2MG NICORETTE MINT 20 TABLETS TO SUCK

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2MG NICORETTE MINT 20 TABLETS SUCKING A: It is indicated in the treatment of tobacco dependence, to relieve the symptoms of smoking cessation in subjects wishing to stop their use of tobacco.

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2MG NICORETTE MINT 20 TABLETS TO SUCK

 

For warnings, precautions for use and cons-indications, see the instructions.


Description 2MG NICORETTE MINT 20 TABLETS SUCKING A

 

The drug 2mg Nicorette Mint 20 tablets suck is indicated for the treatment of tobacco dependence, to relieve the symptoms of smoking cessation in subjects wishing to stop their use of tobacco. Although the final judgment of tobacco use is preferred, this drug can be used in:

  • Cases where a smoker temporarily refrains from smoking,
  • A tobacco reduction strategy as a step towards the final judgment.

 

Using advice 2MG NICORETTE MINT 20 TABLETS SUCKING A

 

For adults
In patients under 18, this drug should not be used without a medical prescription.
The number of lozenges used each day depends on your nicotine addiction that can be assessed using the Fagerstrom Test (see Tips / Health Education).
The dosage of the lozenge should be chosen depending on the nicotine dependence of the smoker.
Suckable tablets each containing 2 mg of nicotine are suitable for smoking weakly or moderately dependent on nicotine (score Fageström test 3 to 6 or smoking less than 20 cigarettes per day).

 

Composition 2MG NICORETTE MINT 20 TABLETS TO SUCK

 

The active substance is:
........................................... 2.00 mg nicotine
Form of nicotine resinate ..................................... 10.50 mg
For a lozenge

The other ingredients are:
Core
Mannitol (E421), xanthan gum, Winterfresh flavor, soda ash, sucralose, acesulfame potassium, magnesium stearate.

Immediate dissolution envelope
Hypromellose, Winterfresh flavor, titanium dioxide (E171), sucralose, SEPIFILM gloss, acesulfame potassium, polysorbate 80.

 

Introducing 2MG NICORETTE MINT 20 TABLETS TO SUCK

 

Box of 20 tablets

 

Warnings on drugs

 

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

Please tell your online pharmacist ongoing treatment to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Agency of Medicines Safety and Health Products.

Pharmacovigilance : Reporting an or effect (s) Junk (s) connected (s) to the use of a drug

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 - Updated on: 21/08/2017

Name of the medicinal product

NICORETTE 2 mg, sucked tablet

Nicotine

framed

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

You should always use 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 2 mg, tablet to be sucked and in which cases it is used?

2. What should I know before taking NICORETTE 2 mg tablet to suck?

3. How to take NICORETTE 2 mg, tablet to suck?

4. What are the possible side effects?

5. How to store NICORETTE 2 mg, tablet to suck?

6. Package contents and other information.

1. WHAT IS NICORETTE 2 mg, tablet to be sucked AND WHAT IT IS USED FOR?

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

This drug is indicated for the treatment of tobacco dependence in order to relieve 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 final stop.

2. BEFORE YOU TAKE NICORETTE 2 mg, tablet to suck?

Do not take NICORETTE 2 mg, tablet to suck:

· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.

· if you do not smoke or if you are an occasional smoker.

Warnings and Precautions

Special warnings

In order to succeed in quitting smoking, complete cessation of smoking is essential.

Carefully read the health education tips

Talk to your doctor or pharmacist before taking NICORETTE 2 mg tablet to suck .

· 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 tablets to suck out of the reach of children. Indeed, the therapeutic dose intended for the adult could cause a serious poisoning or even fatal in the child.

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.

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 2 mg, sucked tablet

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 2 mg, tablet to suck 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 2 mg tablet to suck, the dose should be taken immediately after breastfeeding or more than 2 hours before the next breastfeeding.

Driving and using machines

NICORETTE 2 mg, sucked tablet has no or negligible effect on the ability to drive and use machines.

3. HOW TO TAKE NICORETTE 2 mg, tablet to suck?

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.

Do not use the tube for any other purpose, due to the presence of tablet residues that may be deposited on the new contents.

Dosage

Reserved for adults only.

This medication should not be used without prescription in patients younger than 18 years of age.

The number of tablets to suck to be used each day depends on your nicotine addiction which can be assessed using the Fagerström test (see "Health Education Tips").

Nicotine 2 mg sucking tablets are suitable for use by nicotine-dependent and moderately dependent smokers (test score Fagerström from 3 to 6 or smoking less than 20 cigarettes per day).

Complete cessation of smoking

The treatment of nicotine addiction is usually done in 3 steps.

Step 1

Weeks 1 to 6

2nd step

Weeks 7 to 9

Step 3

Weeks 10 to 12

To help with weaning after 12 weeks: 1 to 2 tablets to suck per day only in case of strong temptations

Initial Treatment Phase

Treatment follow-up

Smoking cessation

1 tablet to suck every 1 to 2 hours

1 tablet to suck every 2 to 4 hours

1 tablet to suck every 4 to 8 hours

During weeks 1 to 6, the dosage should be at least 9 tablets to be sucked per day.

In no case should the number of tablets to be sucked exceed 15 tablets per day.

Temporary abstinence from tobacco

Suck one tablet every time the urge to smoke appears.

The number of 2 mg tablets should not exceed 15 tablets per day.

Reduction in tobacco consumption

As much as possible, alternate nicotine tablets and cigarettes.

Suck a tablet 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 tablets to be sucked per day is variable and depends on the needs of the patient.

However, it should not exceed 15 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 must gradually lead the patient to complete cessation of smoking. This should be stopped as soon as possible within 6 months of starting treatment. If after more than 6 months after initiation of treatment, the attempt to stop smoking has failed, it is recommended to seek advice from a health professional.

It is recommended not to use tablets to suck for more than 6 months.

Method and route of administration

Mouth.

The tablet to be sucked should be placed in the mouth where it will dissolve. It should be regularly placed from one side of the mouth to the other until it dissolves completely (about 20 to 30 minutes). The tablet should not be chewed or swallowed, as nicotine released gradually should be absorbed by the buccal mucosa.

You should refrain from eating or eating when the tablet is in your mouth.

Duration of treatment

The total duration of treatment should not exceed 6 months.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist of all prescription and nonprescription / herbal products you may use before using this medication.

If you take more NICORETTE 2 mg tablet to suck you should not have

Consult your doctor or pharmacist immediately.

In case of accidental overdose or if a child has swallowed one or more tablets to suck, 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 2 mg, tablet to suck

Not applicable.

If you stop taking NICORETTE 2 mg, tablet to suck

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 following adverse reactions have been reported:

Very common : affects more than 1 in 10 patients

  • Headache
  • hiccough
  • Irritation of the throat
  • 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.

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 2 mg, sucked tablet?

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 carton. The expiry date refers to the last day of that month.

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 contains 2 mg, sucked tablet

· The active substance is:

Nicotine................................................. .................................................. .................... 2.00 mg

In the form of nicotine resinate ............................................ ................................... 10.50 mg

For a tablet to suck.

· The other components are:

Core

Mannitol (E421), xanthan gum, Winterfresh flavor, anhydrous sodium carbonate, sucralose, potassium acesufame, magnesium stearate.

Immediate dissolving envelope

Hypromellose, Winterfresh flavor, titanium dioxide (E171), sucralose, sepifilm gloss, acesulfame potassium, polysorbate 80.

What is NICORETTE 2 mg, tablet to suck and contents of the pack

This medication is in the form of an oval, white to almost white tablet with an "n" printed on one side and a "2" on the other.

24 tablets in platelets (OPA / PVC / Aluminum).

20 and 80 tablets in a tube (Polypropylene).

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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