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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. Patient counselling and…
Verbatim from this product's MHRA label. Tap a section to expand.
Nicotinell Mint Lozenge 1 mg may be used alone (a) or in combination with Nicotinell Transdermal Patch (b).
Posology:
Adults and elderly (a) Treatment with Nicotinell Lozenges only Nicotinell Mint 1 mg Lozenge is recommended in smokers with a low to moderate nicotine dependency. It is not recommended in the case of smokers with a strong or very strong nicotine dependency.
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 Treatment with Nicotinell Mint Lozenge only 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 24 lozenges.
Do not use more than one lozenge per hour. Nicotinell Lozenge should primarily be used for smoking cessation.
Low dosage forms High dosage forms Smoking cessation:
Users should stop smoking completely during treatment with Nicotinell Lozenge. 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.
Treatment should be discontinued when the dose has been reduced to 1-2 lozenges per day. Use of nicotine medicinal products like Nicotinell Mint 1 mg Lozenge beyond 6 months is generally not recommended. Some ex-smokers may need treatment with the lozenge longer to avoid returning to smoking.
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 diarrhoea, 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 Lozenges contain aspartame, maltitol and sodium. Each Nicotinell Mint 1 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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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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.
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. (b) Treatment with Nicotinell Lozenge in combination with Nicotinell Transdermal Patch Smoking cessation: People who have failed when treated with only Nicotinell Lozenge can use Nicotinell Patches together with Nicotinell 1 mg Lozenge.
Users should stop smoking completely during treatment with Nicotinell Lozenge in combination with Nicotinell Transdermal Patch. e. over 20 cigarettes per day. It is strongly recommended that the combination therapy is used in conjunction with the advice and support from a health care professional.
The maximum total treatment duration is 9 months (for the initial treatment and reduction of nicotine dose) Initial combination therapy: Treatment should begin with one patch 21 mg/24 hours in combination with Nicotinell 1mg Lozenge.
At least 4 pieces of lozenge (1 mg) per day should be used. In most cases, 5-6 lozenges are enough. Not more than 15 pieces of lozenge a day should be used. In normal cases, the treatment may last for 6-12 weeks. Thereafter, the nicotine dose is reduced gradually.
The patch is applied on a clean, dry, hairless, intact area of skin on the trunk, arms or hips. The patch is pressed against the skin for 10-20 seconds. To minimize the risk of local irritation the placement of Nicotinell Patches should be alternated between different application sites.
Hands should be washed thoroughly after application of transdermal patches to avoid irritation of the eyes with nicotine from the fingers.
Reduction of nicotine dose:
This can be done in two ways. e. 14 mg/24 hours patches for 3-6 weeks followed by 7 mg/24 hours for another 3-6 weeks together with the initial dose of Nicotinell 1 mg Lozenge. Thereafter, the number of lozenges is reduced gradually. It is generally not recommended to use Nicotinell Mint Lozenge for longer than 6 months.
However, some ex- smokers may need treatment for longer to avoid returning to smoking but it should not be more than9 months.
Alternative 2:
Discontinuation of the use of the patches and gradual reduction of the number of 1 mg lozenges. It is generally not recommended to use Nicotinell Mint Lozenge for longer than 6 months. However, some ex-smokers may need treatment for longer to avoid returning to smoking but it should not be more than 9 months.
Recommended dosage:
Period Patches Lozenge 1 mg Initial treatment (followed by alternative 1 or 2 below) First 6-12 weeks 1 patch 21 mg/24 hours When necessary, 5-6 lozenges per day is recommended Reduction of nicotine dose – alternative 1 Next 3-6 weeks 1 patch 14 […]
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 Dysphagia, eructation, salivary hypersecretion Disorders 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. For undesirable effects for the Nicotinell Patch, see the Summary of Product Characteristics for the specific product. 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 1 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’. For special warnings and precautions for the Nicotinell Patch, see the Summary of Product Characteristics for the specific product.