Nicorette Clear 15 mg/16 hours transdermal patches

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicorette Clear 15mg/16 hours Transdermal Patches

Nicotine

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Follow exactly the instructions for taking this medicine as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 leaflet:

1. What Nicorette Clear is and what it is used for
2. What you need to know before using Nicorette Clear
3. How to use Nicorette Clear
4. Possible adverse effects
5. Storage of Nicorette Clear
6. Contents of the pack and other information

1. What Nicorette Clear 15 mg/16 hours transdermal patches are and what they are 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 stop smoking. This treatment is intended for adult smokers aged 18 years and over.

Nicorette Clear 15 mg/16 hours transdermal patches help relieve nicotine withdrawal symptoms, including anxiety, associated with stopping tobacco use. When you suddenly stop supplying nicotine from tobacco to your body, you experience various unpleasant sensations known as withdrawal symptoms, such as irritability or aggression, depression, anxiety, restlessness, difficulty concentrating, increased appetite or weight gain, cigarette cravings (craving), nighttime awakenings or sleep disturbances, dizziness, transient disturbances of consciousness, cough, constipation, gum bleeding, mouth ulcers, or colds. The nicotine in Nicorette Clear 15 mg/16 hours transdermal patches can help you prevent or reduce these unpleasant symptoms, as well as your urge to smoke.

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

To improve your chances of successfully quitting smoking, it is advisable to seek medical advice and support.

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

Do not use Nicorette Clear 15 mg/16 hours transdermal patches

• if you are allergic to nicotine or to any of the other ingredients of this medicine (listed in section 6).
• if you have a skin disease that might be affected by applying the patches.
• if you are under 18 years of age.
• if you are a non-smoker.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Nicorette Clear 15 mg/16 hours transdermal patches.

Contact your doctor if you suffer from any of the following conditions, as although you may still be able to use Nicorette Clear 15 mg/16 hours transdermal patches, you must first consult your doctor:

• if you have recently had a heart attack or stroke.
• if you have chest pain (unstable angina) or angina at rest.
• if you have a heart disease affecting heart rhythm or rate (arrhythmia).
• if you have uncontrolled high blood pressure despite medication.
• if you have heart failure or circulation problems.
• if you have previously had an allergic reaction with swelling of the lips, face, and throat (angioedema) or skin irritation (urticaria). Nicotine replacement therapy may sometimes trigger such reactions.
• if you suffer from oesophagitis, stomach or duodenal ulcer.
• if you have overactivity of the thyroid gland (hyperthyroidism).
• if you have diabetes.
• if you have a tumour of the adrenal medulla (pheochromocytoma).
• if you have severe or moderate liver disease.
• if you have severe kidney disease.

If you have a history of epilepsy or seizures

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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain chemical compounds present in tobacco can affect how other medicines are metabolized in the body. When a smoker stops smoking, with or without Nicorette Clear 15 mg/16 hours transdermal patches, the metabolism of these medicines may decrease, resulting in increased blood levels of such medicines.

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

The warnings and precautions for using Nicorette Clear transdermal patches in combination with the chosen flexible formulation are those applicable to each treatment used separately. For warnings and precautions regarding the flexible formulation, refer to its product information.

Use of Nicorette Clear 15 mg/16 hours transdermal patches with food and drink

Food or drink does not affect the effectiveness of treatment with this medicine.

Pregnancy and breastfeeding

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

Pregnancy

It is very important to stop smoking during pregnancy, as smoking may lead to low birth weight or cause miscarriage. It is advisable to stop smoking without using nicotine-containing medications. If you are unable to do so, you may use Nicorette Clear 15 mg/16 hours transdermal patches only after consulting your doctor.

Medications such as lozenges may be preferable to nicotine patches, because with lozenges you do not receive nicotine continuously. However, patches may be preferable if you experience nausea or vomiting.

Breastfeeding

Since nicotine passes into breast milk and may affect the infant, this product should only be used during breastfeeding after consulting your doctor. It is preferable to use medicines taken at specific times of day (such as chewing gum or lozenges) rather than patches. It is also advisable to breastfeed just before taking the medication, as this helps ensure your baby receives the lowest possible amount of nicotine.

Driving and operating machinery

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

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

3. How to use Nicorette Clear

This medicine must not be used by individuals under 18 years of age.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

You must stop smoking completely and immediately, using the patches to help relieve your urge to smoke.

The patch should be applied to an intact area of skin upon waking and removed after 16 hours.

Monotherapy

It is recommended to start treatment by using 1 patch of 15 mg/16 hours per day for 8 weeks. This should then be followed by a reduction in the initial dose, using 1 patch of 10 mg/16 hours per day for 4 weeks.

The duration of treatment is about 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, counseling and support increase the chances of success.

Combination Therapy

Heavily dependent smokers, smokers who experience strong urges to smoke, or those who were unable to quit smoking using single-agent Nicotine Replacement Therapy (NRT), may benefit from using Nicorette Clear in combination with oral nicotine, using a flexible dosing regimen consisting of nicotine 2 mg medicated chewing gum, nicotine 2 mg lozenges, or nicotine 1 mg/puff oral spray solution, to more easily manage their cravings.

In the case of combination therapy, Nicorette Clear transdermal patches and the oral medication should be used according to the same dosage recommendations as when used separately. Read the leaflet for oral forms to understand how to use them correctly 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, injured, or irritated, as this could alter the amount of nicotine absorbed. To ensure better adhesion of the patch, the skin must be clean, hair-free, dry, and free of creams, lotions, oils, or powders.

The patch should be applied upon waking and removed after 16 hours.

Choose a different application site each day, allowing several days to pass before reusing the same site.

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

Patch application:

1. Wash your hands before applying the patch.

2. Cut one of the side edges of the pouch containing the patch with scissors.

3. Peel off half of the protective liner, taking care not to touch the adhesive surface of the patch with your fingers.

4. Apply the adhesive side of the patch to the chosen site and remove the remaining half of the liner.

5. Press the patch onto the skin firmly with the palm of your hand or fingertips.

6. Check that the patch is properly adhered by running your fingers along its edges.

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

After 16 hours, remove the patch with a quick pull and dispose of it carefully.

If you feel that the effect of Nicorette Clear is too strong or too weak, inform your doctor or pharmacist.

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

If you feel the urge to smoke again:

If you are:

• Concerned that you might start smoking again, or
• Experiencing difficulties in stopping the use of Nicorette Clear patches, consult your doctor.

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

If you use more Nicorette Clear than you should

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

Overdose may occur if you smoke while 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 seizures.

In case of overdose or accidental poisoning, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 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 package leaflet and the medication container to the healthcare professional.

Nicorette Clear must not be used by individuals under 18 years of age or by people who have never smoked. If this occurs, symptoms of overdose may appear. If a child uses Nicorette Clear, contact immediately your doctor or go to the nearest hospital. Doses of nicotine tolerated by adult smokers during treatment may cause poisoning in young children and may even lead to death.

If you have any further 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 a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

The act of quitting smoking itself may cause symptoms such as dizziness, headache, sleep disturbances, cough, and cold-like symptoms. Adverse effects are usually dose-dependent. Symptoms such as depression, irritability, anxiety, restlessness, increased appetite, and insomnia may also be related to smoking cessation.

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

• Itching.

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

• Headache.
• Nausea, vomiting.
• Rash, urticaria.

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

• Palpitations (unusual awareness of heartbeat), increased heart rate.
• Fatigue, malaise, chest pain.
• Reactions at the application site.
• Hypersensitivity, muscle pain.
• Tingling, sleep disorders, difficulty breathing.
• Excessive sweating.
• Hot flushes and hypertension.

Adverse effects with unknown frequency (cannot be estimated from available data):

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

If you notice any of the following serious adverse effects, stop using Nicorette Clear 15 mg/16 hours transdermal patches and contact your doctor immediately, as they may be symptoms of a severe allergic reaction:

• Urticaria (a skin condition characterized by itching and red patches).
• Swelling of the face, tongue, or throat.
• Difficulty breathing.
• Difficulty swallowing.

Most of these adverse effects occur during the initial stages of treatment.

Rarely, allergic reactions (including symptoms of anaphylaxis) may 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 medicated chewing gum, Nicorette Ice Mint 2 mg medicated chewing gum, Nicorette Freshfruit 2 mg medicated chewing gum, Nicorette Supermint 2 mg oral dissolving tablets, or Nicorette Bucomist 1 mg/puff oral spray solution, carefully read the package leaflet of these medicines.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse 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 sachet containing the patch, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nicorette Clear

• The active substance is nicotine. One transdermal patch of 13.5 cm² contains 23.62 mg of nicotine and delivers a dose of 0.93 mg of nicotine per hour for 16 hours.
• The other components are: medium-chain triglycerides, butylated methacrylate copolymer, polyethylene terephthalate film, acrylate matrix (containing acrylic adhesive solution, potassium hydroxide, sodium croscarmellose, aluminium acetylacetonate), protective layer (containing single-layer polyethylene terephthalate (PET) film, aluminium-coated 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 multilayer pouch and stored in the carton.

Nature and contents of the container

Nicorette Clear is available in cartons containing 7, 14 and 28 patches.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 the most recent revision of the leaflet: June 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es