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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 initial 75 mg/day dose may be increased up to a maximum dose of 375 mg/day. Dosage increases can be made after clinical evaluation at intervals of 2 weeks or more, but not less than 4 days. Treatment should continue for at least six months following remission. Elderly patients: No specific dose adjustments are considered necessary. Hepatic and renal impairment: A 50% dose reduction should be considered. Withdrawal symptoms seen on discontinuation of venlafaxine: The dose should be gradually reduced over a period of at least one to two weeks. For oral use, taken with food 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 may occur, particularly with concomitant use of other serotonergic agents. Patients with raised intraocular pressure or patients at risk for acute narrow-angle glaucoma (angle-closure glaucoma) 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 and Torsade de Pointes, ventricular tachycardia and fatal cardiac arrhythmias have been reported. 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. The risk of haemorrhage and the risk of skin and mucous membrane bleeding may be increased. Risk of postpartum haemorrhage may be increased. 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. 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. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice: Not applicable. Legal Category: POM. A list of very common and common reactions is presented below and refer the SmPC for other reactionVery common: Dizziness, headache, nausea, dry mouth, hyperhidrosis. 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, yawning, constipation, vomiting, diarrhoea, dysuria, pollakiuria, ejaculation disorder, anorgasmia, erectile dysfunction, menstrual disorders associated with increase bleeding, asthenia, fatigue, chills, and blood cholesterol increased. Pack Size and NHS Price: 37.5mg/5ml x 150ml – £178.00, 75mg/5ml x 150ml – £233.00. 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 2023

Adverse Drug Events

Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400