NOTICE
ANSM - Updated on : 29/06/2023
Name of medicinal product
NICORETTESKIN 25 mg/16 hours, transdermal device
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 given 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 NICORETTESKIN 25 mg/16 hours, transdermal device and what is it used for?
2. What do I need to know before using NICORETTESKIN 25 mg/16 hours, transdermal device?
3. How do I use NICORETTESKIN 25 mg/16 hours, transdermal device?
4. What are the possible side effects?
5. How do I keep NICORETTESKIN 25 mg/16 hours, transdermal device?
6. Package contents and other information.
1. WHAT IS NICORETTESKIN 25 mg/16 hours, transdermal device AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: DRUGS FOR NICOTINE DEPENDENCE - ATC code: N07BA01
NICORETTESKIN 25 mg/16 hours, transdermal device belongs to the range of products designed to help you stop smoking.
This medication is indicated in the treatment of tobacco dependence to relieve nicotine withdrawal symptoms in subjects wishing to stop smoking.
2. WHAT DO I HAVE TO KNOW BEFORE USING NICORETTESKIN 25 mg/16 hours, transdermal device?
Never use NICORETTESKIN 25 mg/16 hours, transdermal device:
- if you are allergic to nicotine or any of the other ingredients of this product, as listed in section 6.
- if you do not smoke or if you are an occasional smoker,
- if you suffer from a skin condition that may interfere with the use of a transdermal system.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and precautions
Talk to your doctor or pharmacist before using NICORETTESKIN 25 mg/16 hours, transdermal system.
In order to successfully stop smoking, it is essential to quit completely.
Read the health education advice carefully.
Certain diseases require medical examination and follow-up before using this medication.
It is therefore 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.
Keep the transdermal device out of the reach of children before and after use.
The therapeutic dose intended for adults could cause serious or even fatal intoxication in children.
Certain signs indicate underdosing. If, despite treatment, you feel a sensation of "withdrawal", such as :
- urge to smoke
- irritability, sleep disturbances,
- restlessness or impatience,
- difficulty concentrating.
Consult your doctor or pharmacist. It may be necessary to adjust the dosage.
Certain signs may indicate an overdose. If signs of overdosage appear, such as :
- 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.
When NICORETTESKIN transdermal device is used in combination with oral forms of nicotine substitutes such as NICORETTE 2 chewing gum mg, NICORETTE 10 inhaler mg, NICORETTE 2 chewable tablets mg, NICORETTE sublingual tabletss sublingual tablets NICORETTE MICROTAB 2 mg or NICORETTESPRAY 1 mg/dose, solution for mouth spray, refer to the package leaflet for each of these medicines for warnings and precautions for use.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Children and teenagers
Not applicable.
Other medicinal products and NICORETTESKIN 25 mg/16 hours, transdermal device
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 medicines containing clozapine (an antipsychotic), methadone (an opiate substitution therapy), ropinirole (a treatment for Parkinson's disease) or theophylline (used in the treatment of asthma).
NICORETTESKIN 25 mg/16 hours, transdermal device with food and drink
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
It's important to stop smoking during pregnancy, as it can slow the growth of your baby. 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, NICORETTESKIN 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 use artificial milk. The use of this medication is not recommended while breast-feeding, as nicotine passes into breast milk and may affect your child.
However, if you wish to stop smoking and breastfeed your child, seek the advice of your doctor or a doctor at a center specializing in smoking cessation.
Driving and using machines
NICORETTESKIN 25 mg/16 hours, transdermal device has no or negligible effect on the ability to drive and use machines.
3. HOW DO I USE NICORETTESKIN 25 mg/16 hours, transdermal device?
Always use NICORETTESKIN 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 and children over 15 years of age.
Dosage
Three transdermal device sizes are available: 9; 13.5; 22.5 cm2, corresponding to 3 different dosages: 10 mg/16 hours, 15 mg/16 hours, 25 mg/16 hours.
The transdermal device should be applied to a healthy part of the skin in the morning on rising, and removed in the evening at bedtime, i.e. around 16 h later. The treatment mimics nicotine fluctuations during the day in smokers, without the administration of nicotine at night. Daytime administration of nicotine by the transdermal device does not cause the sleep disturbances seen with nighttime nicotine administration.
- It is recommended for highly dependent smokers (Fagerström test score ≥ 7) to start with the transdermal device 25 mg/16 hours. A transdermal device will be applied daily in the morning and removed in the evening, for 8 weeks.
- Dose reduction is then initiated. A 15 mg/16 hours transdermal device is used daily for 2 weeks, followed by a 10 mg/16 hours transdermal device, also for 2 weeks.
- It is recommended for moderately dependent smokers (Fagerström test scores 5 and 6) to start with step 2, using the 15 mg/16 hour transdermal device.
o If smoking cessation is achieved in the first week with the 15 mg/16 hours dosage, a transdermal device will be applied daily in the morning and removed in the evening, for 8 weeks, then a 10 mg/16 hours transdermal device will be applied for 4 weeks.
o If, after 1-7 days' use of the 15 mg/16 hours transdermal device, signs of craving persist, it is recommended that a 25 mg/16 hours transdermal device be used, and that treatment be continued according to the schedule for heavily dependent patients (see "heavily dependent smokers").
- It is recommended that lightly dependent smokers (Fagerström test scores 3 and 4) are recommended to start with step 2, using the 15 mg/16 hour transdermal device, applied daily for 8 weeks, and to continue with the 10 mg/16 hour transdermal device, applied for 4 weeks.
Highly to lightly dependent smokers
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Highly dependent smokers
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Moderately dependent smokers
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Low-dependency smokers
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(Fagerström test ≥ 7)
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(Fagerström test 5 - 6)
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(Fagerström test 3-4)
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Transdermal device
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Duration
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Transdermal device
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Duration
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Transdermal device
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Duration
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Step 1
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NICORETTESKIN 25 mg/16 hours
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First 8 weeks
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Step 2
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NICORETTESKIN 15 mg/16 hours
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Next 2 weeks
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Step 2
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NICORETTESKIN 15 mg/16 hours
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First 8 weeks (NB: if smoking persists or if there is heavy consumption of oral substitutes, refer from the first week to step 1 of the "heavily dependent smokers" scheme)
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Step 2
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NICORETTESKIN 15 mg/16 hours
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First 8 weeks
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Step 3
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NICORETTESKIN 10 mg/16 hours
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last 2 weeks
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Step 3
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NICORETTESKIN 10 mg/16 hours
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Next 4 weeks
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Step 3
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NICORETTESKIN 10 mg/16 hours
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Next 4 weeks
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Overall treatment should last at least 3 months.
However, the duration of treatment may vary according to individual response.
It is recommended not to use transdermal devices beyond 6 months. However, some "ex-smokers" may require a longer duration of treatment to avoid relapse.
If, during your treatment, you continue to experience cravings to smoke, or if your treatment has failed, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Your doctor or pharmacist may advise you to combine NICORETTESKIN transdermal devices with oral substitutes (NICORETTESKIN chewing gum, NICORETTESKIN tablets).NICORETTE 2 mg chewing gum, NICORETTE 10 mg inhaler, NICORETTE 2 mg chewable tablets, NICORETTE MICROTAB 2 mg sublingual tablets or NICORETTESPRAY 1 mg/dose oral spray solution).
When NICORETTESKIN is used in combination with an oral substitute, the dosage is the same as when these drugs are used alone as monotherapy. For the dosage of the oral form, consult the package insert for the chosen medication.
In case of combination, use only one oral form at a time over a 24 hour period.
Directions for use
- Wash your hands before applying the transdermal device.
- Open the sachet with a pair of scissors and remove the transdermal device.
- Immediately after opening, apply the transdermal device to a dry, hairless area of skin (hip, upper arm or chest).
- Remove as much of the aluminium foil as possible. As far as possible, avoid touching the sticky surface of the transdermal device with your fingers.
- Apply the sticky part with your fingers and remove the remaining aluminium foil.
- Press the transdermal device firmly onto the skin with your fingers.
- Rub the edges firmly with your fingers to ensure that the transdermal device sticks properly.
- The transdermal device should be applied in the morning and removed at bedtime, around 16 hours later.
- The application site should be changed every day, avoiding if possible replacing the transdermal device in the same place for a few days.
- It is essential to fold the transdermal device onto itself after use, before disposing of it in a safe place.
- All transdermal devices, whether used or not, should be kept out of the reach of children.
- During handling, avoid contact with eyes and nose, and wash hands after application.
- Do not cut the transdermal device.
- In the event of prolonged sea or pool bathing, you have 2 options :
o Before bathing, remove the transdermal device and immediately replace it in its holder. It can then be re-adhered to dry skin.
o Cover the transdermal device with a waterproof adhesive bandage for the duration of the bath.
- In the event of a short shower, the transdermal device can be held in place by avoiding directing the shower jet onto it.
Duration of treatment
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Use is limited to 6 months.
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In the event of persistent craving or difficulty in stopping the drug, consult your doctor.
If you have used more NICORETTESKIN 25 mg/16 hours, transdermal device than you should have
Consult your doctor or pharmacist immediately.
In case of accidental overdose, or if a child has sucked or applied a transdermal device, CONTACT A PHYSICIAN OR EMERGENCY SERVICE.
Severe intoxication may occur, manifested by hypotension, weak and irregular pulse, respiratory distress, prostration, cardiovascular collapse and convulsions.
If you forget to use NICORETTESKIN 25 mg/16 hours, transdermal device
Not applicable.
If you stop using NICORETTESKIN 25 mg/16 hours, transdermal device
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, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Very common: affects more than 10 out of 100 users
- itching (pruritus).
Common: affects 1 to 10 users out of 100
- rash and urticaria,
- nausea and vomiting,
- digestive disorders,
- skin redness,
- headache,
- dizziness.
Uncommon: affects 1 to 10 users in 1000
- palpitations (unusual sensation in your heartbeat), or rapid heartbeat (tachycardia),
- abnormal dreams,
- excessive sweating, hot flushes,
- fatigue, malaise, chest pain/discomfort, difficulty breathing (dyspnea),
- application site reaction,
- allergic reactions,
- hypertension,
- muscle pain,
- tingling sensation that may spread around the application site.
Very rare: affects less than 1 in 10,000 users.
- Heart rhythm disorders.
Undetermined frequency: cannot be estimated on the basis of available data.
- pain/discomfort in the abdomen,
- allergic reaction including swelling of the face and mouth (angioedema),
- convulsions.
Dizziness, headaches, sleep disturbances, mouth ulcers may be related to smoking cessation and not to your treatment.
When NICORETTESKIN transdermal device is used in combination with NICORETTE oral nicotine replacement products (NICORETTE 2 chewing gum mg, NICORETTE 10 chewing gum mg, NICORETTE tablets2 mg tablets, NICORETTE MICROTAB 2 mg sublingual tablets or NICORETTESPRAY 1 mg/dose oral spray solution), please refer to the package insert for each product.
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 are helping to provide more information on drug safety.
5. HOW TO CONSERVE NICORETTESKIN 25 mg/16 hours, transdermal device?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box and sachet. 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 NICORETTESKIN 25 mg/16 hours, transdermal device contains
- The active substance is :
Nicotine....................................................................................................................... 39.37 mg
For one 22.5 cm2 transdermal device.
One transdermal device delivers 25 mg nicotine for 16 hours.
- Other components are :
Medium-chain triglycerides, butyl methacrylate basic copolymer, polyethylene terephthalate (PET) film.
Acrylate matrix
Adhesive solution of acrylic copolymer, potassium hydroxide, croscarmellose sodium, aluminum acetylacetonate.
Release liner
Polyethylene terephthalate (PET) film, aluminized on 1 side and siliconized on 2 sides.
Each transdermal device is packaged in a heat-sealed laminated sachet.
What NICORETTESKIN 25 mg/16 hours, transdermal device is and what it contains
Transdermal device (box of 7, 14 or 28).
Semi-transparent, beige transdermal device consisting of an outer layer, a nicotine source layer, an adhesive layer and a siliconized, aluminized release liner.
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
LTS LOHMANN THERAPIE-SYSTEME AG (LTS)
LOHMANNSTR. 2
56626 ANDERNACH
GERMANY
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 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.
- 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 attempts to quit.
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