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NICOTINELL MINT is a brand name for Nicotine Bitartrate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of tobacco dependence by providing relief of nicotine withdrawal symptoms including cravings (see section 5.1), thereby facilitating smoking cessation or temporary smoking reduction in smokers motivated to quit smoking. Permanent cessation of tobacco use is the eventual objective. The 2 mg strength is used…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology:
Adults and elderly Nicotinell Mint 2 mg Lozenge 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 strength is selected according to the following table:
Low to moderate dependency Moderate to strong dependency Strong to very strong dependency Less than 20 cigarettes / day From 20 to 30 cigarettes / day Over 30 cigarettes / day Low dose forms are preferable (1 mg lozenge) Low (1 mg lozenge) or high (2 mg lozenge) dose forms are acceptable depending on patient characteristics and preference.
High dose forms are preferable (2 mg lozenge) If an adverse event occurs with the use of the high dose form (2 mg lozenge), use of the low dose form (1 mg lozenge) should be considered. The initial dosage should be individualised on the basis of the patient’s nicotine dependence.
One piece of lozenge to suck when the user feels the urge to smoke. Initially, 1 lozenge should be taken every 1-2 hours. The usual dosage is 8-12 lozenges per day. For smoking cessation and smoking reduction with Nicotinell Lozenge, the maximum daily dose is 15 lozenges.
Do not use more than one lozenge per hour. Nicotinell Lozenge should primarily be used for smoking cessation.
Smoking cessation:
Users should stop smoking completely during treatment with Nicotinell Lozenge. Low dosage forms acceptable High dosage forms acceptable The treatment duration is individual. Normally, treatment should continue for at least 3 months. After 3 months, the user should gradually reduce the number of lozenges or alternatively the user should switch to nicotine 1 mg lozenges and then gradually reduce the number of lozenges per day.
Treatment should be discontinued when the dose has been reduced to 1-2 lozenges per day. Use of nicotine medicinal products like Nicotinell Mint 2 mg Lozenge beyond 6 months is generally not recommended. Some ex-smokers may need treatment with the lozenge longer to avoid returning to smoking.
Patients who have been using oral nicotine replacement therapy beyond 9 months are advised to seek additional help and information from health care professionals. Counselling may help smokers to quit.
Nicotinell Lozenge can cause adverse reactions similar to those associated with nicotine administered by smoking. These can be attributed to the pharmacological effects of nicotine, which are dose-dependent. Non dose- dependent adverse reactions are as follows: hypersensitivity, angioneurotic oedema and anaphylactic reactions.
Most of the adverse reactions which are reported by patients occur generally during the first 3-4 weeks after initiation of therapy. Nicotine from lozenges may sometimes cause a slight irritation of the throat and increased salivation at the start of the treatment.
Excessive swallowing of nicotine which is released in the saliva may, at first, cause hiccups. Those who are prone to indigestion may suffer initially from minor degrees of dyspepsia or heartburn; slower sucking will usually overcome this problem.
Excessive consumption of lozenges by subjects who have not been in the habit of inhaling tobacco smoke, could possibly lead to nausea, faintness and headache. Increased frequency of aphthous ulcer may occur after abstinence from smoking.
The following undesirable effects detailed in Table 1 are nicotine related adverse events for all oral dosage forms. Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000, <1/1,000) or very rare (<1/10,000).
Table 1 shows events which were identified from a double-blind, randomised, placebo-controlled lozenge clinical study involving 1818 patients. Adverse events reported in this study have been considered for inclusion, where the incidence in the 2 mg or 4 mg nicotine arm was higher than the corresponding placebo arm.
Frequencies are calculated from safety data of the study. g. , abdominal pain, upper diarrhea, dry mouth, constipation. g. atrial fibrillation) Respiratory, thoracic and mediastinal disorders - Pharyngitis, cough*, pharyngolaryngeal pain - - *These events may also be due to withdrawal symptoms following smoking cessation.
Cardiovascular disease: smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetal’s angina, severe cardiac arrhythmias, uncontrolled hypertensions or recent cerebrovascular accident should be encouraged to stop smoking with non-pharmacological interventions (such as counselling).
If this fails, Nicotinell Lozenges may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the nicotine lozenge dose should be reduced or discontinued.
Nicotinell Lozenges should be used with caution in patients with hypertension, stable angina pectoris, cerebrovascular disease, occlusive peripheral arterial disease, heart failure, hyperthyroidism or pheochromocytoma. Diabetes mellitus: blood glucose levels may be more variable during smoking cessation, with or without nicotine replacement therapy.
So, it is important for diabetics to closely monitor their blood glucose levels while using this product. Renal or hepatic impairment: moderate to severe hepatic and/or severe renal impairment. Seizures: potential risks and benefits of nicotine should be carefully evaluated before use in subjects taking anti-convulsant therapy or with a history of epilepsy as cases of convulsions have been reported in association with nicotine.
Patients should initially be encouraged to stop smoking with non-pharmacological interventions (such as counselling). Gastrointestinal disease: swallowed nicotine may exacerbate symptoms in subjects suffering from active oesophagitis, oral and pharyngeal inflammation, gastritis or peptic ulcer.
Nicotine oral products should be kept out of sight and reach of children. 9). Special warnings about excipients Nicotinell Mint contains aspartame, maltitol and sodium. Each Nicotinell Mint 2 mg Lozenge contains 10 mg aspartame (E951), a source of phenylalanine equivalent to 5 mg/dose and may be harmful for people with phenylketonuria.
1. Nicotinell Lozenge should not be used by non-smokers.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nicotine Bitartrate in United Kingdom.
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Smoking reduction:
Nicotinell Lozenge should be used between periods of smoking in order to prolong smoke-free intervals and with the intention of reducing smoking as much as possible. The number of cigarettes should be gradually replaced by Nicotinell Lozenge.
If a reduction of at least 50 % in the number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought. A quit attempt should be made as soon as the smoker feels ready, but not later than 4 months after start of treatment.
After that the number of lozenges should be gradually reduced, for example by quitting one lozenge every 2-5 days. If a quit attempt cannot be made within 6 months after starting treatment, professional advice should be sought. Regular use of Nicotinell Lozenge beyond 6 months is generally not recommended.
Some ex-smokers may need treatment with the lozenges for longer to avoid returning to smoking. Counselling may improve the chance for smokers to quit. Paediatric population Nicotinell Lozenge should not be used by adolescents 12-17 years of age without prescription from a healthcare professional.
There is no experience in treating adolescents under the age of 18 with Nicotinell Lozenge.
Children below 12 years of age:
Nicotinell Lozenges should not be used by children under 12 years.
Renal and hepatic impairment:
Use with caution in patients with moderate to severe renal impairment and/or moderate to severe hepatic impairment as the clearance of nicotine or its metabolites maybe decreased with the potential for increased adverse effects. Method of administration: 1.
One lozenge to be sucked until the taste becomes strong. 2. The lozenge should then be lodged between the gum and cheek. 3. When the taste fades, sucking of the lozenge should commence again. 4. The sucking routine will be adapted individually and should be repeated until the lozenge dissolves completely (about 30 minutes).
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 sucking the lozenge. Users should not eat or drink while a lozenge is in the mouth.
Post Marketing Data Table 2 shows events which were identified from post-marketing experience of nicotine oral forms. As these reactions are reported voluntarily from a population of uncertain size, the frequency of these reactions is unknown.
Table 2:
Adverse Reactions from post-marketing data System Organ Class Adverse Reactions Immune System Disorders Hypersensitivity, angioedema, urticaria, ulcerative stomatitis, and very rare anaphylactic reactions. Nervous System Disorders Tremor.
Cardiac Disorders Palpitations, tachycardia, arrhythmias. Respiratory, Thoracic and Mediastinal Disorders Dyspnoea. Gastrointestinal Disorders Dysphagia, eructation, salivary hypersecretion. General Disorders and Administration Site Conditions Asthenia**, fatigue**, malaise**, influenza type illness**.
**These events may also be due to withdrawal symptoms following smoking cessation. Certain symptoms which have been reported such as dizziness, headache and insomnia may be ascribed to withdrawal symptoms in connection with smoking cessation and may be due to insufficient administration of nicotine.
Cold sores may develop in connection with smoking cessation, but any relation with the nicotine treatment is unclear. The patient may still experience nicotine dependence after smoking cessation. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Because Nicotinell Mint 2 mg Lozenge contains maltitol (E965), a source of fructose: - patients with rare hereditary problems of fructose intolerance should not take this medicinal product, - patients may experience a mild laxative effect.
3 kcal/g maltitol. This medicinal product contains less than 1 mmol (23 mg) per lozenge that is to say essentially ‘sodium-free’.