NOTHING BEATS
FOR HEAVY SMOKERS/THOSE WHO HAVE TRIED TO QUIT WITH NRT BEFORE. nicotine Abbreviated Prescribing Information. Please consult the summary of product characteristics for full prescribing information.
Nicorette 2mg Medicated Chewing Gums (Classic, Freshmint, Freshfruit and Icy White Flavours). Nicorette Invisi 10mg/16 hours, 15mg/16. Nicorette 15mg Inhaler. Indications: For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit. Helping smokers temporarily abstain from smoking (Gum and Inhaler only). In smokers currently unable or not ready to stop smoking abruptly, Nicorette Gum, Inhaler and Lozenges may also be used as part of a programme to reduce smoking prior to stopping completely. Nicorette 2mg Gum or Nicorette Inhaler may be used in combination with Nicorette Invisi 10mg and 15mg Transdermal Patch for the treatment of tobacco dependence as part of a stop smoking programme. Dosage: Smoking cessation: Gum: The chewing gum should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. Not more than 15 pieces of the chewing gum may be used each day. Nicorette Gum may be used for up to 3 months during which time the habits associated with smoking will be lost. If not successful after 12 weeks the patient should be encouraged to make a fresh attempt to stop smoking. Inhaler: The frequency of use should depend on the previous smoking habit of the individual. Nicorette Inhaler should be used whenever the urge to smoke is felt, up to a maximum usage of 6 cartridges per day. In the treatment of nicotine dependence, a course not exceeding three months is suggested, the patient stopping smoking completely at the start of the course. Patch: Light smokers are recommended to start at Step 2 (15 mg) for 8 weeks and decrease the dose to Step 3 (10 mg) for the final 4 weeks. Temporary Abstinence: During periods of temporary abstinence, the patient should use Nicorette Gum or Inhaler when required to relieve nicotine cravings and withdrawal symptoms. Gradual cessation: For smokers who are unwilling or unable to quit abruptly. Use the gum/inhaler/Lozenge whenever there is a strong urge to smoke in order to reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. The number of cartridges/gums/lozenges is variable and depends on the patient’s needs. Not more than 15 pieces of the gum, 6 cartridges, 15 lozenges should be used per day. If a reduction in number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought. Reduced tobacco consumption should lead to complete cessation of smoking. A quit attempt should be made as soon as the number of cigarettes has been reduced to a level whereby the smoker feels ready to quit completely, then start as outlined for “smoking cessation” as given above. Combination therapy (15mg/10mg patch and 2mg gum or Inhaler): Step 1: The Nicorette Invisi 15mg Patch would be applied daily on waking for 16 hours and removed just before bedtime for a total of 8 weeks. The Nicorette 2mg medicated chewing gum or Nicorette Inhaler would be used ad libitum when the smoker felt an urge to smoke or in situations where he/she feels that breakthrough cravings may occur, up to a maximum of 15 pieces of gum per day or 6 cartridges per day. Step 2: After the initial 8 weeks the lower dose Nicorette Invisi 10mg Patch should be used for a total of 4 weeks. The Nicorette 2mg medicated chewing gum or Nicorette Inhaler would be used ad libitum when the smoker felt an urge to smoke or in situations where he/she feels that breakthrough cravings may occur, up to a maximum of 15 pieces of gum per day or 6 cartridges per day. Step 3: Use of the Nicorette Invisi Patch should be stopped after the 12 week treatment program. The Nicorette 2 mg medicated chewing gum or Nicorette Inhaler can continue to be used for a further 3 months during which time the habits associated with smoking will be lost. Contraindications: Use in non-smokers,
Use in persons hypersensitive to nicotine or any ingredient in the formulation. Children under the age of 12 years (Lozenges) or under 18 years (Quickmist). Special Warnings and Precautions: The benefits of quitting smoking outweigh any risks associated with correctly administered nicotine replacement therapy (NRT). A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions: - Cardiovascular disease: Dependent smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetal’s angina, severe cardiac arrhythmias, recent cerebrovascular accident, and/or who suffer with uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, Nicorette Gum may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision.
impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects Gastrointestinal Disease: Nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and NRT preparations should be used with caution in these conditions Phaeochromocytoma and uncontrolled hyperthyroidism. Nicotine, both from NRT and smoking, causes the release of catecholamines from the adrenal medulla. Therefore, Nicorette should be used with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma. - Diabetes Mellitus. Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when smoking is stopped and NRT is initiated, as reductions in nicotine- induced catecholamine release can affect carbohydrate metabolism. Patients with diabetes mellitus may require lower doses of insulin as a result of smoking cessation. - Smokers who wear dentures may experience difficulties in chewing Nicorette Gum. The chewing gum may stick to, and may in rare cases damage dentures. Transferred dependence: Nicotine in any dose form is capable of inducing a dependence syndrome after chronic use and is highly toxic after acute use. However, dependence with Nicorette Gum is a rare side-effect and is both less harmful and easier to break than smoking dependence. Danger in children: Doses of nicotine tolerated by smokers can produce severe toxicity in children that may be fatal. Products containing nicotine should not be left where they may be handled or ingested by children. Nicorette Inhaler should be used with caution in smokers with chronic throat diseases and bronchospastic disease. Nicorette Inhaler should be used with caution in smokers with chronic throat diseases and bronchospastic disease Nicorette Invisi Patch should be removed prior to undergoing any Magnetic Resonance Imaging (MRI) procedures to prevent the risk of burns. Undesirable Effects: Effects of Smoking Cessation: Regardless of the means used, a variety of symptoms are known to be associated with quitting habitual tobacco use. These include emotional or cognitive effects such as dysphoria or depressed mood; insomnia; irritability,
restlessness or impatience. There may also be physical effects such as decreased heart rate; increased appetite or weight gain, dizziness or presyncopal symptoms, cough, constipation, gingival bleeding or aphthous ulceration or nasopharyngitis. In addition, and of clinical significance, nicotine cravings may result in profound urges to smoke. Adverse Drug Reactions: Nicorette may cause dose dependent adverse reactions similar to those associated with nicotine administered by other means and are dose dependent. Most of the undesirable effects reported by the subjects occur during the early phase of treatment. Gum:
frustration or anger; anxiety; difficulty concentrating, and Renal and hepatic
Immune System Disorders: Hypersensitivity - Common Anaphylactic reaction - Not known. Nervous System Disorders:
Paraesthesia – Common. Eye Disorders: Blurred Vision, Lacrimation increased – Common. Cardiac Disorders: Palpitations,
Hypertension – Uncommon. Respiratory, Thoracic and Mediastinal Disorders: Cough, Throat irritation - Very common. Bronchospasm, Dysphonia, Dyspnoea, Nasal Congestion, Sneezing, Throat tightness – Uncommon. Gastrointestinal Disorders: Hiccups, Nausea - Very common. Abdominal pain:
Stomatitis, Vomiting – Common. Eructation Glossitis, Oral mucosal blistering and exfoliation, Paraesthesia oral – Uncommon. Dysphagia, Hypoaesthesia oral, Retching – Rare. Dry throat, Gastrointestinal
site conditions Common Fatigue Uncommon Asthenia Chest discomfort and pain Malaise. Patch: Immune system disorder Uncommon Hypersensitivity Rare Anaphylactic reaction Nervous system disorder Common Headache Uncommon Paraesthesia Cardiac disorders Uncommon Palpitations Tachycardia Vascular disorders Uncommon Flushing Hypertension Respiratory, Thoracic and Mediastinal Disorders Uncommon Dyspnoea Gastrointestinal disorders: Common Nausea Vomiting Rare Gastrointestinal discomfort and/or pain Skin and subcutaneous tissue disorders Very common Pruritus Common Rash Urticaria Uncommon Hyperhidrosis Rare Angioedema Erythema Musculoskeletal and Connective Tissue Disorders Uncommon Myalgia Rare Pain in extremity General disorders and administration site conditions: Uncommon Application site reactions Asthenia Chest discomfort and pain Malaise Fatigue. Marketing Authorisation Holder: McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland. Marketing Authorisation Number: PA 823/49/1-4, 14-15, 21, 22, 24-25, 26. Date of Revision of the Text: July 2015 (Gum) November 2015 (Nicorette Icy White Gum). March 2016 (Inhaler, 15mg and 10mg Patch). Legal Category: Products not subject to medical prescription. Further information available upon request from Johnson & Johnson (Ireland) Ltd.
IRE/NI/16-1864a
Hyperhidrosis, Pruritus, Rash, Urticaria Disorders – Uncommon. Erythema - Not known. Musculoskeletal and Connective Tissue Disorders: Pain in jaw – Uncommon. Muscle tightness - Not known. General Disorders and Administration Site Conditions: Fatigue – Common. Asthenia, Chest discomfort and pain, Malaise – Uncommon. Allergic reactions including angioedema - Rare. Inhaler: Immune system disorders: Common – Hypersensitivity. Not known - Anaphylactic reaction Nervous system disorders Very common Headache Common Burning sensation Dysgeusia Paraesthesia Eye disorders Not known Blurred vision Lacrimation increased Cardiac disorders Uncommon Palpitations Tachycardia Vascular disorders Uncommon Flushing Hypertension Respiratory, thoracic and mediastinal disorders Very common Cough Throat irritation Bronchospasm Dysphonia Dyspnoea Nasal congestion Sneezing Throat tightness Gastrointestinal disorders Very common Hiccups Nausea Common Abdominal pain Diarrhoea Dry mouth Dyspepsia Flatulence Salivary hypersecretion Stomatitis Vomiting Uncommon Eructation Glossitis Oral mucosal blistering and exfoliation. Paraesthesia oral Rare Dysphagia Hypoaesthesia oral Retching Not known Dry throat Gastrointestinal discomfort Lip pain Skin and subcutaneous disorder Uncommon Hyperhidrosis Pruritus Rash Urticaria Not known Angioedema Erythema Muscoskeletal and connective tissue disorders Uncommon Pain in jaw Not known Muscle tightness .
General disorders and administration discomfort Lip pain - Not known. Skin and Subcutaneous Tissue: Diarrhoea, Dry mouth, Dyspepsia, Flatulence, Salivary hypersecretion, Tachycardia - Not known. Vascular Disorders: Headache - Very Common,
Burning sensation, Dysgeusia, Flushing,
NICORETTE DUAL SUPPORT
®
or
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