PROSPECTO: INFORMATION FOR THE USER

Nicorette Clear 10mg/16 hours Transdermal Patches

Nicotine

Read this prospect carefully before starting to use this medication because it contains important information for you.

Follow exactly the medication administration instructions contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if you worsen or do not improve after 6 months.

Nicorette Clear is used to relieve the symptoms of nicotine withdrawal and reduce nicotine cravings that occur when trying to quit smoking. This treatment is indicated for adult smokers 18 years of age or older.

Nicorette Clear relieves nicotine withdrawal symptoms, including anxiety, associated with tobacco cessation. When you stop providing nicotine from tobacco to your body suddenly, you are affected by different types of unpleasant sensations, known as withdrawal symptoms, such as irritability or aggression, depression, anxiety, restlessness, concentration problems, increased appetite or weight gain, cravings to smoke (anxiety), nocturnal awakenings or sleep disorders,dizziness, transient alterations in consciousness, cough, constipation, gum bleeding, mouth ulcers, or colds. The nicotine in Nicorette Clear may help you prevent or reduce these unpleasant symptoms, as well as your cravings to smoke.

You should consult your doctor if it worsens or does not improve after 6 months.

To improve the chances of help to quit smoking, it is recommended to seek medical advice and support.

No useNicorette Clear 10 mg/ 16 horas transdermal patches

• if you areallergicto nicotine or any of the other components of this medication (listed in section 6).
• if you have anyskin diseasethat may be affected by the application of the patches.
• if you are under 18 years old.
• if you are a non-smoker.

Warnings and precautions

Consult your doctor or pharmacist before starting to useNicorette Clear 10 mg/16 hours transdermal patches.

Contact your doctor if you experience any of the following conditions, as you may need to consult your doctor before taking Nicorette Clear 10 mg/16 hours transdermal patches:

• if you have recently experienced anyheart attackorheart attack.
• if you suffer fromchest pain(unstable angina) or resting angina.
• if you suffer from anyheart diseasethat affects heart rhythm or frequency (arrhythmia).
• if you havehigh blood pressurethat is not controlled with medication.
• if you haveheart failureor circulation problems.
• if you have had anyallergic reactionwith inflammation of the lips, face, and throat (angioedema) or skin irritation (urticaria). Nicotine replacement therapy may sometimes cause this type of reaction.
• if you suffer fromesophagitis, stomach or duodenal ulcer.
• if you havehyperthyroidism.
• if you suffer fromdiabetes.
• if you have apheochromocytoma(adrenal gland tumor).
• if you suffer fromsevere or moderate liver disease.
• if you suffer fromsevere kidney disease.
• If you have a history of epilepsy or seizures

Other medications and Nicorette Clear 10 mg / 16 hours transdermal patches

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take another medication.

Some chemicals present in tobacco may affect how other medications are metabolized in the body. When a smoker quits smoking, with or without Nicorette Clear 10 mg/16 hours transdermal patches, it may cause a decrease in metabolism and as a result, an increase in blood levels of such medications.

You may need to adjust your dose with your doctor if you are taking any of the following medications: asthma medications (theophylline, salbutamol), antidepressants (imipramine, clomipramine, fluvoxamine), painkillers (pentazocine, phenacetin), anti-inflammatory medications (phenylbutazone), dementia treatments (Alzheimer's disease) (tacrine), schizophrenia treatments (olanzapine, clozapine), heart rhythm treatments (flecainide), diabetes medications (insulin), Parkinson's disease treatments (ropinirole), heart medications (prazosin, propranolol, isoprenaline, salbutamol), medications containing caffeine or antiarrhythmics (adenosine).

Use of Nicorette Clear 10 mg/ 16 hours transdermal patches with food and drinks

Food or drinks do not affect the efficacy of this medication treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

It is very important to quit smoking during pregnancy, as it may lead to low birth weight or miscarriage. It is recommended to quit smoking without using medications containing nicotine. If you cannot, you may use Nicorette Clear 10 mg/16 hours transdermal patches only after consulting your doctor.

Products like gum tablets may be preferred over nicotine patches. This is because with gum tablets, you do not receive nicotine all the time, however, patches may be preferred if you experience nausea or vomiting.

Breastfeeding

Since nicotine passes through breast milk and may affect the baby, you should only use it during breastfeeding after consulting your doctor. It is better to use medications taken at specific times of the day (such as gum or tablets) rather than patches. It is also better to breastfeed just before taking the medication, which helps your baby receive the least amount of nicotine possible.

Driving and operating machines

No effects have been observed on the ability to drive or operate machines.

Nicorette Clear 10 mg / 16 hours transdermal patches should be removed before undergoing any Magnetic Resonance Imaging (MRI) procedure to avoid the risk of burns.

Combined therapy

Before using Nicorette Clear transdermal patches in combination with Nicorette 2 mg medicated gum, Nicorette Ice Mint 2 mg medicated gum, Nicorette Freshfruit 2 mg medicated gum, Nicorette Supermint 2 mg tablets, or Nicorette Bucomist 1 mg/pulse oral solution, read the prospectus of these medications carefully.

Children under 18 years old should not use this medication.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

You must stop smoking completely immediately, using patches to relieve the desire to smoke.

The patch should be placed on an intact area of the skin when getting up and removed after 16 hours.

Monotherapy

It is recommended to start using 1 patch of 15 mg/16 hours per day for 8 weeks. Then, the initial dose should be reduced by starting to use 1 patch of 10 mg/16 hours per day for 4 weeks.

The duration of treatment is approximately 3 months, but it 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, the recommendation and support increase the chances of success.

Combined 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 medication, 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/pulse nicotine buccal spray to control their cravings to smoke more easily.

In the case of combined therapy, Nicorette Clear transdermal patches and oral medication should be used following the same dose recommendations as when used separately. Read the leaflet for oral forms to understand how to use it precisely and safely.

Use only one type of oral medication per day.

Instructions for correct application

Any area of the trunk, upper arm, or hip will be chosen. The skin should not be inflamed, injured, 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 without creams, lotions, oils, or powders. The patch should be placed when getting up and removed after 16 hours.

Choose a different area every day for application, leaving several days before using the same area again.

Once removed from the package, the patch should be placed immediately.

Placing the patch:

1. Wash your hands before placing the patch.

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

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

4. Place the adhesive side of the patch on the chosen area and remove the other half of the backing.

5. Press the patch placed on the skin with the palm of your hand or with your fingertips.

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

If the patch comes off during the day, replace it with a new one as soon as possible.

Once 16 hours have passed, remove the patch by pulling it off 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, inform your doctor or pharmacist.

Do not exceed the established dose. Follow the usage instructions carefully.

If you feel the need to smoke again:

If you are:

• Worried that you may start smoking again.
• Having difficulty quitting using 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

The excessive use of nicotine from nicotine replacement therapy may cause symptoms similar to those derived from excessive smoking: pallor, cold sweat, nausea, salivation, burning sensation in the throat, vomiting, stomach pain, diarrhea, headache, dizziness, hearing disturbances, tremors, confusion, and extreme weakness.

Overdose may 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 (phone 91 562 04 20), indicating the medication and the amount ingested.

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

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

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

If you forgot to use Nicorette Clear

Do not use a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

The fact of quitting smoking can cause symptoms such as dizziness, headaches, 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 consumption 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.

- Hives, 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 site of administration.

- Hypersensitivity, muscle pain.

- Tingling, sleep disorders, difficulty breathing.

- Excessive sweating.

- Hot flashes and hypertension.

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

- Gastrointestinal discomfort.

- Anaphylactic reaction.

- Angioedema.

- Erythema.

- Convulsions

If you notice any of the following severe 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 patches).

- Inflamed face, tongue, or throat.

- Difficulty breathing.

- Difficulty swallowing.

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

In rare cases, allergic reactions (including anaphylaxis symptoms) may occur during the use of Nicorette Clear 10 mg/16 hours transdermal patches.

Combined therapy

Before using Nicorette Clear transdermal patches in combination with Nicorette 2 mg medicated chewing gum, Nicorette Ice Mint 2 mg medicated chewing gum, Nicorette Freshfruit 2 mg medicated chewing gum, Nicorette Supermint 2 mg lozenges, or Nicorette Bucomist 1 mg/pulse oral solution, read the prospectus of these medicines carefully.

Reporting side effects

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

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above25°C.

Do not use this medication after the expiration date that appears on the packaging and on the overwrap that contains the patch after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofNicorette Clear

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

Appearance of the product and contents of the packaging

Nicorette Clear is presented in cases with 7 and 14 patches.

You may not find all packaging sizes on the market.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-Madrid

Spain

Responsible manufacturer

LTS Lohman Therapie-Systeme AG

Lohmannstrasse 2, D-56626

Andernach. Germany

Last review date of this leaflet:June 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es