Nicorette Icy White 4 mg Gum

McNeil Products Ltd🇬🇧 Electronic Medicines Compendium

Approval Date: N/A
Approval ID: ad427c281495c817
Company: McNeil Products Ltd
Type: Standard

Approval Details

Approval Id: ad427c281495c817
Drug Approval Emc Name: Nicorette Icy White 4 mg Gum
Drug Name: Nicorette Icy White 4 mg Gum
Company Name: McNeil Products Ltd
Company Address: 50-100 Holmers Farm Way, High Wycombe, HP12 4EG, UK
Company Medical Info Direct Line: 0808 238 9999 (freephone)
Company Medical Info Email: consumer-gb@kenvue.com
Atc Code: N07BA01
Legal Category: General Sales List
Authorisation Holder: McNeil Products Limited 50 – 100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UK
Authorisation Number: PL 15513/0153
Authorisation Date: 18/07/2006
Instruction Authorisation Holder: McNeil Products Limited 50 – 100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UK
Instruction Authorisation Number: PL 15513/0153
Instruction Authorisation Date: 18/07/2006
Instruction Composition: Chewing Gum containing 4 mg nicotine, as nicotine resinate. For excipients, see 6.1.
Instruction Dosage Form: Medicated Chewing Gum A square, coated, crème coloured piece of gum.
Instruction Clinical Particulars: 4.1 Therapeutic indications Nicorette Icy White 4 mg Gum relieves and/or prevents craving and nicotine withdrawal symptoms in nicotine dependence such as those arising from the use of tobacco or electronic cigarettes. It is indicated to aid quitting or reduction prior to quitting, to assist those who are unwilling or unable to use such products, and as a safer alternative to smoking for smokers and those around them. Nicorette Icy White 4 mg Gum is indicated in pregnant and lactating women making a quit attempt.4.2 Posology and method of administration \*Adults and children over 12 years of age\* Nicorette Icy White 4 mg Gum should be chewed slowly according to the instructions. The strength of gum to be used will depend on the smoking/vaping habits of the individual. In general, if the patient smokes 20 or less cigarettes a day, 2 mg nicotine gum is indicated. If more than 20 cigarettes per day are smoked, 4 mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking. Light to moderate vapers (e.g. vape infrequently or use low strength e-liquid) should start with 2 mg nicotine gum. If the 2 mg nicotine gum does not relieve the urge to vape, 4 mg nicotine gum should be used. Heavy vapers (e.g. vape frequently or use high strength e-liquid) should use 4 mg nicotine gum. Nicorette Icy White 4 mg Gum should be used whenever the urge to smoke or vape is felt or to prevent cravings in situations where these are likely to occur. Patients willing or able to stop smoking/vaping immediately should initially replace all their cigarettes/e-cigarettes with the gum and as soon as they are able, reduce the number of gums used until they have stopped completely. Patients aiming to reduce cigarettes/e-cigarettes should use Nicorette Icy White 4 mg Gum between smoking/vaping episodes, as needed, to prolong smoke/vape-free intervals and to reduce their use as much as possible. As soon as they are ready patients should aim to quit smoking/vaping 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/vaping but are having difficulty discontinuing Nicorette Icy White 4 mg 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/vape according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Absorption of nicotine is through the buccal mucosa, any nicotine, which is swallowed being destroyed by the liver.4.3 Contraindications Hypersensitivity to nicotine or any component of the chewing gum. Nicorette Icy White 4 mg Gum is contraindicated in children under the age of 12 years.4.4 Special warnings and precautions for use Any risks that may be associated with NRT are substantially outweighed by the well-established dangers of continued smoking. The risks of continued vaping are not yet established. A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions: \*Underlying cardiovascular disease:\* In stable cardiovascular disease this product presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, unstable or worsening angina including Prinzmetal angina, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable and/or who suffer with uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions. If this fails, this product may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. The risks of continued vaping are not yet established. \*Diabetes mellitus:\* Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when quitting and NRT is initiated as reductions in nicotine induced catecholamine release can affect carbohydrate metabolism. \*GI disease:\* Nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported. \*Renal or hepatic impairment:\* This product should 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. \*Seizures:\* Potential risks and benefits of nicotine should be carefully evaluated before use in subjects with a history of epilepsy as cases of convulsions have been reported in association with nicotine. \*Danger in children:\* Doses of nicotine tolerated by adult and adolescent smokers or vapers can produce severe toxicity in children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotine gum should be disposed of with care. \*Phaeochromocytoma and uncontrolled hyperthyroidism:\* As nicotine causes release of catecholamines, this product should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma. \*Transferred dependence:\* Transferred dependence is rare and is both less harmful and easier to break than smoking dependence. \*Stopping smoking:\* Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole. \*Excipients\*: This product also contains butylated hydroxyl toluene (E321); this may cause irritation to the mucous membranes. \*Denture warning:\* Patients who wear dentures may experience difficulty in chewing this product. The chewing gum may stick to and may in rare cases damage dentures.4.5 Interaction with other medicinal products and other forms of interaction No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.4.6 Fertility, pregnancy and lactation \*Pregnancy\* Stopping 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. Ideally smoking cessation during pregnancy should be achieved without NRT. Nicotine passes to the foetus and affects its breathing movements and circulation. The effect on the circulation is dose-dependent. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but if this is not achievable this product 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 considered as an alternative if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine. There is no or limited data regarding the effect of vaping in pregnancy. Use of NRT by the pregnant smoker/vaper should only be initiated after advice from a health care professional. \*Lactation\* Nicotine should be avoided during breast-feeding. The 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. There is no or limited data regarding the effect of vaping in lactating women. Use of NRT by breast feeding smokers/vapers should only be initiated after advice from a health care professional. Women should use the product as soon as possible after breastfeeding. \*Fertility\* In females tobacco smoking delays time to conception, decreases in-vitro fertilization success rates, and significantly increases the risk of infertility. In males tobacco smoking reduces sperm production, increases oxidative stress, and DNA damage. Spermatozoa from smokers have reduced fertilizing capacity. The specific contribution of nicotine to these effects in humans is unknown. There is no or limited data regarding the effect of vaping on fertility.4.7 Effects on ability to drive and use machines This product has no or negligible influence on the ability to drive and use machines\*\*.\*\*4.8 Undesirable effects Effects of Smoking Cessation Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance, decreased heart rate, dizziness, presyncopal symptoms, cough, constipation, gingival bleeding or nasopharyngitis. Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear. Effects of Vaping Cessation The nicotine withdrawal effects of vaping cessation have not been established; however it is anticipated that many of the effects relating to nicotine withdrawal will be the same as those seen with tobacco smoking cessation. Adverse Drug Reactions This product may cause adverse reactions similar to those associated with nicotine given by other means, including smoking and vaping, and these are mainly dose-dependent. At recommended doses this product has not been found to cause any serious adverse effects. Most of the undesirable effects reported by the patients occur during the first 3-4 weeks after start of treatment. Excessive consumption of this product by those who have not been in the habit of inhaling tobacco smoke or vaping could possibly lead to nausea, faintness or headaches. Excessive swallowing of dissolved nicotine may, at first, cause hiccupping. Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment, however most subjects adapt to this with ongoing use. This product may also cause increased salivation. Allergic reactions (including symptoms of anaphylaxis) can occur during the use of the product. Those who are prone to indigestion may suffer initially from minor degrees of indigestion or heartburn if the 4 mg nicotine gum is used; slower chewing and the use of the 2 mg nicotine gum (if necessary more frequently) will usually overcome this problem. The chewing gum may stick to and may in rare cases damage dentures. The adverse reactions observed in patients treated with oral nicotine formulations during clinical trials and post-marketing experience are listed below by system organ class (SOC). Frequencies are defined in accordance with current guidance, as: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), not known - cannot be estimated from the available data. | | | | | --- | --- | --- | | \*\*System Organ Class\*\* | \*\*Reported Adverse Event\*\* | \*\*Incidence\*\* | | Immune System Disorders | Hypersensitivitya Anaphylactic reactiona | Common Not known | | Psychiatric Disorders | Abnormal dreams\\* | Uncommon | | Nervous System Disorders | Headachea# Burning sensationc Dizziness Dysgeusia Paraesthesiaa Seizures | Very common Common Common Common Common Not known | | Eye Disorders | Blurred vision Lacrimation increased | Not known Not known | | Cardiac Disorders | Palpitationsa Tachycardiaa Reversible atrial fibrillation | Uncommon Uncommon Very rare | | Vascular Disorders | Flushinga Hypertensiona | Uncommon Uncommon | | Respiratory, Thoracic and Mediastinal Disorders | Cough\\*\\* Sore mouth or throat Throat irritation\\*\\* Bronchospasm Dysphonia Dyspnoeaa Nasal congestion Sneezing Throat tightness | Common Very common Very common Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon | | Gastrointestinal Disorders | Nauseaa Hiccups\\*\\*\\*\\* Abdominal pain Diarrhoea\\*\\*\\* Dry mouth Flatulence Salivary hypersecretion Stomatitis Vomitinga Dyspepsia Eructation Glossitis Oral mucosal blistering and exfoliation Paraesthesia oral\\*\\*\\* Dysphagia Hypoaesthesia oral\\*\\*\\* Retching Dry throat Gastrointestinal discomforta Lip pain | Very common Very common Common Common Common Common Common Common Common Common Uncommon Uncommon Uncommon Uncommon Rare Rare Rare Not known Not known Not known | | Skin and Subcutaneous Tissue Disorders | Urticariaa Hyperhidrosisa Pruritusa Rasha Erythemaa | Uncommon Uncommon Uncommon Uncommon Not known | | Musculoskeletal and Connective Tissue Disorders | Pain in jawb Muscle tightnessb | Uncommon Not known | | General Disorders and Administration Site Conditions | Fatiguea Astheniaa Chest discomfort and paina Malaisea Allergic reactions including angioedema | Common Uncommon Uncommon Uncommon Rare | a Systemic effects; b Tightness of jaw and pain in jaw with nicotine gum formulation c At the application site \\*Identified only for formulations applied during the night \\*\\*Higher frequency observed in clinical studies with inhaler formulation. \\*\\*\\*Reported the same or less frequently than placebo \\*\\*\\*\\* Higher frequency observed in clinical studies with mouth spray formulation # Although the frequency in the active group is less than that of the placebo group, the frequency in the specific formulation in which the PT was identified as a systemic ADR was greater in the active group than the placebo group. \*\*Reporting of suspected adverse reactions\*\* Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose \*Symptoms:\* Symptoms of overdose with nicotine from this product may occur in smokers/vapers who have previously had a low nicotine intake from cigarettes/e-cigarettes or if other sources of nicotine are used concomitantly with this product. Acute or chronic toxicity of nicotine in man is highly dependent on mode and route of administration. Adaptation to nicotine (e.g. in smokers/vapers) is known to significantly increase tolerability compared with non- smokers/vapers. The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60 mg. Symptoms of acute nicotine poisoning include nausea, vomiting, increased salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions. \*Management of an overdose\*: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine. The risk of poisoning as a result of swallowing the gum is very small, as absorption in the absence of chewing is slow and incomplete. Doses of nicotine that are tolerated by adult smokers/vapers during treatment may produce severe symptoms of poisoning in children and may prove fatal. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.
Instruction Pharmacology: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Drugs used in nicotine dependence ATC code: N07B A01 The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicorette 4 mg Gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs. The main pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis. The gum contains a number of ingredients that are recognized as having properties for removal of dental staining. Clinical studies have shown that the gum helps to improve tooth whiteness. Increased appetite is a recognised symptom of nicotine withdrawal and post- cessation weight gain is common. Clinical trials have demonstrated that Nicotine Replacement Therapy can help control weight following a quit attempt.5.2 Pharmacokinetic properties Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes. Demonstrable blood levels are obtained within 5 – 7 minutes and reach a maximum about 30 minutes after the start of chewing. Blood levels are roughly proportional to the amount of nicotine chewed and have been shown never to exceed those obtained from smoking cigarettes.5.3 Preclinical safety data Preclinical data indicate that nicotine is neither mutagenic nor genotoxic. There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the product, which have not been considered in other relevant sections of this Summary of Product Characteristics.
Instruction Pharmaceutical Particulars: 6.1 List of excipients Core gum Chewing gum base, containing butylated hydroxyl toluene (E321) Xylitol Peppermint oil Sodium carbonate, anhydrous Acesulfame Potassium Levomenthol Magnesium oxide, light Quinoline yellow Al lake (E104) Talc Sub coating Winterfresh Hypromellose Sucralose Polysorbate 80 Purified water Hard coating Xylitol Starch Titanium dioxide (E171) Winterfresh Quinoline yellow Al lake (E104) Carnauba wax Purified water6.2 Incompatibilities Not applicable6.3 Shelf life Blister: 3 years Box: 3 years. Shelf life after opening 3 months.6.4 Special precautions for storage Do not store above 25°C.6.5 Nature and contents of container Blister packed strips each containing 6, 10 or 15 pieces supplied in packs of 10, 12, 15, 30, 75, 105, 165 and 210 pieces. and Laminated cardboard box, wrapped in a transparent plastic film, containing 25 pieces, supplied in packs of 25, 100 and 200. Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling Dispose of Nicorette Gum sensibly. Any unused product or waste material should be disposed of in accordance with local requirements.
Instruction Content: ## Composition Chewing Gum containing 4 mg nicotine, as nicotine resinate. For excipients, see 6.1. ## Pharmaceutical Form Medicated Chewing Gum A square, coated, crème coloured piece of gum. ## Clinical Particulars 4.1 Therapeutic indications Nicorette Icy White 4 mg Gum relieves and/or prevents craving and nicotine withdrawal symptoms in nicotine dependence such as those arising from the use of tobacco or electronic cigarettes. It is indicated to aid quitting or reduction prior to quitting, to assist those who are unwilling or unable to use such products, and as a safer alternative to smoking for smokers and those around them. Nicorette Icy White 4 mg Gum is indicated in pregnant and lactating women making a quit attempt.4.2 Posology and method of administration \*Adults and children over 12 years of age\* Nicorette Icy White 4 mg Gum should be chewed slowly according to the instructions. The strength of gum to be used will depend on the smoking/vaping habits of the individual. In general, if the patient smokes 20 or less cigarettes a day, 2 mg nicotine gum is indicated. If more than 20 cigarettes per day are smoked, 4 mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking. Light to moderate vapers (e.g. vape infrequently or use low strength e-liquid) should start with 2 mg nicotine gum. If the 2 mg nicotine gum does not relieve the urge to vape, 4 mg nicotine gum should be used. Heavy vapers (e.g. vape frequently or use high strength e-liquid) should use 4 mg nicotine gum. Nicorette Icy White 4 mg Gum should be used whenever the urge to smoke or vape is felt or to prevent cravings in situations where these are likely to occur. Patients willing or able to stop smoking/vaping immediately should initially replace all their cigarettes/e-cigarettes with the gum and as soon as they are able, reduce the number of gums used until they have stopped completely. Patients aiming to reduce cigarettes/e-cigarettes should use Nicorette Icy White 4 mg Gum between smoking/vaping episodes, as needed, to prolong smoke/vape-free intervals and to reduce their use as much as possible. As soon as they are ready patients should aim to quit smoking/vaping 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/vaping but are having difficulty discontinuing Nicorette Icy White 4 mg 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/vape according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Absorption of nicotine is through the buccal mucosa, any nicotine, which is swallowed being destroyed by the liver.4.3 Contraindications Hypersensitivity to nicotine or any component of the chewing gum. Nicorette Icy White 4 mg Gum is contraindicated in children under the age of 12 years.4.4 Special warnings and precautions for use Any risks that may be associated with NRT are substantially outweighed by the well-established dangers of continued smoking. The risks of continued vaping are not yet established. A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions: \*Underlying cardiovascular disease:\* In stable cardiovascular disease this product presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, unstable or worsening angina including Prinzmetal angina, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable and/or who suffer with uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions. If this fails, this product may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. The risks of continued vaping are not yet established. \*Diabetes mellitus:\* Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when quitting and NRT is initiated as reductions in nicotine induced catecholamine release can affect carbohydrate metabolism. \*GI disease:\* Nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported. \*Renal or hepatic impairment:\* This product should 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. \*Seizures:\* Potential risks and benefits of nicotine should be carefully evaluated before use in subjects with a history of epilepsy as cases of convulsions have been reported in association with nicotine. \*Danger in children:\* Doses of nicotine tolerated by adult and adolescent smokers or vapers can produce severe toxicity in children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotine gum should be disposed of with care. \*Phaeochromocytoma and uncontrolled hyperthyroidism:\* As nicotine causes release of catecholamines, this product should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma. \*Transferred dependence:\* Transferred dependence is rare and is both less harmful and easier to break than smoking dependence. \*Stopping smoking:\* Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole. \*Excipients\*: This product also contains butylated hydroxyl toluene (E321); this may cause irritation to the mucous membranes. \*Denture warning:\* Patients who wear dentures may experience difficulty in chewing this product. The chewing gum may stick to and may in rare cases damage dentures.4.5 Interaction with other medicinal products and other forms of interaction No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.4.6 Fertility, pregnancy and lactation \*Pregnancy\* Stopping 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. Ideally smoking cessation during pregnancy should be achieved without NRT. Nicotine passes to the foetus and affects its breathing movements and circulation. The effect on the circulation is dose-dependent. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but if this is not achievable this product 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 considered as an alternative if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine. There is no or limited data regarding the effect of vaping in pregnancy. Use of NRT by the pregnant smoker/vaper should only be initiated after advice from a health care professional. \*Lactation\* Nicotine should be avoided during breast-feeding. The 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. There is no or limited data regarding the effect of vaping in lactating women. Use of NRT by breast feeding smokers/vapers should only be initiated after advice from a health care professional. Women should use the product as soon as possible after breastfeeding. \*Fertility\* In females tobacco smoking delays time to conception, decreases in-vitro fertilization success rates, and significantly increases the risk of infertility. In males tobacco smoking reduces sperm production, increases oxidative stress, and DNA damage. Spermatozoa from smokers have reduced fertilizing capacity. The specific contribution of nicotine to these effects in humans is unknown. There is no or limited data regarding the effect of vaping on fertility.4.7 Effects on ability to drive and use machines This product has no or negligible influence on the ability to drive and use machines\*\*.\*\*4.8 Undesirable effects Effects of Smoking Cessation Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance, decreased heart rate, dizziness, presyncopal symptoms, cough, constipation, gingival bleeding or nasopharyngitis. Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear. Effects of Vaping Cessation The nicotine withdrawal effects of vaping cessation have not been established; however it is anticipated that many of the effects relating to nicotine withdrawal will be the same as those seen with tobacco smoking cessation. Adverse Drug Reactions This product may cause adverse reactions similar to those associated with nicotine given by other means, including smoking and vaping, and these are mainly dose-dependent. At recommended doses this product has not been found to cause any serious adverse effects. Most of the undesirable effects reported by the patients occur during the first 3-4 weeks after start of treatment. Excessive consumption of this product by those who have not been in the habit of inhaling tobacco smoke or vaping could possibly lead to nausea, faintness or headaches. Excessive swallowing of dissolved nicotine may, at first, cause hiccupping. Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment, however most subjects adapt to this with ongoing use. This product may also cause increased salivation. Allergic reactions (including symptoms of anaphylaxis) can occur during the use of the product. Those who are prone to indigestion may suffer initially from minor degrees of indigestion or heartburn if the 4 mg nicotine gum is used; slower chewing and the use of the 2 mg nicotine gum (if necessary more frequently) will usually overcome this problem. The chewing gum may stick to and may in rare cases damage dentures. The adverse reactions observed in patients treated with oral nicotine formulations during clinical trials and post-marketing experience are listed below by system organ class (SOC). Frequencies are defined in accordance with current guidance, as: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), not known - cannot be estimated from the available data. | | | | | --- | --- | --- | | \*\*System Organ Class\*\* | \*\*Reported Adverse Event\*\* | \*\*Incidence\*\* | | Immune System Disorders | Hypersensitivitya Anaphylactic reactiona | Common Not known | | Psychiatric Disorders | Abnormal dreams\\* | Uncommon | | Nervous System Disorders | Headachea# Burning sensationc Dizziness Dysgeusia Paraesthesiaa Seizures | Very common Common Common Common Common Not known | | Eye Disorders | Blurred vision Lacrimation increased | Not known Not known | | Cardiac Disorders | Palpitationsa Tachycardiaa Reversible atrial fibrillation | Uncommon Uncommon Very rare | | Vascular Disorders | Flushinga Hypertensiona | Uncommon Uncommon | | Respiratory, Thoracic and Mediastinal Disorders | Cough\\*\\* Sore mouth or throat Throat irritation\\*\\* Bronchospasm Dysphonia Dyspnoeaa Nasal congestion Sneezing Throat tightness | Common Very common Very common Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon | | Gastrointestinal Disorders | Nauseaa Hiccups\\*\\*\\*\\* Abdominal pain Diarrhoea\\*\\*\\* Dry mouth Flatulence Salivary hypersecretion Stomatitis Vomitinga Dyspepsia Eructation Glossitis Oral mucosal blistering and exfoliation Paraesthesia oral\\*\\*\\* Dysphagia Hypoaesthesia oral\\*\\*\\* Retching Dry throat Gastrointestinal discomforta Lip pain | Very common Very common Common Common Common Common Common Common Common Common Uncommon Uncommon Uncommon Uncommon Rare Rare Rare Not known Not known Not known | | Skin and Subcutaneous Tissue Disorders | Urticariaa Hyperhidrosisa Pruritusa Rasha Erythemaa | Uncommon Uncommon Uncommon Uncommon Not known | | Musculoskeletal and Connective Tissue Disorders | Pain in jawb Muscle tightnessb | Uncommon Not known | | General Disorders and Administration Site Conditions | Fatiguea Astheniaa Chest discomfort and paina Malaisea Allergic reactions including angioedema | Common Uncommon Uncommon Uncommon Rare | a Systemic effects; b Tightness of jaw and pain in jaw with nicotine gum formulation c At the application site \\*Identified only for formulations applied during the night \\*\\*Higher frequency observed in clinical studies with inhaler formulation. \\*\\*\\*Reported the same or less frequently than placebo \\*\\*\\*\\* Higher frequency observed in clinical studies with mouth spray formulation # Although the frequency in the active group is less than that of the placebo group, the frequency in the specific formulation in which the PT was identified as a systemic ADR was greater in the active group than the placebo group. \*\*Reporting of suspected adverse reactions\*\* Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose \*Symptoms:\* Symptoms of overdose with nicotine from this product may occur in smokers/vapers who have previously had a low nicotine intake from cigarettes/e-cigarettes or if other sources of nicotine are used concomitantly with this product. Acute or chronic toxicity of nicotine in man is highly dependent on mode and route of administration. Adaptation to nicotine (e.g. in smokers/vapers) is known to significantly increase tolerability compared with non- smokers/vapers. The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60 mg. Symptoms of acute nicotine poisoning include nausea, vomiting, increased salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions. \*Management of an overdose\*: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine. The risk of poisoning as a result of swallowing the gum is very small, as absorption in the absence of chewing is slow and incomplete. Doses of nicotine that are tolerated by adult smokers/vapers during treatment may produce severe symptoms of poisoning in children and may prove fatal. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately. ## Pharmacological Properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Drugs used in nicotine dependence ATC code: N07B A01 The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicorette 4 mg Gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs. The main pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis. The gum contains a number of ingredients that are recognized as having properties for removal of dental staining. Clinical studies have shown that the gum helps to improve tooth whiteness. Increased appetite is a recognised symptom of nicotine withdrawal and post- cessation weight gain is common. Clinical trials have demonstrated that Nicotine Replacement Therapy can help control weight following a quit attempt.5.2 Pharmacokinetic properties Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes. Demonstrable blood levels are obtained within 5 – 7 minutes and reach a maximum about 30 minutes after the start of chewing. Blood levels are roughly proportional to the amount of nicotine chewed and have been shown never to exceed those obtained from smoking cigarettes.5.3 Preclinical safety data Preclinical data indicate that nicotine is neither mutagenic nor genotoxic. There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the product, which have not been considered in other relevant sections of this Summary of Product Characteristics. ## Pharmaceutical Particulars 6.1 List of excipients Core gum Chewing gum base, containing butylated hydroxyl toluene (E321) Xylitol Peppermint oil Sodium carbonate, anhydrous Acesulfame Potassium Levomenthol Magnesium oxide, light Quinoline yellow Al lake (E104) Talc Sub coating Winterfresh Hypromellose Sucralose Polysorbate 80 Purified water Hard coating Xylitol Starch Titanium dioxide (E171) Winterfresh Quinoline yellow Al lake (E104) Carnauba wax Purified water6.2 Incompatibilities Not applicable6.3 Shelf life Blister: 3 years Box: 3 years. Shelf life after opening 3 months.6.4 Special precautions for storage Do not store above 25°C.6.5 Nature and contents of container Blister packed strips each containing 6, 10 or 15 pieces supplied in packs of 10, 12, 15, 30, 75, 105, 165 and 210 pieces. and Laminated cardboard box, wrapped in a transparent plastic film, containing 25 pieces, supplied in packs of 25, 100 and 200. Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling Dispose of Nicorette Gum sensibly. Any unused product or waste material should be disposed of in accordance with local requirements.

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UK EMC

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ad427c281495c817

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