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Block nicotine to help smokers quit successfully


CHAMPIX blocks nicotine. It releases lower levels of dopamine than nicotine to reduce the positive reinforcements of smoking and also reduces cravings and withdrawal symptoms. 1-4


This is how CHAMPIX works to break the pharmacologic basis of addiction in your patients.5


Help your patients go smoke-free and nicotine-free with CHAMPIX1


nicotine-free quit


This medical product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.


References:


1. CHAMPIX Summary of Product Characteristics. 2. Coe JW, Brooks PR, Vetelino MG et al. Varenicline: an a4β2 nicotinic receptor partial agonist for smoking cessation. J Med Chern 2005; 48: 3474-3477.


3. Gonzales D, Rennard Sl, Nides M et al. Varenicline, an a4β2 nicotinic acetylcholine receptor partial agonist, vs sustained release bupropion and placebo for smoking cessation. A randomized controlled trial. JAMA 2006; 296: 47-55.


4. Jorenby DE, Hays JT, Rigotti NA et al. Effi cacy of varenicline, an a4β2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation. A randomized controlled trial. JAMA 2006; 296: 56-63.


5. Benowitz NL. Pharmacology of Nicotine: Addiction, Smoking-Induced Disease, and Therapeutics. Annu Rev Pharmacol Toxico 2009; 49: 57-71.


Prescribing information: 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 “Pfi zer” on one side and “CHX 0.5” on the other side and light blue, capsular-shaped, biconvex tablets debossed with “Pfi zer” 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 varenicline 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 usually start 1-2 weeks before this date. Patients who are not willing or able to set the target quit date within 1-2 weeks, could be off ered to start treatment and then choose their own quit date within 5 weeks. 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 for the maintenance of abstinence. A gradual approach to quitting smoking with CHAMPIX should be considered for patients who are not able or willing to quit abruptly. Patients should reduce smoking during the fi rst 12 weeks of treatment and quit by the end of that treatment period. Patients should then continue taking CHAMPIX for an additional 12 weeks for a total of 24 weeks of treatment. Patients who are motivated to quit and who did not succeed in stopping smoking during prior CHAMPIX therapy, or who relapsed after treatment, may benefi t from another quit attempt with CHAMPIX. Patients who cannot tolerate adverse eff ects may have the dose lowered temporarily or permanently to 0.5 mg twice daily. Following the end of treatment, dose tapering may be considered in patients with a high risk of relapse. Patients with renal impairment; Mild to


Date of preparation: December 2014.


moderate renal impairment: No dosage adjustment 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 fi rst 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 adjustment 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: Eff ect of smoking cessation; Stopping smoking may alter the pharmacokinetics or pharmacodynamics of some medicinal products, for which dosage adjustment 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 varenicline 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). In a trial of patients with stable cardiovascular disease (CVD) certain cardiovascular events were reported more frequently in patients treated with CHAMPIX. A meta-analysis of 15 clinical trials, which included the smoking cessation trial of patients with stable CVD, had similar results. Patients taking CHAMPIX should be instructed to notify their doctor of new or worsening cardiovascular symptoms and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke. CHAMPIX smoking cessation studies have provided data in patients with major depressive disorder and limited data in patients with stable schizophrenia or schizoaff ective disorder. Care should be taken with patients with a history of psychiatric illness and patients should be advised accordingly. In clinical trials and post-marketing experience there have been reports of seizures in patients with or without a history of seizures, treated with CHAMPIX. CHAMPIX should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold. 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 varenicline. Patients experiencing these symptoms should discontinue treatment with varenicline and contact a health care provider immediately. Fertility, pregnancy and lactation: CHAMPIX should not be used during pregnancy. It is unknown whether varenicline is excreted in human breast milk. CHAMPIX should only be prescribed to breast feeding mothers when the benefi t outweighs the risk. There are no clinical data on the eff ects of varenicline on fertility. Non-clinical data revealed no hazard for humans based on standard male and female fertility studies in the rat. Driving and operating machinery: CHAMPIX may have minor or moderate infl uence on the ability to drive and use machines. CHAMPIX may cause dizziness and somnolence and therefore may infl uence 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 aff ects their ability to perform these activities. Side-Eff ects: Adverse reactions during clinical trials were usually mild to moderate. Very commonly reported side eff ects were nasopharyngitis, abnormal dreams, insomnia, headache and nausea. Commonly reported side-eff ects were bronchitis, sinusitis, weight increased, decreased appetite, increased appetite, somnolence, dizziness, dysgeusia, dyspnoea, cough, gastrooesophageal refl ux disease, vomiting, constipation, diarrhoea, abdominal distension, abdominal pain, toothache, dyspepsia, fl atulence, dry mouth, rash, pruritis, arthralgia, myalgia, back pain, chest pain, fatigue and abnormal liver function tests. Other side eff ects were, diabetes mellitus, suicidal ideation, seizures, cerebrovascular accident, angina pectoris, atrial fi brillation, electrocardiogram ST segment depression, myocardial infarction, haematemesis, haematochezia, Stevens Johnson Syndrome, angioedema and decreased platelet count. For full list of side eff ects see SmPC. 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 1mg tablets Card (EU/1/06/360/014) £27.30. Pack of 28 1mg tablets Card (EU/1/06/360/015) £27.30. Pack of 56 0.5 mg tablets HDPE Bottle (EU/1/06/360/001) £54.60. Pack of 56 1mg tablets Card (EU/1/06/360/016) £54.60. Not all pack sizes may be marketed / marketed at launch. Marketing Authorisation Holder: Pfi zer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom. Further information on request: Pfi zer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS. Last revised: 11/2014. Ref: CI17_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 Pfi zer Medical Information on 01304 616161


CHA1780


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