- nicotine polacrilin
GSL: General Sales Licence
This information is intended for use by health professionals
Adults and elderlyOne piece of Nicotinell gum to be chewed when the user feels the urge to smoke. Normally, 8-12 pieces per day can be used, up to a maximum of 15 pieces per day.The 4 mg chewing gum is intended to be used by smokers with a strong or very strong nicotine dependency and those who have previously failed to stop smoking with the aid of nicotine replacement therapy.The optimal dosage form is selected according to the following table: If an adverse event is noted when high dose forms are initiated, this should be replaced by the lower dosage form.The characteristics of chewing-gum as a pharmaceutical form are such that individually different nicotine levels can result in the blood. Therefore, dosage frequency should be adjusted according to individual requirements within the stated maximum limit.Directions for use:1. One piece of gum should be chewed until the taste becomes strong.2. The chewing gum should be rested between the gum and cheek.3. When the taste fades, chewing should commence again.4. The chewing routine should be repeated for 30 minutes.The treatment time is individual. Normally, treatment should continue for at least 3 months.After three months, the user should gradually cut down the number of pieces chewed each day until they have stopped using the product.Treatment should be discontinued when the dose has been reduced to 1-2 pieces of gum per day. Nicotinell gum is sugar free.
Adolescents (aged 12-18 years of age)The above recommendation can be used for adolescents aged between 12 and 18 years of age. As data are limited in this age group, medical advice should be obtained should it be found necessary to use the gum beyond 12 weeks.Concomitant use of acidic beverages such as coffee or soda may decrease the buccal absorption of nicotine. Acidic beverages should be avoided for 15 minutes prior to chewing the gum.
Cardiovascular diseaseIn stable cardiovascular disease Nicotinell gum presents a lesser hazard than continuing to smoke. However dependant smokers currently hospitalised as a result of a recent myocardial infarction, unstable or worsening angina pectoris including Prinzmetal's angina, severe cardiac arrhythmias, uncontrolled hypertension, or recent cerebrovascular accident who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, Nicotinell gum may be considered but as data on safety in this patient group are limited, initiation should only be under medical supervision.
Diabetes mellitusPatients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when nicotine replacement therapy is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.
Allergic reactionsAngioedema and urticaria have been reported.
Gastro-intestinal diseaseSwallowed nicotine may exacerbate symptoms in patients suffering from active oesophagitis, oral or pharyngeal inflammation, gastritis, or peptic ulcers and oral nicotine replacement therapy preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.
Renal and or hepatic impairmentShould be used 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.
Danger in small childrenDoses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal (please see section 4.9). Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotinell gum should be disposed of with care.Pheochromocytoma and uncontrolled hyperthyroidismNicotinell gum should be used with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma as nicotine causes the release of catecholamines.
Transferred dependenceTransferred dependence is rare and is both less harmful and easier to break than smoking dependence.
Stopping smokingPolycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly CYP 1A1). When a smoker stops, this may result in slower metabolism and a consequential rise in blood levels of drugs such as theophylline, tacrine, olanzaprine and clozaprine.
Other warningsPeople having problems with the joint of the jawbone and denture wearers may experience difficulty in chewing the gum. In this case, it is recommended that they use a different pharmaceutical form of nicotine replacement therapy.Because Nicotinell gum contains sorbitol: Patients with rare hereditary conditions of fructose intolerance should not take this medicine.Nicotinell Icemint 4mg gum contains sorbital (E420) 0.1g per gum, a source of 0.02g fructose. Calorific value 1.2 kcal/piece of gum.Nicotinell Icemint 4mg gum contains sodium 11.45 mg per piece of gum.The gum base contains butylhydroxytoluene (E321) which may cause local irritation to mucous membranes.
PregnancyStopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the fetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but Nicotinell gums may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the fetus would not normally be exposed to nicotine.
LactationThe relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.
|Nervous system disorders:||Common: Headache, dizziness|
|Gastrointestinal disorders:||Common: Salivary hypersecretion, stomatitis, oral pain, pharyngolaryngeal pain, hiccups, nausea, vomiting, dyspepsia and flatulence.|
|Musculoskeletal, connective and bone disorders:||Common: Jaw muscle ache|
|Cardiac disorders:||Uncommon: palpitations Rare: Atrial arrhythmia.|
|Skin and subcutaneous tissue disorders:||Uncommon: Erythema, urticaria.|
|Immune system disorders:||Rare: Hypersensitivity, angioneurotic oedema and anaphylactic reactions.|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continue monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the Yellow Card Scheme at: www.mhra/gov.uk/yellowcard.
SymptomsSymptoms of acute nicotine poisoning include nausea, vomiting, salivation, throat burn, abdominal pain, diarrhoea, perspiration, headache, dizziness, hearing and visual disturbances and marked weakness. In extreme cases, these symptoms may be followed by hypotension, tachycardia, cardiac arrhythmia, dyspnoea, prostration, circulatory collapse, coma and terminal convulsions.
Treatment of overdoseTreatment of overdose should be immediate as symptoms may develop rapidly (particularly in children). All nicotine intake should stop immediately. Emesis is usually spontaneous. Artificial respiration with oxygen should be instituted if necessary. Consider activated charcoal, provided airway can be protected in those presenting within 1 hour of ingestion of more than 0.2mg/kg of nicotine. Monitor vital signs and treat symptomatically.
ToxicityNicotine is highly toxic by ingestion, inhalation and skin contact. The fatal dose has been estimated to be as little as 40 mg of nicotine in an adult and just a few milligrams of nicotine have caused severe symptoms. It can be very rapidly absorbed with CNS, neuromuscular and autonomic features. The half-life of nicotine ranges from 24 minutes to 2 hours but symptoms may persist for up to 72 hours in severe cases of poisoning.• All patients who have taken a deliberate overdose should be referred for assessment.• Children and adults who have ingested 0.2 mg/kg or more nicotine, or those who are symptomatic, should be referred for medical assessment.• Children or adults who have accidentally ingested less than 0.2 mg/kg nicotine and who have no new symptoms since the time of ingestion do not need to be referred for medical assessment. Patients should be advised to seek medical attention if symptoms develop.• All symptomatic children and adults following accidental transdermal patch application should be referred for medical assessment.
Features• Early features of ingestion include burning in the mouth and throat, nausea, vomiting, confusion, dizziness, weakness, hypersalivation, sweating and increased bronchial secretions. There may be sympathetic features including tachycardia, tachypnoea, hypertension and agitation followed by bradycardia, systemic hypotension and respiratory depression.• More severe poisoning leads to arrhythmias including atrial fibrillation, coma, convulsions and respiratory and cardiac arrest. Recovery is likely if survival exceeds 2-3 hours.• Skin contact may lead to irritation followed by variable absorption depending on the length of exposure and concentration. Systemic features may follow. • Eye contact with liquid may lead to irritation and lacrimation.
General measures• Maintain a clear airway/ensure adequate ventilation. Monitor pulse and BP. Perform 12 lead ECG and measure QRS duration and QT interval and repeat especially if the patient is symptomatic or has taken slow release preparations• Good neurological outcome after cardiac arrest (due to nicotine poisoning) may occur after prolonged resuscitation. Cardiac arrest in hospital or witnessed out of hospital, with bystander CPR, should be continued for at least 1 hour (discuss with local poisons centre)• The benefits of gastric decontamination are uncertain. Consider activated charcoal (50g adults: 1g/kg children) provided airway can be protected in those presenting within 1 hour of ingestion of more than 0.2mg/kg of nicotine.• Asymptomatic patients who have ingested more than 0.2mg/kg of nicotine should be observed for at least 4 hours. However, if other cardiac/cardiotoxic agents have been taken monitor for the longest period recommended for these.• In symptomatic patients check U&Es, creatinine kinase and arterial blood gases.• Contact the local poisons information centre (UK NPIS: Ireland - NPIC) for specific advice
Bradycardia• If symptomatic give IV atropine• If associated with hypotension, dobutamine or isoprenaline may be considered• Temporary pacemaker or external pacing may be required
Agitation• Agitated adults can be sedated (IV diazepam: if ineffective oral or parenteral haloperidol)• Agitated children are better managed without sedation. Exclude other causes (e.g. hypoxia: infection: hypoglycaemia: raised ICP). Seek expert paediatric advice
Hypertension• Adults: in agitated patient hypertension may settle with sedation. If hypertension persists give IV nitrates until blood pressure controlled. Calcium antagonists are an alternative as second line therapy. Phentolamine or sodium nitroprusside are options if there is hypertension without evidence of cardiac ischaemia (but may cause a rapid fall in blood pressure) or alternatively IV labetalol.• Children (under 5 years): Seek expert paediatric advice
Convulsions• Give oxygen, check blood sugar, U&Es and arterial blood gases. Correct acid-base balance and metabolic disturbances as necessary• A single brief convulsion does not require treatment. Otherwise control with IV diazepam or lorazepam. If unresponsive seek advice from NPIS/NPIC or appropriate specialist
Other points to note• A high percentage of urine screens will be positive for nicotine in both smokers and non-smokers• Quantitative blood concentrations are not readily available. Appropriate history and recognition of clinical finding are important• Other treatments/measures indicated by patient's clinical condition• On discharge patients should be advised to seek medical attention if symptoms develop
Skin exposure• Remove soiled clothes, nicotine patches or contaminating fluid• Wash skin with soap and water• Treat symptoms of systemic toxicity as above.Contact the local poisons information centre (UK National poisons information service, NPIS) for specific advice.
980 Great West Road, Brentford, Middlesex, TW8 9GS
0800 783 8881
0800 783 8881