Nicorette Clear 10 mg/16 hours transdermal patches

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicorette Clear 10mg/16 hours Transdermal Patches

Nicotine

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

Follow exactly the instructions for use provided 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 if you do 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. How to store Nicorette Clear
6. Contents of the pack and other information

1. What Nicorette Clear is and what it is used for

Nicorette Clear is 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 relieves nicotine withdrawal symptoms, including craving, 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, desire to smoke (craving), nocturnal awakenings or sleep disturbances, dizziness, transient disturbances of consciousness, cough, constipation, gum bleeding, mouth ulcers, or colds. The nicotine in Nicorette Clear can help you prevent or reduce these unpleasant symptoms as well as your cravings 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 using Nicorette Clear 10 mg/16 hours transdermal patches

Do not use Nicorette Clear 10 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

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

Contact your doctor if you suffer from any of the following conditions, as although you may still use Nicorette Clear 10 mg/16 hours transdermal patches, you should 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 condition affecting your 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 had an allergic reaction with swelling of the lips, face, and throat (angioedema) or skin irritation (urticaria). Nicotine replacement therapy may sometimes cause 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 10 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 substances in tobacco can affect how some medicines are metabolized in the body. When a smoker stops smoking, with or without Nicorette Clear 10 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: anti-asthma drugs (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 heartbeat (flecainide), antidiabetic medicines (insulin), treatments for Parkinson's disease (ropinirole), medicines for heart problems (prazosin, propranolol, isoprenaline, salbutamol), medicines containing caffeine, or antiarrhythmics (adenosine).

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

Food and drink do not affect the effectiveness 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 stop smoking during pregnancy, as smoking may lead to low birth weight or miscarriage. It is advisable to stop smoking without using nicotine-containing medicines. If you are unable to do so, you may use Nicorette Clear 10 mg/16 hours transdermal patches only after consulting your doctor.

Products such as nicotine 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 medicine 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 better to breastfeed just before taking the medicine, which helps ensure your baby receives the lowest possible amount of nicotine.

Driving and using machines

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

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

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 lozenges, or Nicorette Bucomist 1 mg/puff oral spray solution, carefully read the package leaflet of these medicines.

3. How to use Nicorette Clear

People under 18 years of age must not use this medicine.

Follow exactly the instructions for using this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

You must completely and immediately stop smoking, using the patches to 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 with 1 patch of 15 mg/16 hours per day for 8 weeks. This should then be followed by a stepwise reduction of 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

Highly dependent smokers, those experiencing strong cravings to smoke, or those who were unable to quit smoking with single-agent Nicotine Replacement Therapy (NRT), may benefit from using Nicorette Clear in combination with oral nicotine using a flexible dosing regimen—such as nicotine 2 mg medicated chewing gum, nicotine 2 mg oral tablets, 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 of the oral formulations 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. For better adhesion, 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.

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

Once removed from the sachet, 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 liner, taking care not to touch the adhesive surface of the patch with your fingers.
4. Place the adhesive side of the patch onto the chosen site and remove the other 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 10 mg/16 hours transdermal patches 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
• Having difficulty discontinuing 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 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 from smoking too much: pallor, cold sweats, 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, breathing difficulties, 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 taken.

If you experience any of these symptoms, contact your doctor immediately or go to the nearest hospital immediately. It is recommended to bring this leaflet and the medication packaging with you when seeing a 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 10 mg/16 hours transdermal patches, contact your doctor immediately 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 medication, consult your doctor or pharmacist.

If you forget to use Nicorette Clear

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

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

4. Possible adverse effects

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

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

The act of stopping 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 experience any of the following serious adverse effects, stop using Nicorette Clear 10 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 welts).
• Swelling of the face, tongue, or throat.
• Difficulty breathing.
• Difficulty swallowing.

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

Rarely, allergic reactions (including symptoms of anaphylaxis) may 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 medicated chewing gum, Nicorette Ice Mint 2 mg medicated chewing gum, Nicorette Freshfruit 2 mg medicated chewing gum, Nicorette Supermint 2 mg soluble 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 adverse effects, 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 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 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 collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nicorette Clear

• The active substance is nicotine. A 9.0 cm² transdermal patch contains 15.75 mg of nicotine and delivers 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 polyethylene terephthalate (PET) film, aluminum-coated and silicone-coated on both sides), printing ink (containing varnish mixture, beige printing ink, and brown printing ink). Each nicotine patch is individually packed in a sealed multilayer pouch and stored in the carton.

Nature of the product and pack contents

Nicorette Clear is available in packs containing 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.
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 this 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