Nicorette Inhaler 10MG CARTRIDGES 6

Nicorette Inhaler 10MG CARTRIDGES 6 View larger

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Nicorette Nicorette

Nicorette Inhaler 10MG 6 CARTRIDGES: Nicorette inhaler 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.

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

Description

Nicorette inhaler is indicated for the treatment of tobacco dependence in order to relieve the symptoms of nicotine withdrawal in patients who wish to stop their tobacco use.

For adults (from 15 years).


This medicine may be used in:

  • Where a smoker abstains temporairment smoking
  • A strategy to reduce smoking as a step towards the final judgment.

Composition:

  • Nicotine 10mg
  • Excipients: levomenthol porous buffer (PE-HD).

Dosage:

  • For an immediate shutdown:   6-12 cartridges / day depending on the needs of the person. Gradually reduce the number of cartridges / day for 6-8 weeks.
  • For a gradual reduction before stopping:   alternate inhaler and cigarettes. Minimize the consumption of cigarettes and try stopping within 6 months.
  • For temporary abstinence from tobacco   : Use the inhaler in temporary abstinence situations without exceeding 12 cartridges per day.

The cartridge is to be used within 12 hours after its opening.
Up to 12 cartridges per day

Cons-indications:

  • Non-smoker or occasional smoker.
  • Hypersensitivity to the components.

Oral inhalation

Read carefully the instructions

Packaging:  
6 cartridges + 1 device

Warnings on drugs

Warning, 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. Attention to incompatibilities on products in your.

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

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

Pharmacovigilance : Report or a related adverse event (s) (s) (s) the use of a drug

VIDAL OF THE FAMILY

NICORETTE inhaler

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 INHALEUR 10 mg: cartridge for oral inhalation; box of 6 pads + 1 device.
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NICORETTE INHALEUR 10 mg: cartridge for oral inhalation; box of 42 pads + 1 device.
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Laboratory

COMPOSITION (summary)
p cartridge
Nicotine 10 mg

INDICATIONS (summary)
This medication helps smokers to detoxify tobacco or better tolerate a temporary period during which they can not or should not smoke. If the method of inhalation approaches the use of a cigarette, the mechanism of absorption of nicotine is different: the buffer contained in the cartridge releases a small dose of nicotine on every inhalation that does not reach the lungs , but is deposited in the mouth. Nicotine is then slowly absorbed by the buccal mucosa. This absorption mechanism is therefore closer to that of pipe or cigar smokers who do not smoke. It is also similar in its effect to the use of chewing gums containing nicotine.
Inhalation of the smoke of a cigarette allows immediate absorption of nicotine and a rapid rise in its blood level. This succession of blood peaks and strong variations in nicotine levels are among the mechanisms that maintain tobacco dependence. Instead, this device, like chewing gum or patches, provides much more stable blood levels and facilitates nicotine withdrawal.
It is therefore not to be expected to find, with the inhaler, sensations identical to those provided by tobacco: the blood levels of nicotine obtained with this substitute are of the order of 1/3 of those obtained with a cigarette.
This medication can be used either to stop smoking permanently or to stop temporarily.
CONTRAINDICATIONS (summary)
This medication should not be used in non-smokers or occasional smokers.
WARNING (Contents)
With a view to definitive detoxification, cessation of smoking is a necessary condition for successful treatment.
Medical advice is required in case of stomach or duodenal ulcer , severe liver or kidney failure , asthma , chronic throat disease.
Do not use other medicines containing nicotine, including transdermal devices without medical advice
Since some drugs are more rapidly degraded by the liver in smokers, their effect may be increased at the onset of smoking cessation (see Drug Interactions).
Nicotine is a toxic substance. Do not leave new or used cartridges within the reach of children. Use of this medication is restricted to adults and adolescents over 15 years of age.
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 :
Smoking 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 use the device after the head.
DIRECTIONS FOR USE AND DOSAGE (summary)
Open the device by aligning the markings on each of its two parts.
Remove a sealed cartridge from the insert and push it firmly into the bottom of the device until the protective film breaks.
Position the top of the device by aligning the markings again and bring the two parts together (opening the other end of the cartridge). Rotate one part to the other to misalign the markers and lock the device.
The normal life of a new cartridge is 20 minutes in one intensive and continuous use and up to 4 times 20 minutes in low intensive and discontinuous use.

Usual dosage:

Complete cessation of tobacco:
For this purpose, the treatment of nicotine addiction usually follows 2 phases: for 3 months, use a cartridge whenever the urge to smoke is felt, without exceeding 12 cartridges 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 cartridges per day, until the stop. Treatment should not exceed 6 months in total.
The inhaler can be used alone or in combination with Nicorette transdermal devices. In this case, treatment begins with a 15 mg / 16 h patch, usually associated with 4 or 5 inhaler cartridges per day. In a second step, less dosed transdermal devices are gradually used: 10 mg / 16 h devices for 3 to 6 weeks then 5 mg / 16 h for 3 to 6 weeks while continuing to use the same number of 10 mg cartridges at the beginning of treatment.
Temporary cessation of tobacco:
The principle is the same, but the duration of treatment depends on the context that required a temporary cessation of smoking.
Reduction in tobacco consumption:
Use inhaling as soon as the urge to smoke is felt to reduce as much as possible the consumption of cigarettes and stay as long as possible without smoking. The number of cartridges to be used per day is variable but should not be greater than 12. If a significant reduction in cigarette consumption has not been obtained after 6 weeks of treatment, 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.
After opening, any cartridge must be used within 12 hours.
POSSIBLE ADVERSE EFFECTS (summary)
Headache, throat irritation, nausea, vomiting, hiccups, stomach pain, cough, nasal congestion, sinusitis; these disorders are caused by nicotine.
Rarely (less than 1% of subjects): palpitations , sleep disorders, dizziness , canker sores.


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.


asthma
Disease characterized by difficulty breathing, often resulting in wheezing. Asthma, permanent or occurring by crisis, is due to a narrowing and inflammation of the bronchi.


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.


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 insufficiency
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.).


kidney
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.


overdose
Excessive intake of a drug may result in an increase in the intensity of adverse effects or even in the development of specific 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.


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.).


dizziness
Symptom that can mean an impression of loss of balance (common sense) or, more strictly, a sense of rotation on oneself or the environment (medical sense).


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 (airways), 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 INHALEUR 10 mg, cartridge for oral inhalation

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 INHALEUR 10 mg, cartridge for oral inhalation and in which cases it is used?

2. What should I know before using NICORETTE INHALEUR 10 mg oral inhalation cartridge?

3. How to use NICORETTE INHALEUR 10 mg, cartridge for oral inhalation?

4. What are the possible side effects?

5. How to store NICORETTE INHALEUR 10 mg, cartridge for oral inhalation?

6. Package contents and other information.

1. WHAT INHALER NICORET 10 mg, cartridge for oral inhalation 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 the symptoms of nicotine withdrawal in subjects wishing to stop their tobacco consumption.

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 USE NICORETTE INHALER 10 mg, cartridge for oral inhalation?

Never use NICORETTE INHALEUR 10 mg, cartridge for oral inhalation:

· 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.

Warnings and Precautions

Talk to your doctor or pharmacist before using NICORETTE INHALEUR 10 mg oral inhalation cartridge.

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 inhalation cartridges out of the reach of children.
After use, remove the cartridge from the inhalation device and dispose of it 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.

Precautions for use

Some signs indicate an under-dosage . If you feel, despite the treatment, a feeling of "lack" such as 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 indicate 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 you are taking NICORETTE INHALEUR 10 mg, cartridge for oral inhalation with the NICORETTESKIN transdermal patch, refer to the package leaflet for each of these medicines.

IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

Children and Youth

Not applicable.

Other medicines and NICORETTE INHALEUR 10 mg, cartouche pour inhalation buccale

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 medicines containing clozapine (an antipsychotic), methadone (an opiate substitution treatment), ropinirole (a treatment for Parkinson's disease) or theophylline (used in treatment of asthma).

NICORETTE INHALEUR 10 mg, cartridge for oral inhalation with food and beverages

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 quit smoking during your 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 wish to stop smoking and breastfeed your child, seek 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 INHALEUR, the dose should be taken after breastfeeding or more than 2 hours before the next breastfeeding. However, if you want to stop smoking and breast-feed your child, take advice from your doctor or a doctor at a smoking cessation center.

Driving and using machines

NICORETTE INHALEUR has no or negligible influence on the ability to drive and use machines.

3. HOW TO USE INHALER NICORET 10 mg, cartridge for oral inhalation?

Always use 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

The daily number of cartridges to use depends on the extent of your nicotine addiction which can be assessed using the Fagerström test (see Health Education Tips).

Use inhaler whenever the urge to smoke appears. The frequency of the aspirations (more or less repeated) and their intensity will have to be adapted according to your needs. If the urge is not relieved, increase the frequency and / or the magnitude of the puffs.

As a result, the life of a cartridge can vary from 20 minutes in a single intensive and continuous use, and up to 4 times 20 minutes if the use is not intensive and discontinuous.

After opening, any cartridge must be used within 12 hours because the amount of nicotine decreases when opened by evaporation.

Complete cessation of smoking

Treatment of nicotine dependence is usually done in 2 phases.

1 st phase

The number of cartridges to use depends on your needs. It is usually from 6 to 12 per day and should under no circumstances exceed 12 cartridges per day.

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

2 nd phase

When the desire to smoke is completely overcome, gradually reduce the number of cartridges per day for 6 to 8 more weeks if necessary.

It is recommended not to use cartridges beyond 12 months.

If you continue to experience irrepressible cravings for treatment or if your treatment has failed, seek advice from your physician or pharmacist. He may advise you to associate NICORETTE INHALEUR with a form delivering nicotine throughout the day: the transdermal devices NICORETTESKIN.

Temporary abstinence from tobacco

The number of cartridges to use per day is variable and depends on the duration and number of situations requiring temporary abstinence that you encounter. However, it should not exceed 12 cartridges per day.

Reduction in tobacco consumption

To the extent possible, alternate use of inhaler and cigarettes.

Use inhaler 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 cartridges to use per day is variable and depends on your needs. However, it must not exceed 12 cartridges 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 attempted 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 cartridges beyond 12 months.

Administration mode

ORAL WAY.

The nicotine contained in the cartridges is released during suction through the inhalation device provided for this purpose.

In order to obtain an optimal release of the nicotine contained in the device, it is recommended to use it at a temperature higher than 15 ° C.

Use of the device

Figure 1 :

Remove the device, align the markings on each of the two parts of the device, and then open it.

Figure 2:

Take a sealed cartridge from the insert, insert it into the device.

Press firmly into the bottom of the device until the protective film breaks.

Figure 3:

Replace the top of the device by re-aligning the markings and pressing the bottom and top at the same time to open the cartridge at its second end.

Figure 4:

Turn until the two markers are no longer aligned. The device is then locked and ready for use.

Frequency of Administration

Use the device whenever the need for smoking is felt, not exceeding 12 cartridges per day.

You will adapt your mode of inhalation with the device (more or less repeated aspirations) according to your needs.

Duration of treatment

For the complete cessation of tobacco:

The duration of use is limited to 12 months.

If you have persistent drowsiness or if you have difficulty with this medication, talk to your doctor.

If you have used more INHALANT NICORETTE 10 mg, cartridge for oral inhalation than you should have

Immediately consult your doctor or pharmacist.

In case of accidental overdose or if a child has sucked an inhalation cartridge, 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 use NICORETTE INHALEUR 10 mg, oral inhalation cartridge

Not applicable.

If you stop using NICORETTE INHALEUR 10 mg, oral inhalation cartridge

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.

Nicotine cartridges can cause nicotine-like side effects by other modes; these effects are mainly dose-dependent and appear at the beginning of the uses.

The following adverse reactions have been reported:

Very common: affects more than 10 users out of 100

Cough, throat irritation, headache, hiccups, nausea.

Common: affects 1 to 10 users out of 100

Diarrhea, impaired taste, sensory disturbances, irritation of the mouth, stuffy nose (nasal congestion), sinusitis, abdominal pain, dry mouth, fatigue, burning sensation, vomiting, stomach pain, mucosal inflammation buccal, flatulence, irritation of the mouth, digestive disorders / difficult digestion, hypersalivation.

Uncommon: affects 1 to 10 users in 1000

Palpitations (unusual sensation of heartbeat), rapid heartbeat (tachycardia), abnormal dreams, sleep disturbances, wheezing (bronchospasm) or difficult breathing (dyspnea), change in voice, sneezing, inflammation of the tongue (glossitis), excessive sweating, itching / rash (pruritus / urticaria), flushing, tiredness, discomfort, vertigo, chest pain or discomfort, hypertension, oropharyngeal pain, tight throat sensation, eructation mouth, tingling sensation in the mouth.

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

Difficulty swallowing, decreased sensitivity in the mouth, heart rhythm disorders.

Not known: not to be estimated based on available data

Blurred vision, increased tears (tearing), dry throat, discomfort in the abdomen, allergic reaction including swelling of the face and mouth (angioedema), redness of the skin (erythema), pain in the lips.

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

If NICORETTE INHALEUR 10 mg is combined with NICORETTESKIN transdermal patch, refer to the package leaflet 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 INHALEUR 10 mg, cartridge for oral inhalation?

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.

The possible discoloration of the primary packaging does not affect the quality (and therefore the effectiveness) of the product.

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 INHALEUR 10 mg contains, cartridge for oral inhalation

· The active substance is:

Nicotine................................................. .................................................. 10 mg

For a cartridge.

· The other components are:

Levomenthol, porous pad (PE-HD).

What is NICORETTE INHALEUR 10 mg oral inhalation cartridge and contents of the pack

This medication is in the form of cartridges for oral inhalation.

Box of 6 buffers in cartridge + 1 device + 1 protective case.

Box of 18 cartridge pads + 1 device.

Box of 42 cartridge pads + 1 device.

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 reduce 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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