Nicopass 1.5mg nicotine 96 TABLETS WITHOUT SUGAR EUCALYPTUS

3400937680554

Pierre Fabre Pierre Fabre

Nicopass box of 96 lozenges in 1.5mg of nicotine, flavor without sugar eucalyptus is recommended for medium- or low-dependent smokers. Nicopass is indicated for the treatment of tobacco dependence in order to alleviate the symptoms of nicotine withdrawal in patients who wish to stop their tobacco use.

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Nicopass 1.5mg nicotine 96 TABLETS WITHOUT SUGAR EUCALYPTUS

For warnings, precautions for use and against-indications, please refer to the operating instructions of Nicopass eucalyptus box of 96 lozenges in 1.5mg of nicotine.

Description Nicopass 1.5 mg TABLETS WITHOUT SUGAR EUCALYPTUS 36

Nicopass eucalyptus box of 96 lozenges in 1.5mg of nicotine, flavor without sugar eucalyptus is recommended for medium- or low-dependent smokers. This drug is indicated for the treatment of tobacco dependence in order to alleviate the symptoms of nicotine withdrawal in patients who wish to stop their tobacco use. The pellets can be used alone or in combination with nicotine patches (medical advice is recommended).

Reserved for over 18 years adult.

This drug can be used in:

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

Stopping smoking is never easy. To put the odds on his side, choose the withdrawal method that best suits, according to its degree of dependence, lifestyle and habits.

An alternative or complementary method to quit smoking is acupuncture, which involves implanting thin needles into the tissues or organs in specific points, depending on the desired effect.
The urge to smoke would decrease by activating the energy networks. The Ministry of Health, however, that acupuncture has not proven effective in smoking cessation and that the effects are no different from those of placebo.
Nevertheless, the empirical experience of many former smokers have been able to show that this method helped them to wean, placebo effect or not. This is why a shade of the Ministry of Health was given since it is accepted that acupuncture can be used, provided that the smoker believes and that it be followed by a psychotherapist or physician.

Nicopass composition eucalyptus box of 96 lozenges in 1.5mg of nicotine

1.5mg nicotine as catiorésine carboxylate 8,33mg nicotine.

Excipients: isomalt (E 953), hypromellose (E 464), aspartame (E951), acesulfame potassium, sodium bicarbonate, soda ash, natural flavor extracts of mint and eucalyptus (trans-anethole, eucalyptol, L menthol), flavor masking Permaseal Givaudan (natural flavoring substances, maltodextrin, acacia, propylene glycol).

Excipient with known effect: aspartame.

Nicopass dosage eucalyptus box of 96 lozenges in 1.5mg of nicotine

Do not exceed 30 lozenges per day

Cons-indications: Non-smoker or occasional smoker. Hypersensitivity to any component. Phenylketonuria, due to the presence of aspartame.

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Packaging Nicopass eucalyptus box 96 lozenges in 1.5mg of nicotine

box of 96 lozenges.

Warnings about medications

Attention, the drug Nicopass eucalyptus box of 96 lozenges in 1.5mg of nicotine is not a product like any other. Read the package leaflet before ordering. Do not let drugs Nicopass eucalyptus box of 96 lozenges in 1.5mg of nicotine in the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

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

Click here to find the manual of this drug on the website of the National Agency of Drug Safety and health products.

Pharmacovigilance : Declare one or effect (s) undesirable (s) connected (s) to the use of a drug Nicopass eucalyptus box of 96 lozenges in 1.5mg of nicotine.

VIDAL OF THE FAMILY

Nicopass

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)

NICOPASS 1.5 mg Eucalyptus: lozenge to be sucked (beige); box of 12.
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NICOPASS 1.5 mg Eucalyptus: lozenge to be sucked (beige); box of 36.
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NICOPASS 1.5 mg Eucalyptus: lozenge to be sucked (beige); box of 96.
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NICOPASS 1.5 mg Mint Freshness: lozenge (beige); box of 12.
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NICOPASS 1.5 mg Mint Freshness: lozenge (beige); box of 36.
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NICOPASS 1.5 mg Mint Freshness: lozenge (beige); box of 96.
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NICOPASS 1.5 mg Mint Freshness: lozenge (beige); box of 144.
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NICOPASS 1,5 mg Licorice Mint: lozenge (brown); box of 12.
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NICOPASS 1,5 mg Licorice Mint: lozenge (brown); box of 36.
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NICOPASS 1,5 mg Licorice Mint: lozenge (brown); box of 96.
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NICOPASS 2.5 mg Mint Freshness: pellet to suck (beige); box of 12.
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NICOPASS 2.5 mg Mint Freshness: pellet to suck (beige); box of 36.
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NICOPASS 2.5 mg Mint Freshness: pellet to suck (beige); box of 96.
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NICOPASS 2.5 mg Licorice Mint: lozenge (brown); box of 12.
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NICOPASS 2.5 mg Licorice Mint: lozenge (brown); box of 36.
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NICOPASS 2.5 mg Licorice Mint: lozenge (brown); box of 96.
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Laboratory Pierre Fabre Medicine

COMPOSITION (summary)
p pastille p pastille
Nicotine 1.5 mg 2.5 mg
aspartame + +

INDICATIONS (summary)
This medication helps smokers detoxify tobacco. The pellet brings nicotine, the main active substance in tobacco, responsible for habituation, into the blood via saliva.
It is used either to stop smoking permanently or to stop temporarily.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • non-smoker or occasional smoker,
  • phenylketonuria (presence of aspartame).
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 pellets within reach of children.
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 take the medication after the headache.
DIRECTIONS FOR USE AND DOSAGE (summary)
Suck very slowly the pellet to allow the slow and steady absorption of nicotine through the blood vessels of the tongue. The pellet dissolves for about 30 minutes and must be regularly moved from one side of the mouth to the other during this time. It is important not to drink or eat as long as the lozenge is in the mouth.
The choice of the dosage depends on the initial dependence on nicotine. The pellets to suck at 2.5 mg are suitable for smokers who are highly or very highly dependent.
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.

Usual dosage:

  • Adult :
Complete cessation of tobacco:
For this purpose, the treatment of nicotine dependence usually follows 2 phases: for 3 months, suck a pellet whenever the urge to smoke is felt, usually 8 to 12 times a day, without exceeding 30 pellets to 1.5 mg or 2.5 mg pellets 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 pellets per day until the stop. Treatment should not exceed 6 months in total.
The 1.5 mg pellets may be used alone or in combination with the transdermal devices. In this case, follow the recommendations of your doctor.
Temporary cessation of tobacco:
Suck one pellet whenever the urge to smoke is on average 8 to 12 times a day, not to exceed 30 1.5 mg pellets or 15 pills at 2.5 mg per day.
Reduction in tobacco consumption:
Suck a pellet as soon as the desire 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 pellets to be used per day is variable but should not be greater than 30 1.5 mg or 2.5 mg pellets. If a significant reduction in cigarette consumption has not been achieved after a few 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 9 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.
Nausea, vomiting, digestive disorders, hiccups, headache, dizziness, rash , palpitations .
Rarely: insomnia, aphthous, heart rhythm disorders , allergic reaction .


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.


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 sense 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.


phenylketonuria
An inherited disease that is characterized by the absence of an enzyme and that leads to the accumulation in the blood of a toxic product. Screening is systematic at birth. Treatment is based on a specific diet during early childhood.


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
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.


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 (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 - Updated on: 02/08/2017

Name of the medicinal product

NICOPASS 1.5 mg WITHOUT EUCALYPTUS SUGAR, sweetened with aspartame 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 medicine by following the information provided 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.

· If you are experiencing difficulties or are unable to stop smoking within 6 months, see your doctor or pharmacist

What is in this leaflet?

1. What is NICOPASS 1.5 mg EUCALYPTUS SUGAR-free, sweetened with aspartame and acesulfame potassium and in which cases it is used?

2. What information should I take before taking NICOPASS 1.5 mg EUCALYPTUS-FREE SUGAR, sweetened with aspartame and acesulfame potassium?

3. How to take NICOPASS 1.5 mg WITHOUT EUCALYPTUS SUGAR, sweetened with aspartame and acesulfame potassium?

4. What are the possible side effects?

5. How to store NICOPASS 1.5 mg WITHOUT EUCALYPTUS SUGAR, sweetened with aspartame and acesulfame potassium?

6. Package contents and other information.

1. WHAT IS NICOPASS 1.5 mg EUCALYPTUS-FREE SUGAR, sweetened with aspartame and acesulfame potassium AND WHAT IT IS USED FOR?

Pharmacotherapeutic group: Drugs used in nicotine addiction. - ATC code: N07BA01

Reserved for adults and adolescents over 15 years of age.

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.

Tailored management improves the chances of success in stopping smoking.

Read the health education tips carefully at the end of this leaflet.

2. BEFORE YOU TAKE NICOPASS 1.5 mg WITHOUT EUCALYPTUS SUGAR, sweetened with aspartame and acesulfame potassium?

Never take NICOPASS 1.5 mg WITHOUT EUCALYPTUS SUGAR , sweetened with aspartame and acesulfame potassium in the following cases:

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

· if you are allergic (hypersensitive) to nicotine or any of the other ingredients of this medication mentioned in section 6.

· if you have phenylketonuria (hereditary disease detected at birth), because of the presence of aspartame.

If in doubt, it is essential to seek the advice of your doctor or pharmacist.

Warnings and Precautions

Talk to your doctor or pharmacist before taking NICOPASS 1.5 mg WITHOUT EUCALYPTUS SUGAR, sweetened with aspartame and acesulfame potassium .

As part of a "complete smoking cessation," you must quit smoking completely when using this medication. Read the health education tips at the end of this leaflet carefully.

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

Thus, in the case of:

· severe hepatic and / or renal insufficiency or

· of stomach ulcer or evolving duodenum

It is essential to consult your doctor before using this medication.

If NICOPASS 1.5 mg tablets are combined with a nicotine patch, refer to the package leaflet for each of these medicines.

· Some signs indicate an under-dosage. If you feel, despite the treatment, a feeling of lack, such as:

o compelling need to smoke,

o irritability, sleep disturbances,

o agitation or impatience,

o 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: if there are signs of overdose, ie:

o nausea, abdominal pain, diarrhea,

o hypersalivation,

o sweating, headache, dizziness, loss of hearing,

o general weakness,

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

This medicine contains isomalt (E953 ) It is not recommended for use in patients with fructose intolerance (rare hereditary disease).

If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.

children

It is imperative to keep the pellets 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.

Other medicines and NICOPASS 1.5 mg WITHOUT SUGAR EUCALYPTUS, tablet sweetened with aspartame and acesulfame potassium

Stopping smoking, with or without this medication, may affect the action of certain other medicines taken at the same time.

Dose adjustments by your doctor may be necessary if you are taking the following medications:

· treatment of asthma (theophylline),

· treatment of schizophrenia (clozapine),

· treatment of Parkinson's disease (ropinirole),

· treatment of diabetes (insulin),

· substitution treatment for opioid dependence (methadone)

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

NICOPASS 1.5 mg WITHOUT SUGAR EUCALYPTUS, tablet sweetened with aspartame 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 quit smoking during your pregnancy as this can harm your baby. Besides a low birth weight, smoking can also cause premature birth or the birth of a stillborn baby. The ideal would be to quit smoking without using medication. If this does not work, this medication may be recommended to help you because the risk to your baby is much lower than the risk of smoking. Nicotine, whatever its form, can harm your unborn child.

Therefore, this medication should only be used after consulting the healthcare professional who is following your pregnancy, or your general practitioner, or a doctor at a smoking cessation center.

feeding

This medication, just like smoking during breastfeeding should be avoided, as nicotine passes into breast milk which can harm your child.

If you smoke a lot and do not plan to stop smoking, you must use artificial feeding.

If you have not been able to stop smoking and are breastfeeding, use this tablet only on medical advice

Driving and using machines

This medicinal product has no known effect on the ability to drive and use machines when used at the recommended dosage.

NICOPASS 1.5 mg EUCALYPTUS-FREE SUGAR, sweetened tablet with aspartame and acesulfame potassium contains: aspartam (E951), isomalt (E953).

3. HOW TO TAKE NICOPASS 1.5 mg WITHOUT EUCALYPTUS SUGAR, sweetened with aspartame and acesulfame potassium?

Reserved for adults and adolescents over 15 years of age

NICOPASS should not be used in smokers under 18 years of age without recommendation from a health care professional.

1.5 mg pellets are suitable for moderately or nicotine-dependent smokers (Fagerström test score ≤ 6 - see chapter "Health education advice").

Dosage

Whatever the method of use, do not exceed 30 pellets per day.

Complete cessation of smoking

Treatment of nicotine dependence is usually done in 2 phases.

1st phase:

Slowly toss a pellet whenever the urge to smoke appears.

The number of pellets dosed at 1.5 mg is generally from 8 to 12 per day and should in no case exceed 30 pellets 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 tablets sucked per day. Treatment will be stopped when consumption is reduced to 1 to 2 tablets per day.

It is recommended not to use pellets beyond 12 months.

In combination with a nicotine patch:

If at the end of your treatment you continue to feel irrepressible cravings or if your treatment has failed, consult your doctor. He may advise you to combine the pellets with a nicotine-delivering form throughout the day: the nicotine patches.

Slowly squeeze a lozenge every time the urge to smoke appears despite treatment with a transdermal patch.

The number of pellets to be used per day is variable and depends on your needs.

Generally, the number of pellets is 5 to 6 per day.

Gradually reduce, during weaning, the number of pellets dosed at 1.5 mg used per day.

Temporary abstinence from tobacco

Slowly toss a pellet whenever the urge to smoke appears.

The number of pellets dosed at 1.5 mg is generally from 8 to 12 per day and should in no case exceed 30 pellets per day.

Tobacco reduction

As much as possible, alternate pills to nicotine and cigarettes. Slowly suck a tablet when the urge to smoke appears, to stay as long as possible without smoking.

The number of pellets is variable and depends on your needs.

However, it should not exceed 30 pellets 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.

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

This should be stopped as soon as possible within 6 months of starting treatment. If, after more than 9 months of treatment, the attempted complete cessation of tobacco has failed, it is recommended to seek advice from a health professional.

It is recommended not to use pellets beyond 12 months.

Administration mode

ORAL WAY

The pellet should be placed in the mouth where it will dissolve gradually. It must be regularly moved from one side of the mouth to the other, until it is completely dissolved. The matrix structure of the pellet has been designed to ensure its dissolution in about 30 minutes, thus allowing a progressive release of the nicotine and therefore a slow absorption of the latter at the level of the buccal mucosa. Therefore, it should not be chewed or swallowed.

It is necessary to refrain from drinking or eating when the pellet is in the mouth.

Duration of treatment

The duration of treatment should not exceed 12 months.

In case of persistent feeling of lack or in case of difficulty to stop this medicine, consult your doctor.

If you take more NICOPASS 1.5 mg WITHOUT EUCALYPTUS SUGAR, sweetened with aspartame and acesulfame potassium you should not have

In case of accidental overdose or if a child swallows one or more lozenges: contact a doctor, or an emergency service.

In fact, small amounts of nicotine are dangerous in children.

Severe intoxication may occur and may include hypotension, weak and irregular heartbeat, respiratory discomfort, prostration, cardiovascular collapse, and convulsions, leading to a fatal outcome.

Immediately consult your doctor or pharmacist.

If you forget to take NICOPASS 1.5 mg WITHOUT EUCALYPTUS SUGAR, sweetened with aspartame and acesulfame potassium

Not applicable.

If you stop taking NICOPASS 1.5 mg WITHOUT SUGAR EUCALYPTUS, tablet sweetened with aspartame and acesulfame potassium

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

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

Severe allergic reactions that cause swollen face and throat rarely occur (affecting 1 to 10 people in 10,000).

If you notice symptoms of severe allergic reactions you should stop taking NICOPASS and consult your doctor immediately.

At the beginning of treatment , irritations of the mouth can be felt. As with other nicotinic substitutes, gastritis (inflammation of the stomach) may appear during treatment.

Other side effects listed below are classified according to the probability that they may occur.

Common (affects 1 in 10): headache, dizziness, hiccups, sore throat, irritation of the mouth, dry mouth, nausea, vomiting, digestive disorders, esophagitis (inflammation of the esophagus), stomatitis of the mouth), flatulence

Uncommon (affecting 1 in 100 people): palpitations (irregular heartbeat and rapid heart rate), urticaria or redness of the skin

Rare (affecting 1 in 1000 people): heart rhythm disorders (uncontrolled, rapid and reversible)

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

If NICOPASS 1.5 mg tablets are combined with a nicotine 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 NICOPASS 1.5 mg WITHOUT EUCALYPTUS SUGAR, sweetened with aspartame 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 carton. The expiry date refers to the last day of that month.

Store at a temperature not exceeding + 30 ° C.

Store in the original package in order to protect from moisture.

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 NICOPASS 1.5 mg contains: EUCALYPTUS-FREE SUGAR, sweetened tablet with aspartame and acesulfame potassium

· The active substance is:

Nicotine................................................. .................................................. ..................... 1.50 mg

In the form of nicotine resinate ............................................ ............................. 8.33 mg

For a pellet.

· The other components are:

Isomalt (E953), hypromellose (E464), aspartam (E951), acesulfame potassium, aroma with natural extracts of mint and eucalyptus, permafrost masking aroma GIVAUDAN (contains maltodextrin = source of glucose), sodium bicarbonate of anhydrous sodium. (see section 2 "NICOPASS 1.5 mg WITHOUT SUGAR EUCALYPTUS contains").

What is NICOPASS 1.5 mg EUCALYPTUS-FREE SUGAR, sweetened with aspartame and acesulfame potassic and contents of the pack

This medication is in the form of a square, opaque, white pellet.

Boxes of 12, 24, 36, 48, 60, 72, 84, 96, 144 or 180 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

PIERRE FABRE MEDICAMENT

45, PLACE ABEL GANCE

92100 BOULOGNE

Marketing Authorization Operator

PIERRE FABRE MEDICAMENT

45, PLACE ABEL GANCE

92100 BOULOGNE

Maker

PIERRE FABRE MEDICAMENT PRODUCTION

DIETETIC SITE AND PHARMACY

ZI OF THE COUDETTE

32290 AIGNAN

OR

PIERRE FABRE MEDICAMENT PRODUCTION

SITE OF CAHORS

THE PAYRAT

46000 CAHORS

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:

Other

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


Health Education Council:

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. 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 D 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 may 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 have to foresee 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.

FAGERSTRÖM 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 7 to 10 : you are highly 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.

Weaning-related disorders 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" such as:

o compelling need to smoke,

o irritability, sleep disturbances,

o agitation or impatience,

o 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 time,

because of psychological difficulties which have arisen in the cessation of smoking (depression, anxiety, etc.)

because of a very tempting situation. Understand the reason for this relapse to prevent it if possible during the 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.

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Traitement Anti tabac disponible en Pharmacie en ligne

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Nicotine substitutes bring you nicotine, so that you do not feel any more physical and psychic deprivation during weaning in tobacco smokers. These drugs increase your chances of staying smoke-free by 50%. Anti-smoking treatment should be followed for an average of 3 to 6 months. Your doctor or pharmacist can advise you on the proper dosage of nicotine to take as a tablet to suck or patches, depending on your degree of dependence. Do not hesitate to consult a health professional to accompany you in your desire to stop smoking . The accompaniment by an addictology expert specialized in stopping smoking, increases your chances of success .

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