematoma, haemothorax, epistaxis, haematemesis, pancreatitis, diarrhoea, nausea, vomiting, melaena, rash, alopecia, purpura, erythematous swollen skin patches leading to ecchymosis, infarction and skin necrosis, calciphylaxis, jaundice, haematuria, unexplained drop in haematocrit, haemoglobin decreased, cerebral haemorrhage, haemorrhage, gastrointestinal haemorrhage, rectal haemorrhage, purple toes syndrome’, hepatic dysfunction, osteoporosis increasing the risk of bone fracture and anticoagulant- related nephropathy. Refer to the SmPC for details of other adverse reactions. Pack Size and NHS Price: 150ml- £202.24. Marketing Authorisation Number: PL 00427/0156. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE. Date of Preparation: June 2025.