Venlafaxine Oral Solution Abbreviated Prescribing Information

Abbreviated Prescribing Information: Venlafaxine 37.5mg/5ml and 75mg/5ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear colourless to almost colourless solution, containing 37.5mg/5ml or 75mg/5ml Venlafaxine (as Hydrochloride). Therapeutic Indications: Treatment of major depressive episodes. For prevention of recurrence of major depressive episodes. Posology and Method of Administration: Major depressive episodes: The recommended starting dose is 75mg/day. Patients not responding to this dose may benefit from dose increases up to a maximum of 375mg/day. Dose increases can be made at intervals of 2 weeks or more, but not less than 4 days. The lowest effective dose should be maintained. Treatment should continue for at least six months following remission. Elderly patients: No specific dose adjustment is required based on age alone; however, caution should be exercised and the lowest effective dose used. Hepatic and renal impairment: A 50% dose reduction should generally be considered; further individualisation of dose may be required. Withdrawal symptoms seen on discontinuation: Withdrawal reactions are common, particularly if discontinuation is abrupt. The dose should be gradually reduced over at least one to two weeks, and longer tapering may be required based on patient needs. Method of administration: For oral use. Take with food at approximately the same time each day. Suitable for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. Paediatric population: Not recommended for use in children and adolescents under the age of 18 years. Contra-indications: Hypersensitivity to the active substance or to any of the excipients, concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs). Must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI and must be discontinued for at least 7 days before starting treatment with an irreversible MAOI. Special Warnings and Precautions for use: Caution should be exercised when co-administered with alcohol and/or other drugs due to overdose and possible adverse interactions and death. Increased risk of suicide/suicidal thoughts or self-harm especially in early treatment and following dose changes. Should not be used in the treatment of those under the age of 18 years. Serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions may occur, especially with concomitant serotonergic or dopaminergic agents. Patients with raised intraocular pressure or patients at risk for acute narrow-angle glaucoma (angle-closure glaucoma) should be closely monitored. Blood pressure should be monitored, especially after dose increases. Heart rate increases can occur. Should be used with caution in patients with cardiac disease and risk of arrhythmia. QTc prolongation, Torsade de Pointes, ventricular arrhythmias and fatal cardiac events have been reported. Use caution in patients at risk. Treatment should be discontinued in any patient who develops seizures. Cases of hyponatraemia and/or the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion may occur; caution should be exercised in volume-depleted or dehydrated patients, elderly patients, and patients taking diuretics. Increased risk of haemorrhage, including mucosal bleeding and postpartum haemorrhage. Serum cholesterol levels should be monitored. Co-administration with weight loss agents is not recommended. Mania/hypomania or aggression may occur. Akathisia and dry mouth may develop. In patients with diabetes, venlafaxine may alter glycaemic control. May cause symptoms of sexual dysfunction, including persistent symptoms. False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported. Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt. Venlafaxine should be gradually tapered when discontinuing treatment according to the patient’s needs. Excipients: Contains sodium methyl and sodium ethyl parahydroxybenzoate – may cause allergic reactions (possibly delayed). Contains liquid maltitol – patients with rare hereditary fructose intolerance should not take this medicine. This medicine contains less than 1 mmol sodium per 5 ml (essentially sodium-free). Any warning from the MC, CHM CSM or MHRA: No Black Triangle: Not applicable. A list of very common, common and serious adverse reactions is presented below:  Very common: Dizziness, headache, nausea, dry mouth, hyperhidrosis (including night sweats). Common: Serum cholesterol increased, weight loss, decreased appetite, confusional state, depersonalisation, anorgasmia, libido decreased, nervousness, insomnia, abnormal dreams, paraesthesia, sedation, tremor, somnolence, hypertonia, accommodation disorder, mydriasis, visual impairment including blurred vision, tinnitus, palpitations, hypertension, vasodilatation (mostly hot flashes/flushes), yawning, constipation, vomiting, diarrhoea, dysuria (mostly urinary hesitation), pollakiuria, ejaculation disorder, anorgasmia, erectile dysfunction, menstrual disorders associated with increased bleeding or irregular bleeding, asthenia, fatigue, chills. Serious adverse reactions: suicidal ideation/behaviour, serotonin syndrome, akathisia/psychomotor restlessness, abnormal liver function tests, hyponatraemia, anaphylactic reaction, angioedema, angle-closure glaucoma, aplastic anaemia, bleeding (mucous membrane bleeding), bleeding time prolonged, blood disorder (including agranulocytosis, aplastic anaemia, neutropenia and pancytopenia), convulsion, delirium, derealisation, dyskinesia, dyspnoea, electrocardiogram QT prolonged, ventricular arrhythmias (including torsade de pointes), bleeding events, anaphylactic reaction, erythema multiforme, extrapyramidal reactions (including dystonia and dyskinesia), gastrointestinal haemorrhage, hallucination, hepatitis, hypomania, hypotension, mania, manic reaction, myoclonus, Neuroleptic Malignant Syndrome (NMS), pancreatitis, postpartum haemorrhage, prolonged bleeding time, pulmonary eosinophilia, rhabdomyolysis, serotonin syndrome, Stevens-Johnson Syndrome, suicidal ideation and suicidal behaviours, syncope, Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH), tardive dyskinesia, thrombocytopaenia, toxic epidermal necrolysis, orthostatic hypotension, , blood prolactin increased, urinary retention, ventricular fibrillation, and ventricular tachycardia (including torsade de pointes). Refer to the SmPC for full details of other adverse reactions. Legal Category: Prescription only medicine. Pack Size and NHS Price: 37.5mg/5ml x 150ml – £192.51, 75mg/5ml x 150ml – £251.99. Marketing Authorisation Number: 37.5mg/5ml: PL 00427/0253 and 75mg/5ml: PL 00427/0254. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: May-2026