![]() ![]() Zyban 1. 50 mg prolonged release tablets - Summary of Product Characteristics (SPC)Zyban. For the full list of excipients, see section 6. Prolonged release tablet. White, film- coated, biconvex, round tablet printed on one side with GX CH7 and plain on the other side. Zyban tablets are indicated as an aid to smoking cessation in combination with motivational support in nicotine- dependent patients. Posology. Use in Adults. It is recommended that treatment is started while the patient is still smoking and a . There should be an interval of at least 8 hours between successive doses. Bupropion side effects. Get emergency medical help if you have any of these signs of an allergic reaction to bupropion: hives; difficult breathing; swelling of your. ![]() The maximum single dose must not exceed 1. Insomnia is a very common adverse event which can be reduced by avoiding bedtime doses of Zyban (provided there is at least 8 hours between doses). ![]() Zyban (bupropion) is used to help people stop smoking by reducing cravings and other withdrawal effects. Bupropion may also be used for purposes not listed in this.![]() ![]() ![]() Paediatric population. Use in patients under 1. Zyban tablets have not been evaluated in these patients. Older people Zyban should be used with caution in older people. Greater sensitivity in some older individuals cannot be ruled out. The recommended dose in older people is 1. Patients with hepatic impairment Zyban should be used with caution in patients with hepatic impairment. Because of increased variability in the pharmacokinetics in patients with mild to moderate impairment the recommended dose in these patients is 1. Patients with renal impairment Zyban should be used with caution in patients with renal insufficiency. The recommended dose in these patients is 1. Method of administration. Zyban should be used in accordance with smoking cessation guidelines. Prescribers should assess the patient's motivation to quit. Zyban is contraindicated in patients with a known central nervous system (CNS) tumour. Zyban is contraindicated in patients who, at any time during treatment, are undergoing abrupt withdrawal from alcohol or any medicinal product known to be associated with risk of seizures on withdrawal (in particular benzodiazepines and benzodiazepine- like agents). Zyban is contraindicated in patients with a current or previous diagnosis of bulimia or anorexia nervosa. Zyban is contraindicated for use in patients with severe hepatic cirrhosis. Concomitant use of Zyban and monoamine oxidase inhibitors (MAOIs) is contraindicated. For reversible MAOIs, a 2. Zyban is contraindicated in patients with a history of bipolar disorder as it may precipitate a manic episode during the depressed phase of their illness. Zyban should not be administered to patients being treated with any other medicinal product containing bupropion as the incidence of seizures is dose dependent and to avoid overdosage. Seizures The recommended dose of Zyban must not be exceeded, since bupropion is associated with a dose- related risk of seizure. At doses up to the maximum recommended daily dose (3. Zyban daily), the incidence of seizures is approximately 0. There is an increased risk of seizures occurring with the use of Zyban in the presence of predisposing risk factors which lower the seizure threshold. All patients should be assessed for predisposing risk factors, which include: . Zyban should be discontinued and not recommenced in patients who experience a seizure while on treatment. Interactions (see section 4. Due to pharmacokinetic interactions plasma levels of bupropion or its metabolites may be altered, which may increase the potential for undesirable effects (e. Therefore care should be taken when bupropion is given concomitantly with medicinal products which can induce or inhibit the metabolism of bupropion. Bupropion inhibits metabolism by cytochrome P4. D6. Caution is advised when medicinal products metabolised by this enzyme are administered concomitantly. In the literature it has been shown that medications that inhibit CYP2. D6 may lead to reduced concentrations of endoxifen which is the active metabolite of tamoxifen. Therefore the use of bupropion, which is an inhibitor of CYP2. D6, should whenever possible be avoided during tamoxifen treatment (see section 4. Neuropsychiatry Zyban is a centrally- acting noradrenaline/dopamine reuptake inhibitor. Neuropsychiatric reactions have been reported (see section 4. In particular, psychotic and manic symptomatology have been reported mainly in patients with a known history of psychiatric illness. Depressed mood may be a symptom of nicotine withdrawal. A meta- analysis of placebo controlled clinical trials of antidepressant drugs in adults with major depressive disorder and other psychiatric disorders showed an increased risk of suicidal thinking and behaviour associated with antidepressant use compared to placebo in patients less than 2. Clinicians should be aware of the possible emergence of significant depressive symptomatology in patients undergoing a smoking cessation attempt, and should advise patients accordingly. Data in animals suggest a potential for drug abuse. Hypersensitivity Zyban should be discontinued if patients experience hypersensitivity reactions during treatment. Clinicians should be aware that symptoms may progress or recur following the discontinuation of Zyban and should ensure symptomatic treatment is administered for an adequate length of time (at least one week). Symptoms typically include skin rash, pruritus, urticaria or chest pain but more severe reactions may include angioedema, dyspnoea/bronchospasm, anaphylactic shock, erythema multiforme or Stevens- Johnson Syndrome. Arthralgia, myalgia and fever have also been reported in association with rash and other symptoms suggestive of delayed hypersensitivity. These symptoms may resemble serum sickness (See section 4. In most patients symptoms improved after stopping bupropion and initiating treatment with antihistamine or corticosteroids, and resolved over time. Hypertension In clinical practice, hypertension, which in some cases may be severe (see section 4. This has been observed in patients with and without pre- existing hypertension. A baseline blood pressure should be obtained at the start of treatment with subsequent monitoring, especially in patients with pre- existing hypertension. Consideration should be given to discontinuation of Zyban if a clinically significant increase in blood pressure is observed. Limited clinical trial data suggest that higher smoking cessation rates may be achieved by the combination use of Zyban together with Nicotine Transdermal System (NTS). Specific patient groups Older people – Clinical experience with bupropion has not identified any differences in tolerability between older and other adult patients. However, greater sensitivity of some older individuals cannot be ruled out; hence 1. Patients with hepatic impairment - Bupropion is extensively metabolised in the liver to active metabolites, which are further metabolised. No statistically significant differences in the pharmacokinetics of bupropion were observed in patients with mild to moderate hepatic cirrhosis compared with healthy volunteers, but bupropion plasma levels showed a higher variability between individual patients. Therefore Zyban should be used with caution in patients with mild to moderate hepatic impairment and 1. All patients with hepatic impairment should be closely monitored for possible undesirable effects (e. Patients with renal impairment - Bupropion is mainly excreted into urine as its metabolites. Therefore 1. 50 mg once a day is the recommended dose in patients with renal impairment, as bupropion and its active metabolites may accumulate to a greater extent than usual (see sections 4. The patient should be closely monitored for possible undesirable effects that could indicate high drug or metabolite levels. Interference with urine testing. Having an amphetamine- like chemical structure, bupropion interferes with the assay used in some rapid urine drug screens, which can result in false positive readings, particularly for amphetamines. A positive result should usually be confirmed with a more specific method. Inappropriate routes of administration. Zyban is intended for oral use only. The inhalation of crushed tablets or injection of dissolved bupropion has been reported, and may lead to a rapid release, faster absorption and a potential overdose. Seizures and/or cases of death have been reported when bupropion has been administered intra- nasally or by parenteral injection. In patients receiving medicinal products known to lower the seizure threshold, Zyban must only be used if there is a compelling clinical justification for which the potential medical benefit of smoking cessation outweighs the increased risk of seizure (see section 4. The effect of bupropion on other medicinal products: Although not metabolised by the CYP2. D6 isoenzyme, bupropion and its main metabolite, hydroxybupropion, inhibit the CYP2. D6 pathway. Co- administration of bupropion hydrochloride and desipramine to healthy volunteers known to be extensive metabolisers of the CYP2. D6 isoenzyme resulted in large (2- to 5- fold) increases in the Cmax and AUC of desipramine. Inhibition of CYP2. D6 was present for at least 7 days after the last dose of bupropion hydrochloride. Concomitant therapy with medicinal products with narrow therapeutic indices that are predominantly metabolised by CYP2. D6 should be initiated at the lower end of the dose range of the concomitant medicinal product. If Zyban is added to the treatment regimen of a patient already receiving such a medicinal product, the need to decrease the dose of the original medicinal product should be considered. Drugs which require metabolic activation by CYP2. D6 in order to be effective (e. Co- administration of digoxin with bupropion may decrease digoxin levels. Digoxin AUC 0- 2. Clinicians should be aware that digoxin levels may rise on discontinuation of bupropion and the patient should be monitored for possible digoxin toxicity. The effect of other medicinal products on bupropion: Bupropion is metabolised to its major active metabolite hydroxybupropion primarily by the cytochrome P4. CYP2. B6 (see section 5.
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