NIQUITIN CLEAR 14 mg/24 hours TRANSDERMAL PATCH

Introduction

Patient Information Leaflet

NiQuitin Clear 14 mg/24 h Transdermal Patches

Nicotine

Contents of the Pack

1. What NiQuitin Clear is and what it is used for
2. What you need to know before you use NiQuitin Clear
3. How to use NiQuitin Clear
4. Possible side effects
5. Storing NiQuitin Clear
6. Package contents and further information

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

NiQuitin Clear are patches that release nicotine to help people quit smoking. This type of treatment is called Nicotine Replacement Therapy (or NRT for short).

NiQuitin Clear patches come in 3 doses: 21 mg, 14 mg, and 7 mg/24 h. People who want to quit smoking should start with the higher-dose patches and gradually switch to lower doses (see section 3: How to use NiQuitin Clear). Each dose comes in its own packaging.

The nicotine in cigarettes is what makes them addictive. NiQuitin Clear helps you quit smoking by replacing some of the nicotine you get from cigarettes. Each patch releases nicotine slowly into your body, relieving some of the unpleasant effects that smokers may experience when trying to quit, such as craving for cigarettes and the urge to smoke.

NiQuitin Clear patches can be used along with any NiQuitin oral product (lozenges or gum) if you have relapsed after trying to quit smoking with NRT, or when a NiQuitin product is not enough to control your cravings, or if you are a highly dependent smoker (for example, if you smoke more than 10 cigarettes a day) (see section 3: How to use NiQuitin Clear).

NRT does not have the health hazards of tobacco since it does not contain tar, carbon monoxide, or other toxins found in cigarette smoke. Some people worry that they might become dependent on NRT nicotine. This is very rare, but if it happens, it would be less harmful than continuing to smoke. Additionally, it is a habit that is easier to break.

Your chances will improve if you are part of a support program. If you want information about them, consult a healthcare professional.

Smoking has no health benefits. It is always better to quit smoking. Using Nicotine Replacement Therapy (NRT) like NiQuitin Clear can help. In general, any side effects associated with NRT are far outweighed by the dangers of smoking.

2. What you need to know before you use NiQuitin Clear

Do not use NiQuitin Clear

• If you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6).
• If you are a non-smoker, occasional smoker, or under 12 years old.

Warnings and precautions

Consult your healthcare professionalbefore starting to use NiQuitin Clear:

• if you are in the hospital due to a heart attack, severe heart rhythm problems, or stroke.You should try to quit smoking without using nicotine replacement therapy (NRT) unless your doctor tells you to use it. Once you are out of the hospital, you can use NRT normally.

• if you have diabetes.You should monitor your blood sugar levels more often than usual when you start using NiQuitin Clear. Your insulin or medication needs may change.

• if you have had allergic reactionsthat involved swelling of the lips, face, and throat, or itchy skin rash. Using NRT can sometimes trigger this type of reaction.

• if you have had allergic eczema or dermatitis.You may have a reaction to the patches.

• if you have stomach or duodenal ulcersor esophagus or throat (the passage between the mouth and stomach) inflammation. NRT may worsen your symptoms.

• if you have a history of epilepsy (seizures).

• if you have a history of cardiovascular disease(such as heart disease, angina, or high blood pressure) and you want to use NiQuitin Clear patches in combination with NiQuitin lozenges or gum.

• if you have severe liver or kidney problems.You may be more susceptible to side effects.

• if you have an overactive thyroid gland or a pheochromocytoma (a tumor of the adrenal gland that can affect blood pressure). Nicotine may worsen your symptoms.
• if you have any concerns about being dependent on this product or if you believe you are dependent on this product.

Consult a healthcare professional before using NiQuitin Clear if you are affected by any of the above points.

Children (under 12 years old)

The nicotine levels in NRT are not suitable for children under 12 years old. Nicotine affects children more than adults. It could cause severe poisoning in children, which can be fatal.

Using NiQuitin Clear with other medicines

Tell your healthcare professional that you are taking, have recently taken, or might take any other medicines.

Quitting smoking may change the effects of other medicines you are taking. If you have questions or concerns about this, talk to a healthcare professional.

Pregnancy and Breastfeeding

Smoking during pregnancyhas risks for the baby, including low birth weight, premature birth, and miscarriage. Quitting smoking is the best way to improve both your health and your baby's health. The sooner you quit smoking, the better.

Ideally, if you are pregnant, you should quit smoking without using NRT. However, if you have tried this and it has not worked, Nicotine Replacement Therapy may be recommended by a healthcare professional.This is because it is better for your baby than if you continue smoking. You should use NRT as soon as possible in pregnancy and ideally only for 2-3 months. Remember, the most important thing is to quit smoking. Oral NRT, such as lozenges, may be preferable to patches because you do not receive nicotine all the time. However, patches may be better if you suffer from nausea or vomiting.

If you are breastfeeding, cigarette smoke causes breathing difficulties and other problems in babies and children. You should try to quit smoking without using NRT. If you need NRT, the amount of nicotine your baby may receive is small but will be present. It is much less harmful to your baby than breathing cigarette smoke. Products like lozenges are better than patches because you do not receive nicotine continuously.

It is also better to breastfeed right before using NRT so that your baby receives as little nicotine as possible.

Do not useNiQuitin patches in combination with NiQuitin lozenges or gum if you are pregnant or breastfeeding, except if a healthcare professional considers it necessary. This is because this combination has not been tested in pregnant or breastfeeding women.

Driving and using machines

There are no known effects of NiQuitin Clear that may affect your ability to drive or operate machinery. However, quitting smoking may cause behavioral changes that can affect you in this way.

3. How to use NiQuitin Clear

Follow the instructions for administration of this medicine contained in this leaflet or as indicated by your healthcare professional. In case of doubt, consult your healthcare professional.

As your body adjusts to not smoking, reduce the dose of the patches used until you no longer need them.This reduction program allows you to gradually overcome your body's need for nicotine.

To increase your chances of success, it is essential to complete the entire reduction program.

Use a new patch every day. The patch should only be used once for 24 hours. Do not use more than the recommended dose.

Patches for adults (18 years and older)

Table 1: Highly dependent smokers (more than 10 cigarettes a day)

Table 2: Less dependent smokers (less than 10 cigarettes a day)

*You can continue using the patches after the recommended 8 or 10 weeks if you need them to not smoke.However, if you are still using them after 9 months, consult a healthcare professional.

Talk to a healthcare professional if you:

• are concerned that you might start smoking again
• are finding it difficult to stop using the patches completely.

If you start smoking again, they can advise you on how to get the best results from additional NRT courses.

Use in children and adolescents

Adolescents (12-17 years old inclusive)should follow the instructions in Tables 1 and 2, but they should only use the patches for a total of 12 weeks. If you feel you need to use NiQuitin Clear for more than 12 weeks, consult a healthcare professional. They should not use NiQuitin patches in combination with NiQuitin lozenges or gum. Do not exceed the recommended dose.

Children under 12 years old should not use NiQuitin Clear

Combining NiQuitin Clear patches with NiQuitin oral products (lozenges or gum)

NiQuitin Clear patches are not always enough on their own. Using NiQuitin oral products at the same time as the patches can help control sudden cravings for cigarettes and increase your chances of quitting smoking compared to using patches alone. NiQuitin oral products come in the form of lozenges or gum.

The combination of patches and NiQuitin oral products can help:

• if you have relapsed after trying to quit smoking with NRT.
• if a NiQuitin product is not enough to control your cravings.
• if you are a heavy smoker (for example, if you smoke 10 or more cigarettes a day).
• only if you are 18 years or older and any of the above situations apply to you.

Follow the same phase process with the patches, but take NiQuitin in oral products when you experience a sudden craving; about 5-6 lozenges or pieces of gum per day are recommended. Consult Tables 3 and 4 on the back of this leaflet for more details.

When using NiQuitin Clear patches and NiQuitin oral products at the same time:

• do not take more than 15 units of NiQuitin oral product 1.5 mg or 2 mg in 24 hours
• do not take more than 10 units of NiQuitin oral product 4 mg in 24 hours

For more information, read the leaflet that comes with the NiQuitin oral product.

Table 3: Combination therapy for highly dependent smokers (10 cigarettes or more a day)

Table 4: Combination therapy for less dependent smokers (less than 10 cigarettes a day)

How to apply the patches

Choose a clean, dry, and hairless area of skin to apply the patch, to ensure it sticks properly. Avoid cracked skin (such as over a joint), or where the skin folds when you move. Also, avoid red, broken, or irritated skin.

• Do not remove the patch from its packaging until you are ready to use it. Do not use it if the packaging is broken.
• Cut along the dotted line with scissors, being careful not to damage the patch inside.
• Remove the patch carefully. A clear protective layer covers the adhesive part of the patch, which is the part that goes on your skin.
• Remove the patch from the packaging that contains it and peel off the transparent layers, folding it and trying not to touch the inside of the patch

• With the adhesive side facing you, remove half of the protective layer of the patch, starting from the middle. Hold the patch by the outer edge (touching the adhesive side as little as possible), and remove the other half of the protective layer.
• Apply the adhesive side of the patch to your skin immediately. Press the patch firmly with the palm of your hand for at least 10 seconds. Make sure it sticks well, especially around the edges.
• When applying the patch, avoid touching your eyes and nose. After you finish, always wash your hands with only water. Do not use soap, as it may increase nicotine absorption.

Water will not damage the patch if it has been applied correctly. You can bathe, swim, or shower for short periods while wearing the patch.

NiQuitin Clear generally sticks well to most people's skin. However, it is possible that a patch may occasionally come off. If the patch falls off, apply a new patch, making sure to choose a different area of skin. You can then continue changing the patches at your usual time.

How to change the patches

You should apply a new patch once a day, approximately at the same time, preferably shortly after waking up. Leave the patch in place for 24 hours, and always choose a different area of skin to apply a new patch. Do not reuse the same area of skin for at least 7 days.

Disposal of patches

When you remove a patch, fold it in half with the adhesive side inward and place it in the packaging of the new patch you just removed or wrap it in aluminum foil. Dispose of it carefully, making sure it is out of the reach of children and pets.

If you wish, you can remove the patch before bedtime (after approximately 16 hours) and apply a new one in the morning. However, removing it before sleeping will reduce its effectiveness in relieving the urge to smoke in the mornings.

If you use more NiQuitin Clear than you should:

If you use too many patches at the same time, you may start to feel nauseous, dizzy, and unwell. Remove all patches and wash and dry your skin with only water (without soap). In case of overdose or accidental ingestion, consult a doctor, pharmacist, or go to the nearest hospital or call the Toxicology Information Service (telephone 91 562 04 20), indicating the name and amount used.

These patches are not suitable for children under 12 years old or non-smokers. If they are used by children or non-smokers, they may show symptoms of nicotine overdose, including headache, nausea, stomach pain, or diarrhea.

If a child has stuck or ingested a patch, remove any patch from the skin and wash the area with only water, without soap, and then dry the area. Contact your doctor or the nearest hospital immediately. If possible, show them the packaging or this leaflet.

If you forget to use NiQuitin Clear:

When you realize it, apply a patch immediately. You can continue changing the patches at your usual time.

If you stop using NiQuitin Clear

If you stop using this medicine before the recommended time, you may feel the urge to smoke again.

If you have any other questions about using this medicine, ask your healthcare professional.

4. Possible Adverse Effects

Like all medicines, NiQuitin Clearcan cause adverse effects, although not all people suffer from them. At the recommended doses, no serious adverse effects have been found to be caused by NiQuitin Clear.

The fact of quitting smoking itself can produce some symptoms, such as a feeling of weakness, dizziness, headache, cough, and symptoms similar to those of the flu.

Other symptoms that may also be related to the withdrawal symptoms associated with quitting smoking are mood changes, insomnia, sleep disturbances, lack of concentration, feeling of depression, irritability, anxiety, somnolence, restlessness, or nervousness.

Very Common(may affect more than 1 in 10 people):

- Skin reactions in the area where the patch is applied

- Sleep disturbances, including insomnia and abnormal dreams.

- Nausea, vomiting

- Headache

- Dizziness

Common(may affect up to 1 in 10 people):

- Nervousness

- Tremor

- Difficulty breathing

• Throat pain or inflammation
• Cough
• Indigestion, stomach pain, diarrhea, constipation, dry mouth

- Sweating

- Joint, muscle, chest, or limb pain

- Weakness or fatigue

Uncommon(may affect up to 1 in 100 people):

- Allergic reaction

• Increased heart rate
• Flu-like symptoms

Rare(may affect up to 1 in 10,000 people):

- Skin reactions, skin sensitivity to sunlight

- Severe symptoms of allergic reactions, which may include wheezing (whistling) or chest tightness, skin rash, and feeling of fainting.

Unknown(frequency not known):

- Seizures (attacks)

You may experience mild redness, itching, burning, and tingling on the skin where a patch has been applied. This usually disappears quickly after removing the patch. Rarely, a more severe reaction may occur at the application site, including redness, swelling, or rash that does not disappear after 4 days or a generalized skin reaction. This is more likely if you have a history of dermatitis. If this happens, stop using the patch and tell your doctor.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if it is a possible adverse 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 adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of NiQuitin Clear

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.
• Store below 30 °C. Keep all patches in the box, in their protective pouches until you are ready to use one.
• Do not use NiQuitin Clear patches if the pouch is open or damaged.

Dispose of the packaging responsibly. Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the 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

Composition of NiQuitin Clear patches.

The active ingredient is nicotine.

The other ingredients are: Ethylene Vinyl Acetate copolymer, Polyethylene Terephthalate, polyethylene foil, polyisobutylene, and printing ink.

Appearance and Package Contents of NiQuitin Clear

NiQuitin Clear are transparent and colorless rectangular patches for application to the skin.

Each phase (dose) comes in its own packaging, and each package contains 7, 14, 21, 28, or 42 patches. Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer.

The marketing authorization holder is:

Perrigo España, S.A.

Pza. Xavier Cugat, 2 - Edif. D, Pl. 1ª

08174 Sant Cugat del Vallès (Barcelona)

Spain.

The manufacturer is:

LTS Lohmann Therapie-Systeme AG

Lohmannstrasse 2

56626 Andernach

Germany

This medicine is authorized in some Member States of the European Economic Area under the following names:

Germany: Niquitin Clear 14mg/24 Stunden transdermales Pflaster

Austria: Niquitin Clear 14mg/24 Stunden transdermales Pflaster

Spain: Niquitin 14 mg/24 h patches transdermicos

Ireland: Niquitin Clear 14mg/24 hrs Transdermal Patch

Italy: Niquitin 14mg/24 ore cerotti transdermici trasparenti (nicotina)

Portugal: Niquitin Clear 14mg/24 h systems Transdermicos

United Kingdom: Nicabate Clear 14mg/24 hrs transdermal patches.

Date of the last revision of this leaflet:May 2021

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