NOTICE
ANSM - Updated on : 27/05/2024
Product name
NICORETTE 2 mg, sucking tablet
Nicotine
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided 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 2 mg chewable tablet and what is it used for?
2. What do I need to know before taking NICORETTE 2 mg Sucking Tablets?
3. How do I take NICORETTE 2 mg Sucking Tablets?
4. What are the possible side effects?
5. How do I keep NICORETTE 2 mg chewable tablet?
6. Package contents and other information.
1. WHAT IS NICORETTE 2 mg SUCTION TABLET AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: DRUGS FOR NICOTINE DEPENDENCE, ATC code: N07BA01.
This drug is indicated 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,
- as a step towards permanent cessation.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING NICORETTE 2 mg, chewable tablet?
Never take NICORETTE 2 mg chewable tablet:
- if you are allergic to the active substance or to any of the other ingredients of this medicine, as listed in section 6.
- if you do not smoke or if you are an occasional smoker.
Warnings and precautions
Special warnings
In order to successfully stop smoking, it is essential to quit completely.
Read the health education advice carefully
Talk to your doctor or pharmacist before taking NICORETTE 2 mg chewable tablet.
- 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 :
o a recent history (< 3 months) of heart attack or stroke,
o chest pain (unstable angina pectoris), or stable angina pectoris,
o a heart problem affecting your heart rate or rhythm,
o high blood pressure not controlled by medication,
o 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,
o severe or moderate hepatic insufficiency,
o severe renal insufficiency,
o diabetes,
o hyperthyroidism,
o adrenal gland tumor (pheochromocytoma),
o an evolving stomach or duodenal ulcer,
o chronic throat disease,
o asthma,
o a history of seizures or convulsions.
Sucking tablets must be kept out of the reach of children. The therapeutic dose intended for adults could cause serious or even fatal poisoning in children.
Sucking tablets may present a choking hazard. Use with caution if you have difficulty swallowing solids or liquids, or if you cough frequently during or after swallowing.
Precautions for use
- Certain signs indicate underdosing. If, despite treatment, you experience a sensation of "withdrawal", such as
o craving for a cigarette
o irritability, sleep disorders,
o restlessness or impatience,
o 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:
o nausea, abdominal pain, diarrhea,
o hypersalivation,
o sweating, headache, dizziness, hearing loss,
o general weakness,
It is imperative to adapt treatment with the help of your doctor or pharmacist.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Children and teenagers
Not applicable.
Other medicines and NICORETTE 2 mg chewable tablet
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 therapy), ropinirole (a treatment for Parkinson's disease) or theophylline (used to treat asthma).
NICORETTE 2 mg chewable tablet with food and beverages
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 2 mg, sucking tablet, the dose should be taken immediately after feeding or more than 2 hours before the next feeding.
Driving and use of machinery
NICORETTE 2 mg tablets have no or negligible effect on the ability to drive and use machines.
This medicine contains less than 1 mmol (23 mg) of sodium per sucking tablet, i.e. it is essentially "sodium-free".
3. HOW TO TAKE NICORETTE 2 mg tablets?
Always take NICORETTE exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Do not use the tube for any other purpose, as tablet residues may be deposited on the new contents.
Instructions for use
For the cardboard box :
1- Gently press the tab marked "press here".
2- At the same time, pull firmly on the top of the box
To close: push on the top of the box.
[Note: these instructions for use will only be printed on the cardboard box leaflet].
Dosage
For adults only.
In subjects under 18 years of age, this medicine must not be used without a doctor's prescription.
The number of sucking tablets to be used each day depends on your nicotine dependence, which can be assessed using the Fagerström test (see "Health education").
Sucking tablets containing 2 mg nicotine are suitable for smokers with low to moderate nicotine dependence (Fagerström test score of 3 to 6, or smoking fewer than 20 cigarettes a day).
Complete cessation of smoking
Nicotine dependence is usually treated in 3 stages.
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Stage 1
Weeks 1 to 6
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Stage 2
Weeks 7 to 9
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Stage 3
Weeks 10 to 12
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To help continue withdrawal after 12 weeks: 1 to 2 tablets to be sucked daily only in case of strong temptations
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Initial phase of treatment
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Follow-up treatment
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Smoking cessation
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1 sucking tablet every 1 to 2 hours
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1 sucking tablet every 2 to 4 hours
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1 sucking tablet every 4 to 8 hours
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During weeks 1 to 6, the dosage should be at least 9 suckable tablets a day.
In no case should the number of tablets to be sucked exceed 15 per day.
Temporary abstinence from smoking
Suck one tablet each time you feel the urge to smoke.
The number of 2 mg tablets should not exceed 15 per day.
Reducing tobacco consumption
As far as possible, alternate nicotine tablets and cigarettes.
Suck on a tablet as soon as the urge to smoke arises, to reduce cigarette consumption as much as possible and go as long as possible without smoking.
The number of tablets to be sucked per day is variable and depends on the patient's needs.
However, it should not exceed 15 per day.
If a reduction in cigarette consumption has not been achieved after 6 weeks of treatment, advice should be sought from a healthcare professional.
Reduction in tobacco consumption should gradually lead to complete cessation of smoking. This should be attempted as soon as possible within 6 months of starting treatment. If after 6 months from the start of treatment, the attempt to stop smoking completely has failed, it is advisable to seek advice from a healthcare professional.
Sucking tablets should not be used beyond 6 months.
Method and route of administration
Oral route.
Sucking tablets should be placed in the mouth, where they will dissolve. It should be regularly placed from one side of the mouth to the other, until complete dissolution (about 20 to 30 minutes). The tablet should not be chewed or swallowed, as the gradually released nicotine must be absorbed by the oral mucosa.
Do not eat or drink while the tablet is in your mouth.
Duration of treatment
The total duration of treatment should not exceed 6 months.
In the event of persistent craving, or if you find it difficult to stop taking the drug, consult your doctor.
If you have taken more NICORETTE 2 mg chewable tablet than you should have
Consult your doctor or pharmacist immediately.
In the event of accidental overdose, or if a child has swallowed one or more tablets, 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 2 mg chewable tablet
Not applicable.
If you stop taking NICORETTE 2 mg chewable tablet
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 those of nicotine administered by other means; these effects are mainly dose-dependent and appear at the start of treatment.
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.
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 - Website: https://signalement.social-sante.gouv.fr
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE NICORETTE 2 mg chewable tablet?
Keep out of sight and reach of children.
For cardboard boxes: keep sucking tablets in their original packaging to protect them from moisture. Use within 3 months of removing overwrap.
Do not use after the expiration date indicated on the box. The expiration date refers to the last day of that month.
Do not dispose of any medicine in the garbage . Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What NICORETTE 2 mg chewable tablet contains
- The active substance is :
Nicotine....................................................................................................................... 2.00 mg
As nicotine resinate............................................................................... 10.50 mg
For one sucking tablet.
- The other components are :
Core
Mannitol (E421), xanthan gum, Winterfresh flavoring, anhydrous sodium carbonate, sucralose, acesufame potassium, magnesium stearate.
Immediately dissolving envelope
Hypromellose, Winterfresh flavour, titanium dioxide (E171), sucralose, sepifilm gloss, acesulfame potassium, polysorbate 80.
What NICORETTE 2 mg is and what it contains
This medicine takes the form of a white to almost white, oval tablet with an "n" printed on one side and a "2" on the other.
20 and 80 tablets in tube (Polypropylene).
Each cardboard box contains 40 suckable tablets. One presentation may contain 1, 2 or 4 cardboard boxes.
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 :
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.
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 you receive from 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.
- Because of 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 a specialized smoking cessation consultation.
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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 quit attempts.
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