Nicotinell Mint 2mg Tablets 36 belongs to the range of drugs to help you quit smoking. Contains nicotine, a tobacco substances, then released slowly absorbed by buccal absorption whenever the chewed gum.
For warnings, precautions for use and contraindications, please consult the instructions for use.
NICOTINELL MENTHE 2 mg is a drug indicated in the treatment of tobacco dependence in order to relieve the symptoms of nicotine withdrawal in subjects wishing to stop their smoking.
NICOTINELL MENTHE 2 mg, sucking tablet is for use in subjects with severe smoking cessation symptoms.
Appropriate management improves the chances of success in stopping smoking.
Dosage in adults over 18 :
Frequency of administration
The initial dose should be 1 tablet every 1 to 2 hours. Otherwise, suck on one tablet each time you feel the need to smoke. The usual dose is 8 to 12 tablets per day. The maximum dose is 15 tablets per day.
Duration of treatment
The duration of treatment is to be adjusted individually. Normally, treatment should be continued for at least 3 months. After this time, gradually reduce the number of tablets; stop treatment when the dose is reduced to 1-2 tablets per day. It is generally not recommended to continue treatment beyond 6 months. However, some "ex-smokers" may need longer treatment to avoid relapse. In case of difficulty in stopping this medication beyond 9 months, seek advice from a health professional.
Advice and follow-up can increase your chances of success.
Children and adolescents under 18:
In subjects under 18 years of age, this medication should not be used without medical advice.
The active substance is :
Nicotine: 1,000 mg or 2,000 mg, in the form of bitartrate, nicotine dihydrate: 3,072 mg or 6,144 mg, for a sucking tablet.
The other ingredients are : maltitol (E 965), anhydrous sodium carbonate, sodium bicarbonate, 30% polyacrylate dispersion, xanthan gum, anhydrous colloidal silica, levomenthol, peppermint essential oil, aspartame (E 951), stearate magnesium.
Excipients with known effect : aspartame, maltitol, sodium.
Never take NICOTINELL FRUIT 2 mg WITHOUT SUGAR, medicated chewing gum in the following cases:
1 Box of 36 nicotinell 2mg mint tablets.
Your motivation and your will are the keys to successful treatment. If you are using Nicotinell 2mg Mint as part of an addiction treatment, you should quit smoking completely, because if you do not reduce your consumption, there is a risk of side effects, especially cardiac and circulatory, because of the rates higher than when you smoke as usual. It is therefore important that you are highly motivated to quit smoking before starting treatment with Nicotinell. Advice from professionals increases your chances of successfully quitting smoking. Nicotinell lozenges are not a pleasure product. It may take several days before you get used to the taste of Nicotinell lozenges. All Nicotinell lozenges are sugar free. Instead of sugar, they contain aspartame as a sweetener. Nicotinell lozenges can therefore also be used by diabetics, provided that the precautions for use are observed. Nicotinell lozenges do not contain lactose or galactose. If you take lozenges to reduce your tobacco consumption, be sure to do so only during periods when you do not smoke. In case of prolonged use, there is a risk of damage to the oral mucous membranes. Nicotinell 1 mg and 2 mg should not be used in case of known hypersensitivity to nicotine or to other constituents of the lozenges to be sucked. It should also not be consumed during pregnancy and lactation. Nicotinell lozenges should not be used by non-smokers and children under the age of 12! For adolescents aged 12 to 18 years, the drug should only be used in cases of heavy dependence on nicotine and only after consultation with a doctor, pharmacist or druggist.
Please note, the drug Nicorette 2mg Mint is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 12/08/2016
NICOTINELL MENTHE 2 mg, sucked tablet
Nicotine
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If you are still using NICOTINELL MENTHE 2 mg, tablet to suck after 9 months, consult a doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
In this notice :
1. WHAT NICOTINELL MENTHE 2 mg, tablet to suck AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE NICOTINELL MENTHE 2 mg, tablet to suck?
3. HOW TO TAKE NICOTINELL MENTHE 2 mg, tablet to suck?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE NICOTINELL MENTHE 2 mg, sucked tablet?
6. ADDITIONAL INFORMATION
1. WHAT NICOTINELL MENTHE 2 mg, tablet to suck AND WHAT IT IS USED FOR?
NICOTINELL MENTHE 2 mg, sucking tablet contains nicotine, one of the tobacco substances.
NICOTINELL MENTHE 2 mg, sucking tablet belongs to the range of medications intended to help you to quit smoking.
Nicotine is released slowly and then absorbed through the oral mucosa whenever a tablet is sucked.
Tailored management increases the chances of success when stopping smoking.
NICOTINELL is indicated for smokers aged over 18 years.
2. BEFORE YOU TAKE NICOTINELL MENTHE 2 mg, tablet to suck?
List of information needed before taking the medication
Not applicable.
Never take NICOTINELL MENTHE 2 mg, tablet to suck:
· in case of allergy to nicotine or to any of the excipients,
· if you are not usually smoker.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Precautions for use; special warnings
Take special care with NICOTINELL MENTHE 2 mg, tablet to suck:
Consult your doctor or pharmacist if you:
· cardiovascular disease (myocardial infarction, heart failure, angina pectoris, Prinzmetal angina, heart rhythm disorder),
· history of stroke,
· high blood pressure,
· circulatory problems,
· diabetes,
· thyroid disease (hyperthyroidism),
· pheochromocytoma (disease of the adrenal glands causing severe hypertension),
· hepatic or renal insufficiency,
· inflammation of the mouth or throat, esophagitis, gastritis, ulcer of the stomach or duodenum.
Nicotine in small amounts is dangerous in children and can cause severe symptoms or death. This is why it is imperative to keep NICOTINELL MENTHE 2 mg, sucked tablet out of the reach and sight of children.
Children and adolescents under 18 years of age
This medication should not be used without medical advice in subjects younger than 18 years of age.
Interaction with other medicines
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription. If you stop smoking and are taking other medications, your doctor may want to adjust the dosage.
There are no data on possible interactions between NICOTINELL MENTHE 2 mg, tablet to suck and other medicines. However, substances in cigarettes, other than nicotine, may have an effect on certain drugs.
Stopping tobacco can affect the action of certain drugs, for example:
· theophylline (a drug used in the treatment of asthma),
· tacrine (a drug used in the treatment of Alzheimer's disease),
· olanzapine and clozapine (drugs used in the treatment of schizophrenia),
· insulin (a drug used in the treatment of diabetes),
may require dose adjustment.
Interactions with food and beverages
Food and drinks
Consumption of coffee, acidic and soft drinks (sodas) may decrease nicotine absorption and should be avoided within 15 minutes of taking a sucking tablet.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
It is very important to stop smoking during your pregnancy as this can lead to a delayed growth of your child or even prematurity or fetal death. Ideally, you should try to stop smoking without taking medication. In case of failure, NICOTINELL MENTHE can be advised to help you. Indeed, the risk to the fetus is probably lower than that related to smoking. Nicotine in all its forms can harm your child. NICOTINELL MENTHE can only be taken after consulting the doctor who is following your pregnancy or a doctor specializing in smoking cessation assistance.
feeding
NICOTINELL MENTHE as smoking should be avoided during breastfeeding, as nicotine passes into breast milk. If your doctor recommends the use of NICOTINELL MENTHE 2 mg, tablet to suck during breast-feeding, the tablet should be sucked immediately after breastfeeding and not during the two hours before the next breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
Driving and using machines:
Stopping smoking can cause behavioral changes. At the recommended doses, there is no particular risk associated with NICOTINELL MENTHE 2 mg, tablet to suck.
List of excipients with known effect
Important information about some of the ingredients of NICOTINELL MENTHE 2 mg, sucked tablet
The sucking tablet NICOTINELL MENTHE contains sweeteners, namely aspartame and maltitol.
Each tablet of NICOTINELL MENTHE 2 mg contains aspartame (E951) source of phenylalanine in an amount equivalent to 5 mg per tablet; which can be dangerous in subjects suffering from phenylketonuria.
NICOTINELL MENTHE 2 mg, sucking tablet contains maltitol (E965), source of fructose:
· if you know you are intolerant to certain sugars, consult your doctor before taking this medicine,
· a slight laxative effect is sometimes observed.
The caloric value of maltitol is 2.3 kcal / g. The constituents of NICOTINELL MENTHE 2 mg, sucked tablet may be suitable for diabetics.
Each sucking tablet of NICOTINELL MENTHE 2 mg contains 9.8 mg of sodium, to be taken into account in people on a diet low in salt.
3. HOW TO TAKE NICOTINELL MENTHE 2 mg, tablet to suck?
NICOTINELL MENTHE sucking tablets are available in 2 strengths (1 mg and 2 mg).
The choice of your dosage depends on your smoking habits.
You should use NICOTINELL MENTHE 2 mg tablets to suck if:
· you are a highly dependent or highly dependent smoker,
· you have previously failed in an attempt to quit smoking with the tablets to suck NICOTINELL MENTHE 1 mg, sucked tablet,
· your withdrawal symptoms remain so strong that you fear a relapse.
Otherwise, NICOTINELL MENTHE 1 mg, sucked tablet should be used.
Adults over 18 years
The table below shows the dosage that is suitable for you:
If side effects occur with the use of 2 mg tablets, use 1 mg tablets.
Administration mode
ORAL WAY.
Do not swallow the tablet.
· Suck one tablet until the taste becomes strong.
· Then place the tablet between the gum and cheek.
· Repeat sucking the tablet when the taste has faded
· Continue this process until the tablet is completely dissolved (about 30 minutes)
Dosage in adults over 18 years of age
Frequency of Administration
Suck one tablet every time you feel the need to smoke . The initial dose should be 1 tablet every 1 to 2 hours. The usual dose is 8 to 12 tablets per day. If you still feel an urge to smoke, you can take an extra tablet. The maximum dose is 15 tablets per day (this applies both to complete cessation and to reduction in tobacco consumption).
NICOTINELL MENTHE 2 mg, sucked tablet should be used as a priority for complete cessation of smoking.
Duration of treatment
Complete cessation of smoking
At the beginning and throughout the treatment, complete cessation of tobacco is necessary to increase your chances of success.
The duration of the treatment must be adapted individually. Normally, treatment should be continued for at least 3 months. After this time, gradually reduce the number of tablets; stop treatment when the dose is reduced to 1-2 tablets per day. It is generally not recommended to continue treatment beyond 6 months. However, some "ex-smokers" may require longer treatment to avoid relapse.
If you have difficulty in stopping this medication for more than 9 months, seek medical advice.
Advice and follow-up can increase your chances of success.
Reduction in tobacco consumption
NICOTINELL MENTHE 2 mg, sucked tablet should be used between 2 cigarettes in order to prolong periods without smoking and with the intention of reducing to the maximum the consumption of cigarettes. Cigarettes should be replaced as needed by NICOTINELL MENTHE 2 mg, tablet to be sucked.
If after six weeks you have not been able to reduce the number of cigarettes smoked per day to at least half, it is recommended to seek advice from a health care professional.
You should try to stop smoking as soon as you feel ready, but no more than 4 months after the initiation of the treatment. After this period, the number of tablets should be reduced gradually, for example by stopping a tablet every 2-5 days. If after more than 6 months after initiation of treatment, the attempt to stop smoking has failed, it is recommended to seek advice from a health professional. Regular use of NICOTINELL MENTHE 2 mg, tablet to suck, after 6 months is not generally recommended. Some former smokers may require longer treatment to avoid resuming smoking.
Counseling can improve your chances of stopping.
Symptoms and Instructions for Overdose
If you have taken more than NICOTINELL MENTHE 2 mg, tablet to suck you should:
If you suck too many tablets, you may feel the same signs as if you had smoked too much. These general signs of nicotine overdose are: general weakness, sweating, hypersalivation, throat irritation, nausea, vomiting, diarrhea, abdominal pain, hearing and vision disorders, headache, palpitations, shortness of breath and circulatory problems.
In this case, inform your pharmacist or doctor.
If you suspect poisoning in a child, contact a doctor or emergency department. Indeed, nicotine in small amounts is dangerous in children and can cause severe symptoms or death.
Instructions for omission of one or more doses
Not applicable.
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, NICOTINELL MENTHE 2 mg, tablet to suck is likely to have undesirable effects, although not everyone is subject to it.
Some side effects such as dizziness, headaches and insomnia may occur at the start of treatment and may be due to symptoms of withdrawal associated with smoking cessation or nicotine underdosing.
Common side effects (affecting 1 to 10 people out of 100)
· Dizziness, headache,
· Dry mouth, hiccups, digestive upset, nausea, flatulence, heartburn, hypersalivation, irritation of the mouth and throat may occur, especially if you suck too fast the tablets.
These signs can be diminished by sucking the tablet more slowly.
Uncommon side effects (affecting 1 to 10 people in 1000)
· Palpitations.
Uncommon side effects (affecting 1 to 10 people out of 10,000)
· Heart rhythm disorders and allergic reactions. These reactions may be in very rare cases. You should consult your doctor immediately if you experience symptoms such as edema of the face, mouth and / or pharynx and / or difficulty in swallowing or if you have an urticaria associated with difficulty breathing (angioedema) .
Mouth ulcers can occur when smoking cessation, but their relationship to nicotine therapy is not established.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE NICOTINELL MENTHE 2 mg, sucked tablet?
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
Store at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
Full list of active substances and excipients
What does NICOTINELL MENTHE 2 mg contain, sucked tablet?
The active substance is:
Nicotine ................................................. .................................................. ..................................... 2,000 mg
In the form of nicotine bitartrate dihydrate ........................................... ....................................... 6.144 mg
For a tablet to suck.
The other components are:
Maltitol (E965), anhydrous sodium carbonate, sodium bicarbonate, 30% polyacrylate dispersion, xanthan gum, anhydrous colloidal silica, levomenthol, peppermint essential oil, aspartame (E951), magnesium stearate.
This medication does not contain sugar.
Pharmaceutical form and content
What is NICOTINELL MENTHE 2 mg, sucked tablet and contents of the pack?
NICOTINELL MENTHE 2 mg, sucked tablet is a white, mint-flavored, round and biconvex tablet.
NICOTINELL MINT, sucking tablet exists in two dosages (1 and 2 mg).
This medication is in the form of a tablet to be sucked in 12, 36, 72, 96, 144 or 204 tablets.
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100 ROUTE OF VERSAILLES
CS 80001
78164 MARLY-LE-ROI CEDEX
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100 ROUTE OF VERSAILLES
CS 80001
78164 MARLY-LE-ROI CEDEX
ZIELSTATTSTRASSE 40
81379 MUNICH
GERMANY
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
In accordance with the regulations.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
COUNCIL / HEALTH EDUCATION
As soon as you stop smoking:
· You will not absorb the irritating and toxic substances of cigarettes,
· You will see some improvements: progressive disappearance of headaches, cough, irritation of the throat, shortness of breath,
· You will often have the satisfaction of regaining better sleep, food flavor, odor and improve your physical performance,
· You will decrease your risk of developing lung cancer or cardiovascular disease.
It's never too late to quit even if you've smoked a long time and a lot. |
What is tobacco dependence?
Tobacco addiction is twofold:
· Psychological dependence:
Smoking a cigarette involves a ritual of automatic and repetitive gestures associated with particular circumstances (pleasure, response to stress, intellectual stimulation, support for morale, need for a gesture of conviviality). This is psychological and behavioral dependence.
· Physical dependence:
The need for the nicotine body is due to the effects of this substance on the nervous system. This is physical dependence. Failure to satisfy this need results in a sense of lack (see description in the chapter "How to overcome your physical dependence?").
Nicotinic substitutes aim to treat this dependence.
How to overcome your psychological addiction?
· Stopping smoking is necessary to increase your chances of success, but more:
o Choose a J day in the period that you think is the most favorable.
o Throw away your last pack of cigarettes, your lighter and put away your ashtrays.
o In a couple of smokers, it is preferable that the attempt to stop is made at the same time by both spouses.
· Tell your family and co-workers that you quit smoking. Ask them to respect your decision (no smoking near you, no longer offering you cigarettes).
· Prepare yourself to cope with the desire to smoke. It may occur suddenly and severely, especially during the first few weeks after the cessation of smoking, but does not last more than 3 or 4 minutes. You have to anticipate what you will do in this case and act very quickly so as not to "crack" as for example:
o drink a large glass of water,
o to chew gum,
o counting up to 100,
o do some deep breaths,
o out of the room,
o change activity ...
· Avoid situations associated with taking cigarettes (coffee, aperitif, ...), avoid temptations (settle with non-smokers).
· Find cigarette compensation (leisure, sport, cultural activity ...).
How to overcome your physical addiction?
If you are addicted to nicotine, the success of your approach may require the use of nicotine substitutes.
In order to assess your level of dependence, the Fagerström test is offered.
FAGERSTROM TEST
How long after you wake up do you smoke your first cigarette? · within 5 minutes: 3 · from 6 to 30 minutes: 2 · from 31 to 60 minutes: 1 · after 60 minutes: 0 | ||
Do you find it difficult to not smoke in places where it is forbidden? · yes: 1 · no: 0 | ||
What cigarette of the day would it be the most difficult for you to give up? · the first: 1 · another: 0 | ||
How many cigarettes do you smoke per day? · 10 or less: 0 · 11 to 20: 1 · 21 to 30: 2 · 31 or more: 3 | ||
Do you smoke at a more sustained pace in the morning than in the afternoon? · yes: 1 · no: 0 | ||
Do you smoke when you are so sick that you have to stay in bed almost all day? · yes: 1 · no: 0 | ||
TOTAL POINTS |
· score 0 to 2: you are not addicted to nicotine.
You can stop smoking without the need for nicotine replacement.
If you are concerned about this decision, consult your pharmacist or doctor.
· score 3 to 4: you are weakly dependent on nicotine.
· score 5 to 6: you are moderately addicted to nicotine.
The use of nicotine substitutes will increase your chances of success.
Consult with your pharmacist or doctor to help you choose the treatment best suited to your situation.
· score 7 to 10: you are strongly or very strongly dependent on nicotine.
The use of nicotine substitutes is recommended to help you overcome this addiction to nicotine. This treatment should be used in sufficient and appropriate dosage.
Consult with your pharmacist or doctor, possibly as part of a specialized smoking cessation counseling.
Weaning-related disorders may persist for a long time and the duration of treatment should be sufficient, usually one to three months.
If you feel despite the treatment, a persistent lack of feeling like especially:
· compelling need to smoke,
· irritability, sleep disturbances,
· agitation or impatience,
· difficulty of concentration,
Take the advice of your doctor or pharmacist as doses may need to be adjusted.
How do you get help?
· Support from health professionals
The support, advice and follow-up that your doctor or pharmacist can give you will be valuable during the first six months of your smoking cessation. You can also use a specialized smoking cessation counseling, especially if you have already failed.
· Psychological support
Stopping smoking requires a supportive family and social environment. If you are concerned that the difficulties are too great, psychological support or temporary treatment can help.
· Dietetics
In the months following tobacco cessation, you may find moderate weight gain.
If you have any concerns in this area, you can contact a health professional who will be able to advise you.
You started smoking again, why?
Consider this relapse as an accident of course, as a normal event that allows to learn: the relapse is not a failure.
Analyze the reasons why you took back the tobacco.
· Because of the physical dependence
This may have been poorly taken into account or reappeared after several months, occasionally, for example, by prolonged stays in smoky atmospheres.
· Because of excessive weight gain.
It may be necessary to change your diet somewhat before your next attempt to quit smoking.
· Because of a decline in motivation, because of a painful event or a difficult period, because of psychological difficulties appearing at the cessation of smoking (depression, anxiety ...), because of a situation very tempting. Understand the reason for this relapse to prevent it if possible during the next attempt.
In all cases, do not hesitate to ask for advice from a health professional or to use a specialized consultation to help with smoking cessation.
If you have started smoking again, do not get discouraged, experience shows that your chances of success increase after one or more attempts to quit. |
Medication for smoking cessation
nicotine
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
NICOTINELL MENTHE 1 mg: sucking tablet (white, mint flavoring); box of 36.
-
NICOTINELL MENTHE 1 mg: sucking tablet (white, mint flavoring); box of 96.
-
NICOTINELL MENTHE 1 mg: sucking tablet (white, mint flavoring); box of 144.
-
NICOTINELL MENTHE 2 mg: sucking tablet (white, mint flavoring); box of 36.
-
NICOTINELL MENTHE 2 mg: sucking tablet (white, mint flavoring); box of 96.
-
NICOTINELL MENTHE 2 mg: sucking tablet (white, mint flavoring); box of 144.
-
Laboratory GlaxoSmithKline Consumer Healthcare
| p cp | p cp | |
| Nicotine | 1 mg | 2 mg |
| maltitol | + | + |
| aspartame | + | + |
Usual dosage:
