Nicotinell Fruit 2mg Gum Chewing 96 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.
For warnings, precautions for use and contraindications, please consult the instructions for use.
This drug is indicated in the treatment of tobacco dependence in order to relieve the symptoms of nicotine withdrawal in subjects wishing to stop their consumption of tobacco.
Use NICOTINELL chewing gum as directed in the package leaflet. Ask your doctor or pharmacist for advice if in doubt. At the initiation and throughout the treatment, stopping smoking completely is necessary to increase your chances of success. NICOTINELL FRUIT gums are available in 2 dosages: 2 mg and 4 mg. The right dose will depend on your smoking habits.
Frequency of administration :
The initial dose should be 1 tablet every 1 to 2 hours. Otherwise, suck on one tablet each time 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 adjusted individually. Normally, treatment should be continued for at least 3 months. After this time, 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 6 months. However, some "ex-smokers" may need longer treatment to avoid relapse.
In case of difficulty in stopping this medication beyond 9 months, seek advice from a health professional.
Advice and follow-up can increase your chances of success.
Children and adolescents under 18 :
In subjects under 18 years of age, this medication should not be used without medical advice.
NICOTINE-POLACRILINE (1: 4) 10 MG, OR NICOTINE 2 MG. EXCIPIENTS: BASE GUM; (BUTYLHYDROXYTOLUENE (E 321)); CALCIUM CARBONATE ; SORBITOL (E 420); ANHYDROUS SODIUM CARBONATE; SODIUM BICARBONATE ; POLACRILINE; LEVOMENTHOL; TUTTI FRUTTI FLAVOR; POTASSIC ACESULFAME; SACCHARINE; SACCHARINE SODIUM; CARNAUBA WAX; PURIFIED WATER ; XYLITOL (E 967); MANNITOL (E 421); TALC; GELATINE; TITANIUM DIOXIDE (E 171); QSP 1 CHEWING CHEWING GUM.
Never take NICOTINELL FRUIT 2 mg WITHOUT SUGAR, medicated chewing gum in the following cases:
1 Box of 96 Nicotinell chewing gums without sugar 2mg fruit.
Your motivation and your will are the keys to successful treatment. If you are using Nicotinell Fruit Chewing Gum as part of an addiction treatment, you should quit smoking completely, because if you do not reduce your intake, there is a risk of side effects, especially heart and circulatory, because higher nicotine levels than when you smoke as usual. It is therefore important that you are highly motivated to quit smoking before starting treatment with Nicotinell. Advice from professionals increases your chances of successfully quitting smoking. Nicotinell lozenges are not a pleasure product. It may take several days before you get used to the taste of Nicotinell lozenges. All Nicotinell lozenges are sugar free. Instead of sugar, they contain aspartame as a sweetener. Nicotinell lozenges can therefore also be used by diabetics, provided that the precautions for use are observed. Nicotinell lozenges do not contain lactose or galactose. If you take lozenges to reduce your tobacco consumption, be sure to do so only during periods when you do not smoke. In case of prolonged use, there is a risk of damage to the oral mucous membranes. Nicotinell 1 mg and 2 mg should not be used in case of known hypersensitivity to nicotine or to other constituents of the lozenges to be sucked. It should also not be consumed during pregnancy and lactation. Nicotinell lozenges should not be used by non-smokers and children under the age of 12! For adolescents aged 12 to 18 years, the drug should only be used in cases of heavy dependence on nicotine and only after consultation with a doctor, pharmacist or druggist.
Attention, the drug Nicorette 2mg Fruit is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 14/12/2015
NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum
Nicotine
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.
In this notice :
1. What is NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum and in which cases it is used?
2. What should I know before taking NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum ?
3. How to take NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum ?
4. What are the possible side effects?
5. How to store NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum ?
6. Additional information.
1. WHAT NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum AND WHAT IT IS USED FOR?
NICOTINELL FRUIT chewing gum contains nicotine, one of the tobacco substances.
NICOTINELL FRUIT 2 mg, medicated chewing gum belongs to the range of medications to help you quit smoking.
Nicotine is released slowly and then absorbed by buccal absorption every time a gum is chewed.
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 FRUIT 2 mg SUGAR-FREE, medicated chewing gum?
List of information needed before taking the medication
Not applicable.
Never take NICOTINELL FRUIT 2 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 FRUIT 2 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 FRUIT 2 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, ulcer of the stomach or duodenum.
· 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 FRUIT, chewing gum out of the reach and sight of children.
In the event that dental prosthesis wearers experience difficulties in chewing gums, it is recommended that treatment be discontinued 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 FRUIT, 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 adjustment of dosage.
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 stop 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 FRUIT 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 FRUIT can be taken only after consulting the doctor who is following your pregnancy or a doctor specializing in help with smoking cessation.
feeding
NICOTINELL FRUIT chewing gum, such as smoking, should be avoided during breastfeeding, as nicotine passes into breast milk.
If your doctor recommends the use of NICOTINELL FRUIT, chewing gum during lactation, the gum should be chewed immediately after breastfeeding and not during the two hours before breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
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 FRUIT 2 mg, medicated chewing gum.
List of excipients with known effect
Important information about some of the ingredients of NICOTINELL FRUIT 2 mg SANS SUGAR, medicated chewing gum
NICOTINELL FRUIT 2 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 FRUIT 2 mg contains sugars including 0.2 g of sorbitol (E420), source of fructose (0.04 g / gum). The caloric intake is 1.0 Kcal / gum.
Each chewing gum contains 11.50 mg of sodium, take it into account in people on a diet low in salt.
3. HOW TO TAKE NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum?
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 treatment, complete cessation of tobacco is necessary to increase your chances of success.
NICOTINELL FRUIT gums are available in 2 strengths: 2 mg and 4 mg. The appropriate dose will depend on your smoking habits.
NICOTINELL FRUIT 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 the gum when the taste has faded.
· Continue this process until the gum is completely dissolved (about 30 minutes).
DO NOT SWALLOW
Dosage in adults over 18 years of age
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 FRUIT 2 mg is 25 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 FRUIT 2 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.
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 FRUIT 2 mg SUGAR-FREE, medicated chewing gum is likely to have undesirable 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 FRUIT 2 mg SUGAR-FREE, medicated chewing gum?
Keep out of the reach and sight of children.
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.
Store at a temperature not exceeding 25 ° C.
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.
Full list of active substances and excipients
What contains NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum?
The active substance is :
Nicotine ................................................. .................................................. ..................................... 2,000 mg
In the form of nicotine-polacriline (1: 4) ....................................... .................................................. .. 10.00 mg
For a chewing gum.
The other components are :
Gum base (containing butylhydroxytoluene (E321)), calcium carbonate, sorbitol (E420), glycerol (E422), anhydrous sodium carbonate, sodium bicarbonate, polacrilin, levomenthol, aroma Tutti frutti, acesulfame potassium, saccharin, Carnauba wax, talc, purified water, xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171).
Pharmaceutical form and content
What is NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum and contents of the pack?
This medication is in the form of medicated chewing gums. Boxes of 2, 12, 24, 36, 48, 60, 72, 96, 120 or 204.
Not all pack sizes may be marketed.
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100 ROUTE OF VERSAILLES
CS 80001
78164 MARLY-LE-ROI CEDEX
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100 ROUTE OF VERSAILLES
CS 80001
78164 MARLY-LE-ROI CEDEX
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.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
COUNCIL / HEALTH EDUCATION
As soon as you stop smoking
You will no longer absorb the irritating and toxic substances of the cigarette.
You will see some improvements: progressive disappearance of the headaches, the cough, the irritation of the throat, the shortness of breath.
You will often have the satisfaction of getting better sleep, food flavor, odor and improve your physical performance.
You will decrease 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 have to foresee 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? | |
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? | |
How many cigarettes do you smoke per day? | |
Do you smoke at a more sustained pace in the morning than in the afternoon? | |
Do you smoke when you are so sick that you have to stay in bed almost all day? | |
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. |
Medication for smoking cessation
nicotine
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
NICOTINELL FRUIT 2 mg SUGAR-FREE: chewing gum (white, aroma tutti frutti); box of 36.
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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.
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NICOTINELL FRESH MINT 4 mg WITHOUT SUGAR: chewing gum (white); box of 36.
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NICOTINELL FRESH MINT 4 mg WITHOUT SUGAR: chewing gum (white); box of 96.
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Laboratory GlaxoSmithKline Consumer Healthcare
| p gum | p gum | |
| Nicotine | 2 mg | 4 mg |
| sorbitol | 200 mg | 200 mg |
| Sodium | 11.5 mg | 11.5 mg |
Usual dosage:
