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 25 pieces of 2mg gum per day or 15 pieces of 4mg gum per day. After 3 months, gradually cut down the gum usage. The 4mg gum is for those with a strong nicotine dependency. Adolescents (12 to 18 years): As for adults but seek medical advice if more than 12 weeks treatment required.
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 18 years): Follow above recommendations. 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 24 1mg lozenges per day or 15 2mg 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. Children and young adults (<18 years): Use only on medical advice.
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 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 reach and sight of children at all times due to potential poisoning risk. Patches: 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.
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. Very common: vomiting, application site reactions. Common: agitation, anxiety, nervousness, cough, pharyngitis, dyspnoea, abdominal pain, upper dyspepsia, dry mouth, increased sweating, myalgia, asthenia, fatigue, insomnia, abnormal dreams, nausea, headache, dizziness, stomatitis, flatulence, oesophagitis, arthritis, constipation, diarrhoea. Uncommon: palpitations, application site pain, 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, tremor, chest pain. Very Rare: anaphylactic reactions, allergic dermatitis, contact dermatitis, photosensitivity. 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: £21.24; 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: £21.24; 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 44673/0118: GSL,12: £2.37, 96: £13.61, 144: £17.14, 204: £19.05, Nicotinell Mint 2 mg Compressed Lozenges, PL 44673/0119: GSL, 96: £15.83, 144: £20.00, 204: £22.29.
PL holder: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, U.K.
Date of preparation: May 2020.
