Microsoft word - bupropion__zyban__a_summary_final_210709[1].doc

Bupropion (Zyban) is an effective aid for smoking cessation. It acts to reduce the severity of withdrawal symptoms and roughly doubles the chances of stopping smoking long-term.1 Prescribing bupropion HCL SR (Zyban) 150 mg tablets Day 4 onwards take one tablet twice daily, keeping at least 8 hours between each dose Complete a course of 120 tablets (approximately 8 weeks); Zyban can be continued for longer if needed on an individual basis The person can smoke as normal for the first 7 days and can quit on day 8. Things to tell your patients 1. It’s not a magic cure, but it will make quitting easier. 2. Smoke as normal for the first week, then aim not to have a single puff from your quit day (day 8) onwards. 3. Headache, dry mouth, and difficulty sleeping are common side effects, but are usually tolerable. 4. Exercise caution before driving or using machinery until you are reasonably certain that Zyban does not affect your ability to perform tasks that require judgement or motor and cognitive skills. Current seizure disorder or any history of Use of Monoamine Oxidase Inhibitors (MAOIs) A known central nervous system (CNS) tumour Hypersensitivity to any ingredients in Zyban Use extreme caution in patients with severe hepatic cirrhosis, a reduced dosing frequency is recommended. Treatment of patients with renal impairment should be initiated at reduced frequency and/or dose. Zyban must not be used in patients with predisposing risk factors for seizures unless there is a compelling clinical justification for which the potential medical benefit of smoking cessation outweighs the potential increased risk of seizure. In these patients, a maximum dose of 150mg should be considered for the duration of treatment. Predisposing risk factors for seizures include: use of medicines known to lower the seizure threshold (e.g. antipsychotics, antidepressants, antimalarials, tramadol, theophylline, systemic steroids, quinolones and sedating antihistamines); excessive use of alcohol or sedatives; history of head trauma; diabetes treated with hypoglycaemics or insulin; use of stimulants or anorectic products Depression, rarely including suicidal ideation, has been reported in patients undergoing a smoking cessation attempt, including during early stages of treatment. Patients should be advised accordingly. The safety of Zyban for use in human pregnancy has not been established. Use of Zyban should only be considered during pregnancy if the expected benefits are greater than the potential risks. Zyban is excreted in human breast milk; mothers should be advised not to breast feed while taking Zyban. The safety and efficacy of Zyban in patients under 18 years of age have not been established. Adverse effects Dry mouth, insomnia, headache, rash. Seizure has been rarely reported. The risk of seizure is similar to other antidepressants.2 Refer to the New Zealand data sheet for Zyban for a complete list of known adverse effects. REFERENCES 1. Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev 2007(1):CD000031. 2. Oke A, Adhiyaman V, Aziz K, Ross A. Dose-dependent seizure activity associated with fluoxetine therapy. QJM 2001;94(2):113-4. For the full prescribing information on Zyban, please see the New Zealand data sheet, available at: http://www.medsafe.govt.nz/profs/datasheet/z/zybantab.htm Additional information is available in the New Zealand Smoking Cessation Guidelines: http://www.moh.govt.nz/moh.nsf/indexmh/nz-smoking-cessation-guidelines

Source: http://www.networknorth.org.nz/file/Smokefree/bupropion_zyban_a_summary.pdf

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Questions and answers on the withdrawal of the application for a change to the marketing authorisation On 19 November 2008, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for the medicinal product Viagra 50 mg tablets . The change concerned ‘switching�

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