nicorette® transdermal patch 15mg/16h

Product Information & Legal Disclosures

Nicotine patches to support smoking cessation from Nicorette® – recommended for smokers who consume up to 20 cigarettes daily.

Legal Information

Nicorette® transdermal patch 15 mg/16 h

Active ingredient: Nicotine.

Area of Application

Nicorette® transdermal patch 15 mg/16 h belongs to a category of medicines that help with smoking cessation. The active ingredient, nicotine, is released steadily through the skin over 16 hours and can help to reduce withdrawal symptoms while quitting.

Typical withdrawal symptoms include nervousness, restlessness, anxiety, increased appetite, and problems with concentration and sleep. The controlled release of nicotine can reduce cravings for cigarettes.

Nicorette® can also be used during temporary smoking breaks, for example, in non-smoking areas or situations where one wishes to refrain from smoking.

Additional counseling and supportive measures can increase the chances of success for smoking cessation.

How it Works

The Nicorette® patch continuously releases nicotine into the body during wear time. This achieves a stable nicotine level without inhaling tobacco smoke. This application can help alleviate withdrawal symptoms and facilitate quitting smoking.

The highest nicotine level is reached approximately eight hours after application. The patch is applied in the morning and removed before going to bed in the evening, so that nicotine release follows the natural wake-sleep rhythm.

Application and Dosage

Dosage depends on previous cigarette consumption.

Smokers who smoke more than 20 cigarettes daily

• Phase 1: Nicorette® 25 mg/16 h for 8 weeks

• Phase 2: Nicorette® 15 mg/16 h for 2 weeks

• Phase 3: Nicorette® 10 mg/16 h for 2 weeks

Smokers who smoke up to 20 cigarettes daily

• Phase 1: Nicorette® 15 mg/16 h for 8 weeks

• Phase 2: Nicorette® 10 mg/16 h for 4 weeks

The recommended treatment duration is usually three months. Longer use should be discussed with a doctor or pharmacist.

Instructions for Use

Every morning after waking up, a patch should be applied to a clean, dry, hairless, and unbroken area of skin on the upper body, upper arm, or hip. The patch should be pressed firmly for 10 to 15 seconds.

The application site should be changed daily. The same skin area should not be used again until after several days.

The patch is removed in the evening before going to bed. The next morning, a new patch is applied to a different skin area.

Important Notes

• Smoking should be completely stopped during therapy.

• The patch can be used alone or in combination with certain Nicorette® chewing gums, lozenges, inhalers, or sprays.

• The patch is not suitable for children under 12 years of age.

• Adolescents between 12 and 18 years of age should only use the patch under medical supervision.

Side Effects

Like all medicines, Nicorette® can cause side effects, although not everybody gets them.

Skin reactions at the application site, such as redness, itching, burning, or skin irritation, are common. Headaches, dizziness, nausea, sleep disturbances, palpitations, or gastrointestinal complaints are also possible.

Some complaints can also be caused by nicotine withdrawal itself and are not necessarily attributable to the use of the patch.

In case of signs of an overdose such as nausea, vomiting, severe sweating, dizziness, heart rhythm disorders, or circulatory problems, use should be stopped immediately, and a doctor should be consulted without delay.

Please note the complete information in the package leaflet.

Active & Excipient Ingredients

Active ingredient

• Nicotine 15 mg per 16 hours

Excipients

• Medium-chain triglycerides

• Basic butyl methacrylate copolymer

• Polyethylene terephthalate film (PET)

• Acrylate matrix

• Acrylic adhesive solution

• Potassium hydroxide

• Croscarmellose sodium

• Aluminum acetylacetonate

• Polyethylene terephthalate film (PET), aluminized on one side and siliconized on both sides

• Printing ink

• Epoxy-amine 2-component ink for pharmaceutical applications