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Vencarm XL (venlafaxine) Prolonged-release Capsules Prescribing Information
(please refer to the full SmPC before prescribing)
Indications: Major depressive episodes (MDEs), prevention of recurrence of MDEs, generalised anxiety disorder (GAD), social anxiety disorder (SAD) and panic disorder, with or without agoraphobia. Available strengths: 37.5, 75, 150 and 225mg x 28 capsules. Dosage: MDEs: recommended starting dose 75mg once daily or, if not responding, increases up to maximum of 375 mg/day. GAD and SAD: recommended starting dose 75mg once daily. Panic disorder: 37.5mg/day for 7 days, then increased to 75mg/day. GAD, SAD and panic disorder patients not responding to 75mg/day increase up to maximum of 225mg/day. For all indications lowest effective dose should be maintained; dose increases can be made at 2 weeks intervals or more; because of risk of dose-related adverse effects, dose increments should be made only after clinical evaluation; patients should usually be treated for several months or longer with regular reassessment. Caution in elderly. Not recommended in those under 18 years. In mild or moderate hepatic impairment, severe renal impairment (GFR < 30 ml/min) or haemodialysis reduce dose by 50%. Caution in severe hepatic impairment – reduce dose by more than 50%. Abrupt discontinuation should be avoided. Gradually reduce over at least 1-2 weeks to reduce risk of withdrawal reactions. Administration: Take with food, at approximately same time each day. Swallow capsules whole with fluid – do not divide, crush, chew, or dissolve. Patients on venlafaxine immediate-release tablets may be switched to venlafaxine prolonged-release capsules at nearest equivalent daily dosage. Contraindications: Hypersensitivity to active substance or excipients. Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) due to risk of serotonin syndrome. Do not initiate for at least 14 days after discontinuation of an irreversible/reversible MAOI. Discontinue for at least 7 days before starting an irreversible/reversible MAOI. Special warnings and precautions for use: Monitor patients for risk of suicide-related events until improvement occurs. Monitor for clinical worsening, suicidal behaviour or changes in behaviour. Observe carefully (risk of serotonin syndrome) if given concomitantly with other agents affecting serotonergic and/or dopaminergic neurotransmitter systems, such as SSRI, SNRI, serotonin receptor agonists, particularly during treatment initiation and dose increases. Concomitant use with serotonin precursors not recommended. Monitor patients with raised intraocular pressure or at risk for acute narrow-angle glaucoma. Screen for high blood pressure and control pre-existing hypertension before starting treatment. Review blood pressure after starting treatment and dose increases. Caution in patients whose underlying conditions might be compromised by increases in blood pressure or heart rate, patients with recent history of myocardial infarction, unstable heart disease or at high risk of serious cardiac arrhythmia or QTc prolongation. Caution if history of bipolar disorder, aggression or convulsions; if predisposition to bleeding, including use of anticoagulants or platelet inhibitors; if volume-depleted (risk of hyponatraemia/SIADH); Discontinue in patients who develop seizures. Measure serum cholesterol during long-term treatment. Co-administration with weight loss agents not recommended.
n patients who develop akathisia, increasing dose may be detrimental. Advise patients about importance of dental hygiene. In diabetic patients, insulin and/or oral antidiabetic dosage may need adjustment. Interactions: Must not be used with irreversible, non-selective MAOIs; concomitant treatment with reversible, selective MAOIs and linezolid not recommended. Caution in patients taking an SSRI, SNRI or serotonin receptor agonist, particularly when starting treatment and dose increases. Caution when used in combination with other CNS-active substances, CYP3A4 inhibitors, lithium, imipramine, metoprolol.150mg contains Allura red (E129) and Sunset Yellow FCF (E110) and 225mg contains Carmoisine (E122), which may cause allergic reactions. Avoid alcohol consumption. Avoid co-administration with medicines prolonging QTc interval. Decision to use during pregnancy or lactation should be made on risk-benefit basis. Caution patients on their ability to drive or operate hazardous machinery. Side effects: For full list of side effects consult SmPC. ‘Very Common’ ‘Common’ and ‘Serious’ side effects included in this prescribing information. Very common (≥1/10) side effects: insomnia, headache, dizziness, sedation, nausea, dry mouth, constipation and hyperhidrosis (including night sweats). Common (≥1/100 to <1/10) side effects: decreased appetite, confusional state, depersonalisation, abnormal dreams, nervousness, libido decreased, agitation, anorgasmia, akathisia, tremor, paraesthesia, dysgeusia, visual impairment, accommodation disorder, including vision blurred, mydriasis, tinnitus, tachycardia, palpitations, hypertension, hot flush, dyspnoea, yawning, diarrhoea, vomiting, rash, pruritus, hypertonia, urinary hesitation, urinary retention, pollakiuria, menorrhagia, metrorrhagia, erectile dysfunction, ejaculation disorder, fatigue, asthenia, chills, weight decreased, weight increased and blood cholesterol increased. Uncommon (≥1/1,000 to <1/100) serious side effects: gastrointestinal haemorrhage, angioedema. Rare serious (≥1/10,000 to <1/1,000) side effects: agranulocytosis, aplastic anaemia, pancytopenia, neutropenia, anaphylactic reaction, neuroleptic malignant syndrome (NMS), serotonin syndrome, convulsion, Torsades de Pointes, ventricular tachycardia, ventricular fibrillation, ECG QT prolonged, interstitial lung disease, pancreatitis, hepatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and rhabdomyolysis. Very rare (<1/10,000) serious side effects: thrombocytopaenia, tardive dyskinesia, prolonged bleeding time. Not known (cannot be estimated) serious side effects: suicidal ideation and behaviours. MA number: PL 35533/0074-0077 Cost: ￡3.30 for 37.5mg; ￡2.59 for 75mg; ￡3.89 for 150mg and ￡9.90 for 225mg (x28). MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG. Legal category: POM. Date reviewed: November 2017. Version number: 1010344190 v 2.0
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148. 1010344273 v 2.0 January 2018