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Nicotinell Mint 1 mg Lozenges Overview
Nicotinell Mint 1 mg is a lozenge that contains nicotine, a substance found in tobacco. This product is used to help people quit smoking by reducing withdrawal symptoms. It does not contain sugar.
What's in it?
- Main Ingredient: 1 mg of nicotine in the form of nicotine bitartrate dihydrate (3.072 mg)
- Other Ingredients: maltitol (E 965), anhydrous sodium carbonate, sodium bicarbonate, 30% polyacrylate dispersion, xanthan gum, anhydrous colloidal silica, levomenthol, peppermint oil, aspartame (E 951), and magnesium stearate.
Package Size: You can buy it in boxes of 36, 96, or 144 lozenges.
Who Can Use It?
This product is intended for adults (18+) who are mildly to moderately dependent on nicotine. It is not recommended for heavily dependent smokers. If you're under 18, you should seek medical advice before using.
How to Use It?
Place a lozenge in your mouth and suck on it. Once the taste gets strong, move it between your cheek and gum until the taste fades, then start sucking again. Repeat until the lozenge is completely dissolved, which should take around 30 minutes. Use 1 lozenge every 1-2 hours or whenever you feel the urge to smoke. The usual dose is 8 to 12 lozenges per day, with a maximum of 30.
Dosage Based on Smoking Habits:
- If you smoke fewer than 20 cigarettes a day, the 1 mg lozenge is recommended.
- If you smoke 20 to 30 cigarettes a day, you can use either 1 mg or 2 mg lozenges based on your needs.
- If you smoke more than 30 cigarettes a day, it's recommended to use the 2 mg lozenges.
Treatment Duration
The length of treatment will vary based on your response, but it should be continued for at least 3 months. You should gradually reduce the number of lozenges used after this period and stop using them entirely once you're down to 1-2 per day. It's generally not recommended to continue treatment for longer than 6 months.
Warning
Overdose can cause a variety of symptoms, ranging from sweating and throat irritation to nausea, vomiting, diarrhea, and heart problems. In children, even small amounts can cause severe symptoms or death. If you suspect an overdose, contact a healthcare professional immediately.
Who Shouldn't Use It?
People who don't smoke or are allergic to nicotine or any of the other ingredients should not use this product. Also, seek medical advice before using it if you have certain medical conditions or are taking certain medications.
Avoid coffee, acidic, and carbonated drinks 15 minutes before taking a lozenge as it can reduce the absorption of nicotine.
Nicotinell Mint 1mg is not recommended for use during pregnancy and breastfeeding without medical consultation.
Additional Information
The lozenges contain sweeteners such as aspartame and maltitol, a source of fructose, and each lozenge contains 9.8 mg of sodium. These factors should be considered if you're diabetic or on a low-salt diet.
Please read the following full disclosure:
SUMMARY OF PRODUCT CHARACTERISTICS
ANSM - Updated on: 16/07/2020
- NAME OF THE MEDICINE
NICOTINELL MINT 1 mg, lozenge
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicotine ........................................................................................................................... 1.000 mg
In the form of nicotine bitartrate dihydrate ................................................................... 3.072 mg
For one lozenge.
Excipient(s) with known effect: aspartame (0.01 g) and maltitol (0.9 g).
For the full list of excipients, see section 6.1.
- PHARMACEUTICAL FORM
Lozenge.
White lozenge, mint-flavored, round and biconvex.
- CLINICAL DATA
4.1. Therapeutic Indications
Treatment of tobacco dependence in order to alleviate the symptoms of nicotine withdrawal, including craving (see section 5.1), with the aim of facilitating complete cessation of tobacco use or temporarily reducing its consumption in smokers motivated to quit.
Complete cessation of tobacco use is the ultimate goal. Appropriate support increases the chances of success in quitting smoking.
4.2. Dosage and Method of Administration.
NICOTINELL MINT 1 mg, lozenge can be used alone (a) or in combination with NICOTINELL TTS, transdermal patch (b).
Dosage
Adults and elderly:
a) Treatment with NICOTINELL MINT 1 mg, lozenge only
Patients must completely stop smoking during treatment with this medicine.
NICOTINELL MINT 1 mg, lozenge is recommended for smokers with low to moderate nicotine dependence. It is not recommended for highly or very highly nicotine dependent smokers.
The initial dosage will be personalized based on the individual's nicotine dependence. The optimal dosage is described in the table below:
Low to moderate nicotine dependence
Moderate to high nicotine dependence
High to very high nicotine dependence
Low dosage accepted
Low dosage accepted
High dosage accepted
High dosage accepted
Smoker < 20 cigarettes / day.
Smoker of 20 to 30 cigarettes / day.
Smoker > 30 cigarettes / day.
The use of 1 mg lozenges is recommended.
Depending on the characteristics of the smoker, the 1 mg and 2 mg lozenges can be used.
The use of 2 mg lozenges is recommended.
In case of occurrence of adverse effects observed with the use of 2 mg tablets, use the 1 mg tablets.
The initial dose is one tablet every 1 to 2 hours. Suck on a tablet each time the need to smoke is felt.
The usual consumption is 8 to 12 tablets per day. For quitting smoking as well as for reduction, the maximum daily dose is 24 tablets. Do not use more than one tablet per hour.
NICOTINELL tablets should be used as a priority for quitting smoking.
Complete cessation of tobacco
Patients must stop smoking completely during treatment with NICOTINELL tablets.
The duration of treatment is individual. Normally, this treatment should last at least 3 months. After 3 months, the individual gradually reduces the number of tablets. The treatment is stopped when consumption is reduced to 1 or 2 tablets per day. It is generally recommended not to use lozenges beyond 6 months. However, some ex-smokers may need longer treatment to avoid relapses.
Patients who have used a nicotine substitute for more than 9 months are advised to seek advice from a healthcare professional.
The advice of a healthcare professional can help smokers quit smoking.
Reduction of tobacco consumption
NICOTINELL tablets should be used between periods when the individual smokes, with the aim of prolonging smoke-free periods, and with the intention of reducing cigarette consumption as much as possible. The number of cigarettes should be gradually replaced by NICOTINELL tablets.
If a reduction in daily cigarette consumption of at least 50% has not been achieved after 6 weeks of treatment, it is recommended to seek advice from a healthcare professional.
An attempt to quit should be considered as soon as the smoker feels ready, but no more than 4 months after initiating treatment. After this period, the number of tablets should be gradually reduced, for example by stopping one tablet every 2-5 days. If after 6 months from the start of treatment, the attempt to completely quit smoking has failed, it is recommended to seek advice from a healthcare professional. Regular use of NICOTINELL tablets after 6 months is generally not recommended. Some ex-smokers may need longer treatment to avoid returning to tobacco consumption.
The advice of a healthcare professional can help smokers quit smoking.
b) Treatment with NICOTINELL 1 mg, lozenge in combination with NICOTINELL TTS, transdermal patch.
Complete cessation of tobacco
People who have failed after being treated with NICOTINELL 1 mg, lozenge alone, can combine it with NICOTINELL TTS, transdermal patch.
It is advisable to stop smoking completely during treatment with NICOTINELL 1 mg, lozenge in combination with NICOTINELL TTS, transdermal patch.
The use of NICOTINELL TTS, transdermal patch in combination with NICOTINELL 1 mg, lozenge is recommended for smokers moderately to highly dependent on nicotine (more than 20 cigarettes per day). It is highly recommended to use this medication combination with the advice and support of a healthcare professional.
The maximum total treatment duration is 9 months (for the initial treatment and the reduction of the nicotine dose)
Initial combined treatment:
It is advisable to start treatment with a 21 mg / 24 hour patch in combination with NICOTINELL 1 mg, lozenge. At least 4 tablets (1 mg) per day must be used. In most cases, 5 to 6 tablets are sufficient. Do not take more than 15 tablets per day. Normally, the treatment should last 6 to 12 weeks. Subsequently, the nicotine dose must be gradually reduced.
The patch is applied to a clean, dry, undamaged area where hair is rare on the trunk, upper arm, or hips. The patch should be pressed onto the skin for 10 to 20 seconds.
To minimize the risk of local irritation, it is advisable to apply NICOTINELL TTS, transdermal patch to a different application site than the previous one.
It is advisable to wash hands rigorously after handling the transdermal devices to avoid eye irritation from the nicotine deposited on the fingers.
Reduction of the nicotine dose:
This can be done in 2 ways.
Option 1: Use of patches at a lower dose, that is to say: NICOTINELL TTS 14 mg / 24 hours, transdermal device for 3 to 6 weeks followed by NICOTINELL TTS 7 mg / 24 hours, transdermal device for another 3 to 6 weeks with the initial dose of NICOTINELL 1 mg, lozenge. Subsequently, the number of tablets should be gradually reduced. It is generally not recommended to use NICOTINELL 1 mg, lozenge for more than 6 months. However, some ex-smokers may need treatment for longer in order to avoid relapse of smoking but this should not exceed more than 9 months.
Option 2: Discontinuous use of patches and gradual reduction in the number of 1 mg tablets. It is generally not recommended to use NICOTINELL 1 mg, lozenge for more than 6 months. However, some ex-smokers may need treatment for longer to avoid relapse of smoking but should not exceed more than 9 months.
Pediatric population
NICOTINELL MINT 1 mg, lozenge should not be administered in adolescents (12-17 years) without the advice of a healthcare professional. There are no data regarding the administration of this medicine in adolescents under 18 years of age.
NICOTINELL MINT 1 mg, lozenge should not be administered in children under 18 years old.
Renal and hepatic insufficiency
This medication should be used with caution in patients with moderate to severe renal insufficiency and/or moderate to severe hepatic insufficiency, as the clearance of nicotine or its metabolites may be decreased with the possibility of increased side effects.
Usage tips:
· Suck the tablet until the taste becomes strong.
· Then place the tablet between the gum and the cheek.
· Start sucking the tablet again when the taste has faded.
· This process will be adapted individually and should be repeated until the tablet is completely dissolved (about 30 minutes).
The intake of acidic drinks such as coffee or soda can decrease the absorption of nicotine through the oral mucosa. These drinks should be avoided in the 15 minutes before taking the lozenge. Do not eat or drink with the lozenge in the mouth.
4.3. Contraindications
· Hypersensitivity to nicotine or to any of the excipients mentioned in section 6.1.
· Non-smokers.
4.4. Special warnings and precautions for use
Cardiovascular diseases: in case of recent myocardial infarction, unstable or worsening angina (including Prinzmetal angina), severe cardiac rhythm disorder, unstable arterial hypertension, or recent cerebrovascular accident, it is always recommended first to completely stop smoking without nicotine replacement therapy.
In case of failure in these smokers, the use of NICOTINELL MINT lozenges should be considered; however, as clinical safety data in these patients are limited, initiation of treatment should only be under medical supervision. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the dose of nicotine should be reduced or the medication discontinued.
Use NICOTINELL MINT lozenges with caution in patients with hypertension, stable angina, cerebrovascular disorder, occlusive peripheral arterial diseases, heart failure, hyperthyroidism, or pheochromocytoma.
Diabetes mellitus: Blood glucose can be more variable when quitting smoking, with or without nicotine replacement therapy. Therefore, it is important for diabetics to closely monitor their blood glucose when using this product.
Renal or hepatic insufficiency: moderate to severe hepatic insufficiency and/or severe renal insufficiency.
Seizures: The potential risks and benefits of nicotine should be carefully evaluated before use in subjects taking anticonvulsant therapy or with a history of epilepsy as cases of seizures have been reported in association with nicotine.
In these patients, complete cessation of smoking without nicotine replacement therapy should first be recommended.
Gastrointestinal diseases: swallowed nicotine can exacerbate symptoms in subjects suffering from esophagitis, oral or pharyngeal inflammation, gastritis, or gastric or peptic ulcer.
Keep out of sight and reach of children.
Danger in young children: doses of nicotine tolerated in adult smokers can cause serious, even fatal, intoxication in young children (see section 4.9).
Specific warnings related to excipients:
The NICOTINELL MINT lozenge contains aspartame, maltitol, and sodium.
Each NICOTINELL MINT 1 mg lozenge contains 10mg of aspartame (E951), a source of phenylalanine equivalent to 5 mg/dose; this can be dangerous
4.5. Interactions with other medicinal products and other forms of interaction
Drug interactions: there are no data on possible interactions between nicotine-containing lozenges and other medications.
Other reported effects of smoking include a reduction in the analgesic effect of propoxyphene, a decrease in the diuretic effect of furosemide, a decrease in the pharmacological effect of propranolol on blood pressure and heart rate, and a decrease in the anti-ulcer effect of H2 antagonists.
Tobacco and nicotine can lead to an increase in blood concentrations of cortisol and catecholamines, such as a decrease in the effect of nifedipine or adrenergic antagonists and an increase in the effect of adrenergic agonists.
The increase in subcutaneous absorption of insulin that occurs when stopping smoking may require a decrease in the dose of insulin.
Regarding interactions with other medicinal products and other forms of interaction for NICOTINELL TTS, transdermal device, see the Summary of Product Characteristics for this specialty.
4.6. Fertility, pregnancy and lactation
Pregnancy
Smoking during pregnancy is associated with risks such as intrauterine growth retardation, premature delivery, or stillbirth. Quitting smoking is the most effective intervention to improve the health of the pregnant woman and her baby. The earlier smoking is stopped, the better. Nicotine is transmitted to the fetus and affects its respiratory movements as well as its circulation. The effect on circulation is dose-dependent.
Pregnant women should first be advised to stop smoking without the aid of nicotine replacement therapy. If unsuccessful, the use of a nicotine substitute should only be considered after the advice of a healthcare professional.
Breastfeeding
Nicotine passes into breast milk in amounts that could affect the child, including at therapeutic doses.
Therefore, both NICOTINELL MENTHE 1 mg lozenge and smoking should be avoided during breastfeeding.
If quitting smoking is not fully assured, the use of the lozenge during breastfeeding should only be decided after the advice of a healthcare professional.
In case of use of this medication during breastfeeding, suck the NICOTINELL MENTHE 1 mg lozenge just after breastfeeding and do not take it during the two hours before the next breastfeeding.
Fertility
Smoking increases the risk of infertility in both women and men. Both in humans and in animals, it has been demonstrated that nicotine can impair sperm quality. In animals, reduced fertility has been demonstrated.
4.7. Effects on ability to drive and use machines
There is no evidence of risk regarding driving vehicles or operating machinery when treated with the recommended doses of lozenges. However, the fact that quitting smoking can cause behavioral changes should be considered.
4.8. Side effects
The nicotine from the lozenges can cause side effects similar to those of nicotine absorbed through smoking, due to the pharmacological effects of nicotine, which are dose-dependent. Non-dose dependent side effects are: hypersensitivity, Quincke's edema and anaphylactic shocks.
Most of the reported side effects occur during the first 3 or 4 weeks of treatment.
The nicotine from the lozenges can sometimes cause a slight irritation of the throat and increased salivation at the beginning of treatment. Swallowing too much nicotine can cause hiccups. Sensitive subjects may present mild signs of dyspepsia or gastric burns at the beginning. These symptoms can be reduced by sucking the lozenge more slowly. Excessive consumption of lozenges by subjects who did not inhale tobacco smoke can cause nausea, dizziness, and headaches.
The occurrence of aphthous ulceration may be more frequent when quitting smoking.
The following side effects detailed in Table 1 relate to all oral forms of nicotine.
Side effects are listed below, by organ type and in order of frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000).
Some symptoms such as dizziness, headaches, insomnia may be related to tobacco withdrawal and may be due to the administration of an insufficient dose of nicotine.
Cold sores may occur when quitting smoking, but their relationship with nicotine treatment is not established.
The patient may remain dependent on nicotine after quitting smoking.
Regarding the side effects for NICOTINELL TTS transdermal device, see the Summary of Characteristics of this specialty.
Declaration of suspected adverse effects
The declaration of suspected adverse effects after authorization of the drug is important. It allows continuous monitoring of the benefit/risk ratio of the drug. Healthcare professionals report any suspected adverse effect through the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.
4.9. Overdose
In case of overdose, symptoms corresponding to heavy tobacco consumption may be observed.
Even low doses of nicotine are toxic in children and can cause symptoms of poisoning that can be fatal. If poisoning is suspected in a child, consult a doctor immediately.
An overdose with NICOTINELL MENTHE 1 mg lozenges can only occur if several lozenges are sucked at the same time. Generally, the toxicity of nicotine after ingestion is minimized by the early onset of nausea and vomiting following excessive nicotine exposure.
The signs and symptoms of an overdose should be the same as those of acute nicotine poisoning, including: general weakness, sweats, pallor, hyperhidrosis, hypersalivation, sore throat, nausea, vomiting, diarrhea, abdominal pain, hearing and visual disturbances (sensory disturbances), headache, tachycardia and cardiac arrhythmia, dyspnea, dizziness, tremors, confused state and asthenia. Prostration, hypotension, cardiovascular collapse, coma, respiratory failure and terminal seizures may occur in case of significant overdose.
Course of action in case of overdose:
In case of overdose (for example, too many tablets ingested), immediate medical assistance is required. Any nicotine intake must immediately cease, and the patient should be treated symptomatically and vital signs monitored.
Further management will be clinically indicated or as recommended by the national poison control center.
- PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic class: DRUG USED IN NICOTINE DEPENDENCE, ATC code: N07BA01.
Mechanism of action
Nicotine, the main alkaloid of tobacco-derived products, a natural substance acting on the autonomic nervous system, is an agonist of the nicotinic receptors of the central and peripheral nervous systems that has pronounced effects on the central nervous system and the cardiovascular system. Consumed via tobacco, nicotine creates a dependency resulting in a sensation of lack and other deprivation symptoms at the cessation of administration.
These withdrawal symptoms include a strong urge to smoke, dysphoria, insomnia, irritability, frustration or anger, anxiety, difficulty concentrating, restlessness, and increased appetite or weight gain. The lozenges replace some of the nicotine that would have been administered by tobacco and reduce the intensity of withdrawal symptoms and the strong urge to smoke.
5.2. Pharmacokinetic properties
Absorption
The amount of nicotine absorbed depends on the amount released and absorbed through the oral mucosa.
Most of the nicotine from NICOTINELL MENTHE 1 mg, lozenge is absorbed through the oral mucosa.
Due to the swallowing of saliva containing nicotine, a certain proportion of it reaches the stomach and intestine where it is inactivated. Due to the first pass hepatic effect, the systemic bioavailability of nicotine is low.
Therefore, a high and rapid systemic concentration such as it is obtained by smoking, is rarely obtained during treatment with NICOTINELL MENTHE 1 mg, lozenge.
The maximum plasma concentration after single administration of NICOTINELL MENTHE 1 mg, lozenge is about 4 ng per ml; after repeated administration, this concentration is close to 10.6 ng per ml (the average nicotine level after a cigarette is 15-30 ng per ml). The plasma peak is reached about 45 minutes after a single dose and after about 30 minutes in repeated administration.
Distribution
The volume of distribution after intravenous administration of nicotine is approximately (2-) 3 l/kg and the plasma half-life is two hours. Nicotine is primarily metabolized in the liver and plasma clearance is about 1.2 l/min; nicotine is also metabolized in the kidneys and lungs.
Nicotine crosses the blood-brain barrier.
Metabolism
More than 20 metabolites have been identified, all probably less active than nicotine. The main metabolite is cotinine which has a half-life of 15-20 hours and a plasma concentration about 10 times higher than that of nicotine. The binding to plasma proteins of nicotine is less than 5%. The modification of this binding rate by drug treatments or simultaneous diseases probably has no significant effect on the kinetics of nicotine. The main urinary metabolites are cotinine (15% of the dose) and trans-3-hydroxy-cotinine (45% of the dose).
Elimination
Approximately 10% of the nicotine is excreted unchanged. Urinary excretion can reach 30% in case of increased diuresis or pH lower than 5.
5.3. Preclinical safety data
Nicotine has been found to be positive in some in vitro genotoxicity tests; however, negative results have also been obtained with these same tests. Nicotine was negative in in vivo tests.
Experiments in animals have shown that nicotine causes post-implantation loss and decreases fetal growth.
The results of carcinogenesis tests have not provided clear evidence of a carcinogenic effect of nicotine.
- PHARMACEUTICAL DATA
6.1. List of excipients
Maltitol (E965), anhydrous sodium carbonate, sodium bicarbonate, 30% polyacrylate dispersion, xanthan gum, anhydrous colloidal silica, levomenthol, peppermint essential oil, aspartame (E951), magnesium stearate.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years
6.4. Special precautions for storage
Store at a temperature not exceeding + 25ºC.
6.5. Nature and contents of outer packaging
Polypropylene tube of 24, 72, 96 or 144 tablets with a closure cap containing a molecular sieve desiccant sleeve along the inner wall of the tube.
Boxes of 12, 36, 72, 96, 144 or 204 tablets in opaque thermoformed blisters (Aluminium-PVC/PE/PVDC/PE/PVC).
Not all pack sizes may be marketed.
6.6. Special precautions for disposal and handling
No special requirements.
- MARKETING AUTHORIZATION HOLDER
GLAXOSMITHKLINE CONSUMER HEALTHCARE
23 RUE FRANCOIS JACOB
92500 RUEIL MALMAISON
- MARKETING AUTHORIZATION NUMBER(S)
· 34009 364 088 1 4: 12 lozenges in thermoformed blisters (Aluminium-PVC/PE/PVDC/PE/PVC).
· 34009 364 089 8 2: 36 lozenges in thermoformed blisters (Aluminium-PVC/PE/PVDC/PE/PVC).
· 34009 389 198 5 1: 72 lozenges in thermoformed blisters (Aluminium-PVC/PE/PVDC/PE/PVC).
· 34009 364 090 6 4: 96 lozenges in thermoformed blisters (Aluminium-PVC/PE/PVDC/PE/PVC).
· 34009 389 199 1 2: 144 lozenges in thermoformed blisters (Aluminium-PVC/PE/PVDC/PE/PVC).
· 34009 364 091 2 5: 204 lozenges in thermoformed blisters (Aluminium-PVC/PE/PVDC/PE/PVC).
- DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
[to be completed later by the holder]
- DATE OF UPDATE OF THE TEXT
[to be completed later by the holder]
- DOSIMETRY
Not applicable.
- INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
PRESCRIPTION AND DELIVERY CONDITIONS
Over-the-counter medication.
