NOTICE
ANSM - Updated on : 03/07/2023
Name of medicinal product
NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and lacésulfame potassique
Nicotine
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and lacésulfame potassique and what is it used for?
2. What do I need to know before taking NICORETTE MENTHE GLACIALE 2 mg SANS SUCRE, medicated chewing gum sweetened with xylitol and lacésulfame potassique?
3. How to take NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and lacésulfame potassique?
4. What are the possible side effects?
5. How to store NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and lacésulfame potassique?
6. Package contents and other information.
1. WHAT IS NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and lacésulfame potassique AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: DRUGS FOR NICOTINE DEPENDENCE, ATC code: N07BA01.
This drug is used in the treatment of tobacco dependence to relieve nicotine withdrawal symptoms in subjects wishing to stop smoking.
Although permanent cessation of tobacco consumption is preferable, this drug may be used in :
- when a smoker is temporarily abstaining from smoking,
- a smoking reduction strategy as a step towards permanent cessation.
2. WHAT YOU SHOULD KNOW BEFORE TAKING NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium.
Never take NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium:
- if you do not smoke or if you are an occasional smoker.
- if you are allergic to nicotine or to any of the other components of this medicine mentioned in section 6.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Talk to your doctor or pharmacist before taking NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and lacésulfame potassique.
- Certain diseases require medical examination and follow-up before using this medicine.
It is essential to consult your doctor before using this medicine if you have :
- a recent history (< 3 months) of heart attack or stroke,
- chest pain (unstable angina pectoris), or stable angina pectoris,
- a heart problem affecting your heart rate or rhythm,
- high blood pressure not controlled by medication,
- a history of allergic reactions manifested by swelling of the lips, face and throat (angioedema) or an itchy rash (urticaria). The use of NRT may trigger this type of reaction,
- severe or moderate hepatic insufficiency,
- severe renal insufficiency
- diabetes,
- hyperthyroidism,
- a tumor of the adrenal gland (pheochromocytoma),
- an evolving stomach or duodenal ulcer,
- chronic throat disease,
- asthma,
- a history of seizures or convulsions.
- Chewing gum must be kept out of the reach of children .
The therapeutic dose intended for adults could cause serious or even fatal intoxication in children.
Precautions for use
- Certain signs indicate underdosing. If, despite treatment, you experience a sensation of "withdrawal", such as
- urge to smoke
- irritability, sleep disorders,
- restlessness or impatience,
- difficulty concentrating.
Consult your doctor or pharmacist. It may be necessary to adjust the dosage.
- Certain signs may indicate overdosage: if signs of overdosage appear, i.e:
- nausea, abdominal pain, diarrhea,
- hypersalivation,
- sweating, headache, dizziness, hearing loss,
- general weakness.
It is essential to adapt your treatment with the help of your doctor or pharmacist.
If NICORETTE 2 mg medicated chewing gum is combined with NICORETTESKIN transdermal device, please refer to the package leaflet for each medication.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Children and adolescents
Not applicable.
Other medicines and NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and lacésulfame potassique
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
This is particularly important if you are taking clozapine (an antipsychotic), methadone (an opiate substitution treatment), ropinirole (a treatment for Parkinson's disease) or theophylline (used to treat asthma).
NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and lacésulfame potassique with food and drink
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
It is very important to stop smoking during pregnancy, as it can slow down your baby's growth. It can also lead to premature delivery or late fetal death. It is advisable to stop smoking without using nicotine-containing medication.
If you are unable to stop smoking without nicotine replacement therapy, NICORETTE may be used in consultation with the healthcare professional who is monitoring your pregnancy, your family doctor, or a doctor at a center specializing in helping people who want to stop smoking.
Breast-feeding
If you are a heavy smoker and do not intend to stop smoking, you should not breast-feed your child, but resort to artificial feeding.
If you wish to stop smoking and breastfeed your child, take the advice of your doctor or a doctor at a center specializing in smoking cessation.
Use of this medicine should be avoided while breast-feeding, as nicotine passes into breast milk and may affect your child. If your doctor has recommended that you use NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened withIf your doctor has recommended that you use NICORETTE MENTHE GLACALE, medicated chewing gum sweetened with xylitol and lacésulfame potassique, the dose should be taken immediately after feeding or more than 2 hours before the next feeding.
In addition, because terpene derivatives (mint/eucalyptus flavour) can be passed into milk, and because of the neurological toxicity in infants, you should consider using another chewing gum flavour.
Sportsmen
Not applicable.
Driving and use of machinery
NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and lacesulfame potassium has no or negligible effect on the ability to drive vehicles and use machines.
NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and potassium sulfate contains less than 1 mmol (23 mg) sodium per chewing gum, i.e. it is essentially "sodium-free".
3. HOW TO TAKE NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
For adults only (15 years and over).
Dosage
2 mg chewing gum is not suitable for smokers who are strongly or very strongly dependent on nicotine (Fagerström test score of 7 to 10 or smoking more than 20 cigarettes a day: see "Health education advice").
Complete cessation of smoking
Nicotine dependence is usually treated in 2 phases.
1st phase:
Chew gum every time you feel the urge to smoke.
The number of chewing gums containing 2 mg is generally 8 to 12 per day, and should never exceed 30 per day.
The duration of this phase is around 3 months, but may vary according to individual response.
2nd phase:
When the urge to smoke is completely overcome, gradually reduce the number of gum chews per day.
Treatment should be stopped when consumption has been reduced to 1-2 gum chews per day.
It is recommended not to use chewing gums beyond 12 months.
If you continue to experience cravings during treatment, or if your treatment has failed, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE. He or she may advise you to combine NICORETTE 2 mg medicated chewing gum with a form that delivers nicotine throughout the day: NICORETTESKIN transdermal devices.
Temporary abstinence from smoking
Chew one gum each time you feel the urge to smoke.
The number of chewing gums containing 2 mg is generally 8 to 12 per day, and should never exceed 30 per day.
Reducing tobacco consumption
As far as possible, alternate nicotine gums with cigarettes.
Chew gum as soon as you feel the urge to smoke, to reduce cigarette consumption as much as possible and remain smoke-free for as long as possible.
The number of gum chews per day is variable and depends on your needs. However, it should not exceed 30 gums a day.
If a reduction in cigarette consumption has not been achieved after 6 weeks of treatment, it is advisable to seek advice from a healthcare professional.
Reducing tobacco consumption should gradually lead to complete cessation. This should be attempted as soon as possible within 6 months of starting treatment. If, more than 9 months after the start of treatment, the attempt to stop smoking completely has failed, it is advisable to seek advice from a healthcare professional.
It is recommended not to use gum beyond 12 months.
To increase the chances of success in quitting smoking completely, it is important to aim for a reduction of more than 50% in consumption during this reduction phase. NICORETTE chewing gums help you achieve this goal before you stop smoking for good.
Method and route of administration
By mouth.
To be active, the nicotine contained in the gum and released by chewing must be absorbed by the buccal mucosa.
If nicotine is swallowed with saliva, it has no effect. It is therefore important not to chew the gum too vigorously.
First chew the gum until the taste becomes strong or a slight tingling sensation is felt, then hold it between the cheek and gum for around 10 minutes: the gum softens, allowing the nicotine to be gradually released and absorbed by the oral mucosa, thus passing into the bloodstream.
Then, when the taste has faded, chew the gum very slowly (around 20 times in 20 minutes).
Chewing gum should be kept in the mouth for about 30 minutes. After 30 minutes, the gum will no longer deliver nicotine.
Duration of treatment
For complete smoking cessation:
Use is limited to 12 months.
In the event of persistent craving or difficulty in quitting, consult your doctor.
If you have taken more NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and lacésulfame potassique than you should have done
Consult your doctor or pharmacist immediately.
In case of accidental overdose or if a child swallows one or more chewing gums: CONTACT A PHYSICIAN OR EMERGENCY SERVICE.
Serious intoxication may occur, manifested by hypotension, weak and irregular pulse, respiratory distress, prostration, cardiovascular collapse and convulsions.
If you forget to take NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and lacésulfame potassique
Not applicable.
If you stop taking NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and lacésulfame potassique
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, NICORETTE may cause undesirable effects, but these do not always occur in everyone.
NICORETTE may cause undesirable effects similar to nicotine administered by other means; these effects are mainly dose-dependent and appear at the start of treatment.
Gum may stick, and in rare cases there is a risk of dental damage.
The following adverse reactions have been reported:
Very common: affecting more than 1 in 10 patients
- headache
- hiccups
- throat irritation
- nausea
Common: affects 1 to 10 patients in 100
- diarrhoea
Uncommon: affects 1 to 10 patients in 1000
- palpitations (unusual sensation in your heartbeat), or rapid heartbeat (tachycardia)
- throat pain
- abnormal dreams
- wheezing (bronchospasm) or difficulty breathing (dyspnea), change in the sound of your voice
- blocked nose, sneezing
- excessive sweating, itching/rashes (pruritus/urticaria), hot flushes
- fatigue, malaise, chest pain/discomfort
- hypertension
Rare: affects 1 to 10 in 10,000 patients
- difficulty swallowing, decreased sensitivity in the mouth
Unknown frequency: cannot be estimated on the basis of available data
- blurred vision, increased tears (lacrimation)
- dry throat, lip pain, abdominal pain/discomfort
- allergic reaction including swelling of the face and mouth (angioedema), reddening of the skin
- convulsions
Dizziness, headaches, sleep disturbances, mouth ulcers may be related to smoking cessation and not to your treatment.
In case of combination of NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE chewing gums with NICORETTESKIN transdermal device, please refer to the package leaflet of each medication.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and lacésulfame potassique?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE contains, medicated chewing gum sweetened with xylitol and lacésulfame potassique.
- The active substance is :
Nicotine............................................................................................................................. 2 mg
In the form of nicotine resinate
For one medicated chewing gum.
- Other components are :
Chewing gum base, xylitol, peppermint essential oil, anhydrous sodium carbonate, sodium bicarbonate, acesulfame potassium, levomenthol, light magnesium oxide.
Sub-coating winterfresh* flavor, hypromellose, sucralose, polysorbate 80.
CoatingXylitol, starch, winterfresh* flavor, titanium dioxide (E171).
*Composition of winterfresh flavour Terpene-free spearmint essential oil, natural menthol, terpene-free peppermint essential oil, natural eucalyptol, natural menthone, trans-anethole, sandalwood oil.
What is NICORETTE MENTHE GLACIALE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and lacésulfame potassique and what does it contain?
This medicine comes in the form of chewing gum. Boxes of 10, 12, 15, 20, 24, 30, 36, 40, 45, 90, 96, 105 or 210 chewing gums.
Not all presentations may be marketed.
Marketing authorization holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
43 RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX, FRANCE
Marketing authorization holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
43 RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Manufacturer
McNEIL AB
NORRBROPLATSEN 2
SE-25109 HELSINGBORG
SWEDEN
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
Health education advice :
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Quitting smoking as soon as possible has immediate health benefits. It's never too late to quit, even if you've smoked a lot for a long time.
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As soon as you stop smoking:
- You'll no longer absorb the irritating and toxic substances in cigarettes,
- You'll notice certain improvements: gradual disappearance of headaches, coughing, throat irritation and shortness of breath,
- You'll often enjoy the satisfaction of better sleep, the taste of food and smells, and improved physical performance,
- You'll reduce your risk of developing lung cancer or cardiovascular disease.
In the case of heart or arterial disease (angina pectoris, arteritis of the lower limbs), it is particularly important to succeed in quitting smoking.
What is tobacco dependence?
Tobacco addiction is twofold:
- Psychological dependence :
Smoking a cigarette involves a ritual of automatic, repetitive gestures associated with particular circumstances (pleasure, response to stress, intellectual stimulation, support for morale, need for the gesture of conviviality). This is psychological and behavioral dependence.
- Physical dependence :
The body's need for nicotine is due to the effects of this substance on the nervous system. This is physical dependence. Failure to satisfy this need leads to a sensation of craving (see description in the "How to overcome your physical dependence " chapter).
Nicotine substitutes are designed to treat this dependence.
How to overcome your psychological dependence?
- Stopping smoking altogether is necessary to increase your chances of success:
o Choose a day on which you feel most confident about quitting.
o Throw away your last pack of cigarettes, your lighter and put away your ashtrays.
o In the case of a smoking couple, it's preferable for both partners to quit at the same time.
- Let your family and colleagues know that you're quitting smoking. Ask them to respect your decision (not to smoke near you, not to offer you any more cigarettes).
- Be prepared for the urge to smoke. It may come on suddenly and intensely, especially in the first few weeks after you've stopped smoking, but it shouldn't last more than 3 or 4 minutes.
You need to plan what you're going to do in this case and act very quickly to avoid "cracking", for example:
o drinking a large glass of water
o chew gum,
o count to 100,
o take a few deep breaths,
o leave the room,
o change activities...
- Avoid situations associated with smoking (coffee, aperitifs, etc.), avoid temptations (sit with non-smokers).
- Find ways to compensate for smoking (hobbies, sports, cultural activities, etc.).
How can you overcome your physical dependence?
If you're addicted to nicotine, you may need to use nicotine substitutes to succeed.
To assess your level of dependence, we suggest you take the Fagerström test.
FAGERSTROM TEST
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How soon after waking up do you smoke your first cigarette?
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- within 5 minutes: 3
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- 6 to 30 minutes: 2
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- from 31 to 60 minutes: 1
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- after 60 minutes: 0
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Do you find it difficult not to smoke in places where it's forbidden?
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- yes : 1
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- no : 0
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Which cigarette of the day would be the most difficult for you to give up?
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- the first: 1
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- another : 0
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How many cigarettes do you smoke a day?
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- 10 or less : 0
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- 11 à 20 : 1
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- 21 à 30 : 2
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- 31 or more: 3
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Do you smoke more in the morning than in the afternoon?
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- yes : 1
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- no : 0
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Do you smoke when you are so ill that you have to stay in bed most of the day?
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- yes : 1
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- no : 0
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TOTAL POINTS
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score from 0 to 2 : you are not addicted to nicotine.
You can stop smoking without needing a nicotine substitute.
However, if you're worried about quitting, ask your pharmacist or doctor for advice.
score of 3 to 4 : you are mildly dependent on nicotine.
score 5 to 6 : you are moderately dependent on nicotine.
The use of nicotine substitutes will increase your chances of success.
Ask your pharmacist or doctor for advice on the best treatment for you.
score of 7 to 10 : you are strongly or very strongly dependent on nicotine.
The use of nicotine substitutes is recommended to help you overcome this nicotine dependence. This treatment must be used in sufficient and appropriate doses.
Ask your pharmacist or doctor for advice, possibly in the context of a specialized smoking cessation consultation.
Withdrawal symptoms may persist for a long time, and treatment should be of sufficient duration, usually one to three months.
If, despite treatment, you experience a persistent sensation of "craving", such as :
- the urge to smoke
- irritability, sleep disturbances
- restlessness or impatience,
- difficulty concentrating.
Consult your doctor or pharmacist, as dose adjustments may be necessary.
How can we help you?
- Support from healthcare professionals
The support, advice and follow-up provided by your doctor or pharmacist will be invaluable during the first six months of quitting smoking. You can also turn to a specialized smoking cessation consultation, especially if you've already failed.
- Psychological support
Quitting smoking requires a supportive family and social environment. If you're worried that the difficulties are too great, psychological support or temporary treatment can help.
- Diet
In the months following smoking cessation, you may notice a moderate weight gain.
If you have any concerns in this area, you can consult a health professional who will be able to advise you.
Why have you started smoking again?
Consider this relapse as an accident along the way, as a normal event that helps you learn: relapse is not a failure.
Analyze the reasons why you started smoking again.
- Physical dependence
This may not have been properly taken into account, or it may have reappeared after several months, for example, during prolonged stays in smoky atmospheres.
- Excessive weight gain
You may need to modify your eating habits a little before your next attempt to stop smoking.
- Because of a drop in motivation, a painful event or difficult period, or psychological difficulties that have arisen in the course of quitting smoking.psychological difficulties (depression, anxiety), or a very tempting situation. Understand the reason for this relapse, so you can prevent it if possible the next time you try.
In all cases, don't hesitate to ask a health professional for advice, or seek specialized help in quitting smoking.
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If you've started smoking again, don't be discouraged. Experience shows that your chances of success increase after one or more attempts to quit.
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