Nicorette Classic 4 mg - Chewing gum for smoking cessation

Nicorette belongs to a group of medicines used to help you stop smoking.

How to use

What is Nicorette and what is it used for?

Nicorette belongs to a group of medicines used to help you stop smoking.

Nicorette contains the active ingredient nicotine, which is absorbed into the body through the lining of the mouth.
By replacing nicotine through Nicorette, the withdrawal symptoms that occur when you stop smoking are reduced or at least significantly weakened, thus reducing the patient's cravings. These withdrawal symptoms include irritability, restlessness, anxiety, increased appetite, difficulty concentrating and sleeping, which in many cases cause the patient to start smoking again.
Nicorette helps and makes it easier to quit, even in difficult cases, although appropriate motivation, willpower and perseverance are essential for any withdrawal treatment.

If you want to quit smoking or reduce your cigarette consumption, Nicorette will help you and can therefore be used:

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

The success rate can be improved with additional advice and support measures.

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

How is it used?

What is Nicorette and what is it used for?

Nicorette belongs to a group of medicines used to help you stop smoking.

Nicorette contains the active ingredient nicotine, which is absorbed into the body through the lining of the mouth.
By replacing nicotine through Nicorette, the withdrawal symptoms that occur when you stop smoking are reduced or at least significantly weakened, thus reducing the patient's cravings. These withdrawal symptoms include irritability, restlessness, anxiety, increased appetite, difficulty concentrating and sleeping, which in many cases cause the patient to start smoking again.
Nicorette helps and makes it easier to quit, even in difficult cases, although appropriate motivation, willpower and perseverance are essential for any withdrawal treatment.

If you want to quit smoking or reduce your cigarette consumption, Nicorette will help you and can therefore be used:

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

The success rate can be improved with additional advice and support measures.

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

What should you consider before taking it?

What should you consider 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
• in 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) had a heart attack or a stroke.
• if you have chest pain (unstable angina pectoris) or angina pectoris at rest.
• if you have a heart condition that affects the rate or rhythm of your heartbeat.
• if you have high blood pressure that is not adequately controlled by medication.
• if you have severe or moderate liver disease.
• if you have severe kidney disease.
• if you have diabetes.
• if your thyroid gland is overactive.
• if you have a tumor of the adrenal glands (pheochromocytoma).
• if you have a stomach or duodenal ulcer.
• if you have inflammation of the esophagus (esophagitis).

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

High blood nicotine levels with corresponding side effects can occur if you smoke soon after chewing a Nicorette gum. Please consider in which situations the risk of reaching for a cigarette without thinking is particularly high for you. An existing nicotine addiction caused by tobacco can persist even when using nicotine replacement products, but using nicotine alone is less harmful than smoking tobacco.

Smokers with dentures may have problems chewing Nicorette gum. In this case, using Nicorette inhalations, lozenges, patches or spray may be more beneficial for you.

Danger to children

Dosages of nicotine that are well tolerated by adult smokers during treatment can cause severe poisoning in children, which can be fatal. It is therefore essential that you always keep Nicorette out of the sight and reach of children (see section "If you have used more Nicorette than you should").


Using Nicorette with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or are planning to take/use any other medicines.

If you stop smoking, the body's adjustment can increase the effect of insulin. Therefore, if you are diabetic and need insulin, your doctor may need to 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.

Using Nicorette with food and drink

No influence on the effect by food and beverages is known.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
It is very important to stop smoking during pregnancy, as smoking can lead to reduced growth of your baby and also to premature birth or stillbirth. It is best if you can quit smoking during pregnancy without using nicotine-containing medicines. If you are unable to do so, you should only use Nicorette gum after consulting your doctor or pharmacist.

Breastfeeding
Nicotine should be avoided during breastfeeding as nicotine passes into breast milk and can affect your baby. If your doctor has recommended that you use Nicorette gum, you should use the gum immediately after breastfeeding and not in the last two hours before breastfeeding.

Fertility
Smoking can have adverse effects on female and male fertility
have. It is not known what specific role nicotine plays in these effects. However, women who want to have children should, if possible, neither smoke nor use nicotine replacement therapy. Although smoking can have negative effects on male fertility, there is no evidence that special contraceptive measures are necessary for men undergoing nicotine replacement therapy.

Driving and using machines

Nicorette has no or negligible influence on the ability to drive and use machines.

Nicorette Classic 4 mg, Nicorette Freshfruit 4 mg and Nicorette Icemint 4 mg - Gum contain Butylhydroxytoluene (E 321) and Sodium
Nicorette Freshfruit 4 mg and Nicorette Icemint 4 mg - Gum contain Xylitol (E 967) Nicorette Classic 4 mg - Gum contains Sorbitol (E 420)

Nicorette Classic 4 mg - Gum contains Sorbitol. Sorbitol is a source of fructose. Talk to your doctor before you (or your child) use or receive this medicine if your doctor has told you (or your child) that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI) - a rare, inherited condition in which a person cannot break down fructose.

Nicorette Freshfruit 4 mg and Nicorette Icemint 4 mg - Gum contain Xylitol (E 967). One piece of gum contains 579.5 mg of xylitol. Xylitol can have a mild laxative effect. The calorific value is 2.4 kcal/g xylitol.

Nicorette Classic 4 mg, Nicorette Freshfruit 4 mg and Nicorette Icemint 4 mg - Gum contain Butylhydroxytoluene (E 321), which can irritate the lining of the mouth.
These medicines contain less than 1 mmol sodium (23 mg) per piece of gum, i.e. they are virtually "sodium-free".

How should the medicine be taken?

How to use Nicorette?

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

How should you chew Nicorette gum?

Use in the oral cavity.
The chewing method is not comparable to that of a conventional chewing gum. Please proceed as follows:

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

• Chew a piece of gum when you crave a cigarette.
• As soon as you feel a strong/peppery taste or a slight burning sensation (after
  approx. 1 minute), take a chewing break.
• To do this, slide the gum into the cheek pouch.
• Once the symptoms 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 chewing-chewing break process for about 30 minutes.
• When the gum has lost its flavor, please dispose of it carefully (e.g. you can put it back in the blister strip.).

How often should you use Nicorette gum?

Children and adolescents
Adolescents aged 12 - 18 years may only use Nicorette gum after consulting their doctor. There is limited experience with use in this age group.
Children under 12 years of age must not use Nicorette gum.


Adults and the elderly
You can chew a piece of gum every time you crave a cigarette.
To increase the chances of success in quitting smoking and to avoid relapses, it is important that you chew a sufficient amount of Nicorette gum each day. In smokers over 60 years of age, Nicorette has been shown to be as effective as in younger age groups.

• If you want to quit smoking completely
• Choose a specific day from which you want to quit smoking completely. Chew a Nicorette gum every time you crave a cigarette as described above.
• Most people need 8 to 12 pieces per day. However, you must not use more than 24 pieces per day. If you use more than 15 pieces of Nicorette 2 mg gum per day, you should switch to Nicorette 4 mg.
• After three months, you should start to gradually reduce your gum consumption. Once you are only using 1 to 2 pieces of gum per day, try to stop treatment. However, the gum should still be on hand for some time after the end of the
  treatment to counteract any renewed cravings for smoking.
• If you want to avoid smoking
  Use as described above during smoke-free periods, e.g. in non-smoking areas or in other situations when cravings occur but smoking should be avoided.
• If you want to reduce your cigarette consumption
  Nicorette gum is used between cigarettes and should replace as many cigarettes as possible. The aim is to gradually replace all cigarettes with gum. The gum should be chewed when you crave a cigarette as described above to extend the smoke-free intervals as much as possible. However, you must not use more than 24 pieces per day. The reduction in cigarette consumption should continue until you quit smoking completely. If you have quit smoking completely and are sure that you will not relapse, you should start to gradually reduce your gum consumption. Once you are only using 1 to 2 pieces of gum per day, try to stop treatment. However, the gum should still be on hand for some time after the end of the treatment to counteract any renewed cravings for smoking.
  If a reduction in cigarette consumption is not achieved after 6 weeks, you should seek professional help. You should have quit smoking completely as soon as possible, but no later than 6 months after starting treatment. If this is not possible despite serious efforts within 9 months of starting treatment, professional help should be sought.
  Every cigarette not smoked is a small step towards better health and eventual quitting!
  For example, proceed as follows:
• 1. Step - 0 to 6 weeks: Reduce cigarette consumption by 50%
  Chew a Nicorette 4 mg gum whenever you feel the urge to smoke. Aim to reduce your cigarette consumption by half by the end of the 6th week - or even sooner if you can.
• 2. Step - within 6 months
  Continue to reduce your cigarette consumption until you have quit smoking completely. Chew a Nicorette 4 mg gum whenever you feel the urge to smoke to avoid relapses. Aim to quit smoking within 6 months - or even sooner if you can.
• 3. Step - within 9 months: Quit smoking!

Use of the gum for longer than 12 months is not recommended. However, some ex-smokers may need a longer course of treatment to prevent relapse, which should then be done under medical supervision.
Advice and support from a professional should be sought at any time during smoking cessation therapy if there is a risk of relapse.

Patients with impaired liver and kidney function
Ask your doctor for advice before using Nicorette.

If you have used more Nicorette than you should

If many pieces of gum are chewed at the same time or too quickly after each other, or if you are taking too much nicotine in other ways at the same time (e.g. by smoking heavily), an overdose may occur.
The risk of poisoning from swallowing the gum is very low because nicotine is poorly absorbed by the body without chewing.

Signs of an overdose are: nausea, vomiting, increased salivation,
abdominal pain, diarrhea, sweating, headache, dizziness, hearing disturbances and pronounced weakness. In severe overdose, these symptoms can be followed by a drop in blood pressure, weak and irregular pulse, breathing problems, exhaustion, circulatory collapse and generalized seizures.

Children
Dosages of nicotine that are tolerated by adult smokers during treatment can cause severe poisoning in children, which can be fatal. Suspected nicotine poisoning in a child should be considered a medical emergency - contact a doctor immediately or go to the emergency room of the nearest hospital.

Treatment of overdose
In the event of nicotine overdose symptoms, temporarily stop taking nicotine. You should then reduce your nicotine intake by either reducing the frequency of nicotine intake or, if necessary, using a lower strength.
In the event of poisoning symptoms, nicotine intake must be stopped immediately. Notify a doctor immediately. He will provide symptomatic therapy 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 double the amount if you forget to use the previous one.

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

What side effects are possible?

How should Nicorette be stored?

Do not store above 25° C. Store in the original package 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