nicorette® transdermal patch 15mg/16h

What is Nicorette and what is it used for?
Nicorette belongs to a group of medicines used for smoking cessation. Nicorette contains nicotine as an active ingredient, which is released evenly and controllably through the skin over 16 hours.

By supplying nicotine through Nicorette patches, the withdrawal symptoms caused by nicotine withdrawal are reduced or at least appear in a significantly attenuated form, thus reducing the patient's urge to smoke.

These withdrawal symptoms primarily include irritability, restlessness, anxiety, increased appetite, and difficulties concentrating and falling asleep, which in many cases lead patients to resume smoking.

Nicorette serves as an aid and facilitates cessation even in difficult cases, although appropriate motivation, willpower, and perseverance are necessary prerequisites for any cessation attempt.

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. The success rate can be improved through additional counseling and supportive measures.

How to use Nicorette?
Always use this medicine exactly as described in the package leaflet or exactly as agreed with your doctor or pharmacist. Ask your doctor or
pharmacist if you are not sure.

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

Smoking should be completely stopped during treatment with Nicorette patches.

Smoking cessation with immediate smoking cessation - Monotherapy

The recommended dose is:
The dosage should be based on the smoker's tobacco dependence.

• Smokers who are highly tobacco-dependent (more than 20 cigarettes per day):
  

  Dosing schedule: heavy smokers (more than 20 cigarettes per day)		Duration of use
  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 tobacco-dependent (up to and including 20 cigarettes per day):
  

  Dosing schedule: light smokers (up to and including 20 cigarettes per day)		Duration of use
  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 in monotherapy
The duration of treatment is 3 months. For some former smokers, longer treatment may be necessary to prevent a relapse into old smoking habits. Use of the patch for longer than 6 months is generally not recommended. In this case, a doctor should be consulted.

Children and adolescents
Nicorette 25 mg/16 h - transdermal patch should not be used in adolescents aged 12 - 18 years, as there are no data on safety and efficacy.

Nicorette 15 mg/16 h and 10 mg/16 h - transdermal patch should only be used in adolescents aged 12 - 18 years on the express recommendation of a doctor. There is only limited
experience for the treatment of this age group with Nicorette.

Nicorette must not be used in children under 12 years of age.

Patients with liver and/or kidney dysfunction
Ask your doctor for advice before using Nicorette.

Combination therapy
Use together with Nicorette gum 2 mg, Nicorette 15 mg inhalations, Nicorette Icemint 2 mg lozenges or Nicorette spray (Please also refer to the package leaflet for Nicorette gum 2 mg, Nicorette 15 mg inhalations, Nicorette Icemint 2 mg lozenges or Nicorette spray)

Children and adolescents
Combination therapy is not recommended for children and adolescents aged 12 - 18 years due to a lack of safety data. Use in children under 12 years of age is contraindicated.

Persons under 18 years of age should not use Nicorette Inhalations in combination with Nicorette patches. Children under 12 years of age should not use Nicorette Inhalations or patches.

Adults and elderly persons
If you have not been successful with monotherapy, if you experience acute or uncontrollable urges to smoke during monotherapy, or if you wish to reduce the daily consumption of flexible Nicorette dosage forms (such as gum, inhalations, lozenges, spray) due to local side effects, you can also use Nicorette 2 mg gum, Nicorette 15 mg inhalations, Nicorette Icemint 2 mg lozenges or Nicorette spray in addition to Nicorette patches (10, 15 or 25 mg/16h).

The patch is used with the same dosing schedule as in monotherapy. In addition, another Nicorette dosage form is used as needed. In combination therapy, the dosage is also individual and depends on the smoker's tobacco dependence.

Course of combined use
After the initial combined use of Nicorette patch and Nicorette 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 proceed in two ways.

• Either a lower patch strength (15 mg/16 h and/or 10 mg/16 h) is then used for another 4 weeks. The simultaneous use of the oral dosage forms of Nicorette 2 mg gum, Nicorette 15 mg inhalations, Nicorette Icemint 2 mg lozenges or Nicorette spray is maintained at the daily dose as at the beginning of treatment and then gradually reduced within 12 months after the start of therapy.
• Or, the use of the patch is completely stopped after the initial phase, and the use of the oral dosage forms of Nicorette is gradually reduced within a total of 12 months.

Duration of use in combination therapy
The duration of treatment with the patch in combination therapy is 2 or 3 months. Afterwards, treatment can be continued with the additional dosage form alone. For the
combination therapy, results from controlled clinical studies over a period of 12 months are available.

In general, use beyond 12 months is not recommended. However, some smokers need longer treatment to prevent a relapse into their smoking habits, which should then be accompanied by medical supervision.

When using combination therapy, reference is also made to the professional and patient information leaflet of the chosen additional dosage form. Advice and support from professional help should be sought at any time during smoking cessation therapy if there is a risk of relapse.

Temporary non-smoking (Temporary Abstinence)
Use occurs during smoke-free periods, e.g., in non-smoking areas or in other situations when the urge to smoke arises, but smoking should be avoided.

Use a Nicorette patch instead of smoking - see dosage recommendation for smoking cessation with immediate smoking cessation.

Method of application
Every morning immediately after getting up, a patch is applied to a clean, dry, hairless and unbroken skin area on the torso, upper arm or hip after removing the protective film, as described below. Press the patch firmly against the skin for 10 - 15 seconds.

1. Before applying the patch, you should wash your hands.
2. Cut the pouch with scissors along the pre-marked line and remove the patch.
3. Peel off a part of the silvery aluminum protective layer. Avoid touching the adhesive part of the patch with your fingers to avoid reducing the adhesive properties of the patch.
   to decrease.
4. The adhesive side of the patch is carefully applied to a clean, dry, hairless and unbroken skin area on the torso, upper arm or hip. Then remove
   the second part of the silvery aluminum protective layer.
5. Press the patch firmly onto the skin with the palm of your hand or fingertips.
6. Stroke the edges of the patch firmly with your fingers again to ensure that the patch adheres securely.

Afterwards, you should wash your hands thoroughly so that any nicotine adhering 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 going to bed
the patch is removed again (i.e., usually the patch remains on the skin for 16 hours).

This means that treatment with the 16-hour patch mimics the change in nicotine levels corresponding to the wake/sleep cycle in smokers. They also do not absorb nicotine during sleep.
This side effect can be avoided in patients who react to nicotine administration during sleep with sleep disturbances.

The next morning, apply a fresh patch to a different skin area. The same skin area should only be re-taped after a few days.

If you have used more Nicorette than you should
An overdose can occur if you have applied several patches at the same time, chosen too strong a patch strength, or if nicotine has been supplied in another form
(smoking, nicotine replacement products other than those recommended for combination therapy).

Symptoms of a Nicorette overdose are those of acute nicotine poisoning:
Nausea, vomiting, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing disorders and pronounced weakness. In case of severe overdose, these symptoms can be followed by a drop in blood pressure, a weak and irregular pulse, breathing problems, exhaustion, circulatory collapse and general seizures.

Children
Nicotine dosages tolerated by adult smokers during treatment can cause severe, potentially fatal poisoning symptoms in young children. Suspected nicotine poisoning in a child should be considered a medical emergency – contact your doctor immediately or go to the emergency room of the nearest hospital.

Treatment of overdose
In case of nicotine overdose symptoms, temporarily discontinue nicotine intake. Immediately remove any Nicorette patches and wash the application site. Afterwards, you should reduce nicotine intake by either reducing the frequency of use or, if necessary, using a lower strength.

In case of poisoning symptoms, nicotine intake must be stopped immediately. Immediately remove any Nicorette patches and wash the application site. Immediately notify a doctor. He will, if necessary, provide symptomatic treatment.

If excessive amounts of nicotine are swallowed, activated charcoal reduces the absorption of nicotine in the gastrointestinal tract.

If you have forgotten to use Nicorette transdermal patch
Never apply two patches at the same time to make up for a forgotten application; instead, continue using as usual.

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

What Nicorette transdermal patch contains
The active ingredient is nicotine.

The other ingredients are:
medium-chain triglycerides, basic butyl methacrylate copolymer, polyethylene terephthalate film (PET)

Acrylate matrix
Acrylic adhesive solution, potassium hydroxide, croscarmellose sodium, aluminum acetylacetonate

Peel-off film
Polyethylene terephthalate film (PET) with one side aluminized and both sides siliconized, printing ink, epoxy-amine 2-component ink for pharmaceutical applications.