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

The Nicorette 25 mg/16 h transdermal patch is a medicinal product used to help people give up smoking. Nicorette contains nicotine as its active ingredient, which is released steadily and in a controlled manner through the skin into the body over a period of 16 hours.

The supply of nicotine via the Nicorette patch ensures that the withdrawal symptoms caused by nicotine withdrawal do not occur, or at least occur in a significantly milder form, thereby reducing the patient’s craving for cigarettes. These withdrawal symptoms primarily include irritability, restlessness, anxiety, increased appetite, difficulty concentrating and trouble falling asleep, which in many cases lead patients to start smoking again. Nicorette acts as an aid and makes quitting easier, even in difficult cases, although appropriate motivation, willpower and perseverance are essential prerequisites for any smoking cessation programme.

Nicorette® transdermal patches can also be used as an aid for smokers during periods of temporary abstinence, when smoking is not possible or desirable.

Using the Nicorette® transdermal patch whilst awake (for around 16 hours) is sufficient to effectively reduce withdrawal symptoms.

Benefits

• Easy to use – just one patch a day is enough
• Releases nicotine steadily throughout the day
• Helps combat the urge to smoke and nicotine dependence
• Worn for 16 hours, respecting the natural sleep-wake cycle

Dosage form

Transdermal patch

Usage

Smoking should be stopped completely whilst using Nicorette patches.

Smoking cessation with immediate cessation of smoking

Monotherapy

Adults and older people

The recommended dose is:

The dosage should be based on the smoker’s level of tobacco dependence.

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

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

Smokers with a lower level of tobacco dependence (up to and including 20 cigarettes a day): Dosage regimen: light smokers (up to and including 20 cigarettes a 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 treatment with 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, you should consult your doctor.

Children and adolescents

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

Method of use

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

1. You should wash your hands before applying the patch.
2. Cut open the sachet with scissors along the marked line and remove the patch.
3. Peel off part of the silvery aluminium protective layer. Take care not to touch the adhesive side of the plaster with your fingers, so as not to reduce its adhesive properties.
4. Carefully apply the adhesive side of the plaster to a clean, dry, hairless and unbroken area of skin on the upper body, upper arm or hip. Then remove the second part of the silver aluminium protective film.
5. Press the plaster firmly onto the skin with the palm of your hand or your fingertips.
6. Run your fingers firmly over the edges of the patch once more to ensure it adheres securely.

Note: You should then wash your hands thoroughly to prevent any nicotine accidentally left on your fingers from 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 film (PET); acrylate matrix: acrylic adhesive solution, potassium hydroxide, croscarmellose sodium, aluminium acetylacetonate; release film: polyethylene terephthalate film (PET) with one side aluminised and both sides siliconised; Printing ink: Two-component epoxy-amine ink for pharmaceutical applications.