NICORETTE CLEAR 10 MG/16 HOURS TRANSDERMAL PATCHES

The treatment duration is approximately 3 months but may vary depending on individual response. If you feel the need to continue using Nicorette Clear after 6 months of treatment, you should ask your doctor for advice.

Generally, recommendation and support increase the chances of success.

Combination therapy

Highly dependent smokers, smokers who experience irresistible cravings to smoke, or those who were unable to quit smoking with Nicotine Replacement Therapy (NRT) consisting of a single medicine, may benefit from using Nicorette Clear in combination with oral nicotine with a flexible administration schedule consisting of 2 mg nicotine chewing gum, 2 mg nicotine lozenges, or 1 mg/puff nicotine oral spray to more easily control their cravings to smoke.

In the case of combination therapy, Nicorette Clear transdermal patches and the oral medicine should be used following the same dosage recommendations as when used separately. Read the package leaflet of the oral forms to understand how to use them precisely and safely.

Use only one type of oral medicine per day.

Instructions for correct application

Choose any area of the trunk, upper arm, or hip. The skin should not be inflamed, damaged, or irritated, as this could alter the amount of nicotine absorbed. For the patch to stick better, the skin should be clean, hairless, dry, and free of creams, lotions, oils, or powders. The patch should be applied when waking up and removed after 16 hours.

Choose a different area each day for application, leaving several days before reusing the same area.

Once removed from the packaging, the patch should be applied immediately.

Applying the patch:

1. Wash your hands before applying the patch.

2. Cut one of the lateral ends of the bag containing the patch with scissors.

3. Remove half of the laminate, trying not to touch the adhesive surface of the patch with your fingers.

4. Place the adhesive part of the patch on the chosen area and remove the other half of the laminate.

5. Press the patch applied to the skin with the palm of your hand or with your fingertips.

1. 6. Check that the patch is well stuck, passing your fingers over the edge of the patch.

In case the patch comes off during the day, it should be replaced with a new one as soon as possible.

After 16 hours, remove the patch by pulling and dispose of it carefully.

If you think the action of Nicorette Clear 10 mg/16 hours transdermal patches is too strong or too weak, tell your doctor or pharmacist.

Do not exceed the established dose. Follow the instructions for use carefully.

If you feel the need to smoke again:

If you are:

• Worried that you may start smoking again.
• Having difficulty quitting the use of Nicorette Clear 10 mg/ 16 hours transdermal patches, consult your doctor.

If you start smoking again, your doctor may advise you on how to get the best results in future new treatments with nicotine replacement therapy (NRT).

If you use more Nicorette Clear than you should

Excessive use of nicotine from nicotine replacement therapy can cause symptoms similar to those caused by smoking too much: paleness, cold sweat, nausea, salivation, burning sensation in the throat, vomiting, stomach pain, diarrhea, headache, dizziness, hearing disorders, tremors, mental confusion, and extreme weakness.

Overdose can occur if you smoke at the same time as using Nicorette Clear.

At high doses, the symptoms described above may be followed by: low blood pressure, weak and irregular pulse, difficulty breathing, extreme fatigue, circulatory collapse, and convulsions.

In case of overdose or accidental poisoning, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you experience any of these symptoms, consult your doctor or go to the nearest hospital immediately.It is recommended to bring this package leaflet and the medicine packaging to the healthcare professional with you.

Nicorette Clear cannot be used by minors under 18 years old or by people who have never smoked. If this happens, they may exhibit overdose symptoms. If a child uses Nicorette Clear 10 mg/16 hours transdermal patches, contact your doctor immediatelyor go to the nearest hospital. The nicotine doses tolerated by adult smokers during treatment can cause poisoning symptoms in childrenand even lead to death.

If you have any other questions about the use of this medicine, consult your doctor or pharmacist.

If you forget to use Nicorette Clear

Do not use a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Around 20% of patients experience mild skin reactions during the first weeks of treatment.

The fact of quitting smoking itself can cause symptoms such as dizziness, headache, sleep problems, cough, and symptoms similar to those of a cold. Side effects are usually dose-dependent. Symptoms such as depression, irritability, anxiety, restlessness, increased appetite, and insomnia may also be related to tobacco cessation.

Very common side effects(affect more than 1 in 10 patients):

• Itching.

Common side effects(affect between 1 and 10 in 100 patients):

• Headache.

Nausea, vomiting.

• Rash, urticaria.

Uncommon side effects(affect between 1 and 10 in 1,000 patients):

• Palpitations (unusual sensation of heartbeats), increased heart rate.
• Fatigue, discomfort, chest pain.
• Reactions at the administration site.
• Hypersensitivity, muscle pain.
• Tingling, sleep disorders, breathing difficulties.
• Excessive sweating.
• Hot flashes and hypertension.

Side effects with unknown frequency(cannot be estimated from the available data)

• Gastrointestinal discomfort.
• Anaphylactic reaction.
• Angioedema.
• Erythema.
• Convulsions.

If you notice any of the following serious side effects, stop using Nicorette Clear 10 mg/16 hours transdermal patches and contact your doctor immediately, as they may be symptoms of a severe allergy:

• urticaria (skin condition characterized by itching and red spots).
• swollen face, tongue, or throat.
• difficulty breathing.
• difficulty swallowing.

Most of these side effects appear during the first phases of treatment.

Rarely, allergic reactions (including symptoms of anaphylaxis) can occur during the use of Nicorette Clear 10 mg/16 hours transdermal patches.

Combination therapy

Before using Nicorette Clear transdermal patches in combination with Nicorette 2 mg medicinal chewing gum, Nicorette Ice Mint 2 mg medicinal chewing gum, Nicorette Freshfruit 2 mg medicinal chewing gum, Nicorette Supermint 2 mg lozenges, or Nicorette Bucomist 1 mg/puff oral spray, read the package leaflet of these medicines carefully.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nicorette Clear 10 mg/16 hours transdermal patches

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date that appears on the packaging and on the pouch containing the patch after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition ofNicorette Clear

• The active ingredient is nicotine. A 9.0 cm2 transdermal patch contains 15.75 mg of nicotine and releases a dose of 0.62 mg of nicotine per hour for 16 hours.
• The other components are: medium-chain triglycerides, basic butylated methacrylate copolymer, polyethylene terephthalate film, acrylate matrix (containing acrylic adhesive solution, potassium hydroxide, sodium croscarmellose, aluminum acetylacetonate), protective layer (containing a single layer of polyethylene terephthalate (PET) coated with aluminum and silicone-coated on both sides), printing ink (containing mixture varnish, beige printing ink, and brown printing ink). Each nicotine patch is packaged in a sealed multilaminate pouch and stored in the box.

Product Appearance and Packaging Contents

Nicorette Clear is available in packs of 7 and 14 patches.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

JNTL Consumer Health (Spain), S.L.

Vía de los Poblados 1, Edificio E, 3rd floor

28033-Madrid

Spain

Manufacturer

LTS Lohman Therapie-Systeme AG

Lohmannstrasse 2, D-56626

Andernach, Germany

Date of Last Revision of this Leaflet:June 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es