Nicorette 15 mg/16 h - transdermal patch

Nicorette belongs to a group of medicines used for smoking cessation.Nicorette contains nicotine as the active ingredient, which is delivered to the body through the skin in a steady and controlled manner over 16 hours.

Application

WWhat 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 is delivered to the body through the skin in a steady and controlled manner over 16 hours.
The supply of nicotine by means of Nicorette patches ensures that the withdrawal symptoms caused by nicotine withdrawal do not occur, or at least 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 withdrawal cure.

Nicorette patches can also be used as an aid for smokers during temporary abstinence for periods when cigarette consumption is not possible or not desired.

Additional counselling and supportive measures can improve the success rate.

How is it applied?

WWhat 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 is delivered to the body through the skin in a steady and controlled manner over 16 hours.
The supply of nicotine by means of Nicorette patches ensures that the withdrawal symptoms caused by nicotine withdrawal do not occur, or at least 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 withdrawal cure.

Nicorette patches can also be used as an aid for smokers during temporary abstinence for periods when cigarette consumption is not possible or not desired.

Additional counselling and supportive measures can improve the success rate.

What should you pay attention to before taking it?

WAS S SHOULD S.IE BEWARE BEFORE ANUSING 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 or to the patch itself.
.
• 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.
To avoid the risk of burns, Nicorette patches should be removed before a magnetic resonance imaging (MRI) scan. .
A pre-existing addiction to nicotine caused by tobacco may persist even with the use of nicotine replacement products, but the use of nicotine alone is less harmful than tobacco smoking. .
To avoid side effects and overdose, do not smoke or take nicotine in any other form at the same time (exception: dosage recommendation for combination with Nicorette chewing gum 2 mg, Nicorette 2 mg lozenges, Nicorette 15 mg inhalations or Nicorette spray).
In case of severe or persistent skin irritation, discontinue treatment and switch to another dosage form.
The same warnings and precautions apply to the combination of Nicorette patches with Nicorette 2 mg chewing gum or Nicorette 15 mg inhalers. Nicorette 15 mg inhalers, Nicorette Icemint 2 mg lozenges or Nicorette spray, the same warnings and precautions for use apply as for those of the individual preparations (see leaflet for Nicorette 2 mg chewing gum, Nicorette 15 mg inhalers, Nicorette Icemint 2 mg lozenges or Nicorette 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. Even used nicotine patches contain enough nicotine residues to be harmful to children. 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 or change:

• 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, breastfeeding. and procreative/procreative capacity.
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
Smoking can cause serious harm to the foetus and the infant and should therefore be stopped. Pregnant smokers should undertake smoking cessation without the support of nicotine-containing medicines. The use of Nicorette should only be considered after consultation with the doctor if there is a risk of continuing to smoke. In this case, the doctor must weigh the risks of continuing to smoke (possibly higher nicotine plasma levels, harmful substances from tobacco smoke) against the risk of nicotine replacement treatment.

Breastfeeding time
Nicotine passes freely into breast milk in amounts that can affect the infant even in therapeutic doses. The use of Nicorette should therefore be avoided during breastfeeding. If smoking cessation is not achieved, the use of nicotine replacement therapy in breastfeeding smokers should only be initiated after consultation with a healthcare professional. Flexible-dose products (such as gum, lozenge, inhalers, spray) may be preferable as they usually result in a lower daily nicotine dose than patches. When using flexible dosage products, women should apply the medicine immediately after breastfeeding and allow as much time as possible between the application of the flexible dosage form and the next breastfeeding (2 hours is recommended).

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 negligible effect on the ability to drive and operate machinery.

How should the medicine be taken?

WHYIS NICORETTE TO BE USED?

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.

Nicorette patches can be used alone (monotherapy) or together with Nicorette chewing gum 2 mg, Nicorette 15 mg inhalations, Nicorette Icemint 2 mg lozenges or Nicorette spray (combination therapy)

During treatment with Nicorette patches, smoking should be completely stopped.

Smoking cessation with immediate smoking cessation
<.strong>Monotherapy
Adults and elderly
The recommended dose is:
The dosage should be based on the smoker's tobacco dependence.

• Smokers who are heavily addicted to tobacco (more than 20 cigarettes a day):
  Dosing regimen: Heavy smokers
  Duration of
  (more than 20 cigarettes per day)
  Application
  .Phase 1 Nicorette 25 mg/16 h - transdermal patch 8 weeks
  Phase 2 Nicorette 15 mg/16 h - transdermal patch 2 weeks
  Phase 3 Nicorette 10 mg/16 h - transdermal patch 2 weeks
.
• Smokers who are less heavily addicted to tobacco (up to and including 20 cigarettes a day): Dosing regimen: Weak smokers
  Duration of
  (up to and including 20 cigarettes a day)
  .Application
  Phase 2 Nicorette 15 mg/16 h - transdermal patch 8 weeks
  Phase 3 Nicorette 10 mg/16 h - transdermal patch 4 weeks
.

Duration of use for monotherapy
The duration of the treatment is 3 months. For some former smokers, a longer treatment may be necessary to avoid a relapse into the old smoking habits. Use of the patch for longer than 6 months is generally not recommended. In this case, consultation with the doctor should take place.

Children and young people
In adolescents aged 12 - 18 years, Nicorette 25 mg/16 h - transdermal patch should not be used as no data on safety and efficacy are available.
In adolescents aged 12 - 18 years, Nicorette 15 mg/16 h and 10 mg/16 h - transdermal patch should only be used on the express recommendation of a doctor. There is limited experience for treating this age group with Nicorette.
Nicorette must not be used in children under 12 years of age.

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

Combined therapy
Use together with Nicorette chewing gum 2 mg, Nicorette 15 mg inhalations,. Nicorette Icemint 2 mg lozenges or Nicorette spray.
(Please also refer to the instructions for use of Nicorette chewing gum 2 mg, . Nicorette 15 mg inhalers, Nicorette Icemint 2 mg lozenges or Nicorette . spray)
Children and young people
Combination therapy is not recommended for children and adolescents aged 12 - 18 years due to lack of safety data.
Use is contraindicated in children under 12 years of age.
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 had success with monotherapy, if you experience acute or uncontrollable smoking cravings while on monotherapy, or if you want to reduce your daily consumption of Nicorette flexible dosage forms (such as gum, inhalers, lozenges, spray) because of local side effects.In addition to Nicorette Patches (10, 15 or 25 mg/16h), you can also use Nicorette 2 mg chewing gum, Nicorette 15 mg inhalers, Nicorette Icemint 2 mg lozenges or Nicorette Spray.
The patch is used with the same dosing regimen as for monotherapy. In addition, another Nicorette dosage form is used as needed. Also in combination therapy, the dosage is individual and is based on the smoker's tobacco dependence.
Progress of the combined application
After the initial combined use of Nicorette patches and Nicorette chewing gum 2 mg, Nicorette 15 mg inhalations, Nicorette Icemint 2 mg lozenges or Nicorette spray for 8 weeks, the further course of smoking cessation can be done in two ways.

• Either a lower patch strength (15 mg/16 h and/or 10 mg/16 h) is then used for a further 4 weeks. In this context, the concomitant use of the oral
  drug forms of Nicorette 2 mg chewing gum, Nicorette 15 mg inhalations, Nicorette Icemint 2 mg lozenges or Nicorette Spray 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 use of the oral dosage forms of Nicorette 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
2 mg Suck-
Inhalations
Spray Chewing gum
tablet
15 mg
as required
the first
1 Nicorette
as required
it will
as required
as required
8 weeks
Pavement
there will be 2
5 - 6
(maximum
(maximum
25 mg/16 h
Cartridges
Chewing gums
15 suck-
48 sprays)daily
daily
daily
tablets)
recommended
recommended

Continuation of treatment - 1st variant or.

1 Nicorette
other
as needed as needed as neededPatches
2 weeks
15 mg/16 h
daily
1 Nicorette
other
as needed as needed as neededPatches
2 weeks
10 mg/16 h
daily
no plaster
step by step
step by step
step by step
step by step up to
more
Reduction of the
Reduction of the
Reduction of the
Reduction of the 12 months
Application
Application
Cartridges
Application of the
the
SpraysGums
Sliding tablets

Continuation of treatment - 2nd variant.
step by step
step by step
step by step
step by step no plaster
up to
Reduction of the
Reduction of the
Reduction of the
Reduction of the more
12 months
Application
Application
Cartridges
Application of the
the
SpraysGums
Sliding tablets

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
2 mg Suck-
Inhalations
Spray Chewing gum
tablet
15 mg

as required
the first
1 Nicorette
it will
as required
it will
as required
8 weeks
Pavement
5 - 6
(maximum
2 cartridges
(maximum
15 mg/16 h
Chewing gums
15 suck-
daily
48 sprays)daily
daily
tablets)
recommended
as required
recommended

Continuation of treatment - 1st variant or.

1 Nicorette
other
as needed as needed as neededPatches
4 weeks
10 mg/16 h
daily
no plaster
step by step
step by step
step by step
step by step up to
more
Reduction of the
Reduction of the
Reduction of the
Reduction of the 12 months
Application
Application
Cartridges
Application of the
the
SpraysGums
Sliding tablets

Continuation of treatment - 2nd variant.

step by step
step by step
step by step
step by step no plaster
up to
Reduction of the
Reduction of the
Reduction of the
Reduction of the more
12 months
Application
Application
Cartridges
Application of the
the
SpraysGums
Sliding tablets

Duration of use for combination therapy
The duration of treatment with the patch is 2 or 3 months for combination therapy. Subsequently, treatment can be continued with the additional dosage form alone. Results from controlled clinical studies over a period of 12 months are available for the combination therapy.
Generally, use beyond 12 months is not recommended. However, some smokers need a longer treatment to avoid a relapse into their smoking habits, which should then be done with medical supervision. When using combination therapy, reference is also made to the technical and directions for use of the chosen additional dosage form. The advice and support of professional help should be sought at any stage of smoking cessation therapy when there is a risk of relapse.
Temporary Non-Smoking (Temporary Abstinence)

Use during smoke-free periods, e.g. in non-smoking areas or in other situations when smoking cravings occur but smoking should be avoided.Use a Nicorette patch instead of smoking - see dosage recommendation for smoking cessation with immediate smoking cessation.

Type of application
Daily in the morning, immediately after getting up, a patch is applied as described below after removing the protective film to a clean, dry, hairless and uninjured area of skin on the upper body, upper arm or hip. To do this, press the patch firmly against the skin for 10 - 15 seconds.

1. Before applying the patch, you should wash your hands.

2. Cut the bag with a pair of scissors along the
Put on the line marked and take out the patch.

3. peel off part of the silvery aluminium protective layer.
When doing this, avoid the adhesive part of the plaster with the
Touch the plaster with your fingers so as not to impair its adhesive properties.
to reduce.

4. Carefully apply the adhesive side of the plaster to a clean surface,
dry, hairless and uninjured area of skin on the upper body,
Upper arm or attached to the hip. Then remove
the second part of the silvery aluminium protective layer.

5. Press the plaster firmly with the palm of your hand or the
Finger tips on the skin.
6. once again run your fingers firmly over the edges of the
Patch to ensure that the patch adheres firmly.

Afterwards, you should wash your hands thoroughly so that nicotine sticking to your fingers does not accidentally get into your eyes.

The maximum nicotine level in the blood is reached in the afternoon (approx. 8 hours after applying the patch) when the risk of relapse is greatest. In the evening before bedtime
the patch is removed again (i.e. the patch usually remains on the skin for 16 hours). In this way, treatment with the 16-hour patch mimics the change in nicotine levels corresponding to the wake/sleep change in smokers. These also do not absorb nicotine during sleep. In patients who react to nicotine administration during sleep with sleep disturbances, this side effect can thus be avoided.
The next morning, stick a fresh plaster on another part of the skin. The same skin area should only be reapplied after a few days.
If you have used a larger amount of Nicorette than you should.
Overdose can occur if you have used several patches at the same time, if you have chosen a patch strength that is too strong, or if nicotine has been added in other forms (smoking, nicotine substitutes other than those recommended for combination therapy).

The symptoms of a Nicorette overdose 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. Remove any Nicorette patches immediately and wash the application site. 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 transdermal patch.
Do not apply two patches at the same time to make up for a forgotten application, but continue as usual.

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

What are the possible side effects?

WHATIS NICORETTE TO STORE?

Do not store above 25°C.

Store this medicine out of the reach of children.
As the patches still contain nicotine after use, used patches must be disposed of in such a way that they cannot get into the hands of children under any circumstances. Therefore, dispose of the patches carefully after use by folding them in half with the adhesive layer facing inwards so that the two halves stick together.
You must not use this medicinal product after the expiry date which is stated on the folding box and protective sleeve after "Use by" or "Used by". 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

WHATIS NICORETTE TO STORE?

Do not store above 25°C.

Store this medicine out of the reach of children.
As the patches still contain nicotine after use, used patches must be disposed of in such a way that they cannot get into the hands of children under any circumstances. Therefore, dispose of the patches carefully after use by folding them in half with the adhesive layer facing inwards so that the two halves stick together.
You must not use this medicinal product after the expiry date which is stated on the folding box and protective sleeve after ,,Use by" or ,,Used by". 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

ICONTENTS OF PPACKAGING AND FURTHER .INFORMATION

What Nicorette transdermal patch contains

.

• The active ingredient is nicotine
.
• The other ingredients are:
  medium chain triglycerides
  basicbutyl methacrylate copolymer
  polyethylene terephthalate film(PET)
  acrylate matrix
  acrylic adhesive solution
  potassium hydroxide
  croscarmellosesodium
  acrylic adhesive solution.strong>acrylate matrix
  acrylic adhesive solution
  potassium hydroxide
  croscarmellose sodium
  Aluminium acetylacetonate
  Removable film
  Polyethylene terephthalate film(PET) with one side aluminised and both sides siliconised Printing ink
  Epoxy-amine 2 component ink forpharmaceutical applications.

What Nicorette looks like and contents of the pack.
Nicorette is a semi-transparent patch and is available in packs of 7 and 14 patches.

Not all pack sizes may be marketed.