Nicotinell Mint 2mg/4mg medicated chewing gum, Nicotinell Fruit 2mg/4mg medicated chewing gum (nicotine polacrilin). Nicotinell TTS Patch 10, 20, 30 (nicotine). Nicotinell Mint 1mg/2mg Lozenge (nicotine bitartrate dihydrate). Indications: Treatment of nicotine dependence, as an aid to smoking cessation. Dosage and method of use Gum: Adults and elderly:Chew one piece of gum when urge to smoke is felt. Normally 8 to12 pieces per day, up to a maximum of 24 pieces of 2mg gum per day or 15 pieces of 4mg gum per day. Do not use more than 1 gum per hour. After 3 months, gradually cut down the gum usage. The 4mg gum is for those with a strong nicotine dependency. Adolescents (12 to 17 years): As for adults but seek medical advice if more than 12 weeks treatment required. Paediatric population:Not to be used by children under 12 years. Patches: Adults: For those smoking ≥20 cigarettes a day: Nicotinell TTS30 (Step 1) once daily. Those smoking <20 start with Nicotinell TTS20 (Step 2) once daily. Reduce nicotine dose over treatment periods of 3 to 4 weeks by reducing patch strength in stepwise fashion. Use continuously for three months, if abstinence not achieved after 3 months further treatments may be recommended.Adolescents (12 to 17 years): Patients under the age of 18 years should seek medical advice before using the product. Seek medical advice if treatment is required for longer than 12 weeks. Lozenge: Smoking cessation: Stop smoking completely during treatment. Suck one lozenge slowly. Normally, 8 to 12 lozenges per day, max. Maximum of 24x1mg lozenges per day or 15x2mg lozenges per day. After 3 months, gradually cut down the usage. The higher strength lozenge is for those with a strong nicotine dependency. Smoking reduction: Use to prolong smoke-free intervals to reduce smoking. Gradually replace cigarette number with lozenge. If a cigarette reduction of 50 % per day is not achieved after 6 weeks, or quit attempt not made within 6 months of starting treatment seek medical advice. Start quit attempt once ready but no later than 4 months after treatment starts. Gradually reduce lozenge number. Not generally recommended for regular use beyond 6 months. Combination treatment: For when treatment fails with lozenge alone, 1mg lozenge and patch used together for those smoking >20 cigarettes a day, recommended to seek HCP advice. 2mg lozenge not licensed for combination therapy. Start with one patch 21mg/24 hours plus 1mg lozenge (generally 5-6 pieces per day). Max 15 lozenges a day. Treat for 6-12 weeks, then gradually reduce nicotine dose by either 1) reducing patch strength sequentially at 3-6 weeks intervals, then gradually reducing number of lozenges. OR 2) discontinuing use of patches and gradually reducing number of lozenges. Alternate patch application site to avoid skin irritation. Max treatment duration is 9 months. Paediatric population: Not to be used by children under 12 years. Not to be used by adolescents 12-17 years of age without prescription from a healthcare professional. Contraindications: Known hypersensitivity to nicotine or any of the excipients. Use by non-smokers. Patches: also, diseases of the skin. Precautions: Use with caution in patients with: cardiovascular disease, history of seizure or epilepsy or those taking anti-convulsant therapy, diabetes mellitus, hyperthyroidism, pheochromocytoma, moderate to severe renal and/or hepatic impairment, active oesophagitis, oral and pharyngeal inflammation, gastritis, gastric/peptic ulcer. Patients should initially be encouraged to stop smoking with non-pharmacological interventions (such as counselling). Keep out of the sight and reach of children at all times due to potential poisoning risk. Gums: If there are clinically significant increases in cardiovascular and other effects due to nicotine, reduce or discontinue gum. May loosen fillings or dental implants. Do not use in patients with hereditary conditions of fructose intolerance. Patches: Have a history of dermatitis. Discontinue use if a severe or persistent skin reaction occurs. Nicotinell TTS contains aluminium and should be removed prior to undergoing defibrillation, MRI or cardioversion procedures. Lozenges: May be considered under close medical supervision, where non-pharmacological methods fail in dependent smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetal's angina, severe cardiac arrhythmias, uncontrolled hypertension or recent cerebrovascular accident. Swallowed nicotine may exacerbate symptoms in subjects suffering from active oesophagitis, oral and pharyngeal inflammation, gastric or peptic ulcer. Do not use in patients with hereditary conditions of fructose intolerance. Side effects: See SPCs for full details. Certain symptoms such as depression, irritability, nervousness, restlessness, mood lability, anxiety, drowsiness, impaired concentration and insomnia may be related to withdrawal symptoms associated with smoking cessation. Quitting smoking by any means can lead to asthenia, headache, dizziness, coughing or influenza-like illness. Gum: Common: nausea, salivary hypersecretion, jaw muscle ache and dyspepsia. Uncommon: erythema, urticaria. Not known: seizures. Lozenge: Very common: nausea. Common: abdominal pain, , insomnia, cough. Frequency not known: tremor, urticaria, ulcerative stomatitis, dyspnoea, difficulty swallowing, belching, increased secretion of saliva, asthenic conditions, fatigue, feeling unwell and influenza type illness. Gum and Lozenge: Common: flatulence, stomach discomfort, stomatitis, dizziness, headache, hiccups, vomiting, diarhhoea, constipation, dry mouth, oral discomfort and pain, pharyngitis and pharyngolaryngeal pain. Uncommon: palpitations. Rare: Atrial arrhythmia, hypersensitivity, angioneurotic oedema and anaphylactic reactions. Patch: Very common: application site reactions, nausea, insomnia, abnormal dreams, headache, dizziness. Common: agitation, anxiety, nervousness, cough, pharyngitis, dyspnoea, abdominal pain, upper dyspepsia, motor dysfunction, tremor, palpitations, dry mouth, increased sweating, myalgia, asthenia, fatigue, stomatitis, oesophagitis, arthritis, diarrhoea. Uncommon: flatulence, application site pain, constipation, hypertension, hypersensitivity, disturbance in attention, somnolence, affect lability, irritability, depressed mood and confused state, paraesthesia, dysgeusia, blurred vision, tachycardia, hyperhidrosis, arthralgia, malaise, influenza type illness, asthenic conditions, pain and discomfort. Rare: dyspnoea, atrial arrhythmia. Frequency not known: allergic reactions such as urticaria, rash and pruritus; angioedema and anaphylactoid reaction. Product licence number, legal category, pack size and RSP (excl. VAT): Nicotinell Fruit 2 mg Medicated Chewing Gum, PL 44673/0122: GSL, 96: £12.33, 204: £23.36; Nicotinell Fruit 4 mg Medicated Chewing Gum, PL 44673/0123: GSL, 96: £15.31; Nicotinell Mint 2 mg Medicated Chewing Gum, PL 44673/0126: GSL, 96: £12.33, 204: £23.36; Nicotinell Mint 4 mg Medicated Chewing Gum, PL 44673/0127: GSL, 96: £15.31; Nicotinell TTS 10, PL 44673/0128: GSL, 7: £13.61; Nicotinell TTS 20, PL 44673/0129: GSL, 7: £14.04; Nicotinell TTS 30, PL 44673/0130: GSL, 7: £14.89, 21: £36.59; Nicotinell Mint 1 mg Compressed Lozenges, PL 15545/0003: GSL,12: £2.37, 96: £13.61, 144: £17.14, 204: £19.05, Nicotinell Mint 2 mg Compressed Lozenges, PL 15545/0004: GSL, 96: £15.83, 144: £20.00, 204: £22.29. PL holder for Medicated chewing gums and TTS patches: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, U.K. PL holder for Medicated Compressed Lozenges: GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, County Waterford, Ireland. Date of preparation: October 2022.
