The chemist and druggist, 18/25. December 2010 (issue 6778)
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CHAMPIX Film-Coated Tablets (varenicline tartrate) ABBREVIATED PRESCRIBING INFORMATION - UK (See Champix Summary of Product characteristics for full Prescribing Information). Please refer to the SmPC before prescribing Champix 0.5 mg and 1 mg Presentation: White, capsular-shaped, biconvex tablets debossed with "Pfizer" on one side and "CHX 0.5" on the other side and light blue, capsular- shaped, biconvex tablets debossed with "Pfizer'' on one side and "CHX 1.0" on the other side. Indications: Champix is indicated for smoking cessation in adults. Dosage: The recommended dose is 1 mg vareniclme twice daily following a 1-week titration as follows: Days 1-3:0.5 mg once daily, Days 4-7:0.5 mg twice daily and Day 8-End of treatment: 1 mg twice daily. The patient should set a date to stop smoking. Dosing should start 1-2 weeks before this date. Patients who cannot tolerate adverse effects may have the dose lowered temporarily or permanently to 0.5 mg twice daily Patients should be treated with Champix for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment at 1 mg twice daily may be considered. Following the end of treatment, dose tapering may be considered in patients with a high risk of relapse. Patients with renal insufficiency: Mild to moderate renal impairment: No dosage adiustment is necessary. Patients with moderate renal impairment who experience intolerable adverse events. Dosing may be reduced to 1 mg once daily. Severe renal impairment. 1 mg once daily is recommended. Dosing should begin at 0.5 mg once daily for the first 3 days then increased to 1 mg once daily. Patients with end stage renal disease: Treatment is not recommended Patients with hepatic impairment and elderly patients: No dosage adiustment is necessary Paediatric patients: Not recommended in patients below the age of 18 years Contraindications: Hypersensitivity to the active substance or to any of the excipients Warnings and precautions: Effect of smoking cessation: Stopping smoking may alter the pharmacokinetics or pharmacodynamics of some medicinal products, for which dosage adiustment may be necessary (examples include theophylline, warfarin and insulin). Changes in behaviour or thinking, anxiety, psychosis, mood swings, aggressive behaviour, depression, suicidal ideation and behaviour and suicide attempts have been reported in patients attempting to quit smoking with Champix in the post-marketing experience. Not all patients had stopped smoking at the time of onset of symptoms and not all patients had known pre-existing psychiatric illness. Champix should be discontinued immediately if agitation, depressed mood or changes in behaviour or thinking that are of concern for the doctor, the patient, family or caregivers are observed, or if the patient develops suicidal ideation or suicidal behaviour. In many post-marketing cases, resolution of symptoms after discontinuation of vareniclme was reported, although in some cases the symptoms persisted; therefore, ongoing follow up should be provided until symptoms resolve Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nicotine withdrawal. In addition, smoking cessation, with or without pharmacotherapy, has been associated with the exacerbation of underlying psychiatric illness (e.g. depression). The safety and efficacy of Champix in patients with serious psychiatric illness has not been established. There is no clinical experience with Champix in patients with epilepsy At the end of treatment, discontinuation of Champix was associated with an increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients, therefore dose tapering may be considered. There have been post-marketing reports of hypersensitivity reactions including angioedema and reports of rare but severe cutaneous reactions, including Stevens-Johnson Syndrome and Erythema Multiforme in patients using vareniclme. Patients experiencing these symptoms should discontinue treatment with varenicline and contact a healthcare provider immediately. Pregnancy and lactation: Champix should not be used during pregnancy. It is unknown whether vareniclme is excreted in human breast milk. Champix should only be prescribed to breast-feeding mothers when the benefit outweighs the risk. Driving and operating machinery: Champix may have minor or moderate influence on the ability to drive and use machines. Champix may cause dizziness and somnolence and therefore may influence the ability to drive and use machines. Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform these activities. Side-Effects: Adverse reactions during clinical trials were usually mild to moderate Most commonly reported side-effects were abnormal dreams, insomnia, headache and nausea. Commonly reported side-effects were increased appetite, somnolence, dizziness, dysgeusia, vomiting, constipation, diarrhoea, abdominal distension, stomach discomfort, dyspepsia, flatulence, dry mouth and fatigue. See SmPC for other less commonly reported side effects Overdose: Standard supportive measures to be adopted as required. Varenicline has been shown to be dialyzed in patients with end stage renal disease, however, there is no experience in dialysis following overdose. Legal category POM Basic NHS cost: Pack of 25 11 x 0.5 mg and 14 x 1 mg tablets Card (EU/1/06/360/003) £27.30. Pack of 28 1 mg tablets Card (EU/1/06/360/004) £27 30. Pack of 56 0.5 mg tablets HDPE Bottle (EU/1/06/360/001) £54.60. Pack of 56 1 mg tablets HDPE Bottle (EU/1/06/360/002) £54.60. Pack of 56 1 mg tablets Card (EU/1/06/360/005) £54.60. Not all pack sizes may be marketed / marketed at launch Marketing Authorisation Holder: Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom Further information on request: Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Last revised: 11/2009. Ref: CI7 0 Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Pfizer Medical Information on 01304 616161. For further information, please contact Pfizer Medical Information on 01304 616161 or email medinfo.uk@pfizer.com CHAMPIX varenicline tartrate Date of preparation: December 2010 CHA933X ©Pfizer 2010