Nicorette GUM 2MG MENTE FRESH SUGAR 30

3400936549661

Nicorette Nicorette

Nicorette GUM 2MG 30 MENTE FRESH SUGAR: 2 mg Nicorette gum box of 30, fresh mint flavor sugar free, is recommended for smokers moderately to weakly dependent.

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Partners with: KIT FOR HOMEOPATHIC STOP SMOKING TOBACCO Boiron, Nicorette MOUTH SPRAY 1 * 150, NICORETTESKIN 10MG 16H DEVICE TRANSDERMALLY, NICORETTESKIN 15MG 16H DEVICE TRANSDERMALLY, NICORETTESKIN 25MG/16H patch, NICORETTESKIN 25MG 16H DEVICE TRANSDERMALLY, BAUDOUX PREPARATION STOP TOBACCO ESSENTIAL OILS 10ml

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Nicorette GUM 2MG MENTE FRESH SUGAR 30


For warnings, precautions for use and against-indications, please refer to the user manual.

DESCRIPTION Nicorette GUM 2MG MENTE FRESH SUGAR 30


2 mg Nicorette gum box of 30, fresh mint flavor sugar free, is recommended for smokers moderately to weakly dependent. This medication is indicated for the treatment of tobacco dependence in order to relieve the symptoms of nicotine withdrawal in patients who want to quit their tobacco use.   Chewing gum dosed at 2 mg may be used alone or in combination with transdermal Nicorette (medical opinion recommended).

For adults (from 15 years).

This medicine may be used in:

  • Where a smoker temporarily refrains from smoking,
  • A strategy to reduce smoking as a step towards the final judgment.


Composition Nicorette GUM 2MG MENTE FRESH SUGAR 30


  • Nicotine 2 mg in the form of nicotine resinate
  • Excipients: chewing gum base, xylitol, peppermint essential oil, anhydrous sodium carbonate, sodium bicarbonate, acesulfame potassium, levomenthol, light magnesium oxide. Coating: xylitol, peppermint essential oil, arabic gum, titanium dioxide (E171), carnauba wax.


Dosage Nicorette GUM 2MG MENTE FRESH SUGAR 30


  • For an immediate stop:   1 gum every craving, gums up 8-12 / day. Gradually reduce the number of gums and stop when consumption is January-February gums / day.
  • For a gradual reduction Shutdown   : Alternate gums and cigarettes. Minimize the consumption of cigarettes and try stopping within 6 months.
  • For temporary abstinence from tobacco   1 gum every craving, gums up 8-12 / day.

Do not exceed 30 gums / day.
Chewing gum for the first time, then keep it against the cheek about 10 minutes gum softens and allows the nicotine to be free gradually. And chewing gum very slowly (about 20 times in 20 minutes).

Cons-indications Nicorette GUM 2MG MENTE FRESH SUGAR 30


  • Non-smoker or occasional smoker.
  • Hypersensitivity to any component.

Oral

Read carefully the instructions

Packaging  
: Box of 30 gums

Warnings on drugs

Please note, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your products in.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a field of customized message provided for that purpose.

Click here to find record of this drug on the website of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related side effect (s) (s) (s) the use of a drug

VIDAL OF THE FAMILY

NICORETTE chewing gum

Medication for smoking cessation

nicotine

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

NICORETTE 2 mg: chewing gum; box of 30.
-

NICORETTE 2 mg: chewing gum; box of 105.
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NICORETTE 2 mg: chewing gum; box of 210.
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NICORETTE FRUIT 2 mg: chewing gum (white); box of 30.
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NICORETTE FRUIT 2 mg: chewing gum (white); box of 105.
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NICORETTE FRESH MINT 2 mg: chewing gum (white); box of 30.
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NICORETTE FRESH MINT 2 mg: chewing gum (white); box of 105.
-

NICORETTE FRESH MINT 2 mg: chewing gum (white); box of 210.
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NICORETTE GLACIALE MENTHE 2 mg: chewing gum (white); box of 30.
-

NICORETTE GLACIALE MENTHE 2 mg: chewing gum (white); box of 105.
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NICORETTE GLACIALE MENTHE 2 mg: chewing gum (white); box of 210.
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NICORETTE 4 mg: chewing gum; box of 105.
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NICORETTE FRUIT 4 mg: chewing gum (cream); box of 105.
-

NICORETTE FRESH MINT 4 mg: chewing gum (cream); box of 30.
-

NICORETTE FRESH MINT 4 mg: chewing gum (cream); box of 105.
-

NICORETTE GLACIALE MENTHE 4 mg: chewing gum (cream); box of 30.
-

NICORETTE GLACIALE MENTHE 4 mg: chewing gum (cream); box of 105.
-

Laboratory

COMPOSITION (summary)
p gum p gum
Nicotine 2 mg 4 mg

INDICATIONS (summary)
This medication helps smokers to detoxify from tobacco. The chewing gum brings nicotine, the main active substance in tobacco, responsible for addiction into the blood, through saliva.
It is used either to stop smoking permanently or to stop temporarily.
CONTRAINDICATIONS (summary)
This medication should not be used by a non-smoker or occasional smoker.
WARNING (Contents)
With a view to definitive detoxification, cessation of smoking is a necessary condition for successful treatment.
Precautions are necessary in case of stomach or duodenal ulcer , renal or hepatic insufficiency . In these situations, a prior medical consultation is essential before using this medication; a cessation of smoking without substitution treatment may be necessary.
Do not use other medicines containing nicotine, including transdermal devices without medical advice.
Nicotine is a toxic substance. Do not leave the chewing gum within the reach of children.
Wearing a dental prosthesis can cause problems when chewing gums: consult your dentist.
DRUG INTERACTIONS (summary)
The products contained in tobacco smoke can accelerate the rate of elimination of certain drugs, especially theophylline. When smoking cessation, these drugs can see their effect strengthened and signs of overdose may appear. Contact your doctor in case of any doubt.
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
Tobacco use in pregnant women may cause fetal growth retardation. Stopping tobacco is always desirable. In women who are highly dependent on nicotine, the use of this medication may be an aid, but the effects of nicotine alone on the fetus are poorly understood. This drug has the advantage of not exposing the fetus to other toxic substances present in tobacco smoke. In summary: if the ideal is not to smoke and not to expose the fetus to nicotine intake, the use of this drug is a lesser evil compared to tobacco.

Breastfeeding:
Nicotine passes into breast milk, and breast-feeding is not recommended during treatment.
If breastfeeding is nevertheless chosen, preferably take the gums after the stubborn.
DIRECTIONS FOR USE AND DOSAGE (summary)
The choice of the dosage depends on the initial dependence on nicotine: 4 mg gums are suitable for smokers who are highly or very heavily dependent. They can also be used by low-level smokers who prefer to limit the number of chewing gums daily.
In practice, it is useful to know the signs of under or overdose to adapt the dosage after a few days of treatment:
  • the overdose results in the condition of the smoker who has smoked too much and is mainly reflected in a nauseous condition and headaches. Difficulty in sight or hearing, trembling, dizziness are also possible;
  • an under-dosage causes symptoms of lack: irritability, nervousness, stomach cramps (kind of painful hunger), difficulty concentrating.
As soon as the desire to smoke is overcome, gradually reduce the number of gums or go to the lower dosage, until complete cessation.
Chew very slowly each gum in order to allow the slow and steady absorption of nicotine by the blood vessels of the tongue: after a first chewing, keep the gum against the cheek for 10 minutes to soften it. Then chew gum every minute (about 20 times in 20 minutes). After 30 minutes of chewing, the gum is no longer effective.

Usual dosage:

  • Adult :
Complete tobacco cessation : In this objective, the treatment of nicotine addiction usually follows 2 phases: for 3 months, chew a gum whenever the need to smoke is felt, not to exceed 30 gums to 2 mg or 15 gums at 4 mg per day. This period of 3 months can vary from one person to another and its end corresponds to a great decrease or disappearance of the desire to smoke. The second phase, which lasts 6 to 8 weeks, corresponds to a progressive decrease in the number of daily gums, until the stop. Treatment should not exceed 6 months in total.
The gums can be used alone or in combination with the Nicorette transdermal devices. In this case, follow the recommendations of your doctor.
Temporary cessation of smoking : the principle is the same, but the duration of treatment depends on the context that necessitated a temporary cessation of smoking.
Reducing tobacco consumption : chewing a gum as soon as the urge to smoke is felt in order to minimize the consumption of cigarettes and stay as long as possible without smoking. The number of gums to be used per day is variable but must not be greater than 30 2 mg gums or 4 mg 4 mg gums. If a significant reduction in cigarette consumption has not been obtained after 6 weeks of treatment, it is recommended to seek advice from a doctor. The objective of reducing the number of cigarettes is to achieve a complete cessation of tobacco, which must be tried as soon as possible, necessarily within the first 6 months of treatment. It is not recommended to continue treatment for more than 12 months.
TIPS (summary)
This medication can be used by smokers without medical advice. It is available without a prescription and can be accessed directly in certain pharmacies. Nevertheless, do not hesitate to have your choice chosen by your pharmacist. His advice is precious. He can help you determine the best time to quit and explain the causes of failure.
Nicotine taken by way oral replacing the cigarette has the same cardiovascular harmful than that in tobacco. Only the risk of lung cancer disappears. When smoking cessation is motivated by urgent medical reasons: recent infarction , arteritis , gastritis or ulcer , it is preferable to stop the absorption of nicotine in all its forms.
like all smoke-free methods used to help smokers, this drug can only be effective when the will to quit is personal and accompanied by strong motivation. it is this motivation that will make it possible to fight against the desire to smoke, without being forced to make constant appeal to the will that dulls over time. A cessation of lasting tobacco in the smoker assumes that the smoker considers tobacco to be a poison, an unacceptable addiction. It must be done to the idea that it will never smoke, from the beginning of weaning. Every day without tobacco must be experienced as a release, not as a calvary. The smoker who is in this state of mind is a good candidate for definitive weaning.
Stopping smoking, which is a real drug, causes many problems: weight gain is frequent, concentration disorders can last several weeks. A mild depressive condition is possible. Weight gain should be fought by a diet, and if possible by a sports program that has the advantage of reconciling the smoker with his body.
Do not hesitate to consult your doctor in case of difficulty; his advice and experience will be invaluable in the fight against relapses.
POSSIBLE ADVERSE EFFECTS (summary)
Irritation of the mouth or throat, jaw pain.
Nausea, digestive disorders, hiccups, headaches, rash , palpitations .
Rarely: heart rhythm disorder , allergic reaction .
These sugarless gums contain a non-absorbable sugar (sorbitol or xylitol): possibility of diarrhea in case of large intake.


GLOSSARY (summary)


arteritis
Arterial disease favored by smoking and most often localized to the legs. It is characterized by a thickening of the arterial walls which interferes with blood circulation and causes pain during walking (intermittent claudication). Lower limb arteritis increases the risk of myocardial infarction and requires medication. At an advanced stage, it can be treated surgically.
Synonym: Occlusive arteriopathy of the lower limbs.


addiction
Psychic or physical need caused by taking certain natural or medicinal substances. This condition may be accompanied, at cessation of the catch, by various symptoms, grouped under the term of withdrawal syndrome.


diarrhea
The strict medical sense of diarrhea is "emission of stools too frequent and too abundant". In fact, common sense equates diarrhea with the notion of fluid and frequent stools. Normally the stools are pasty, but the emission of stool fluid or barely formed, without pain or particular associated disorder, is not pathological. Diarrhea may occur when liquid stool emissions are repeated throughout the day and the needs are overwhelming or painful.
Many medicines can accelerate intestinal transit and make the stools more liquid, without this undesirable effect being of real concern.
Antibiotics can alter the digestive flora, essential for digestion, and cause more or less troublesome but benign diarrhea. The effect appears immediately or after a few days of treatment. A severe and exceptional form of diarrhea, pseudomembranous colitis, can be observed after antibiotic treatment; this condition results in the emission of mucus and false membranes (resembling skin flaps) associated with abdominal pain; constipation may replace the initial diarrhea. Pseudomembranous colitis can occur several days after discontinuation of antibiotic treatment and requires urgent medical advice.


transdermal devices
System, sometimes called patch or patch, allowing the absorption of a drug through the skin: it ensures the diffusion of the active substance to the blood vessels of the dermis. The substance then circulates in the blood and can act as if it had been swallowed or injected. This device avoids the first-pass effect of the liver.


duodenum
A part of the intestine into which food from the stomach penetrates.


skin rash
Appearance of pimples or plaques on the skin. These lesions can be due to a food, a drug, and translate an allergy or a toxic effect. Many viruses can also cause pimple eruptions: rubella, roseola and measles are the most common.


depressed state
State of moral suffering associating a demotivation, a fatigue, a feeling of uselessness, of self-depreciation. In the absence of treatment, the depressive state may develop into a serious depression with a feeling of incurability, guilt, and a suicidal risk.


gastritis
Inflammation of the stomach favored by stress, tobacco, alcohol and certain drugs such as aspirin or anti-inflammatory drugs.


infarct
Destruction of part of the cardiac muscle (myocardium), deprived of blood by obstruction of its arteries.


hepatic
Inability of the liver to perform its function, which is essentially the elimination of some waste, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).


renal failure
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.


palpitations
Abnormal perception of irregular heartbeat.


dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


overdose
Taking an excessive amount of a drug exposes you to an increase in the intensity of adverse effects, or even to the appearance of particular adverse effects.
This overdose may result from accidental or voluntary poisoning for suicide, so consult your local Poison Control Center (listed in the appendix to the book). However, in most cases, overdose is the result of an error in the understanding of the prescription, or the search for an increase in efficacy by exceeding the recommended dosage. Finally, untimely self-medication may lead to excessive absorption of the same substance contained in different drugs. Some drugs are particularly prone to this risk because they are (wrongly) considered to be harmless: vitamins A and D, aspirin, etc. Stopping or decreasing drug intake helps to remove the disorders associated with an overdose.


symptoms
Trouble felt by a person with an illness. The same symptom can translate different diseases and the same disease does not necessarily give the same symptoms in all the patients.


heart rhythm disorders
Severe or benign anomaly of the frequency of contractions of the heart. Extrasystole is contraction occurring just before or after a normal contraction, often perceived as a slight shock in the chest. Fibrillation is an irregular and disorderly contraction. Other disorders include torsades de pointes, Wolf-Parkinson-White syndrome, Bouveret's disease, tachysystolia, flutter and atrioventricular block, etc.


ulcer
Injury of skin, mucous membranes or cornea.
  • Leg ulcer: chronic wound due to poor circulation of blood.
  • Gastroduodenal ulcer: a localized wound in the mucosa of the stomach or duodenum due to excess acidity and very often to the presence of a bacterium (Helicobacter pylori). The ulcer is favored by stress, alcohol, smoking and certain medications (aspirin, NSAIDs, etc.).


way
  • Pathway (route of administration) used to administer drugs: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
  • Set of hollow organs allowing the passage of air (respiratory tract), food (digestive tract), urine (urinary tract), bile (bile ducts), etc.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 16/05/2017

Name of the medicinal product

NICORETTE FRESH MINT 2 mg WITHOUT SUGAR, medicated chewing gum sweetened with xylitol and acesulfame potassium

Nicotine

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or 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 talk to your doctor if you do not feel better or feel less well.

What is in this leaflet?

1. What is NICORETTE FRESH 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium and in which cases it is used?

2. What should I know before taking NICORETTE MENTHE FRAICHE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium?

3. How to take NICORETTE MENTHE FRAICHE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium?

4. What are the possible side effects?

5. How to store NICORETTE FRESHNESS 2 mg WITHOUT SUGAR, medicated chewing gum sweetened with xylitol and acesulfame potassium?

6. Package contents and other information.

1. WHAT NICORETTE FRESH MINT 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: MEDICINAL PRODUCTS USED IN NICOTINE DEPENDENCE, ATC code: N07BA01 .

This medication is used in the treatment of tobacco dependence to relieve the symptoms of nicotine withdrawal in subjects wishing to stop their tobacco use.

Although definitive cessation of tobacco use is preferable, this drug may be used in:

· the cases where a smoker temporarily abstains from smoking,

· a strategy to reduce smoking as a step towards the definitive stop.

2. BEFORE YOU TAKE NICORETTE FRESH MINT 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium?

Never take NICORETTE FRESH MINT 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 ingredients of this medication mentioned in section 6.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

Warnings and Precautions

Talk to your doctor or pharmacist before taking NICORETTE MENTHE FRAICHE 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium.

· Some diseases require examination and medical follow-up before using this medication.

Therefore, it is essential to consult your doctor before using this medication if you present:

- 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 heart rate,

- an arterial hypertension that is not controlled by drugs,

- a history of allergic reactions that have manifested as swelling of the lips, face and throat (angioedema) or rash associated with itching (urticaria). It may happen that the use of a NRT triggers this type of reaction,

- severe or moderate hepatic impairment,

- severe renal insufficiency,

- diabetes,

- hyperthyroidism,

- a tumor of the adrenal gland (pheochromocytoma),

- an evolving stomach or duodenal ulcer,

- a chronic condition of the throat,

- of asthma.

· It is imperative to keep the chewing gum out of the reach of children.

Indeed, the therapeutic dose intended for the adult could cause a serious intoxication or even death in the child.

· This medicine contains sodium . This medicine contains 11.4 mg sodium per gum. To be taken into account in patients controlling their sodium dietary intake.

· This medicine contains xylitol and may cause digestive problems (diarrhea).

Precautions for use

· Some signs indicate an under-dosage. If you feel, despite the treatment, a feeling of "lack" like in particular:

- compelling need to smoke,

- irritability, sleep disturbances,

- agitation or impatience,

- difficulty of concentration.

Consult your doctor or pharmacist. Indeed, it may be necessary to change the dosage of the drug.

· Some signs may reflect an overdose: in case of signs of overdose, ie:

- nausea, abdominal pain, diarrhea,

- hypersalivation,

- sweating, headache, dizziness, hearing loss,

- general weakness.

It is imperative to adapt the treatment with the advice of your doctor or pharmacist.

If NICORETTE 2 mg chewing gums are combined with the NICORETTESKIN transdermal patch, refer to the package leaflet for each of these medicines.

IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.

Children and Youth

Not applicable.

Other medicines and NICORETTE FRESH MINT 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

This is especially important if you are taking clozapine (an antipsychotic), methadone (an opiate substitution treatment), ropinirole (a treatment for Parkinson's disease) or theophylline (used in the treatment of anti- asthma).

NICORETTE FRESH MINT 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium with food and drink

Not applicable.

Pregnancy and breast feeding

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

It is very important to stop smoking during pregnancy as this can slow down the growth of your baby. This can also lead to premature delivery or late fetal deaths. It is advisable to stop smoking without using medicines containing nicotine.

If you are unable to stop smoking without nicotine replacement therapy, NICORETTE may be used after consulting the healthcare professional who is following your pregnancy, your family doctor, or a doctor at a center specializing in helping people wishing to stop smoking.

feeding

If you smoke a lot and do not plan to stop smoking, you should not breastfeed your child, but use artificial breastfeeding.

If you want to stop smoking and breastfeed your child, take advice from your doctor or a doctor at a smoking cessation center.

The use of this medication should be avoided during breast-feeding because nicotine passes into breast milk and can affect your child. If your doctor has recommended that you use NICORETTE FRESH 2 mg SUGAR, medicated chewing gum sweetened with xylitol and acesulfame potassium, the dose should be taken just after breastfeeding or more than 2 hours before the next breastfeeding.

Driving and using machines

NICORETTE FRESHNESS 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium has no or negligible effect on the ability to drive and use machines.

NICORETTE FRESH MINT 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium contains xylitol and sodium.

3. HOW TO TAKE NICORETTE FRESH MINT 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium?

Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Reserved for adults (from 15 years).

Dosage

2 mg chewing gums are not suitable for smokers who are highly or highly dependent on nicotine (Fagerström test score of 7 to 10 or smoking more than 20 cigarettes per day: see "Health education tips" ).

Complete cessation of smoking

Treatment of nicotine dependence is usually done in 2 phases.

1st phase:

Chew a gum whenever the urge to smoke appears.

The number of chewing gum at 2 mg is usually 8 to 12 gums per day and should not exceed 30 gums per day.

The duration of this phase is about 3 months, but may vary depending on the individual response.

2nd phase:

When the urge to smoke is completely overcome, gradually reduce the number of chewing gums per day.

Treatment will be stopped when consumption is reduced to 1 to 2 gums per day.

It is recommended not to use chewing gum for longer than 12 months.

If during your treatment you continue to feel irrepressible cravings or if your treatment has failed, ASK YOUR DOCTOR OR YOUR PHARMACIST FOR ADVICE. He may advise you to combine NICORETTE 2 mg medicated chewing gum with a nicotine-delivering form throughout the day: NICORETTESKIN transdermal devices.

Temporary abstinence from tobacco

Chew a gum whenever the urge to smoke appears.

The number of chewing gum at 2 mg is usually 8 to 12 gums per day and should not exceed 30 gums per day.

Reduction in tobacco consumption

Where possible, alternate gums with nicotine and cigarettes.

Chew a gum as soon as the urge to smoke appears to reduce as much as possible the consumption of cigarettes and stay as long as possible without smoking.

The number of chewing gums per day varies and depends on your needs. However, it should not exceed 30 gums per day.

If a reduction in cigarette consumption has not been obtained after 6 weeks of treatment, it is recommended to seek advice from a health care professional.

Reducing tobacco consumption should gradually lead to a complete cessation of smoking. This should be stopped as soon as possible within 6 months of starting treatment. If after more than 9 months after initiating therapy, the attempt to stop smoking has failed, it is recommended to seek advice from a health professional.

It is recommended not to use gums for more than 12 months.

To increase the likelihood of complete smoking cessation, it is important to aim to reduce consumption by more than 50% during this reduction phase. NICORETTE chewing gum helps to achieve this goal before a permanent cessation of smoking.

Method and route of administration

Mouth.

To be active, the nicotine contained in the gum and released by mastication, 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.

For example, the chewing gum should be chewed first, then the gum should be cheeked for about 10 minutes: the gum softens and allows the nicotine to gradually release itself, to be absorbed by the buccal mucosa, thus passing through the circulation .

Then chew the gum very slowly (about 20 times in 20 minutes).

The chewing gum should be kept in the mouth for about 30 minutes. After 30 minutes, the chewing gum will no longer deliver nicotine.

Duration of treatment

For the complete cessation of tobacco:

The duration of use is limited to 12 months.

If you experience a persistent feeling of lack or if you have difficulty with this medication, consult your doctor.

If you take more NICORETTE FRESH 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium that you should have

Consult your doctor or pharmacist immediately.

In case of accidental overdose or if a child swallows one or more chewing gums: CONTACT A DOCTOR OR AN EMERGENCY SERVICE.

Severe intoxication may occur and may include hypotension, weak and irregular heartbeat, respiratory discomfort, prostration, cardiovascular collapse and convulsions.

If you forget to take NICORETTE FRESH MINT 2 mg WITHOUT SUGAR, medicated chewing gum sweetened with xylitol and acesulfame potassium

Not applicable.

If you stop taking NICORETTE FRESHNESS 2 MG WITHOUT SUGAR, medicated chewing gum sweetened with xylitol and acesulfame potassium

Not applicable.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

NICORETTE may cause side effects similar to nicotine administered by other modes; these effects are mainly dose-dependent and appear at the beginning of treatment.

The gums can stick and there is in rare cases a risk of dental alteration.

The following adverse reactions have been reported:

Very common : affects more than 1 in 10 patients

· headache

· hiccough

· throat irritation

· nausea

Common : affects 1 to 10 patients out of 100

· diarrhea

Uncommon : affects 1 to 10 patients in 1,000

· palpitations (feeling unusual to your heartbeat), or fast heartbeat (tachycardia)

· throat pain

· dreams abnormal

· wheezing (bronchospasm) or difficult breathing (dyspnea), change in the sound of the voice

· stuffy nose, sneezing

· excessive sweating, itching / rash (pruritus / urticaria), flushing

· fatigue, discomfort, pain / discomfort in the chest

· hypertension

Rare : affects 1 to 10 patients out of 10,000

· difficulty swallowing, decreased sensitivity in the mouth

Unknown frequency : can not be estimated on the basis of available data

· blurred vision, increased tears (tearing)

· dry throat, lip pain, pain / discomfort in the abdomen

· allergic reaction including swelling of the face and mouth (angioedema), redness of the skin

Dizziness, headaches, sleep disorders, mouth ulcers may be related to smoking cessation and not to your treatment.

Due to the presence of xylitol, possible digestive disorders and diarrhea.

If you combine NICORETTE MENTHE FRESH 2 mg SUGAR-FREE SUGAR with the NICORETTESKIN transdermal patch, refer to the package insert for each of these medicines.

Declaration of side effects

If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE NICORETTE FRESH MINT 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium?

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

Store at a temperature not exceeding 25 ° C.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What NICORETTE MENTHE FRAICHE contains 2 mg SUGAR-FREE, medicated chewing gum sweetened with xylitol and acesulfame potassium

· The active substance is:

Nicotine................................................. .................................................. .......................... 2 mg

In the form of nicotine resinate ............................................ ....................................... 10 mg

For a medicated chewing gum.

· The other components are:

Chewing gum base, xylitol, peppermint essential oil, anhydrous sodium carbonate, sodium bicarbonate, acesulfame potassium, levomenthol, light magnesium oxide.

Coating: Xylitol, essential oil of peppermint, gum arabic, titanium dioxide (E171), carnauba wax.

What is NICORETTE MENTHE FRAICHE 2 mg WITHOUT SUGAR, medicated chewing gum sweetened with xylitol and acesulfame potassium and contents of the pack

This medication is in the form of chewing gum. Box of 10, 12, 15, 24, 30, 36, 40, 45, 90, 96, 105 or 210 chewing gum.

Not all pack sizes may be marketed.

Marketing Authorization Holder

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1 RUE CAMILLE DESMOULINS

92130 ISSY-LES-MOULINEAUX

Marketing Authorization Operator

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1 RUE CAMILLE DESMOULINS

92130 ISSY-LES-MOULINEAUX

Maker

McNEIL AB

NORRBROPLATSEN 2

SE-25109 HELSINGBORG

SWEDEN

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

Health education councils:

Stopping smoking as soon as possible results in immediate health benefits. It's never too late to quit even if you've smoked a long time and a lot .

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.

Moreover, in cardiac or arterial diseases (angina pectoris, arteritis of the lower limbs ...), it is particularly imperative to succeed in quitting smoking.

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 can 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 must 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 you be the hardest 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 from 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 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 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.

The withdrawal symptoms 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 feeling of persistent "lack" :

· 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 very tempting situation . Understand the reason for this relapse to prevent it if possible during your 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.

Get all Nicorette products to help you stop smoking: Nicorette patch, Nicorette gum, inhaler

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All smokers know, quitting smoking is not an easy task! The lack of nicotine leads to withdrawal syndrome which causes irritability, anxiety, sadness. For a stress-free withdrawal, you will find here the suitable products for stop smoking: patch, gum, lozenges, tablets, inhleur and homeopathy anti tobacco ... We are available via chat, do not hesitate to Contact to get personalized advice.

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