Nicorette 25 mg/16 h - transdermal patch, 14 ST

Nicorette 25 mg/16 h - transdermal patch is a medicinal product used for smoking cessation. Nicorette contains nicotine as the active ingredient, which is released evenly and in a controlled manner through the skin over a period of 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 occur in a significantly weakened form, thus reducing the patient's desire to smoke. These withdrawal symptoms primarily include irritability, restlessness, anxiety, increased appetite, concentration and sleep disorders, which in many cases cause the patient to take up smoking again. Nicorette serves as an aid and facilitates cessation even in difficult cases, whereby appropriate motivation, willpower and perseverance are necessary prerequisites for any cessation programme.

Nicorette® Transdermal Patch can also be used as an aid for smokers during temporary abstinence for periods when cigarette consumption is not possible or undesirable.

The use of Nicorette® Transdermal Patch during waking hours (about 16 hours) is sufficient to effectively reduce withdrawal symptoms.

Advantages

• Easy to use - just one patch per day is enough
• Releases nicotine constantly throughout the day
• Helps to combat smoking cravings and nicotine addiction
• Wearing time of 16 hours, respects the natural wake-sleep rhythm

Dosage form

Transdermal patch

How to use

Smoking should be stopped completely during treatment with Nicorette patches.

Smoking cessation with immediate smoking cessation

Monotherapy

Adults and older people

The recommended dose is:

The dosage should be based on the smoker's tobacco dependence.

Smokers who are heavily dependent on tobacco (more than 20 cigarettes a day): Dosage regimen: heavy smokers (more than 20 cigarettes per day)

• Phase 1 Nicorette 25 mg/16 h - transdermal patch 8 weeks (duration of use)
• Phase 2 Nicorette 15 mg/16 h - transdermal patch 2 weeks (duration of use)
• Phase 3 Nicorette 10 mg/16 h - transdermal patch 2 weeks (duration of use)

Smokers who are less dependent on tobacco (up to and including 20 cigarettes a day): Dosing regimen: light smokers (up to and including 20 cigarettes per day)

• Phase 2 Nicorette 15 mg/16 h - transdermal patch 8 weeks (duration of use)
• Phase 3 Nicorette 10 mg/16 h - transdermal patch 4 weeks (duration of use)

Duration of use for monotherapy

The duration of treatment is 3 months. For some former smokers, longer treatment may be necessary to prevent a relapse to the old smoking habit. Use of the patch for longer than 6 months is generally not recommended. In this case, the 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 no data are available on safety and efficacy. 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 only limited experience for the treatment of this age group with Nicorette. Nicorette must not be used in children under 12 years of age.

Method of application

Every morning immediately after getting up, apply a plaster as described below to a clean, dry, hairless and undamaged area of skin on the upper body, upper arm or hip after removing the protective film. To do this, press the plaster firmly against the skin for 10 - 15 seconds.

1. You should wash your hands before applying the plaster.
2. Cut open the bag with scissors along the marked line and remove the plaster.
3. Peel off part of the silvery aluminium protective layer. Avoid touching the adhesive part of the plaster with your fingers so as not to reduce the adhesive properties of the plaster.
4. The adhesive side of the plaster is carefully applied to a clean, dry, hairless and uninjured area of skin on the upper body, upper arm or hip. Then remove the second part of the silvery aluminium protective layer.
5. Press the plaster firmly onto the skin with the palm of your hand or your fingertips.
6. Brush your fingers firmly over the edges of the plaster again to ensure that the plaster adheres firmly.

Note: You should wash your hands thoroughly afterwards to prevent nicotine stuck to your fingers from accidentally getting into your eyes.

Ingredients

• The active ingredient is nicotine. 25 mg/16 h (size = 22.5 cm², contains 39.4 mg nicotine).
• The other ingredients are: medium-chain triglycerides, basic butyl methacrylate copolymer, polyethylene terephthalate (PET) film; acrylate matrix: Acrylic adhesive solution, potassium hydroxide, croscarmellose sodium, aluminium acetylacetonate; peel-off film: polyethylene terephthalate film (PET) with one side aluminised and both sides siliconised; printing ink: epoxy-amine 2 component ink for pharmaceutical applications.