Nicorette® QuickMist
Prescribing information:
Presentation: oromucosal spray containing 13.2ml solution. Each 0.07 ml contains 1 mg nicotine, corresponding to 1 mg nicotine/spray dose. Uses: Relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them. It is indicated in pregnant and lactating women making a quit attempt. Dosage: Adults and Children over 12 years of age: The patient should make every effort to stop smoking completely during treatment with Nicorette QuickMist. One or two sprays to be used when cigarettes normally would have been smoked or if cravings emerge. If after the first spray cravings are not controlled within a few minutes, a second spray should be used. If 2 sprays are required, future doses may be delivered as 2 consecutive sprays. Most smokers will require 1-2 sprays every 30 minutes to 1 hour. Up to 4 sprays per hour may be used; not exceeding 2 sprays per dosing episode and 64 sprays in any 24-hour period. Nicorette QuickMist should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur. Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Nicorette QuickMist and as soon as they are able, reduce the number of sprays used until they have stopped completely. When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Smokers aiming to reduce cigarettes should use the Mouthspray, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. Contraindications: Children under 12 years and Hypersensitivity. Precautions: Unstable cardiovascular disease, diabetes mellitus, G.I disease, uncontrolled hyperthyroidism, phaeochromocytoma, hepatic or renal impairment. Stopping smoking may alter the metabolism of certain drugs. Transferred dependence is rare and both less harmful and easier to break than smoking dependence. May enhance the haemodynamic effects of, and pain response to, adenosine. Keep out of reach and sight of children and dispose of with care. Pregnancy & lactation: Only after consulting a healthcare professional. Side effects: Very common: dysgeusia, headache, hiccups, nausea and vomiting symptoms, dyspepsia, oral soft tissue pain and paraesthesia, stomatitis, salivary hypersecretion, burning lips, dry mouth. Common: dizziness, paraesthesia, palpitations, cough, aphthous stomatitis, gingival bleeding, toothache, pharyngeal hypoaesthesia. Other: chest pain, atrial fibrillation, dyspnoea. See SPC for further details. NHS Cost: 1 dispenser pack £11.48, 2 dispenser pack £18.50. Legal category: GSL. PL holder: McNeil Products Ltd, Roxborough Way, Maidenhead, Berkshire, SL6 3UG. PL number: 15513/0357. Date of preparation: February 2011
NICORETTE® Invisi Patch
Prescribing Information:
Presentation: Transdermal delivery system available in 3 sizes (22.5, 13.5 and 9cm2) releasing 25mg, 15mg and 10mg of nicotine respectively over 16 hours. Uses: Nicorette Invisi Patch relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them. Nicorette Invisi Patch is indicated in pregnant and lactating women making a quit attempt. If possible, Nicorette Invisi Patch should be used in conjunction with a behavioural support programme. Dosage: It is intended that the patch is worn through the waking hours (approximately 16 hours) being applied on waking and removed at bedtime. Smoking Cessation: Adults (over 18 years of age): For best results, most smokers are recommended to start on 25 mg / 16 hours patch (Step 1) and use one patch daily for 8 weeks. Gradual weaning from the patch should then be initiated. One 15 mg/16 hours patch (Step 2) should be used daily for 2 weeks followed by one 10 mg/16 hours patch (Step 3) daily for 2 weeks. Lighter smokers (i.e. those who smoke less than 10 cigarettes per day) are recommended to start at Step 2 (15 mg) for 8 weeks and decrease the dose to 10 mg for the final 4 weeks. Those who experience excessive side effects with the 25 mg patch (Step 1), which do not resolve within a few days, should change to a 15 mg patch (Step 2). This should be continued for the remainder of the 8 week course, before stepping down to the 10 mg patch (Step 3) for 4 weeks. If symptoms persist the advice of a healthcare professional should be sought. Adolescents (12 to 18 years): Dose and method of use are as for adults however, recommended treatment duration is 12 weeks. If longer treatment is required, advice from a healthcare professional should be sought. Smoking Reduction/Pre-Quit: Smokers are recommended to use the patch to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. Starting dose should follow the smoking cessation instructions above i.e. 25mg (Step 1) is suitable for those who smoke 10 or more cigarettes per day and for lighter smokers are recommended to start at Step 2 (15 mg). Smokers starting on 25mg patch should transfer to 15mg patch as soon as cigarette consumption reduces to less than 10 cigarettes per day. A quit attempt should be made as soon as the smoker feels ready. When making a quit attempt smokers who have reduced to less than 10 cigarettes per day are recommended to continue at Step 2 (15 mg) for 8 weeks and decrease the dose to 10 mg (Step 3) for the final 4 weeks. Temporary Abstinence: Use a Nicorette Invisi Patch in those situations when you can’t or do not want to smoke for prolonged periods (greater than 16 hours). For shorter periods then an alternative intermittent dose form would be more suitable (e.g. Nicorette inhalator or gum). Smokers of 10 or more cigarettes per day are recommended to use 25mg patch and lighter smokers are recommended to use 15mg patch.
*Contraindications: Hypersensitivity. Precautions: Unstable cardiovascular disease, diabetes mellitus, renal or hepatic impairment, phaeochromocytoma or uncontrolled hyperthyroidism, generalised dermatological disorders. Angioedema and urticaria have been reported. Erythema may occur. If severe or persistent, discontinue treatment. Stopping smoking may alter the metabolism of certain drugs. Transferred dependence is rare and less harmful and easier to break than smoking dependence. May enhance the haemodynamic effects of, and pain response, to adenosine. Keep out of reach and sight of children and dispose of with care. Pregnancy and lactation: Only after consulting a healthcare professional. Side effects: Very common: itching. Common: headache, dizziness, nausea, vomiting, GI discomfort; Erythema. Uncommon: palpitations, urticaria. Very rare: reversible atrial fibrillation. See SPC for further details. NHS cost: 25mg packs of 7: (£9.97); 15mg packs of 7: (£9.97); 10mg packs of 7: (£9.97). Legal category: GSL. PL holder: McNeil Products Ltd, Roxborough Way, Maidenhead, Berkshire, SL6 3UG. PL numbers: 15513/0161; 15513/0160; 15513/0159. Date of preparation: October 2010
NICORETTE® Gum
Nicorette Gum Prescribing Information.
Presentation: Nicorette 4mg gum and Nicorette 2mg gum contain 4mg and 2mg of nicotine respectively in a chewing gum base. Original, Mint and Freshmint flavours. Uses: Relief of nicotine withdrawal symptoms as an aid to smoking cessation. Used to help smokers ready to stop smoking immediately and also smokers who need to cut down their cigarette use before stopping. Dosage: Adults (over 18 years): No more than 15 pieces of gum should be used each day. Use when there is an urge to smoke. Patients smoking 20 or less a day should use 2mg gum. Those smoking more than 20 should use 4mg gum. Each piece should be chewed slowly for about 30 minutes. Smoking cessation: Patients should stop smoking during treatment. After up to 3 months ad libitum dosage, Nicorette gum use should be gradually reduced. Those who use NRT beyond 9 months should consult a healthcare professional. Smoking reduction: Use the gum between smoking episodes to reduce smoking. A quit attempt should be made as soon as the smoker feels ready but no later than 6 months. Professional advice should be sought if no reduction in 6 weeks or no quit attempt in 9 months. Adolescents (12 to 18 years): No more than 15 pieces of gum should be used each day. Smoking cessation: After 8 weeks ad libitum dosage, reduce gum use over 4 weeks. If not stopped by 12 weeks, a healthcare professional should be consulted. Smoking reduction: Only after consulting a healthcare professional. Under 12 years: Not recommended. Contraindications: Hypersensitivity. Precautions: Denture wearers, GI disease, unstable cardiovascular disease, diabetes mellitus, uncontrolled hyperthyroidism, phaeochromocytoma, renal or hepatic impairment. Stopping smoking may alter the metabolism of certain drugs. Transferred dependence is rare and less harmful and easier to break than smoking dependence. May enhance the haemodynamic effects of, and pain response to, adenosine. Keep out of reach and sight of children and dispose of with care. Pregnancy & lactation: Only after consulting a healthcare professional. Side effects: Headache, sore mouth or throat, jaw-muscle ache, GI discomfort, hiccups, nausea, vomiting, dizziness, erythema, urticaria, palpitations, allergic reactions, reversible atrial fibrillation. See SPC for further details. NHS cost: 2mg gum (30) £3.25, (105) £8.89,; 4mg gum (30) £3.99, (105) £10.83,. Legal category: GSL. PL numbers: Original 2mg 15513/0169, 4mg 15513/0170; Mint 2mg 15513/0171, 4mg 15513/0172; Freshmint 2mg 15513/0173, 4mg 15513/0174. PL holder: McNeil Products Ltd, Roxborough Way, Maidenhead, Berkshire, SL6 3UG. Date of preparation: October 2011
NICORETTE® Icy White and Freshfruit Gum
Nicorette Icy White and Freshfruit Gum Prescribing Information:
Presentation: Nicorette 2mg gum and Nicorette 4mg gum contain 2mg and 4mg of nicotine respectively in a chewing gum base. Icy White and Freshfruit flavours. Uses: Relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them. It is indicated in pregnant and lactating women making a quit attempt. Dosage: Adults and Children over 12 years of age: The strength of gum to be used will depend on the smoking habits of the individual. In general, if the patient smokes 20 or less cigarettes a day, 2 mg nicotine gum is indicated. If more that 20 cigarettes per day are smoked, 4 mg nicotine gum should be used. Nicorette gum should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur. Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the gum and as soon as they are able, reduce the number of gums used until they have stopped completely. Smokers aiming to reduce cigarettes should use Nicorette Gum, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. As soon as they are ready smokers should aim to quit smoking completely. Maximum daily dose: 15 pieces per day. When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking, but are having difficulty discontinuing Nicorette Gum are recommended to contact their pharmacist or doctor for advice. For those using the 4 mg gum, switching to the 2 mg gum may be helpful when stopping treatment or reducing the number of gums used each day. The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Contraindications: Children under 12 years and Hypersensitivity. Precautions: Unstable cardiovascular disease, diabetes mellitus, G.I disease, hepatic or renal impairment, uncontrolled hyperthyroidism, phaeochromocytoma, keep out of reach and sight of children. Smokers who wear dentures may experience difficulty in chewing. The gum may stick to, and may in rare cases damage dentures. Stopping smoking may alter the metabolism of certain drugs. Transferred dependence is rare and both less harmful and easier to break than smoking dependence. May enhance the haemodynamic effects of, and pain response to, adenosine. Dispose of with care. Pregnancy & lactation: Only after consulting a healthcare professional. Side effects: Very common: headache, sore mouth or throat, jaw-muscle ache, GI discomfort, hiccups, nausea. Common: dizziness, vomiting. Other: palpitations, allergic reactions, reversible atrial fibrillation. See SPC for further details.NHS Cost: Icy White 2mg gum (30) £3.25, (105) £8.89, 4mg gum (105) £10.83; Freshfruit 2mg gum (30) £3.25, (105) £8.89; 4mg gum (30) £3.99 (105) £10.83 Legal category: GSL. PL numbers: Icy White 2mg 15513/0152, 4mg 15513/0153; Freshfruit 2mg 15513/0136, 4mg 15513/0137. PL holder: McNeil Products Ltd, Roxborough Way, Maidenhead, Berkshire, SL6 3UG. Date of preparation: October 2011
NICORETTE® Inhalator
Nicorette Inhalator and Nicorette 15 mg Inhalator Product Information:
Presentation: Inhalation cartridge containing 10 mg (Inhalator) or 15 mg (15 mg Inhalator) nicotine for oromucosal use via a mouthpiece. Uses: Relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them. It is indicated in pregnant and lactating women making a quit attempt. Dosage: Adults and Children over 12 years of age: Nicorette Inhalator should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur. Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Inhalator and as soon as they are able, reduce the number of cartridges used until they have stopped completely. Smokers aiming to reduce cigarettes should use the Inhalator, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. As soon as they are ready smokers should aim to quit smoking completely. Maximum of 12 (Inhalator) or 6 (15 mg Inhalator) cartridges per day should be used. When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking, but are having difficulty discontinuing their Inhalator are recommended to contact their pharmacist or doctor for advice.
Contraindications: Children under 12 years and Hypersensitivity. Precautions: Unstable cardiovascular disease, diabetes mellitus, G.I disease, uncontrolled hyperthyroidism, phaeochromocytoma, hepatic or renal impairment, chronic throat disease, obstructive lung disease or bronchospastic disease. Stopping smoking may alter the metabolism of certain drugs. Transferred dependence is rare and both less harmful and easier to break than smoking dependence. May enhance the haemodynamic effects of, and pain response to, adenosine. Keep out of reach and sight of children and dispose of with care. Best used at room temperature. Pregnancy & lactation: Only after consulting a healthcare professional. Side effects: Cough, irritation of throat and mouth, headache, nasal congestion, nausea, vomiting, hiccups, palpitations, GI discomfort, dizziness, reversible atrial fibrillation. See SPC for further details.NHS Cost: Inhalator, 6-Starter pack £4.469, 42-Refill pack £14.02. 15 mg Inhalator, 4 cartridge pack £4.14, 20 cartridge pack £14.03. 36 cartridge pack £22.33. Legal category: GSL. PL holder: McNeil Products Ltd, Roxborough Way, Maidenhead, Berkshire, SL6 3UG. PL number: Inhalator 15513/0179, 15 mg Inhalator 15513/0358. Date of preparation: July 2011
NICORETTE® Freshmint Lozege
Prescribing information:
Presentation: lozenge containing 2 mg nicotine (as nicotine bitartrate dihydrate). Uses: Relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them. It is indicated in pregnant and lactating women making a quit attempt. Dosage: Adults and Children over 12 years of age: Nicorette Freshmint Lozenge is suitable for smokers who smoke 20 or fewer cigarettes per day. Nicorette Freshmint 2mg Lozenge should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur. Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the lozenge and as soon as they are able, reduce the number of lozenges used until they have stopped completely. Smokers aiming to reduce cigarettes should take the lozenge, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. As soon as they are ready smokers should aim to quit smoking completely. Most smokers require 8 to 12 lozenges per day, not to exceed 15 lozenges. When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking, but are having difficulty discontinuing with the lozenge are recommended to contact their pharmacist or doctor for advice. Contraindications: Children under 12 years and Hypersensitivity. Precautions: Unstable cardiovascular disease, diabetes mellitus, susceptibility to angioedema and urticaria, hepatic or renal impairment, uncontrolled hyperthyroidism, phaeochromocytoma, G.I disease, keep out of reach and sight of children. Stopping smoking may alter the metabolism of certain drugs. Transferred dependence is rare and both less harmful and easier to break than smoking dependence. May enhance the haemodynamic effects of, and pain response to, adenosine. Dispose of with care. Pregnancy & lactation: Only after consulting a healthcare professional. Side effects: Common: dizziness, headache, nausea, gastrointestinal discomfort, hiccups, sore mouth or throat, salivary hypersecretion, coughing, palpitations. Other: reversible atrial fibrillation, allergic reactions including angioedema. See SPC for further details. NHS Cost: 24 pack £2.55, 96 pack £8.29. Legal category: GSL. PL holder: McNeil Products Ltd, Roxborough Way, Maidenhead, Berkshire, SL6 3UG. PL number: 15513/0362. Date of preparation: January 2011
NICORETTE® Microtab
Prescribing information:
Presentation: Microtab for sublingual use consisting of nicotine B-cyclodextrin complex 17.4 mg, equivalent to 2 mg nicotine. Lemon Microtab for sublingual use consisting of Nicotine bitartrate equivalent to 2.0 mg nicotine per tablet. Uses: Relief of nicotine withdrawal symptoms as an aid to smoking cessation. It is used to help smokers ready to stop smoking immediately and also smokers who need to cut down their cigarette use before stopping. Dosage: Adults (over 18 years): The tablet is used sublingually with a recommended dose of one tablet per hour or, for heavy smokers (more than 20 cigarettes per day), two tablets per hour. Most smokers require 8-12 or 16-24 tablets per day, not to exceed 40 tablets. Smoking cessation: Patients should stop smoking during treatment. Duration of treatment is individual but up to 3 months of treatment is recommended. The nicotine dose should then be gradually reduced by decreasing the total number of tablets used per day. Treatment should be stopped when daily consumption is down to one or two tablets. Those who use NRT beyond 9 months should consult a healthcare professional. Smoking reduction: Use the microtab between smoking episodes to reduce smoking. A quit attempt should be made as soon as the smoker feels ready but no later than 6 months. Professional advice should be sought if no reduction in 6 weeks or no quit attempt in 9 months. Adolescents (12 to 18 years): No more than 40 tablets should be used each day. Smoking cessation: As adult dosage, but treatment should be used for up to 8 weeks before gradually reducing over 4 weeks. Treatment should be stopped when daily consumption is down to one or two tablets. If further treatment is required, consult a healthcare professional. Smoking reduction: Only after consulting a healthcare professional. Under 12 years: Not recommended. Contraindications: Hypersensitivity. Precautions: Unstable cardiovascular disease, diabetes mellitus, GI disease, renal or hepatic impairment, phaeochromocytoma, uncontrolled hyperthyroidism. Stopping smoking may alter the metabolism of certain drugs. Nicorette Microtab Lemon contains the ingredient aspartame which is a source of phenylalanine and may be harmful for people with phenylketonuria. Transferred dependence is rare and less harmful and easier to break than smoking dependence. May enhance the haemodynamic effects of, and pain response to, adenosine. Keep out of reach and sight of children. Pregnancy & lactation: Only after consulting a healthcare professional. Side effects: Dizziness, headache, palpitations, coughing, GI discomfort, hiccups, nausea, sore mouth or throat, dry mouth, burning sensation in mouth, rhinitis, allergic reactions, reversible atrial fibrillation. See SPC for further details. RRP (excl. VAT): Microtab; 30 – (£4.46); 105 – (£12.04);. Lemon microtab; 30 – (£3.99); 105 – (£11.12); Legal category: GSL. PL holder: McNeil Products Ltd, Roxborough Way, Maidenhead, Berkshire, SL6 3UG. PL number: Microtab 15513/0178; Lemon microtab 15513/0156 Date of preparation: April 2011
NICORETTE® Nasal Spray
Prescribing information:
Presentation: A metered spray bottle containing 10ml of a 10mg/ml solution of nicotine for intranasal use. Each 50 microlitres delivers 0.5mg nicotine. Uses: Relief of nicotine withdrawal symptoms as an aid to smoking cessation. Dosage: Adults (over 18 years): Patients should stop smoking during treatment. Use should be restricted to 3 months. For the first 8 weeks as required to a maximum of one spray into each nostril twice an hour for 16 hours per day. For the subsequent 2 weeks, reduce usage by half. Final 2 weeks, reduce usage to zero. Adults who use NRT beyond 9 months should seek advice from a healthcare professional. Adolescents (12 to 18 years): As adult dosage, but therapy should not exceed 12 weeks without consulting a healthcare professional. Under 12 years: Not recommended. Contraindications: Children under 12 years and Hypersensitivity. Precautions: Unstable cardiovascular disease, diabetes mellitus, GI disease, renal or hepatic impairment, phaeochromocytoma, uncontrolled hyperthyroidism, bronchial asthma. Stopping smoking may alter the metabolism of certain drugs. Should not be used whilst driving or operating heavy machinery. Transferred dependence is rare and less harmful and easier to break than smoking dependence. May enhance the haemodynamic effects of, and pain response to, adenosine. Keep out of reach and sight of children and dispose of with care. May initially cause nasal irritation. Pregnancy & lactation: Only after consulting a healthcare professional. Side effects: Sneezing, running nose, watering eyes and coughing occur commonly at the start of therapy but usually decline within the first few days of treatment. Additional side effects are dizziness, headache, GI discomfort, nausea, vomiting, epistaxis, palpitations, reversible atrial fibrillation. See SPC for further details.NHS Costs: £13.30. Legal category: GSL. PL holder: McNeil Products Ltd, Roxborough Way, Maidenhead, Berkshire, SL6 3UG. PL number: 15513/0180. Date of preparation: December 2009.