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Introducing the UK’s only 225 mg


venlafaxine hydrochloride CAPSULE


EFEXOR® XL (venlafaxine) Prescribing Information.


Refer to Summary of Product Characteristics (SmPC) before prescribing. Presentation: Efexor XL is supplied in hard capsules containing 75 mg, 150 mg or 225 mg of venlafaxine (as hydrochloride) in an extended release formulation. Indications: Treatment of major depressive episodes; for the prevention of recurrence of major depressive episodes; treatment of generalised anxiety disorder; treatment of social anxiety disorder. Dosage: Adults (including the elderly): To be taken with food. Treatment should continue for several months and assessed regularly. Because of the risk of dose-related adverse effects, dose increments should be made only after clinical evaluation. The lowest effective dose should be maintained. Treatment should continue for at least 6 months following remission. Major depressive episodes (MDE): The recommended starting dose is 75 mg given once daily, increasing in stages to a maximum dose of 375 mg once daily if necessary. Long-term treatment may prevent recurrence of MDE. The dosage for prevention of recurrence of MDE is the same as the one used during the current episode. Generalised and social anxiety disorder: 75 mg given once daily, increasing in stages to 225 mg once daily if necessary. Children: Venlafaxine should not be used in children and adolescents under 18 years of age. Hepatic impairment: Doses should be reduced by 50% for patients with mild or moderate hepatic impairment. A dose reduction by more than 50% should be carefully considered in severe hepatic impairment. Renal impairment: No dose changes are necessary for patients with mild or moderate renal impairment, however caution is advised. Doses should be reduced by 50% for patients that require haemodialysis or with severe renal impairment. Discontinuation: Discontinue gradually to reduce the possibility of withdrawal reactions. Contra-indications: Hypersensitivity to venlafaxine or to any of the excipients. Concomitant use with MAOIs, or within 14 days of treatment of MAOIs. Wait 7 days after the discontinuation of venlafaxine before starting treatment with MAOIs. Warnings and precautions: The risk of suicide should be considered in all patients. Efexor XL should not be used in the treatment of children and adolescents under the age of 18 years. If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. Serotonin-syndrome a potentially life-threatening condition may occur with venlafaxine treatment, particularly when concomitantly treated with agents that affect the serotonergic neurotransmitter system, medicinal agents that impair metabolism of serotonin such as MAOIs, with serotonin precursors or with antipsychotics or other dopamine antagonists. Concomitant use of venlafaxine with serotonin precursors is not recommended. Use in caution in patients with myocardial infarction, unstable heart disease, patients at high risk of serious cardiac arrhythmia, narrow angle glaucoma, patients with history or family history of bipolar disorder, a history of convulsions (discontinue in event of seizure), patients using diuretics or are volume-depleted or dehydrated, patients with conditions which could be compromised by increases in heart rate, or patients predisposed to bleeding, including patients on anticoagulants and platelet inhibitors. Cases of QTc prolongation, Torsade de Pointes (TdP), ventricular tachycardia, and fatal cardiac arrhythmias have been reported with the use of venlafaxine, especially in overdose or in patients with other risk factors for QTc prolongation/TdP. The balance of risks and benefi ts should be considered before prescribing venlafaxine to patients at high risk of serious cardiac arrhythmia or QTc prolongation. Bleeding events related to SSRI and SNRI use have ranged from ecchymoses, hematomas, epistaxis and petechiae to gastrointestinal and life-threatening haemorrhages. Blood pressure should be monitored at regular intervals. In patients with diabetes, treatment with an SSRI or venlafaxine may alter glycaemic control. Insulin and/or oral antidiabetic dosage may need to be adjusted. Patients with a history of drug abuse should be monitored carefully.


Cholesterol measurement is recommended with long-term use. Venlafaxine should not be used with weight loss agents. Withdrawal reactions may occur especially on abrupt discontinuation of treatment. As dry mouth has been reported with venlafaxine treatment, patients must be advised on the importance of dental hygiene. Venlafaxine has been associated with reports of aggression and psychomotor restlessness. Ability to drive and use machines: Patients should not drive or operate machinery if their ability to do so is impaired. Interactions: Irreversible non-selective and reversible selective MAOIs: Due to reports of severe adverse reactions, do not use venlafaxine in combination with MAOIs or within 14 days of stopping treatment with an MAOI. Allow 7 days after stopping venlafaxine before starting treatment with an MAOI. Reversible non-selective MAOIs: Reversible and non-selective MAOIs should not be given to patients treated with venlafaxine. See SmPC for the effects of other medicinal products on venlafaxine and for the effects of venlafaxine on other medicinal products. The risk of QTc prolongation and/or ventricular arrhythmias (e.g, Torsade de Pointes) is increased with concomitant use of other medicinal products which prolong the QTc interval. Co-administration of such medicinal products should be avoided. Patients should be advised to avoid alcohol consumption. Pregnancy and lactation: Venlafaxine must only be administered to pregnant and lactating women if the benefi ts to the woman outweigh any possible risk to the child. From epidemiological data, there is a potential risk that the use of selective serotonin reuptake inhibitors (SSRIs) in pregnancy may increase the risk of persistent pulmonary hypertension (PPHN) in the newborn. Side-effects: Very common (≥ 1/10) reported side effects in clinical studies include dizziness, nausea, dry mouth, headache and hyperhidrosis (including night sweats). Common (≥1/100, <1/10) reported side effects were abnormal dreams, decreased libido, hypertonia, insomnia, nervousness, paraesthesia, somnolence, tremor, confusion, depersonalisation, accommodation disorder, mydriasis, visual impairment, including blurred vision, hypertension, vasodilatation (mostly fl ush), tinnitus, palpitations, yawning, decreased appetite, constipation, diarrhoea, vomiting, anorgasmia, menstrual disorders associated with increased bleeding or irregular bleeding (e.g. menorrhagia, metrorrhagia), ejaculation disorder, erectile dysfunction, dysuria (mostly urinary hesitation), pollakiuria, asthenia, fatigue, chills, blood cholesterol increased. See SmPC for all other reported side effects. Symptoms reported on discontinuation of venlafaxine were mostly mild and self-limiting and included dizziness, insomnia, paraesthesia, nausea and nervousness. Legal category: POM Date of revision: 11/2015 Package quantities, marketing authorisation numbers and basic NHS price: Efexor XL 75 mg prolonged release capsules hard, PL 00057/1280, 28 caps: £22.08; Efexor XL 150 mg prolonged release capsules hard, PL 00057/1281, 28 caps: £36.81; Efexor XL 225 mg prolonged release capsules hard, PL 00057/1512, 28 caps: £47.11 Further information is available on request from Medical Information Department at Pfi zer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK. Ref: PI EF UK 7_1


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 Pfi zer Medical Information on 01304 616161


The capsules shown are not actual size and are for illustration purposes only


UK/EFX/15/0002f Date of preparation: November 2015


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