Niquitin Menthe Glaciale 4mg 100 Sugar Chewing gum is a medicine indicated for the treatment of tobacco dependence in order to alleviate the symptoms of nicotine withdrawal in people who want to stop their tobacco use.
For warnings, precautions for use and contraindications, please consult the instructions for use.
Niquitin Ice Mint 4 mg sugar free, Chewing gum 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.
Although stopping smoking altogether is preferable, this medication can be used in:
Immediate shutdown
If you feel ready to quit smoking immediately, all nicotine replacement products can relieve the symptoms of withdrawal while helping you free yourself from your addiction. In the context of an immediate cessation, it is essential to change your habits in order to limit the temptations and to cope with the sudden cessation of nicotine intake which can lead to withdrawal symptoms, unpleasant in your daily life.
Phasing out
If you want to act on your smoking but you do not feel ready to quit overnight, gradually reducing your consumption is a great way to achieve complete cessation.
Treatment for nicotine addiction is usually done in 2 phases.
1st phase
2nd phase
The active substance is :
Nicotine. 4.00 mg (for 1 chewing gum)
In the form of nicotine resinate. 21.80 mg (for 1 chewing gum)
The other components are :
Gum, calcium carbonate, sorbitol (E420), mannitol, liquid maltitol (E965), Mint flavor, anhydrous sodium carbonate, sodium bicarbonate, glycerol, quinoline yellow (E104), butylhydroxytoluene (BHT) (E321), acesulfame potassium , talc.
Coating agent: xylitol, acacia, titanium dioxide (E171), levomenthol flavor, Eucamenthol flavor, carnauba wax, quinoline yellow (E104), talc, purified water.
Take special care with Niquitin Ice Mint 4 mg sugar-free, Medicated chewing gum sweetened with sorbitol and xylitol:
It is essential to consult your doctor before using this medication.
Keep chewing gum out of the reach of children. In fact, the therapeutic dose intended for adults could cause serious or even fatal intoxication in children.
Precautions for use:
Certain signs indicate an under-dosage. If you feel, despite the treatment, a feeling of "lack" such as:
Consult your doctor or your pharmacist. Indeed it may be necessary to modify the dosage of the drug.
Certain signs may indicate an overdose: in the event of the appearance of signs of overdose, that is to say:
It is imperative to adapt the treatment using the advice of your doctor or pharmacist.
In the event that denture wearers find it difficult to chew the gums, it is recommended to stop treatment and use another pharmaceutical form.
Due to the presence of sorbitol (E420) and liquid maltitol (E965), the use of this medicine is not recommended in patients with fructose intolerance (rare hereditary disease).
This medicine contains butylhydroxytoluene (E321) and may cause local irritation of the oral mucosa.
If in doubt do not hesitate to seek the advice of your doctor or pharmacist.
This medication is in the form of 100 chewing gums
Attention, the drug 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 - Updated: 06/23/2018
NIQUITIN GLACIAL MINT 4 mg WITHOUT SUGAR, medicated chewing gum sweetened with sorbitol and xylitol
Nicotine
You should always take this medicine strictly following the information given in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Contact your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects that are not mentioned in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this booklet contain ?
1. What is NIQUITIN GLACIAL MINT 4 mg WITHOUT SUGAR, medicated chewing gum sweetened with sorbitol and xylitol and in which cases is it used?
2. What should I know before taking NIQUITIN GLACIAL MINT 4 mg WITHOUT SUGAR, medicated chewing gum sweetened with sorbitol and xylitol?
3. How to take NIQUITIN GLACIAL MINT 4 mg WITHOUT SUGAR, medicated chewing gum sweetened with sorbitol and xylitol?
4. What are the possible side effects?
5. How to store NIQUITIN GLACIAL MINT 4 mg WITHOUT SUGAR, medicated chewing gum sweetened with sorbitol and xylitol?
6. Contents of the pack and other information.
MEDICINES USED IN NICOTINE DEPENDENCE - ATC code: N07BA01.
Although stopping smoking permanently is preferable, this medicine can be used in:
· cases where a smoker temporarily abstains from smoking,
· a smoking reduction strategy as a step towards quitting permanently.
Never take NIQUITIN GLACIAL MINT 4 mg WITHOUT SUGAR, medicated chewing gum sweetened with sorbitol and xylitol:
· If you do not smoke or are an occasional smoker
· If you are allergic (hypersensitive) to nicotine or any of the other ingredients of this medicine, listed in section 6.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Warnings and Precautions
Talk to your doctor or pharmacist before taking NIQUITIN MENTHE GLACIALE.
· Some illnesses require examination and medical monitoring before using this medication.
Therefore, it is essential to consult your doctor before using this medication if you have:
o recent history (<3 months) of heart attack or stroke,
o chest pain (unstable angina pectoris), or stable angina pectoris
o a heart problem affecting your heart rate or rhythm
o high blood pressure that is not controlled by medication
o a history of allergic reactions including swelling of the lips, face and throat (angioedema) or rash associated with itching (hives). Sometimes the use of Nicotine Replacement Therapy triggers this type of reaction,
o severe or moderate hepatic impairment,
o severe kidney failure
o diabetes,
o hyperthyroidism,
o a tumor of the adrenal gland (pheochromocytoma),
o a developing stomach or duodenum ulcer,
o a chronic throat condition
o asthma,
o fillings or dental implants.
· It is imperative to keep chewing gum out of the reach of children.
Indeed, the therapeutic dose intended for adults could cause serious poisoning or even death in children.
Precautions for use
· Certain signs indicate an under-dosage. If you feel, despite the treatment, a feeling of "lack" such as:
o craving to smoke,
o irritability, sleep disturbances,
o restlessness or impatience,
o difficulty concentrating.
Consult your doctor or your pharmacist. Indeed it may be necessary to modify the dosage of the drug.
· Certain signs may reflect an overdose: in the event of the appearance of signs of overdose, that is to say:
o nausea, abdominal pain, diarrhea,
o hypersalivation,
o sweating, headache, dizziness, hearing loss,
o general weakness.
It is imperative to adapt the treatment with the help of the advice of your doctor or pharmacist.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST.
Children and adolescents
Not applicable.
Other medicines and NIQUITIN GLACIAL MINT 4 mg WITHOUT SUGAR, medicated chewing gum sweetened with sorbitol and xylitol
Tell your doctor if you are taking, have recently taken or might take any other medicines.
This is especially important if you are taking clozapine (an antipsychotic), methadone (an opioid substitution treatment), ropinirole (a treatment for Parkinson's disease) or theophylline (used in the treatment of asthma).
NIQUITIN GLACIAL MINT 4 mg WITHOUT SUGAR, medicated chewing gum sweetened with sorbitol and xylitol with food and drink
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
It is very important to stop smoking during pregnancy as it can slow down the growth of your baby. It can also lead to premature labor or late fetal death. It is advisable to stop smoking without using drugs containing nicotine.
If you cannot quit smoking without nicotine replacement therapy, NIQUITIN MENTHE GLACIALE can be used after consulting the healthcare professional who is monitoring your pregnancy, your family doctor, or a doctor from a center specializing in help. for people wishing to quit smoking.
Feeding with milk
If you smoke a lot and do not plan to quit, you should not breastfeed your baby, but resort to artificial breastfeeding.
If you want to stop smoking and breastfeed your child, seek the advice of your doctor or a doctor at a center specializing in smoking cessation.
This is because the use of this medicine should be avoided during breast-feeding because nicotine passes into breast milk and can affect your baby. If your doctor has recommended you to use NIQUITIN GLACIAL MINT, the dose should be taken immediately after a feed or more than 2 hours before the next feed.
In addition, due to the passage into milk of the terpene derivatives (mint / eucalyptus flavoring) contained in this drug and the potential neurological toxicity in infants, you should consider another chewing gum flavor.
Driving and using machines
NIQUITIN GLACIAL MINT has no or negligible influence on the ability to drive and use machines.
NIQUITIN GLACIAL MINT 4 mg WITHOUT SUGAR, medicated chewing gum sweetened with sorbitol and xylitol contains sorbitol (E420).
If your doctor has informed you of an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains sorbitol (E420). Its use is not recommended in patients with fructose intolerance (a rare hereditary disease).
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Reserved for adults (from 15 years old).
Dosage
Chewing gum dosed at 4 mg are more particularly suitable for smokers who are heavily or very heavily dependent on nicotine (Fagerström score of 7 to 10 or smoking more than 20 cigarettes per day: see "Health education advice" ).
Complete smoking cessation
Treatment for nicotine addiction is usually done in 2 phases.
1st phase
Chew a gum whenever the urge to smoke appears.
The number of chewing gums dosed at 4 mg is generally 8 to 12 gums per day and should in no case exceed 15 gums per day.
The duration of this phase is approximately 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 gums chewed per day.
The treatment will be stopped when the consumption is reduced to 1 to 2 gums per day.
It is recommended not to use the chewing gum beyond 12 months.
If during your treatment you continue to have an irrepressible urge to smoke or if your treatment has failed, CONSULT YOUR DOCTOR.
Temporary abstinence from tobacco
Chew a gum whenever the urge to smoke appears.
The number of chewing gums dosed at 4 mg is generally 8 to 12 gums per day and should in no case exceed 15 gums per day.
Reduction in tobacco consumption
Whenever possible, alternate nicotine gums and cigarettes.
Chew a gum as soon as you feel the urge to smoke in order to minimize cigarette consumption and stay as long as possible without smoking.
The number of chewing gums per day is variable and depends on your needs. However, it should not exceed 15 gums 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 healthcare professional.
Reducing tobacco consumption should gradually lead you to stop smoking altogether. This stopping should be attempted as soon as possible within 6 months of the start of treatment. If more than 9 months after the start of treatment, the attempt to stop smoking has failed, it is recommended to seek advice from a health professional.
It is recommended not to use the gums beyond 12 months.
To increase the chances of success in quitting smoking completely, it is important to aim for a reduction of more than 50% in consumption during this phase of reduction. NIQUITIN MENTHE GLACIALE chewing gums help achieve this goal before you quit smoking.
Method and route of administration
Oral route.
To be active, the nicotine contained in the gum and released by chewing, must be absorbed through the oral mucosa.
If nicotine is swallowed with saliva, it has no effect. It is therefore important not to chew the gum too vigorously.
Thus, it is advisable to chew the gum for the first time, then keep it against the cheek for about 10 minutes: the gum softens and allows the nicotine to be released gradually, to be absorbed by the oral mucosa, thus passing into the circulation. .
Then chew the gum very slowly (about 20 times in 20 minutes).
The chewing gum should be kept in the mouth for about 30 minutes. After 30 minutes, the chewing gum will no longer deliver nicotine.
Duration of treatment
For complete cessation of smoking:
The duration of use is limited to 12 months.
If the feeling of withdrawal persists or if it is difficult to stop this medication, consult your doctor.
If you take more NIQUITIN GLACIAL MINT 4 mg WITHOUT SUGAR, medicated chewing gum sweetened with sorbitol and xylitol than you should
Immediately consult your doctor or pharmacist.
In case of accidental overdose or if a child swallows one or more chewing gum: CONTACT A DOCTOR OR EMERGENCY SERVICE.
Severe poisoning can occur and is manifested by hypotension, weak and irregular heartbeat, difficulty in breathing, prostration, cardiovascular collapse and convulsions.
If you forget to take NIQUITIN GLACIAL MINT 4 mg WITHOUT SUGAR, medicated chewing gum sweetened with sorbitol and xylitol
Do not take a double dose to make up for the dose you forgot to take .
If you stop taking NIQUITIN GLACIAL MINT 4 mg WITHOUT SUGAR, medicated chewing gum sweetened with sorbitol and xylitol
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
NIQUITIN GLACIAL MINT may cause side effects similar to nicotine given by other modes; these effects are mainly dose-dependent and appear at the start of treatment.
The gums can stick and in rare cases there is a risk of damage to the dental apparatus.
The following side effects have been reported:
Very common: affects more than 1 in 10 people
· Headache
· Hiccups
· Throat irritation
· Nausea
Common: affects 1 to 10 in 100 patients
· diarrhea
Uncommon: affects 1 to 10 in 1,000 people
· palpitations (unusual feeling of your heart beat), or fast heartbeat (tachycardia)
· throat pain
· abnormal dreams,
· wheezing (bronchospasm) or difficult breathing (dyspnea), change in the sound of the voice
· stuffy nose, sneezing
· excessive sweating, itching / rash (pruritus / hives), hot flashes
· fatigue, discomfort, chest pain / discomfort
· hypertension
Rare: affects 1 to 10 in 10,000 patients
· difficulty swallowing, decreased sensitivity in the mouth
Unknown frequency: cannot be estimated from the available data
· blurred vision, increased tears (tearing)
· dry throat, lip pain, stomach pain / discomfort
· allergic reaction including swelling of the face and mouth (angioedema) redness of the skin
Dizziness, headache, trouble sleeping, mouth ulcers may be related to stopping smoking and not your treatment.
Due to the presence of sorbitol, possibility of digestive disorders and diarrhea.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 30 ° C. Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
· The active substance is:
Nicotine................................................. .................................................. ..................... 4.00 mg
In the form of nicotine resinate ............................................ .................................. 28.40 mg
For a medicated gum.
· The other ingredients are:
Composition of the gum: 25048 gum consisting of 0.09% butylhydroxytoluene (BHT) (E321), sorbitol (E420), xylitol (E967), calcium carbonate, anhydrous sodium carbonate, eucamenthol flavor, glycerol, levomenthol flavor, flavor optacool, acesulfame potassium, sucralose, talc.
Coating agent: xylitol (E967), mannitol, acacia, titanium dioxide (E171), levomenthol aroma, eucamenthol aroma, optacool aroma, sucralose, carnauba wax, talc.
This medication is in the form of a white to off-white, rectangular medicated chewing gum.
Box of 4, 10 30 and 200 medicated chewing gums in blister packs (PVC / PE / PVDC / Aluminum) or (PVC / PVDC / Aluminum).
Not all presentations may be marketed.
Marketing authorization holder
OMEGA PHARMA FRANCE LABORATORIES
20 RUE ANDRE GIDE
92320 CHATILLON
Marketing authorization operator
OMEGA PHARMA FRANCE LABORATORIES
20 RUE ANDRE GIDE
92320 CHATILLON
DANDYVEJ 19
DK-7100 VEJLE
DENMARK
Names of the drug in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{month YYYY}.>
Health Education Council:
Stopping smoking as soon as possible has immediate health benefits. It is never too late to quit smoking even if you have smoked a long time and a lot.
As soon as you stop smoking:
· You will no longer absorb the irritating and toxic substances of cigarettes,
· You may notice certain improvements: gradual disappearance of headaches, cough, irritation of the throat, shortness of breath,
· You will often have the satisfaction of finding better sleep, the flavor of food, smells and improving your physical performance,
· You will lower your risk of developing lung cancer or cardiovascular disease.
Tobacco addiction is twofold:
· Psychological dependence:
Smoking a cigarette involves a ritual of automatic and repetitive gestures associated with particular circumstances (pleasure, stress response, intellectual stimulation, support for morale, need for the gesture of conviviality). It is about psychological and behavioral addiction.
· Physical dependence:
The body's need for nicotine is due to the effects of this substance on the nervous system. It is about physical dependence. Non-satisfaction of this need leads to a feeling of lack (see description in the chapter " How to overcome your physical dependence ?").
Nicotine substitutes aim to treat this addiction.
How to overcome your psychological dependence?
· Stopping smoking completely is necessary to increase your chances of success, but in addition:
o Choose a D day in the period which seems most favorable to you.
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 quit be made at the same time by both spouses.
· Tell those around you and co-workers that you are quitting. Ask them to respect your decision (not to smoke near you, not to offer you any more cigarettes).
· Prepare to face the urge to smoke. It can occur suddenly and intensely, especially during the first few weeks after quitting smoking, but does not last more than 3 or 4 minutes.
You must plan what you will do in this case and act very quickly so as not to "crack", for example:
o drink a large glass of water,
o to chew gum,
o count to 100,
o take a few deep breaths,
o leave the room,
o change activity ...
· Avoid situations associated with taking cigarettes (coffee, aperitif ...), avoid temptations (sit with non-smokers).
· Find compensation for smoking (leisure, sport, cultural activity, etc.).
How to overcome your physical addiction?
If you are addicted to nicotine, the success of your process may require the use of nicotine replacement therapy.
In order to assess your level of dependence, the Fagerström test is offered to you.
How long after you wake up do you smoke your first cigarette? | |
· within 5 minutes: 3 | |
· 6 to 30 minutes: 2 | |
· from 31 to 60 minutes: 1 | |
· after 60 minutes: 0 | |
Do you find it difficult not to smoke in places where it is prohibited? | |
· yes: 1 | |
· no: 0 | |
Which cigarette of the day would it be 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 faster rate 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 most of the day? | |
· yes: 1 | |
· no: 0 | |
TOTAL POINTS |
score from 0 to 2 : you are not addicted to nicotine.
You can quit smoking without the need for nicotine replacement therapy.
If, however, you dread stopping, seek advice from your pharmacist or doctor.
score 3 to 4 : you are weakly addicted to nicotine.
score 5 to 6 : you are moderately addicted to nicotine.
Using nicotine replacement therapy will increase your chances of success.
Ask your pharmacist or doctor for advice so that they can help you choose the most suitable treatment for you.
score of 7 to 10 : you are strongly or very strongly dependent on nicotine.
The use of nicotine replacement therapy is recommended to help you overcome this nicotine addiction. This treatment must be used in sufficient and appropriate dose.
Take advice from your pharmacist or your doctor, possibly as part of a specialized consultation to help with smoking cessation.
Withdrawal-related disorders can persist for a long time and the duration of treatment should be sufficient, usually one to three months.
If you feel, despite treatment, a persistent feeling of "lack" such as:
· craving to smoke,
· irritability, sleep disturbances,
· restlessness or impatience,
· difficulty concentrating,
Take the advice of your doctor or pharmacist as dose adjustment may be necessary.
· Support from healthcare professionals
The support, advice and follow-up that your doctor or pharmacist can provide will be invaluable during the first six months after you quit smoking. You can also resort to a specialized consultation to help with smoking cessation, especially if you have already failed.
· Psychological support
Quitting 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 after quitting smoking, you may notice moderate weight gain. If you have any concerns in this area, you can contact a healthcare professional who will be able to advise you.
Why did you start smoking again?
Consider this relapse as a mishap, as a normal learning event: relapse is not a failure.
Analyze the reasons why you have resumed smoking.
· Because of physical dependence
This may have been incorrectly taken into account or may reappear after several months, for example during prolonged stays in smoky atmospheres.
· Because of weight gain considered excessive
You may need to change your eating habits a bit before your next attempt to quit smoking.
· Due to a decrease in motivation ,
because of a painful event or a difficult period, because of psychological difficulties which appeared on stopping smoking (depression, anxiety, etc.), because of a very tempting situation. Understand the reason for this relapse to prevent it if possible on the next attempt.
In any case, do not hesitate to seek advice from a health professional or to resort to a specialized consultation to help with smoking cessation.
If you have started smoking again, do not be discouraged, experience shows that your chances of success increase after one or more attempts to quit.
Nicotine substitute
nicotine
. Presentations . Composition . Indications . Contraindications . Be careful . Drug interactions . Pregnancy and lactation . Instructions for use and dosage . Tips . Adverse effects . Lexicon
NIQUITIN GLACIAL MINT 2 mg: chewing gum (mint flavoring); box of 30.
Not refunded - Free price -
NIQUITIN GLACIAL MINT 2 mg: chewing gum (mint flavoring); box of 100.
Reimbursed at 65%. - price: 10.76 euro (s).
NIQUITIN GLACIAL MINT 4 mg: chewing gum (mint flavoring); box of 30.
Not refunded - Free price -
NIQUITIN GLACIAL MINT 4 mg: chewing gum (mint flavoring); box of 100.
Reimbursed at 65%. - price: 10.76 euro (s).
Perrigo Laboratory
| p eraser | p eraser | |
| Nicotine | 2 mg | 4 mg |
| Sorbitol | + | + |
| Maltitol | + | + |
Usual dosage:
