Nicotinell 36 4MG MINT GUM

Nicotinell 36 4MG MINT GUM View larger

3400936315860

Nicotinell 4mg Mint Gum Chewing 36 belongs to the range of medicines to help you quit smoking. Contains nicotine, a tobacco substances, then released slowly absorbed by buccal absorption when the gum is chewed.

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Partners with: NICOTINE PATCHES Nicotinell 14mg 28 24H, NICOTINE PATCHES Nicotinell 21mg 28 24H, Nicotinell 7MG 24H 28 PATCHES

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Nicotinell 36 4MG MINT GUM

 

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


Description Nicotinell 4mg gum mint 36

Use Nicotinell chewing gum as indicated in the instructions. Ask your doctor or pharmacist if in doubt. At initiation and throughout the treatment, complete cessation is necessary to increase your chances of success. Nicotinell MINT gums are available in two strengths: 2 mg and 4 mg. The appropriate dose depends on your habits of smoking.

Application advice and advice on Nicotinell 4mg gum mint 36

Frequency of administration:

The initial dose should be 1 tablet every 1 to 2 hours. Otherwise, suck a tablet whenever you feel the need to smoke. The usual dose is 8 to 12 tablets per day. The maximum dose is 30 tablets per day.

Duration of treatment:

The duration of treatment is to be adapted individually. Normally, treatment should be continued for at least 3 months. After that, gradually reduce the number of tablets; stop treatment when the dose is reduced to 1-2 tablets per day. It is generally not recommended to continue treatment beyond six months. However, some "ex-smokers" may need longer to avoid relapse treatment.

In case of difficulty in stopping this medication beyond nine months, ask the advice of a healthcare professional.

Advice and monitoring can increase your chances of success.

Children and adolescents under 18 years:

In subjects under 18 years, this drug should not be used without medical advice.

Composition of 4 mg Nicotinell chewing gum mint 36

The active substance is:
Nicotine ....................................................................................................................................... 4,000 mg
As nicotine polacrilin (1: 4) ....................................... .................................................. 20.00 mg


The other ingredients are:
Gum base (containing butylated hydroxytoluene (E321)), calcium carbonate, sorbitol (E420), carbonate
anhydrous sodium bicarbonate, polacrilin, glycerol (E422), purified water, levomenthol, natural flavor
mint, mint flavor, sucralose, acesulfame potassium, xylitol (E967), mannitol (E421), gelatin,
titanium dioxide (E171), carnauba wax, talc

Caution with use Nicotinell 4mg gum mint 36

Never take 4 mg Nicotinell MINT SUGAR, medicated chewing gum in the following cases:

· If you are not smoking,

· If you are allergic to nicotine or any other ingredients of Nicotinell MINT 4 mg without sugar.

Introducing Nicotinell 4mg gum mint 36

1 Box of 36 Nicotinell gum chewing sugarless mint 4mg.

Our expert advice on pharmacy

Your motivation and determination are the keys to successful treatment. If you use Nicotinell Mint Gum chewing in the context of a treatment cessation, you should stop smoking completely, because if you do not reduce your consumption, there is a risk of side effects, including heart and circulatory because higher than when you smoke as usual nicotine levels. It is therefore important that you are highly motivated to quit smoking before starting treatment with Nicotinell. Professional advice increase your chances of successfully quitting smoking. Nicotinell sucking lozenges are not a product approval. It may be necessary for several days before you get used to the taste of Nicotinell lozenges to suck. All Nicotinell lozenges are sugar. In place of the sugar they contain aspartame as sweetening. Nicotinell sucking lozenges can therefore also be used by diabetics, provided you follow the precautions. Nicotinell sucking lozenges do not contain lactose or galactose. If you take lozenges in order to reduce your smoking, do so only during periods when you do not smoke. In long-term use, there is a risk of injury to the oral mucosa. Nicotinell 1 mg and 2 mg should not be used in patients with known hypersensitivity to nicotine or other constituents of lozenges. Should not either consume during pregnancy and lactation. Nicotinell sucking lozenges should not be used by non-smokers and children under 12 years! For ages 12 to 18 years young, the drug should only be used in cases of high nicotine dependence and only after consultation with a doctor, pharmacist or druggist.

Warnings on drugs

 

Attention drug Nicotinell 4mg Mint is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your products in.

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

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

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

VIDAL OF THE FAMILY

NICOTINELL chewing gum

Medication for smoking cessation

nicotine

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

PRESENTATIONS (summary)

NICOTINELL FRUIT 2 mg SUGAR-FREE: chewing gum (white, aroma tutti frutti); box of 36.
-

NICOTINELL FRUIT 2 mg SUGAR-FREE: chewing gum (white, aroma tutti frutti); box of 96.
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NICOTINELL FRUIT 2 mg SUGAR-FREE: chewing gum (white, aroma tutti frutti); box of 204.
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NICOTINELL EXOTIC FRUIT 2 mg WITHOUT SUGAR: chewing gum (white, mango flavor); box of 96.
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NICOTINELL EXOTIC FRUIT 2 mg WITHOUT SUGAR: chewing gum (white, mango flavor); box of 204.
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NICOTINELL FRESH MINT 2 mg WITHOUT SUGAR: chewing gum (white); box of 36.
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NICOTINELL FRESH MINT 2 mg WITHOUT SUGAR: chewing gum (white); box of 96.
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NICOTINELL FRESH MINT 2 mg WITHOUT SUGAR: chewing gum (white); box of 204.
-

NICOTINELL FRESH MINT 4 mg WITHOUT SUGAR: chewing gum (white); box of 36.
-

NICOTINELL FRESH MINT 4 mg WITHOUT SUGAR: chewing gum (white); box of 96.
-

Laboratory GlaxoSmithKline Consumer Healthcare

COMPOSITION (summary)
p gum p gum
Nicotine 2 mg 4 mg
sorbitol 200 mg 200 mg
Sodium 11.5 mg 11.5 mg

INDICATIONS (summary)
This medication helps smokers detoxify tobacco. The chewing gum brings nicotine, the main active substance in tobacco, responsible for habituation into the blood, through saliva.
CONTRAINDICATIONS (summary)
This medication should not be used in non-smokers.
WARNING (Contents)
Stopping smoking is imperative before starting treatment.
Precautions are necessary in case of severe heart disease, hypertension , stomach ulcer or duodenum , hyperthyroidism , pheochromocytoma , diabetes , renal or hepatic insufficiency or arteritis of the lower limbs. 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 without medical advice, including transdermal patches .
This chewing gum is a medicine. Do not leave it within reach of children.
Wearing a dental prosthesis can cause problems when chewing gums: consult your dentist.
If, after 10 days of treatment, you start smoking again: consult your doctor to adopt a new anti-smoking strategy.
The gums contain salt (sodium) in significant quantities.
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.
Absorption of coffee or soft drink within 15 minutes of taking the chewing gum may decrease the absorption of nicotine and therefore the effect of this drug.
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, take the gums preferably after the stubborn.
DIRECTIONS FOR USE AND DOSAGE (summary)
The choice of the dosage depends on the initial dependence on nicotine. 4 mg gums are suitable for heavy or highly dependent smokers; they can also be used by low-level smokers who prefer to limit the number of chewing gums daily.
In practice, it is useful to know the signs of under or overdose to adapt the dosage after a few days of treatment:
  • the overdose results in the condition of the smoker who has smoked too much and is mainly reflected in a nauseous condition and headaches. Difficulty in sight or hearing, trembling, dizziness are also possible;
  • an under-dosage causes symptoms of lack: irritability, nervousness, stomach cramps (kind of painful hunger), difficulty concentrating.
As soon as the desire to smoke is overcome, gradually reduce the number of gums, until complete cessation.
Chew very slowly each gum in order to allow the slow and regular absorption of the nicotine by the blood vessels of the tongue: chew the chewing gum 10 times in a row every 2 minutes approximately. After 30 minutes of chewing, the gum is no longer effective.

Usual dosage:

  • Adult over 18 years: chew a gum whenever the need to smoke is felt, which usually corresponds to 8 to 12 gums per day. Do not exceed 25 mg of 2 mg or 15 mg of 4 mg daily.
Do not exceed 6 months of continuous treatment.
TIPS (summary)
This medication can be used by smokers without medical advice. It is available without a prescription and can be accessed directly in certain pharmacies. Nevertheless, do not hesitate to have your choice chosen by your pharmacist. His advice is precious. He can help you determine the best time to quit and explain the causes of failure.
Nicotine taken by way oral replacing the cigarette has the same cardiovascular harmful than that in tobacco. Only the risk of lung cancer disappears. When smoking cessation is motivated by urgent medical reasons: recent infarction , arteritis , gastritis or ulcer , it is preferable to stop the absorption of nicotine in all its forms.
like all smoke-free methods used to help smokers, this drug can only be effective when the will to quit is personal and accompanied by strong motivation. it is this motivation that will make it possible to fight against the desire to smoke, without being forced to make constant appeal to the will that dulls over time. A cessation of lasting tobacco in the smoker assumes that the smoker considers tobacco to be a poison, an unacceptable addiction. It must be done to the idea that it will never smoke, from the beginning of weaning. Every day without tobacco must be experienced as a release, not as a calvary. The smoker who is in this state of mind is a good candidate for definitive weaning.
Stopping smoking, which is a real drug, causes many problems: weight gain is frequent, concentration disorders can last several weeks. A mild depressive condition is possible. Weight gain should be fought by a diet, and if possible by a sports program that has the advantage of reconciling the smoker with his body.
Do not hesitate to consult your doctor in case of difficulty; his advice and experience will be invaluable in the fight against relapses.
POSSIBLE ADVERSE EFFECTS (summary)
Irritation of the mouth or throat, jaw pain.
Nausea, digestive disorders, hiccups, headache, dizziness, rash , palpitations .
Rarely: heart rhythm disorder , 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.


diabetes
A general term for diseases that result in the emission of abundant urine and intense thirst. The word diabetes, used alone, is generally related to diabetes mellitus, which corresponds to a disruption in the regulation of the body's sugars by insulin. It results in increased sugar (glucose) in the blood and its possible presence in the urine. There are two types of diabetes mellitus: Type 1 or insulin-dependent diabetes, which requires insulin injections, and type 2 or non-insulin dependent diabetes, which can initially be treated with oral antidiabetics.


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


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


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


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


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


hypertension
Excess blood pressure (tension) in the arteries. This pressure is provided by the heart and is expressed by two digits. It is maximal during contraction of the heart, or systole (first digit), and minimal during cardiac rest, or diastole (second digit). High blood pressure is characterized by a maximum (systolic) pressure greater than or equal to 16, or a minimum (diastolic) pressure greater than or equal to 9.5. Treatment is initiated when these numbers are exceeded or for lower blood pressure in some people with cardiovascular risk factors: heredity, smoking, diabetes, excess cholesterol. Permanent antihypertensive therapy reduces damage to the heart and blood vessels due to high blood pressure.


hyperthyroidism
Excessive thyroid hormones, including heart failure, poor heat tolerance, weight loss and chronic fatigue.


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.


pheochromocytoma
Very rare tumor of the adrenal glands, manifested mainly by seizures of hypertension.


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.


salt
Chemical substance of which the best known is sodium chloride, or table salt. The diet salt does not contain sodium; this is generally replaced by potassium.


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 - Last updated: 14/12/2015

Name of the medicinal product

NICOTINELL FRESH MINT 4 mg SUGAR-FREE, medicated chewing gum

Nicotine

framed

Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.

This medication is a specialty of AUTOMEDIZATION which can be used without consultation or prescription from a doctor.

· Keep this leaflet, you may need to read it again.

· If you need more information and advice, ask your pharmacist.

· If you are still using NICOTINELL FRUIT after 9 months, see a doctor.

· If you notice any side effects not listed in this leaflet, or if you feel any of the side effects gets worse, tell your doctor or pharmacist.

Review summary

In this notice :

1. What is NICOTINELL MENTHE FRESH 4 mg SUGAR-FREE, medicated chewing gum and in which cases it is used?

2. What do you need to know before taking NICOTINELL MENTHE FRESH 4 mg SUGAR-FREE, medicated chewing gum?

3. How to take NICOTINELL FRESH MINT 4 mg SUGAR-FREE, medicated chewing gum?

4. What are the possible side effects?

5. How to store NICOTINELL FRESH MINT 4 mg SUGAR-FREE, medicated chewing gum?

6. Additional information.

1. WHAT NICOTINELL MINT FRESHNESS 4 mg SUGAR-FREE, medicated chewing gum AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

NICOTINELL FRESH MINT Chewing gum contains nicotine, one of the tobacco substances.

NICOTINELL MINT FRESHENER 4 mg medicated chewing gum belongs to the range of medications intended to help you quit smoking.

Nicotine is released slowly and then absorbed by buccal absorption every time a gum is chewed.

Therapeutic indications

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.

Tailored management improves the chances of success in stopping smoking.

2. BEFORE YOU TAKE NICOTINELL FRESH MINT 4 mg SUGAR-FREE, medicated chewing gum?

List of information needed before taking the medication

Not applicable.

Cons-indications

Never take NICOTINELL FRESH MINT 4 mg SUGAR-FREE, medicated chewing gum in the following cases:

· if you are not a smoker,

· in case of allergy to nicotine or any of the excipients contained in NICOTINELL MENTHE FRAICHEUR 4 mg.

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

Precautions for use; special warnings

Take special care with NICOTINELL FRESH MINT 4 mg SUGAR-FREE, medicated chewing gum:

Consult your doctor or pharmacist if you:

· cardiovascular disease, eg myocardial infarction, heart failure, angina pectoris, Prinzmetal angina, heart rhythm disorder,

· history of stroke,

· high blood pressure,

· circulatory problems,

· hepatic or renal insufficiency,

· thyroid disease (hyperthyroidism),

· diabetes (follow your blood glucose more often at the beginning of the treatment as it can be altered),

· pheochromocytoma (disease of the adrenal glands causing severe hypertension),

· inflammation of the mouth or throat, esophagitis, gastritis, stomach or duodenal ulcer,

· intolerance to fructose.

Nicotine in small amounts is dangerous in children and can cause severe symptoms or death. This is why it is imperative to keep NICOTINELL MENTHE FRAICHEUR, chewing gum out of the reach and sight of children.

In the event that dental prosthesis wearers have difficulty chewing the gums, it is recommended that treatment be stopped and another pharmaceutical form used. Ask your doctor or pharmacist.

Interaction with other medicines

Taking or using other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription. If you stop smoking and are taking other medications, your doctor may want to adjust the dosage.

There are no data on possible interactions between NICOTINELL MENTHE FRAICHEUR, gum and other medicines. However, substances in cigarettes, other than nicotine, may have an effect on certain drugs.

Stopping tobacco can affect the action of certain drugs, for example:

· theophylline (a drug used in the treatment of asthma),

· tacrine (a drug used in the treatment of Alzheimer's disease),

· olanzapine and clozapine (drugs used in the treatment of schizophrenia),

· insulin (a drug used in the treatment of diabetes).

May require dose adjustment.

Interactions with food and beverages

Food and drinks

Consumption of coffee, acidic and soft drinks (sodas) may decrease nicotine absorption and should be avoided within 15 minutes of taking a chewing gum.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy

It is very important to quit smoking during your pregnancy as this can lead to a delayed growth of your child or even prematurity or fetal death. Ideally, you should try to stop smoking without taking medication. In case of failure, NICOTINELL MENTHE FRAICHEUR can be advised to help you. Indeed, the risk to the fetus is probably lower than that related to smoking. Nicotine in all its forms can harm your child. NICOTINELL FRESH MINT can be taken only after consulting the doctor who is following your pregnancy or a doctor specializing in smoking cessation help.

feeding

NICOTINELL MINT FRESHNESS Chewing gum as smoking should be avoided during breastfeeding, as nicotine passes into breast milk.

If your doctor recommends the use of NICOTINELL MINT FRESH, chewing gum during lactation, the gum should be chewed immediately after breastfeeding and not during the two hours before the next breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Sport

Not applicable.

Effects on ability to drive or use machines

Driving and using machines

Stopping smoking can cause behavioral changes. At the recommended doses, there is no particular risk associated with NICOTINELL FRESH MINT 4 mg, medicated chewing gum.

List of excipients with known effect

Important information about some of the ingredients of NICOTINELL MENTHE 4 mg medicated chewing gum

NICOTINELL FRESH MINT 4 mg chewing gum contains sorbitol, source of fructose:

· if you know you are intolerant to certain sugars, consult your doctor before taking this medicine.

The gum contains butylhydroxytoluene (E321) which may cause local irritation of the oral mucosa.

Each gum NICOTINELL MINT FRESH 4 mg contains sugars including 0.2 g of sorbitol (E420), source of fructose (0.04 g / gum). The caloric intake is 0.9 Kcal / gum.

Each chewing gum contains 11.52 mg of sodium, taking it into account in people on a low-salt diet.

3. HOW TO TAKE NICOTINELL MINT FRESH 4 mg SUGAR-FREE, medicated chewing gum?

Instructions for proper use

Use NICOTINELL chewing gum as directed in the package leaflet. Ask your doctor or pharmacist for advice in case of doubt.

At initiation and throughout the treatment, complete cessation of tobacco is necessary to increase your chances of success.

NICOTINELL MINT FRESH Gums are available in 2 strengths: 2 mg and 4 mg. The appropriate dose will depend on your smoking habits.

NICOTINELL MINT FRESH 4 mg is recommended:

· for smokers who are highly or very heavily dependent on nicotine,

· in the event of failure after use of the 2 mg dosage,

· if the symptoms of lack remain high with risk of relapse.

In other cases use 2 mg gums.

Choose the appropriate dosage using the table below

If adverse effects are observed with the use of the 4 mg chewing gum, use the 2 mg gums.

Administration mode

ORAL WAY.

· Chew a gum until the taste becomes strong.

· Place the gum between the gum and cheek.

· Repeat chewing gum when taste has faded

· Continue this process until the gum is completely dissolved (about 30 minutes)

DO NOT SWALLOW

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage in adults over 18 years:

Frequency of Administration

Chew a gum whenever you feel the need to smoke. In general, the initial dose should be 1 gum every 1 to 2 hours. The usual dose is 8 to 12 gums per day. Alternatively, chew a gum whenever you feel an urgent need to smoke. The maximum dose of NICOTINELL MENTHE FRESH 4 mg is 15 gums per day.

Duration of treatment

The duration of the treatment must be adapted individually. Normally, treatment should be continued for at least 3 months. After this time, gradually reduce the number of chewing gums per day; stop treatment when the dose is reduced to 1-2 chewing gums per day. It is generally not recommended to continue treatment beyond 6 months. However, some "ex-smokers" may require longer treatment to avoid relapse.

If you have difficulty in stopping this medication for more than 9 months, seek medical advice.

Advice and follow-up can increase your chances of success.

Children and adolescents under 18 years of age:

This medication should not be used without medical advice in subjects younger than 18 years of age.

Symptoms and Instructions for Overdose

If you take more NICOTINELL FRESH MINT 4 mg SUGAR-FREE, medicated chewing gum than you should:

If you chew too many gums you will feel the same signs as if you had smoked too much. These general symptoms of nicotine overdose are: general weakness, sweating, hypersalivation, dizziness, throat irritation, nausea, vomiting, diarrhea, abdominal pain, hearing and vision disorders, headache, palpitations , shortness of breath, prostration, circulatory problems, cardiovascular collapse and seizures that can lead to a fatal outcome.

In this case, inform your pharmacist or doctor.

If you suspect poisoning in a child, contact a doctor or emergency department. Indeed, nicotine in small amounts is dangerous in children and can cause severe symptoms or death.

Instructions for omission of one or more doses

Not applicable.

Risk of withdrawal syndrome

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?

Description of adverse reactions

Like all medicines, NICOTINELL MENTHE FRESH 4 mg SUGAR-FREE, medicated chewing gum is likely to have unwanted effects, although not everyone is subject to it.

Some side effects such as dizziness, headaches and insomnia may occur at the start of treatment and may be due to symptoms of withdrawal associated with smoking cessation or nicotine underdosing.

Common side effects (affecting 1 to 10 people out of 100)

· Headache, dizziness.

· Hiccups, digestive upset, nausea, flatulence, vomiting, heartburn, hypersalivation, irritation of the mouth and throat, jaw pain may occur, especially if you chew gums too quickly.

These symptoms can be relieved by chewing the gums more slowly.

Uncommon side effects (affecting 1 to 10 people per 1,000)

· Palpitations.

· Redness of the skin and urticaria.

Uncommon side effects (affecting 1 to 10 people out of 10,000)

· Heart rhythm disorders (accelerated heart rate) and allergic reactions. Allergic reactions may be in very rare cases with the following symptoms: swelling of the skin, swelling of the face and mouth, dizziness, dizziness and fainting (symptoms of hypotension).

If any of these symptoms occur, discontinue use of NICOTINELL gums and contact your doctor immediately.

Mouth ulcers can occur when smoking cessation, but their relationship to nicotine therapy is not established.

In case of adhesion, NICOTINELL gums can in rare cases cause alteration of dental prostheses or amalgams.

If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.

5. HOW TO STORE NICOTINELL FRESH MINT 4 mg SUGAR-FREE, medicated chewing gum?

Keep out of the reach and sight of children.

Expiration date

Do not use after the expiry date stated on the carton. The expiry date refers to the last day of the month.

After use, pay attention to where you throw your chewed gum.

Storage conditions

Store at a temperature not exceeding 25ºC.

If necessary, warnings against visible signs of deterioration

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What does NICOTINELL MENTHE FRESHENER contain 4 mg SUGAR-FREE, medicated chewing gum?

The active substance is:

Nicotine ................................................. .................................................. ..................................... 4,000 mg

In the form of nicotine-polacriline (1: 4) ....................................... .................................................. 20.00 mg

For a chewing gum.

The other components are:

Gum base (containing butylhydroxytoluene (E321)), calcium carbonate, sorbitol (E420), anhydrous sodium carbonate, sodium bicarbonate, polacriline, glycerol (E422), purified water, levomenthol, natural mint fragrance , acesulfame potassium, xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171), Carnauba wax, talc.

Pharmaceutical form and content

What is NICOTINELL MENTHE FRESH 4 mg SUGAR-free, medicated chewing gum and contents of the pack?

This medicine is in the form of rectangular white medicated chewing gums. Boxes of 2, 12, 24, 36, 48, 60, 72, 96, 120 or 204.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100 ROUTE OF VERSAILLES

CS 80001

78164 MARLY-LE-ROI CEDEX

exploiting

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100 ROUTE OF VERSAILLES

CS 80001

78164 MARLY-LE-ROI CEDEX

Maker

FAMAR SA

48TH KM NATIONAL ROAD ATHENS-LAMIA

19011 AVLONAS, ATTIKI

GREECE

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

In accordance with the regulations.

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COUNCIL / HEALTH EDUCATION

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.

It's never too late to quit even if you've smoked a long time and a lot.

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:

· Choose a J day in the period that you think is the most favorable.

· Throw away your last pack of cigarettes, your lighter and put away your ashtrays.

· 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:

· drink a large glass of water,

· to chew gum,

· counting up to 100,

· do some deep breaths,

· out of the room,

· 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 it be the most difficult for you 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 persistent lack of feeling like especially:

· 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 situation very tempting. 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.

Gums anti tobacco Pharmacy: Find a selection of our anti tobacco products in your medicine bio care and kind. Fight effectively against the small inconveniences of daily life with effective remedies and quality.

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