Nicorette Icemint 2 mg - Chewing gum for smoking cessation

Nicorette belongs to a group of medicines used for smoking cessation.

Application

What is Nicorette and what is it used for?

Nicorette belongs to a group of medicines used for smoking cessation.

Nicorette contains nicotine as the active ingredient, which enters the body via the oral mucosa.
The supply of nicotine by means of Nicorette ensures that the withdrawal symptoms that occur as a result of nicotine withdrawal do not occur, or at least occur in a significantly weakened form, thus reducing the patient's desire to smoke. These withdrawal symptoms include above all irritability, restlessness, anxiety, increased appetite, concentration and difficulty falling asleep, which in many cases cause the patient to take up smoking again.
Nicorette serves as a help and facilitates the withdrawal even in difficult cases, whereby appropriate motivation, willpower and perseverance are necessary prerequisites for any cessation cure.

If you want to stop smoking or limit your cigarette consumption, Nicorette will support you in this and can therefore be used:

to help smokers quit smoking
as an aid for smokers during certain periods when cigarette consumption is not possible or desirable.
as an aid for smokers during certain periods when cigarette consumption is not possible or desirable (temporary abstinence)
to restrict cigarette consumption in smokers who do not want to or cannot give up smoking.

The success rate can be improved by additional counselling and supportive measures.

If you smoke less than 20 cigarettes a day, Nicorette 2 mg - chewing gum is suitable. If you smoke more than 20 cigarettes a day, Nicorette 4 mg - chewing gum is cheaper.

How is it applied?

What is Nicorette and what is it used for?

Nicorette belongs to a group of medicines used for smoking cessation.

Nicorette contains nicotine as the active ingredient, which enters the body via the oral mucosa.
The supply of nicotine by means of Nicorette ensures that the withdrawal symptoms that occur as a result of nicotine withdrawal do not occur, or at least occur in a significantly weakened form, thus reducing the patient's desire to smoke. These withdrawal symptoms include above all irritability, restlessness, anxiety, increased appetite, concentration and difficulty falling asleep, which in many cases cause the patient to take up smoking again.
Nicorette serves as a help and facilitates the withdrawal even in difficult cases, whereby appropriate motivation, willpower and perseverance are necessary prerequisites for any cessation cure.

If you want to stop smoking or limit your cigarette consumption, Nicorette will support you in doing so and can therefore be used:

• For smoking cessation in smokers who want to give up smoking
.
• as an aid for smokers during certain periods in which cigarette consumption is not possible or not desired (temporary abstinence)
.
• to restrict cigarette consumption in smokers who do not want to or are unable to give up smoking.

Additional counselling and supportive measures can improve the success rate.

If you smoke less than 20 cigarettes a day, Nicorette 2 mg - chewing gum is suitable. If you smoke more than 20 cigarettes a day, Nicorette 4 mg chewing gum is cheaper.

What should you pay attention to before taking it?

What should you be aware of before using Nicorette?
Nicorette must not be used,

.

• If you are allergic to nicotine or any of the other ingredients of this medicine listed in section 6.
.
• for non-smokers, occasional smokers and children under 12 years of age.

Warnings and precautions
Please talk to your doctor or pharmacist before using Nicorette if you have any of the following conditions:

• If you have recently (within the last 3 months) suffered a heart attack or a stroke.
• If youhave chest pain (unstable angina) or angina at rest.
• if you have a heart condition that affects the speed of your heartbeat or your heart rhythm.
• If you suffer fromhypertension which is not sufficiently adjusted by medicines.
• If you have a severe or moderate liver disease.
• If you suffer from severe kidney disease.
• If you have diabetes.
• If your thyroid is overactive.
• If you have a tumour of the adrenal glands (pheochromocytoma).
• If you have a stomach or duodenal ulcer.
• If you suffer from inflammation of the oesophagus (oesophagitis).

Your doctor will carefully weigh up the risks of nicotine replacement therapy against those of continuing to smoke.

High nicotine concentrations in the blood with corresponding side effects can occur if you smoke soon after chewing Nicorette gum. Think about the situations in which you are most at risk of mindlessly reaching for a cigarette.An existing addiction to nicotine caused by tobacco can persist even with the use of nicotine replacement products, but the use of nicotine alone is less harmful than tobacco smoking.

Smokers with dentures may have problems chewing Nicorette gum. In this case, you may find it more beneficial to use Nicorette inhalers, lozenges, patches or spray.

Danger with small children.
Doses of nicotine that are easily tolerated by adult smokers during treatment can cause severe symptoms of poisoning in young children, which can be fatal. It is therefore essential that you always store Nicorette out of sight and reach of children.

Use of Nicorette with other medicines.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

When you stop smoking, the body's change can increase the effect of insulin. If you are diabetic and need insulin, your doctor may therefore reduce your insulin dose.
The effectiveness of other medicines may also increase:

• Theophylline for the treatment of asthma
.
• Tacrine for the treatment of Alzheimer's disease
.
• Clozapine for the treatment of schizophrenia
.
• Ropinirole for the treatment of Parkinson's disease.

Use of Nicorette. Together with food and drink.
Food and drink are not known to influence the effect.


Pregnancy, lactation and procreation/parturition.
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
It is very important to stop smoking during pregnancy because smoking can lead to reduced growth of your baby and also to premature birth or stillbirth. It is best if you can stop smoking during pregnancy without using nicotine-containing medicines. If you do not succeed, you should only use Nicorette chewing gum after consulting your doctor or pharmacist.

Breastfeeding time
The use of Nicorette chewing gum should be avoided during breast-feeding as nicotine passes into breast milk and can affect your baby. If your doctor has advised you to use Nicorette chewing gum, you should use it immediately after breastfeeding and not in the last two hours before breastfeeding.

Pregnancy (fertility)
Smoking can have adverse effects on female and male fertility (fertility).
have. It is not known what specific part nicotine plays in these effects. However, women who wish to have children should, if possible, neither smoke nor take nicotine replacement therapy. Although smoking may have negative effects on male fertility, there is no evidence that special contraceptive measures are needed for men on nicotine replacement therapy.

Driving ability and ability to operate machinery.
Nicorette has no or only a very slight effect on the ability to drive and use machines.

Important information about certain other ingredients of Nicorette.

Nicorette 2 mg - chewing gum contains sorbitol. Please only take the chewing gum after consulting your doctor if you are known to suffer from a sugar intolerance.Nicorette 2 mg, Nicorette Freshfruit 2 mg and Nicorette Icemint 2 mg - chewing gum contain butylated hydroxytoluene (E 321), which can cause irritation of the oral mucosa.

How should the medicine be taken?

How to use Nicorette?

Always use this medicine exactly as described in this leaflet or as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

How should you chew Nicorette gum ?
The chewing method is not like that of conventional chewing gum. Please proceed as follows:

First chew the gum to release nicotine. Then take a chewing break so that the nicotine is absorbed into the body. Nicotine dissolved in saliva is not effective and can cause throat irritation and hiccups.

.

• Chew a piece of gum if you have a smoking craving.
• As soon as you feel a strong/peppery taste or a slight burning sensation (after approx. 1 minute), take a chewing break.
• Slide the chewing gum into the cheek pocket to do so.
• After the phenomena have subsided, start chewing again until you feel a strong/peppery taste or a slight burning sensation again.
• Then take another chewing break.
• Repeat the chew-chew pause procedures for about 30 minutes.
• If the chewing gum has lost its flavour, please dispose of it carefully (you can return it to the blister strip, for example.).

Nicorette chewing gum can be used alone (monotherapy) or together (combination therapy) with Nicorette patches (25 mg/16 h, 15 mg/16 h, 10 mg/16 h).

Monotherapy

Children and young people:
People under the age of 18 should only use Nicorette chewing gum after consulting their doctor. Children under 12 years of age must not use Nicorette chewing gum.

Adults and elderly:
You can chew gum every time you feel a craving for cigarettes.
To increase the chances of smoking cessation success and avoid relapse, it is important that they chew a sufficient amount of Nicorette gum every day. In smokers over 60 years of age, Nicorette proved equally effective as in younger age groups.

• If you want to stop smoking completely
.
• Commit to a specific day from which you want to stop smoking completely. Chew a Nicorette chewing gum as indicated above
  every time you want to smoke.
• Most people need 8 to 12 a day. However, you may use a maximum of 24 pieces per day. If you use more than 15 pieces of Nicorette 2 mg chewing gum a day,
  you should switch to Nicorette 4 mg.
• After three months, you should start to gradually reduce your chewing gum consumption. As soon as you only use 1 to 2 chewing gums a day, try to stop the treatment. However, the chewing gum should always be at hand for a certain time after the end of the treatment in order to counteract a renewed craving for smoking.
• If you want to avoid smoking
  The application is as described above during smoke-free periods, e.g. in non-smoking zones or in other situations when smoking cravings occur but smoking is to be avoided.
• If you want to cut down on cigarette consumption
  The Nicorette chewing gum is used between cigarette consumption and is intended to replace as many cigarettes as possible. The goal is to gradually replace all cigarettes with chewing gum. The chewing gum should be chewed as indicated above when smoking is desired in order to extend the smoke-free intervals as far as possible. However, you may use a maximum of 24 pieces per day. The reduction of cigarette consumption must be continued until complete cessation. Once you have completely stopped smoking and are sure you will not relapse, you should start to gradually reduce your gum use. As soon as you only use 1 to 2 chewing gums a day, try to stop the treatment. However, the chewing gum should always be at hand for a certain time after the end of treatment to counteract a renewed desire to smoke.
  If a reduction in cigarette consumption is not achieved after 6 weeks, you should seek professional help. You should have given up smoking completely as soon as possible, but at the latest after 6 months from the start of treatment. If this is not achieved within 9 months from the start of treatment despite serious efforts, professional help must be sought.
  Every cigarette you don't smoke is a small step towards better health and eventual cessation!
  For example, do the following:
• 1st step - 0 to 6 weeks: Reduce cigarette consumption by 50%
  Chew a Nicorette gum 2 mg whenever you feel a urge to smoke. Resolve to reduce your cigarette consumption by half by the end of week 6 - or even earlier if you can.
• 2nd step - within 6 months
  Continue to reduce your cigarette consumption until you have given up smoking completely. Chew a Nicorette gum 2 mg whenever you feel the craving for cigarettes to avoid relapses. Resolve to quit smoking within 6 months - or even sooner if you are able.
• 3rd step - within 9 months: Give up smoking!

Combined therapy
Use together with Nicorette patches (25 mg/16 h, 15 mg/16 h, 10 mg/16 h) for . Relaxation
(Please also note the instructions for use of the Nicorette patches).

Children and young people:
People under 18 years of age must not use Nicorette chewing gum in combination with Nicorette patches. Children under the age of 12 should not use Nicorette gum or patches.

Adults and elderly:
If you have not been successful with monotherapy, if you experience acute or uncontrollable smoking cravings while on monotherapy, or if you want to reduce the daily consumption of Nicorette chewing gum because of local side effects in the mouth, you can also use Nicorette patches in addition to Nicorette 2 mg - chewing gum. Also with combination therapy, the dosage is individual and depends on the smoker's cigarette consumption.

Start of treatment
Treatment should be started with a Nicorette patch 25 mg/16 h or 15 mg/16 h daily. The patch is applied to an undamaged area of skin in the morning after waking up and removed before going to bed. The application is combined with Nicorette 2 mg - chewing gum. At least 4 chewing gums of 2 mg should be used daily. Generally, 5 to 6 chewing gums are sufficient to achieve an appropriate effect. This amount should be maintained for 8 weeks and then gradually reduced. No more than 24 chewing gums should be used per day.

Progression of the combined application
After the initial combined use of Nicorette Patch and Nicorette Chewing Gum 2 mg for 8 weeks, the further course of smoking cessation can be done in two ways.

• Either a lower patch strength (15 mg/16 h or 10 mg/16 h) is then used for a further 4 weeks. In this case, the concomitant use of Nicorette 2 mg chewing gum is maintained at the daily dose as at the start of treatment and then then gradually reduced within 12 months of the start of therapy.
• Or the use of the patch is stopped completely after the initial phase and the number of chewing gums is gradually reduced within a total of 12 months.

Recommended dosage for smokers who are heavily addicted to tobacco.
(more than 20 cigarettes a day)

Start of treatment.

Time period Pavement 2 mg of chewing gum.
as required
the first 8 weeks 1 Nicorette patch
5 - 6 chewing gums 25 mg/16 h daily
recommended daily

Continuation of treatment - 1st variant or.

for a further 2 weeks, 1 Nicorette patch 15 mg/16 h daily as needed.

for another 2 weeks 1 Nicorette patch
as required
10 mg/16 h daily
No more patches for up to 12 months Gradual reduction in the use of chewing gum
Continuation of treatment - 2nd variant.

No more patches for up to 12 months Gradual reduction in the use of chewing gum
Recommended dosage for smokers who are less addicted to tobacco.
(up to and including 20 cigarettes a day)

Start of treatment.

Time period Pavement 2 mg of chewing gum.
as required
the first 8 weeks 1 Nicorette patch
There are 5 - 6 chewing gums 15 mg/16 h daily.
recommended daily.

Continuation of treatment - 1st variant or.

for another 4 weeks 1 Nicorette patch
as required
10 mg/16 h daily
No more patches for up to 12 months Gradual weaning from chewing gum

Continuation of treatment - 2nd variant.

No more patches for up to 12 months Gradual weaning from chewing gum

Use of the chewing gum for longer than 12 months is not recommended. For some ex-smokers, however, a longer treatment period might be necessary to prevent the resumption of smoking, which should then be done with medical supervision.
The advice and support of professional help should be sought at any point in smoking cessation therapy when there is a risk of relapse.

Patients with liver and kidney dysfunction
Be sure to ask your doctor for advice before using Nicorette.

If you have used a larger amount of Nicorette than you should.
If many chewing gums are chewed at the same time or too quickly one after the other, or if you ingest excessive nicotine in other ways at the same time (e.g. by smoking heavily), an overdose may occur.
The risk of poisoning from swallowing the chewing gum is very low, because the nicotine is not
chewing is poorly absorbed by the body.

Signs of an overdose are: Nausea, vomiting, increased salivation,
Abdominal pain, diarrhoea, sweating, headache, dizziness, hearing disorders and pronounced feeling of weakness. In severe overdose, these symptoms may be followed by a drop in blood pressure, weak and irregular pulse, breathing problems, exhaustion, circulatory collapse and generalised seizures.

Children
Doses of nicotine that are tolerated by adult smokers during treatment can cause severe symptoms of poisoning in young children that are fatal
can. Suspected nicotine poisoning in a child is considered a medical emergency.
view - sit down immediately contact your doctor or go to the emergency room.
of the nearest hospital.

Treatment of overdose
In case of nicotine overdose symptoms, temporarily stop taking nicotine. Remove any Nicorette patches immediately and wash the application site. You should then reduce your intake of nicotine, either by reducing the frequency of nicotine intake or by using a lower strength if necessary.
If symptoms of poisoning occur, the nicotine intake must be stopped immediately. Notify a doctor immediately. He will treat symptomatically if necessary. If excessive amounts of nicotine are swallowed, taking activated charcoal reduces the absorption of nicotine in the gastrointestinal tract.

If you forget to use Nicorette.
Do not use a double dose if you have forgotten to use it before.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are the possible side effects?

How should Nicorette be stored?

Do not store above 25° C. Keep in the original pack to protect the contents from light.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the blister pack and outer carton. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

How should Nicorette be stored?

Do not store above 25° C. Keep in the original pack to protect the contents from light.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the blister pack and outer carton. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information

What Nicorette contains

The active ingredient is: Nicotine Resinate. 1 chewing gum contains 2 mg nicotine as the active ingredient as a resinate in a special sugar-free chewing gum base.

The other ingredients are:
Nicorette® 2 mg
chewing gum base (contains butylated hydroxytoluene (E 321)), sodium carbonate, sodium hydrogen carbonate, sorbitol, glycerol, flavourings
Nicorette® Freshfruit 2 mg
Core: chewing gum base (contains butylated hydroxytoluene (E 321)), xylitol, peppermint oil, anhydrous sodium carbonate, sodium bicarbonate, acesulfame potassium, menthol, light magnesium oxidecoating (intermediate layer): Tuttifrutti QL84441, hypromellose, sucralose, polysorbate 80
Coating (outer layer): Xylitol, Arabic gum, titanium dioxide (E 171), Tuttifrutti QL84441, carnauba wax
Nicorette® Icemint 2 mg
Core: chewing gum base with abrasive properties (contains butylated hydroxytoluene (E 321)), xylitol, peppermint oil, anhydrous sodium carbonate, sodium hydrogen carbonate, acesulfame potassium, menthol, light magnesium oxide
coating (intermediate layer): Winterfresh, hypromellose, sucralose, polysorbate 80
Coating (outer layer): Xylitol, pregelatinised starch, titanium dioxide (E 171), winterfresh, carnauba wax

.What Nicorette looks like and contents of the pack

Square, beige chewing gum measuring approximately 14 x 14 x 5 mm or.
Square white-coated chewing gum measuring approximately 15 x 15 x 6 mm (Freshfruit and Icemint) is available in blister packs of 15 in packs of 30, 105 and 210 (Nicorette® 2 mg only).

Not all pack sizes may be marketed.