Leaflet: information for the user

Nicotinell 14 mg/24 hours transdermal patch

Nicotine

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

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 6 months, you must consult your doctor.
• If you consider any of the side effects to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

Nicotinell belongs to a group of medications used to help you quit smoking.

Nicotinell is a transdermal patch and is similar to a bandage that contains the medication on the part that adheres to the skin.

This medication is indicated for the relief of symptoms of nicotine withdrawal syndrome, in nicotine dependence as a help to quit smoking.

nicotine withdrawal syndrome, in nicotine dependence as a help to quit smoking.

Do not use Nicotinell transdermal patch

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

If you are unsure whether you should use Nicotinell, consult your doctor or pharmacist.

Be especially careful with Nicotinell transdermal patch

If you are in the immediate recovery period after a heart attack, a stroke, or present severe arrhythmias or uncontrolled hypertension, 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 when starting to use 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 passage between the mouth and stomach) as nicotine replacement therapy may worsen your symptoms.
• if you have severe liver and/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 experiencing these reactions.

The nicotine patches used contain sufficient residual nicotine to be harmful to children. Keep all medications out of the reach and sight of children

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

Use of Nicotinell patches with other medications

Quitting smoking may affect the effect of other medications you may be taking. If you have any questions or concerns, consult a healthcare professional.

Pregnancy

If you are pregnant, you should quit smoking without using nicotine replacement therapy. Quitting completely is, by far, the best option. However, if you have tried and failed, nicotine replacement therapy should only be used to help you quit smoking under the recommendation of a healthcare professional.

Breastfeeding

If you are breastfeeding, you should first quit smoking without using nicotine replacement therapy. However, if you have tried and failed, nicotine replacement therapy should only be used under the recommendation of a healthcare professional, as nicotine may pass into breast milk.

Driving and operating machinery

Although there are no known effects on the ability to drive or operate machinery at the recommended doses,

you should be aware that quitting 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.

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

Do not use Nicotinell and another nicotine product such as gum or lozenges at the same time, unless under strict medical supervision.

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

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

The determination of the appropriate dose for each person is based on the number of cigarettes smoked per day or on 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 evaluate the degree of nicotine dependence.

FAGERSTRÖM TEST

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

You can quit smoking without the need for nicotine replacement therapy.

However, if you are concerned about quitting smoking or are unsure about which patch dose to use, consult your doctor or pharmacist.

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

• Result of 5 to 6: moderate to high 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 appropriate treatment for you.

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

It is recommended to use nicotine replacement therapy as a help to your dependence. The treatment should be used at the sufficient and appropriate dose.

Consult your doctor or pharmacist, if possible within the scope of specialized assistance to quit smoking.

You may need to adjust the dose of Nicotinell transdermal patch during treatment, as nicotine dependence can vary. Sometimes the dose of nicotine in 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 urge 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 (feeling sick), vomiting, abdominal pain, diarrhea.
• if you produce excessive saliva.
• if you sweat.
• if you experience headaches, dizziness, hearing loss, visual disturbances.
• if you experience general weakness (lack of energy)

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

The usual treatment consists of 3 phases:

Initial phase: it will help you quit smoking.

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

Withdrawal phase: this phase will help you complete 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 withdrawal symptoms.

** if the results are satisfactory

Form and route of administration

Transdermal route (through the skin).

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

Remove the disposable precut protective film from the side of the transdermal patch containing the medication. This is the side that should be in contact with the skin.

Immediately after removing the protective film, place the transdermal patch of Nicotinell on a dry and intact area of skin (without cuts, scratches, or bruises) and with little hair: shoulder, waist, outer upper arm, etc. Avoid areas of the body subject to friction with clothing. Apply the entire patch and do not cut it on 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 for 24 hours. If you have difficulty sleeping, consult your doctor or pharmacist.

Replace the transdermal patch of Nicotinell every 24 hours. Use a different area of the skin for the placement of the patch, leaving several days before using the same area again.

When you remove the patch from your skin, you must fold it in half with the face in contact with the skin inside before disposing of it in a safe place and keep it out of the reach of children.

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

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

• before the bath, remove the transdermal patch and place it immediately in its packaging. You can stick it back on dry skin later.

• cover the transdermal patch with a waterproof adhesive (bandage) 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 a patch every 24 hours.

Duration of treatment

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

If you use more Nicotinell transdermal patches than you should:

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

Even small amounts of nicotine are dangerous and can be fatal in children. If poisoning is suspected in a child, consult a healthcare professional immediately.

In addition to the signs of overdose that only require reducing the dose (see the previous dose table), severe intoxications may occur with the following symptoms:

• Pale skin
• excessive sweating
• involuntary muscle contractions
• sensory disturbances
• and may cause confusion

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. Do not use 2 patches at the same time.

If you have any questions about the use of this medication, consult a healthcare professional.

Like all medicines, Nicotinell may have side effects, although not everyone will experience them.

Some side effects can be serious

Allergic reactions such as skin inflammation, facial and oral swelling, 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 in 10 patients) Skin reactions at the application site such as itching, redness, swelling, and a burning sensation (in the area of the skin on your body where the Nicotinell transdermal patch has been applied). If you suffer from a severe skin reaction that does not disappear, you should stop treatment and consult with your doctor or pharmacist to find another nicotine replacement therapy that will help you quit smoking.

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

Sleep disturbances including insomnia and abnormal dreams. Headache, nausea, dizziness, feeling unwell, vomiting.

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

These side effects are often mild and will disappear naturally and quickly once the patch has been removed.

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

Fast heartbeat, general feeling of being unwell.

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

Irregular heartbeat.

Some side effects are very rare(affect fewer than 1 in 10,000 patients)

Tremors, skin sensitivity to the sun.

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 leaflet. 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 out of the reach and sight of children.

Do not use after the expiration date indicated on the packaging and on the container after “EXP”. The expiration date is the last day of the month indicated.

• Do not store at a temperature above 25º

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and the

medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and the medicines you no longer need. In this way, you will help protect the environment.

Composition of Nicotinell transdermal patch:

• The active ingredient is nicotine. Each transdermal patch contains 35.0 mg of nicotine in a 20 cm2patch, which releases a nominal amount of 14 mg of nicotine every 24 hours.
• The other components (excipients) are: Basic butyl methacrylate copolymer (Eudragit E100), aluminum-coated polyester film, vinyl acetate-acrylic copolymer (Duro Tak 387-2516), medium-chain triglycerides (Miglyol 812), 26g/m² paper, siliconized aluminum-coated polyester film, and brown ink.

Appearance of Nicotinell transdermal patch and contents of the package:

Nicotinell 14mg/24h: round yellow-brown transdermal patch (20 cm2in size, marked FEF) sealed in a protective sachet.

Nicotinell 14mg/24h is available in packages of: 7, 14, 21, and 28 patches. Only some package 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

Responsible for Manufacturing:

LTS Lohmann Therapie-Systeme AG

Lohmannstrasse 2

56626 Andernach

Germany

or

Haleon - Gebro Consumer Health GmbH

Bahnhofbichl 13

6391 Fieberbrunn

Austria

This medicine is authorized in the member states of the European Economic Area with the following names:

AustriaNicotinell TTS Depot-Pflaster 20 (14 mg/24 h)

BelgiumNicotinell 14mg/24h, plaster for transdermal use

SpainNicotinell Transdermal Patches 14 mg / 24 hours

GreeceNicotinell TTS® NCH

LuxembourgNicotinell 14mg/24h, transdermal device

NetherlandsNicotinell 14mg/24h, plaster for transdermal use

PortugalNicotinell 14 mg/24 hours

This leaflet was approved in May 2022

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es