Nicorette 15 mg - inhalations 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 through the oral mucosa.
The intake 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.

Additional counselling and supportive measures can improve the success rate.

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 through the oral mucosa.
The intake 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 limit cigarette consumption in smokers who do not want to or cannot give up smoking.

Additional counselling and supportive measures can improve the success rate.

What should you pay attention to 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
.
• 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 (phaeochromocytoma).
• 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.
Transferred dependence on Nicorette inhalations may occur, but it is uncommon, less harmful and easier to break.

To avoid side effects and overdose, do not smoke at the same time as using the inhalations.

Nicorette inhalations should be used with caution in patients with chronic respiratory disease and obstructive pulmonary disease. In such cases, other dosage forms of Nicorette can be used.

In people who are not in the habit of inhaling tobacco smoke, excessive use of Nicorette inhalations can potentially lead to nausea, weakness and headaches (as can be the case when such patients inhale tobacco smoke).

If you are pregnant or breastfeeding, you should avoid all nicotine intake (see also "Pregnancy and breastfeeding").

Danger with small children.
Nicotine doses that are easily tolerated by adult smokers during treatment can cause severe symptoms of poisoning in young children, which can be fatal. If a child swallows a cartridge (unused or used), chews on it. or sucks, there is a risk of poisoning. Nicorette must therefore definitely be used for children. be kept inaccessible.

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.

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 inhalations after consulting your doctor or pharmacist.

Breastfeeding time
The use of Nicorette inhalations 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 inhalers, you should use them immediately after breastfeeding and not in the last two hours before breastfeeding.

Pregnancy (fertility)
Smoking can have adverse effects on female and male fertility. 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.

How should the medicine be taken?

HOW TO USE NICORETTE?

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

How should you use Nicorette inhalations?

.

• Take the mouthpiece out of the packaging. Turn the two parts against each other until the marks form a line. Then you can pull off the top part.
• Then remove a cartridge from the blister pack. Press it into the lower part of the mouthpiece until the aluminium seal of the cartridge is pierced.
• Place the upper part back on the mouthpiece. After re-aligning the markings, press the two parts together to also pierce the upper aluminium seal of the cartridge. The mouthpiece is closed by twisting the two parts against each other.
• Nicorette is now ready for use for inhalation.
• Nicotine is released by sucking air out of the plastic layer and enters your body through the oral mucosa.
• Your individual inhalation technique (deep inhalation or continuous shallow puffs) allows you to control the amount of nicotine released yourself
.
• If withdrawal symptoms are not sufficiently relieved, the intensity and/or frequency of puffs should be increased. For example, one cartridge can be used intensively for 8 times 5 minutes. For less intensive inhalation, the nicotine content of the cartridges may last longer.
• If you feel a burning sensation in your mouth or throat, pause until these phenomena subside.
• After a few days, you will certainly have mastered the inhalation technique that suits you personally.
• Always carry the inhalations with you to have them available in case of need.
• After inhalation, the used nicotine cartridge is removed from the mouthpiece and discarded.

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

Monotherapy

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

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

If you want to stop smoking completely

• Commit to a specific day from which you want to stop smoking completely. For smoking cravings, use Nicorette inhalers as directed above.
• A minimum of 3 cartridges but a maximum of 6 cartridges should be used per day.
• After three months, you should start to gradually reduce cartridge consumption. As soon as you use only 1 cartridge a day, try to stop the treatment. In case you suddenly feel a strong craving for cigarettes, always keep a few cartridges handy.

If you want to avoid smoking

• Application is as described above during smoke-free periods, e.g. in non-smoking areas or in other situations when smoking cravings occur but smoking is to be avoided.

If you want to limit cigarette consumption

• The use of Nicorette inhalations takes place between cigarette consumption and should replace as many cigarettes as possible. The goal is to gradually replace all cigarettes with inhalations. The inhalations should be used as described above in case of smoking cravings in order to extend the smoke-free intervals as far as possible.
• Please note the recommended maximum dose of 6 cartridges per day.
• The reduction of cigarette consumption is to be continued until complete cessation. Once you have completely stopped smoking and are sure you will not relapse, you should start to gradually reduce cartridge consumption.
• Once you stop using only 1 cartridge a day, try stopping the treatment. In case you suddenly feel a strong craving for cigarettes, always keep a few cartridges handy.
• 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, despite serious efforts, this does not succeed within 9 months from the start of treatment, professional help should be sought.
  Every cigarette not smoked is a small step towards better health and eventual cessation!

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

Children and young people:
Persons under 18 years of age must not use Nicorette inhalations in combination with Nicorette patches. Children under the age of 12 should not use Nicorette inhalers 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 inhalations because of local side effects, you can also use Nicorette patches in addition to Nicorette inhalations.

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 inhalations. In general, 2 cartridges daily are sufficient to achieve an appropriate effect. This amount should be maintained for 8 weeks and then gradually reduced. No more than 6 cartridges should be used per day.

Progression of the combined application
After the initial combined use of Nicorette patches and Nicorette inhalations for 8 weeks, the further course of smoking cessation can be done in two ways.

• Either a lower patch strength (15 and/or 10 mg/16 h) is then used for a further 4 weeks. This involves maintaining the concomitant use of Nicorette inhalations at the daily dose as at the start of treatment and then then gradually reducing it within 12 months of starting therapy.
• Or the use of the patch is stopped altogether after the initial phase and the number of cartridges 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 Inhalations 15 mgas needed
the first 8 weeks 1 Nicorette patch
it will be 2 cartridges daily 25 mg/16 h daily.
recommended

Continuation of treatment - 1st variant or.

for another 2 weeks 1 Nicorette patch
as required
15 mg/16 h daily

for another 2 weeks 1 Nicorette patch
as required
10 mg/16 h daily
No more patch for up to 12 months gradual reduction of cartridges

Continuation of treatment - 2nd variant.
Up to 12 months No more patch Gradual reduction of cartridges

Recommended dosage for smokers who are less addicted to tobacco.
(up to and including 20 cigarettes a day)

Start of treatment.

Time period Pavement Inhalations 15mg.
as required
the first 8 weeks 1 Nicorette patch
There are 2 cartridges daily 15 mg/16 h daily.
recommended.

Continuation of treatment - 1st variant or.

for another 4 weeks 1 Nicorette patch
as required
10 mg/16 h daily

No more patch for up to 12 months gradual weaning of cartridges

Continuation of treatment - 2nd variant.

No more patch for up to 12 months gradual weaning of cartridges

Use of the inhalations 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.

If you have used a larger amount of Nicorette than you should.
If several inhalations are inhaled too quickly one after the other or if you ingest excessive nicotine in other ways at the same time (e.g. through heavy smoking), an overdose may occur.
The symptoms of an overdose of Nicorette inhalations correspond to those of acute nicotine poisoning: 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, which can be fatal. Suspected nicotine poisoning in a child is to be considered a medical emergency - 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 use 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 TO STORE NICORETTE?

Do not store above 25 ° C.

Keep this medicine out of the reach of children.

Do not use this medicinal product after the expiry date which is stated on the outer carton and blister packs after "EXP" or "EXP". 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 TO STORE NICORETTE?

Do not store above 25 ° C.

Keep this medicine out of the reach of children.

You must not use this medicinal product after the expiry date which is stated on the outer carton and blister packs after ,,Use by" or ,,Used by". Do not use after the stated expiry date. 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

PACKAGE CONTENTS AND FURTHER INFORMATION

What Nicorette contains

- The active ingredient is: Nicotine. 1 cartridge contains 15 mg nicotine.
- The other ingredients are: Levo-menthol and a permeable polyethylene plastic layer.

What Nicorette looks like and contents of the pack

These are cartridges for inhalation.
Nicorette smoking cessation inhalers consist of a permeable polyethylene layer containing nicotine and menthol. This layer is in a transparent tube, which is sealed on both sides with aluminium foil to form a cartridge. Inserting the cartridge into the mouthpiece breaks the aluminium seal.
Nicorette inhalers are available in packs of 4 cartridges (with mouthpiece) and 20 cartridges (with mouthpiece).

Not all pack sizes may be marketed.