NICORETTE CLEAR 15 MG/16 HOURS TRANSDERMAL PATCHES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicorette Clear 15mg/16 hours Transdermal Patches

Nicotine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

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

Contents of the package leaflet:

1. What is Nicorette Clear and what is it used for
2. What you need to know before you start using Nicorette Clear
3. How to use Nicorette Clear
4. Possible side effects
5. Storage of Nicorette Clear
6. Package contents and additional information

1. What is Nicorette Clear 15 mg/ 16 hours transdermal patches and what is it used for

Nicorette Clear 15 mg/ 16 hours transdermal patches are used to relieve withdrawal symptoms and reduce nicotine cravings that occur when trying to quit smoking. This treatment is indicated for adult smokers over 18 years old.

Nicorette Clear 15 mg/16 hours transdermal patches relieve nicotine withdrawal symptoms, including anxiety, associated with quitting tobacco consumption. When you suddenly stop providing nicotine from tobacco to your body, you are affected by various unpleasant sensations, known as withdrawal symptoms, such as irritability or aggression, depression, anxiety, restlessness, concentration problems, increased appetite or weight gain, craving for cigarettes (anxiety), nocturnal awakenings or sleep disorders, dizziness, transient alterations of consciousness, cough, constipation, gum bleeding, mouth ulcers, or colds. The nicotine in Nicorette Clear 15 mg/16 hours transdermal patches can help prevent or reduce these unpleasant symptoms, as well as your craving for cigarettes.

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

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

2. What you need to know before you start using Nicorette Clear 15 mg/ 16 hours transdermal patches

Do not useNicorette Clear 15 mg/ 16 hourstransdermal patches

• if you are allergicto nicotine or to any of the other components of this medicine (listed in section 6).
• if you have any skin 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 use Nicorette Clear 15 mg/16 hours transdermal patches

Contact your doctor in case you suffer from any of the following diseases, as although you can take Nicorette Clear 15 mg/16 hours transdermal patches, you will first need to consult your doctor:

• if you have recently suffered a heart attackor heart stroke.
• if you suffer from chest pain(unstable angina) or angina at rest.
• if you suffer from any heart diseasethat affects the heart rate or frequency (arrhythmia).
• if you have uncontrolled high blood pressurewith medication.
• if you have heart failureor circulation problems.
• if you have had an allergic reactionwith inflammation of the lips, face, and throat (angioedema) or skin irritation (urticaria). The use of nicotine replacement therapy may sometimes cause this type of reaction.
• if you suffer from esophagitis, stomach ulcer, or duodenal ulcer.
• if you have hyperactivity of the thyroid gland.
• if you suffer from diabetes.
• if you have a pheochromocytoma(adrenal medulla tumor).
• if you suffer from severe or moderate liver disease.
• if you suffer from severe kidney disease.

If you have a history of epilepsy or seizures

Other medicines and Nicorette Clear 15 mg / 16 hours transdermal patches

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Some chemical compounds present in tobacco can affect how other medicines are metabolized in the body. When a smoker quits tobacco, with or without Nicorette Clear 15 mg/16 hours transdermal patches, it may produce a decrease in metabolism and consequently cause an increase in blood levels of such medicines.

A dose adjustment may be necessary by your doctor if you are taking any of the following medicines: asthma medicines (theophylline, salbutamol), antidepressants (imipramine, clomipramine, fluvoxamine), painkillers (pentazocine, phenacetin), anti-inflammatory medicines (phenylbutazone), treatments for dementia (Alzheimer's disease) (tacrine), treatments for schizophrenia (olanzapine, clozapine), treatments for rapid or irregular heart rhythm (flecainide), antidiabetic medicines (insulin), treatments for Parkinson's disease (ropinirol), heart medicines (prazosin, propranolol, isoprenaline, salbutamol), medicines containing caffeine or antiarrhythmics (adenosine).

The warnings and precautions for use of the combination of Nicorette Clear transdermal patches with the chosen flexible format are those of each treatment used separately. For the warnings and precautions for use of the flexible format, refer to its product information.

Using Nicorette Clear 15 mg/ 16 hours transdermal patches with food and drinks

Food or drinks do not affect the efficacy of treatment with this medicine

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

It is very important to quit smoking during pregnancy because it could lead to low birth weight or miscarriage. It is advisable to quit smoking without the use of nicotine-containing medicines. If you cannot, you may use Nicorette Clear 15 mg/16 hours transdermal patches only after consulting your doctor.

Products like lozenges may be preferable to nicotine patches. This is because with lozenges, you do not receive nicotine all the time; however, patches may be preferable if you suffer from nausea or vomiting.

Breastfeeding

Since nicotine passes into breast milk and can affect the baby, it should only be used during breastfeeding after consulting your doctor. It is better to use medicines that are taken at certain times of the day (such as gum or lozenges) instead of patches. It is also better to breastfeed just before taking the medicine, which helps your baby receive the smallest amount of nicotine possible.

Driving and using machines

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

Nicorette Clear 15 mg / 16 hours transdermal patches should be removed before undergoing any Magnetic Resonance Imaging (MRI) procedure to avoid the risk of burns.

3. How to use Nicorette Clear

Minors under 18 years old should not use this medicine.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

You must quit smoking completely and immediately, using the patches to alleviate the desire to smoke.

The patch should be applied to an intact area of 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 reduction should be started, using 1 patch of 10 mg/ 16 hours per day for 4 weeks.

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 consult your doctor.

Generally, recommendation and support increase the chances of success.

Combination therapy

Highly dependent smokers, smokers who experience irresistible cravings for cigarettes, or those who were unable to quit smoking with only 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 gum, 2 mg nicotine lozenges, or 1 mg/puff oral spray to more easily control their cravings for cigarettes.

In the case of combination therapy, Nicorette Clear transdermal patches and the oral medication 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 medication 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 getting 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.

Once 16 hours have passed, remove the patch by pulling and dispose of it carefully.

If you think the effect of Nicorette Clear is too strong or too weak, inform 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 might start smoking again.
• Having difficulty quitting using Nicorette Clear 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 Toxicological 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 the package leaflet and the medicine packaging to the healthcare professional.

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, 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 doubts about the use of this medicine, consult your doctor or pharmacist.

If you forgot to use Nicorette ClearDo not use a double dose to make up for forgotten doses.

If you have any other doubts 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 normally dose-dependent. Symptoms such as depression, irritability, anxiety, restlessness, increased appetite, and insomnia may also be related to quitting tobacco consumption.

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

• Itching.

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

• Headache.

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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 15 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 15 mg/16 hours transdermal patches.

Combination therapy

Before using Nicorette Clear transdermal patches in combination with Nicorette 2 mg gum, Nicorette Ice Mint 2 mg gum, Nicorette Freshfruit 2 mg 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 side effect, consult your doctor or pharmacist, even if it 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 15 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 stated on the packaging and on the patch packaging 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 at the SIGRE collection point in your 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. Package Contents and Additional Information

Nicorette Clear Composition

• The active ingredient is nicotine. A 13.5 cm2 transdermal patch contains 23.62 mg of nicotine and releases a dose of 0.93 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 varnish mixture, beige printing ink, and brown printing ink). Each nicotine patch is packaged in a sealed multilaminated pouch and stored in the box.

Product Appearance and Package Contents

Nicorette Clear is available in packs of 7, 14, and 28 patches.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

JNTL Consumer Health (Spain), S.L.

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

28033-Madrid

Spain

Manufacturer

LTS Lohman Therapie-Systeme AG

Lohmannstrasse 2, D-56626

Andernach, Germany

Date of Last Revision of the 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