NICOTINELL 7 MG/24 HOURS TRANSDERMAL PATCH

Introduction

Package Leaflet: Information for the User

Nicotinell 7 mg/24 hours Transdermal Patch

Nicotine

Read all of this leaflet carefully because it contains important information for you.

This medicine can be obtained without a prescription. However, to get the best results, it should be used with care.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If your symptoms worsen or persist after 6 months, you should consult a doctor.
• If you think any of the side effects is serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

1. What is Nicotinell Transdermal Patch and what is it used for
2. Before using Nicotinell Transdermal Patch
3. How to use Nicotinell Transdermal Patch
4. Possible side effects
5. Storage of Nicotinell Transdermal Patch
6. Additional information

1. What is Nicotinell Transdermal Patch and what is it used for

Nicotinell belongs to a group of medicines used to help you stop smoking.

Nicotinell is a transdermal patch and is similar to a plaster that contains the medicine in the part that sticks to the skin.

This medicine is indicated for the relief of symptoms of nicotine withdrawal syndrome in nicotine dependence as an aid to stop smoking.

2. Before using Nicotinell Transdermal Patch

Do not use Nicotinell Transdermal Patch

• if you smoke occasionally or are not a smoker.
• if you are allergic (hypersensitive) to nicotine or any of the other components of this medicine.

If you are not sure if you should use Nicotinell, consult your doctor or pharmacist.

Be careful with Nicotinell Transdermal Patch

If you are in the immediate recovery period after a heart attack, stroke, or have severe cardiac rhythm disturbances or uncontrolled hypertension, you should consult your doctor before starting treatment with Nicotinell.

You should consult your doctor or a healthcare professional before using Nicotinell:

• if you have stable cardiovascular disorders, severe hypertension, or heart failure,
• if you have had cerebrovascular or arterial occlusion problems,
• if you have diabetes, you should monitor your blood sugar levels more frequently than usual when you start using the nicotine patch. You may need to adjust your insulin or medication treatment.
• if you have stomach or duodenal ulcers, or esophagus or throat inflammation (the duct between the mouth and stomach), as nicotine replacement therapy may worsen your symptoms.
• if you have severe liver or kidney failure,
• if you have any skin disease.
• if you have ever experienced seizures (attacks).

Stop using the patch and consult a healthcare professional

• If you experience redness, inflammation, or rash on the skin. If you have a history of dermatitis, you will be more prone to these reactions.

Used nicotine patches contain enough residual nicotine to be harmful to children. Keep all medicines out of the reach and sight of children.

After use, fold the patch in half before throwing it away carefully and keep it out of the sight and reach of children.

Using Nicotinell patches with other medicines

Stopping smoking may change the effect of other medicines you are taking. If you have any questions or concerns about this, consult a healthcare professional.

Pregnancy

If you are pregnant, you should stop smoking without using nicotine replacement therapy. Stopping completely is, by far, the best option. However, if you have tried and failed, nicotine replacement therapy should only be used to help you stop smoking after a healthcare professional's recommendation.

Breastfeeding

If you are breastfeeding, you should first stop smoking without using nicotine replacement therapy. However, if you have tried and failed to stop, nicotine replacement therapy should only be used after a healthcare professional's recommendation, as nicotine can pass into breast milk.

Driving and using machines

Although there are no known effects on the ability to drive or use machines at the recommended doses, it should be taken into account that stopping smoking causes changes in behavior.

Important information about some components of Nicotinell Transdermal Patch

Nicotinell Transdermal Patch contains aluminum: you should not wear the Nicotinell patch during Magnetic Resonance Imaging (MRI) tests.

3. How to use Nicotinell Transdermal Patch

You should stop smoking completely with this treatment to achieve quitting the smoking habit.

You should not use Nicotinell and another nicotine product simultaneously, such as gum or lozenges, unless under strict medical supervision.

Smokers under 18 years of age should not use Nicotinell without the explicit recommendation of a healthcare professional.

There are three doses of this medicine: Nicotinell 7 mg/24 h, Nicotinell 14 mg/24 h, and Nicotinell 21 mg/24 h.

The determination of the suitable dose for each person is based on the number of cigarettes smoked per day or the results of the Fagerström test. This test measures the degree of nicotine dependence. With the result of this test, the most suitable dose of the patch can be selected for each person.

Use the Fagerström test to assess the degree of nicotine dependence.

FAGERSTRÖM TEST

• Result of 0 to 2: not dependent on nicotine.

You can stop smoking without needing nicotine replacement therapy.

However, if you are concerned about stopping smoking or are not sure what dose of the patch to use, consult your doctor or pharmacist.

• Result of 3 to 4: low nicotine dependence.
• Result of 5 to 6: moderate nicotine dependence.

The use of nicotine replacement therapy will increase the chances of success.

Consult your doctor or pharmacist to help you choose the most suitable treatment for you.

• Result of 7 to 10: high or very high nicotine dependence.

Nicotine replacement therapy is recommended as an aid to your dependence. The treatment should be used at a sufficient and adequate dose.

Consult your doctor or pharmacist, if possible within the specialized care setting for stopping smoking.

It may be necessary to modify the dose of Nicotinell Transdermal Patch during treatment, as nicotine dependence can vary. Sometimes the nicotine dose of the Nicotinell patch is too low and sometimes too high.

You should increase the dose if you experience withdrawal symptoms such as:

• if you still feel a strong desire to smoke
• if you are irritable
• if you have difficulty sleeping
• if you become nervous or impatient
• if you have difficulty concentrating

Consult your doctor or pharmacist; it may be necessary to adjust the dose.

You should reduce the dose if you experience signs of overdose, such as:

• if you experience nausea (feel unwell), vomiting, abdominal pain, diarrhea.
• if you secrete too much saliva.
• if you sweat.
• if you experience headache, dizziness, hearing loss, vision disturbance.
• if you experience general weakness (lack of energy)

It is essential to adapt the treatment with the help of your doctor or pharmacist.

The usual treatment consists of 3 phases:

Initial phase: it will help you stop smoking.

Follow-up treatment: this phase consolidates the abandonment of tobacco and starts the withdrawal of nicotine.

Withdrawal treatment: this phase helps you finish the treatment.

Normally, the treatment should be followed for 3 months, although the duration of the treatment depends on each person.

Do not use Nicotinell for more than 6 months.

• depending on the results obtained in the withdrawal symptoms.

** if the results are satisfactory.

Form and route of administration

Transdermal route (through the skin).

Open the envelope using scissors and remove the transdermal patch. Do not cut the Nicotinell transdermal patch.

Remove the disposable protective film pre-cut on the side of the transdermal patch. This is the side that contains the medicine and the one that should be in contact with the skin.

Immediately after removing the protective film, place the Nicotinell transdermal patch on a dry and unblemished skin area (cuts, scratches, or bruises) and with little hair: shoulder, waist, outer upper arm, etc. Avoid mobile areas of the body such as joints subject to friction with clothing. Apply the entire patch without cutting it to the skin.

To ensure perfect adhesion, press firmly on the entire outer surface of the patch with the palm of your hand for at least 10-20 seconds.

Keep the patch on for 24 hours. If you have difficulty sleeping, consult your doctor or pharmacist.

Change the Nicotinell transdermal patch every 24 hours. Use a different skin area for the placement of the patch, leaving a few days before reusing the same area.

When removing the patch from your skin, you should fold it in half with the side in contact with the skin inside before disposing of it in a safe place and keeping it out of the sight and reach of children.

During handling, avoid contact with the eyes and nose, and wash your hands after application.

In the case of prolonged baths in the sea or pool, you have 2 options:

• before bathing, remove the transdermal patch and place it immediately in its container. You can reattach it to your dry skin later.
• cover the transdermal patch with a water-resistant adhesive (band-aid) during the entire bath.

When showering, the transdermal patch can be left on, avoiding directing the water jet directly at it.

Frequency of administration

Use one patch every 24 hours.

Duration of treatment

Consult your doctor if the withdrawal symptoms worsen or do not improve, anxiety persists, or you have difficulty stopping treatment.

If you use more Nicotinell Transdermal Patch than you should:

In case of accidental overdose or if a child sucks or places a transdermal patch on the skin, remove the patch immediately, wash the skin with water only (do not use soap), consult a doctor or a hospital emergency centeror call the Toxicological Information Service (telephone 91 562 04 20), indicating the name and amount used.

In children, even small amounts of nicotine are dangerous and could be fatal. If you suspect poisoning in a child, consult a healthcare professional immediately.

In addition to the signs of overdose that only require reducing the dose (see the list above the dosage table), serious intoxications can occur with the following symptoms:

• pale skin
• increased sweating
• involuntary muscle contractions
• sensory disturbances
• and confusion may occur

With high overdose

• exhaustion
• seizures
• low blood pressure that can lead to circulatory collapse or respiratory failure

If you forget to use Nicotinell Transdermal Patch:

Use the patch as soon as you remember, and then continue with your schedule as before. You should not use 2 patches at the same time.

If you have more questions about the use of this medicine, consult a healthcare professional.

4. Possible side effects

Like all medicines, Nicotinell can have side effects, although not everyone gets them.

Some side effects can be serious

Allergic reactions such as skin inflammation, swelling of the face and mouth, low blood pressure, and difficulty breathing.

If you experience any of them, remove the patch and inform your doctor immediately.

Some side effects are very common(affect more than 1 patient in 10) Reactions at the application site such as itching, redness, edema (swelling), and burning sensation (in the area of the skin where the Nicotinell patch has been placed). In case of a severe skin reaction that does not disappear, you should stop treatment and consult your doctor or pharmacist to find another nicotine replacement therapy that can help you stop smoking.

These effects are usually caused by not changing the application site of the patch every day. Changing the application site will allow the irritation to disappear naturally, causing you mild discomfort.

Sleep disorders, including lack of sleep and abnormal dreams. Headache, nausea, dizziness, feeling unwell, vomiting.

Some side effects are common(affect 1 to 10 patients in 100) Palpitations (feeling heartbeats), difficulty breathing, nervousness, tremors, feeling unwell, stomach pain, diarrhea, throat pain or inflammation, cough, dry mouth, fatigue or weakness, constipation, joint and muscle pain.

These effects are often mild and will disappear naturally and quickly once the patch is removed.

Some side effects are uncommon(affect 1 to 10 patients in 1000)

Fast heartbeat, general malaise.

Some side effects are rare(affect 1 to 10 patients in 10,000)

Irregular heartbeats

Some side effects are very rare(affect less than 1 patient in 10,000)

Tremors, skin sensitivity to the sun

Reporting side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this 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 contribute to providing more information on the safety of this medicine.

5. Storage of Nicotinell Transdermal Patch

Keep out of the reach and sight of children.

Do not use after the expiration date indicated on the envelope and on the packaging after "EXP". The expiration date is the last day of the month indicated.

• Do not store at a temperature above 25°C.

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

6. ADDITIONAL INFORMATION

Composition of Nicotinell transdermal patch:

• The active ingredient is nicotine. Each transdermal patch contains 17.5 mg of nicotine in a 10 cm2 patch, which releases a nominal amount of 7 mg of nicotine every 24 hours.
• The other components (excipients) are: Basic butyl methacrylate copolymer (Eudragit E100), aluminum-coated polyester film, acrylic-vinyl acetate copolymer (Duro Tak 387-2516), medium-chain triglycerides (Miglyol), 26g/m² paper, siliconized aluminum-coated polyester film, brown ink.

Appearance of Nicotinell transdermal patch and packaging contents:

Nicotinell 7mg/24h: round yellow-ochre transdermal patch (10 cm2 in size, marked CWC) sealed in a protective pouch.

Nicotinell 7mg/24h is available in packs of: 7, 14, 21, and 28 patches. Only some pack sizes may be marketed.

Marketing authorization holder

Haleon Spain, S.A.

Parque Tecnológico de Madrid, Calle de Severo Ochoa, 2

28760 Tres Cantos, Madrid - Spain

Manufacturer

LTS Lohmann Therapie-Systeme AG

Lohmannstrasse 2

56626 Andernach

Germany

or

Haleon - Gebro Consumer Health GmbH

Bahnhofbichl 13

6391 Fieberbrunn

Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria Nicotinell TTS Depot-Pflaster 10 (7 mg/24 h)

Belgium Nicotinell 7mg/24u, pleister voor transdermaal gebruik

Spain Nicotinell 7 mg/24 hours transdermal patch

Greece Nicotinell TTS® NCH

Luxembourg Nicotinell 7mg/24h, dispositif transdermique

Netherlands Nicotinell 7mg/24u, pleister voor transdermaal gebruik

Portugal Nicotinell 7 mg/24 hours

This leaflet was approved in May 2022

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