Leaflet: information for the patient

NiQuitin Clear 21mg/24 h transdermal patches

Nicotine

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

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

3. How to use NiQuitin Clear

4. Possible side effects

5. Storage of NiQuitin Clear

6. Contents of the pack and additional information

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

NiQuitin Clear patches are available in 3 doses: 21 mg, 14 mg, and 7 mg/24 h. People who want to quit smoking should start with the patches of higher dose and gradually change to lower doses (see section 3: How to use NiQuitin Clear). Each one is presented in its own package.

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 the body. This helps alleviate some of the unpleasant effects that smokers may experience when trying to quit, Relieves cigarette cravings and helps you resist the urge to smoke.

NiQuitin Clear patches can be used with any NiQuitin oral (chewable tablets 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 very 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 risks of tobacco since it does not contain tar, carbon monoxide, or other toxins present in cigarette smoke. Some people worry that they might become dependent on the nicotine in NRT. This is very rare, but if it happened, it would be less harmful than continuing to smoke. Additionally, it is a habit 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) such as NiQuitin Clear can help. In general, any side effect associated with NRT is widely outweighed by the dangers of smoking.

Do not use NiQuitin Clear

• If you are allergic to nicotine or any of the other components of this medication (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 thehospital due to a heart attack, severe heart rhythm problems, or cerebral infarction.You should try to quit smoking without using nicotine replacement therapy (NRT) unless your doctor tells you to use it. Once you leave the hospital, you can use NRT normally.

• if you havediabetes.You should monitor your blood sugar levels more frequently than usual when starting to use Niquitin Clear. Your insulin or medication needs may vary.

• if you have hadallergic reactionsinvolving swelling of the lips, face, and throat or skin rash with itching. The use of NRT may sometimes trigger this type of reaction.

• if you have hadallergic eczema or dermatitis.You may experience a reaction to the patches.

• if you havestomach or duodenal ulcersor esophagus or throat inflammation. NRT may worsen your symptoms.

• if you have a history ofepilepsy (seizures).

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

Children (under 12 years)

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

Using Niquitin Clear with other medications

Inform your healthcare professional that you are taking, have taken recently, or may need to take any other medication.

Quitting smoking may alter the effects of other medications you are taking. If you have questions or concerns about this, speak with a healthcare professional.

Pregnancy and Breastfeeding

Smoking duringpregnancyposes risks to 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 to smoke. You should use NRT as soon as possible during pregnancy and ideally only for 2-3 months. Remember, the most important thing is to quit smoking. NRT in the form of gum or lozenges may be preferable to nicotine patches because you do not receive nicotine all the time. However, patches may be better if you experience nausea or vomiting.

If you are breastfeeding, smoke from tobaccocauses respiratory difficulties and other problems in babies and children. You should try to quit it 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 the baby than breathing in tobacco smoke. Products like gum are better than patches because you will not receive nicotine continuously.

It is also better to breastfeed just before using NRT so that your baby receives the smallest amount of nicotine possible.

Do not useNiQuitin patches in combination with NiQuitin tablets 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 women or breastfeeding women.

Driving and operating machinery

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 may affect you in this way.

Follow exactly the administration instructions of this medication contained in this leaflet or those 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 the nicotine needs of your body.

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

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

Adult patches (18 years and older)

Table 1: Very dependent smokers (more than 10 cigarettes per day)

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

*The patches can be continued after the recommended 8 or 10 weeks if you need them to not smoke. However, if you still use them after 9 months, consult a healthcare professional.

Speak with a healthcare professional if you are:

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

Use in children and adolescents

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

Children under 12 years of age should not use NiQuitin Clear

Combination of NiQuitin Clear patches with NiQuitin oral formats (tablets or gum)

NiQuitin Clear patches are not always sufficient on their own. Using oral NiQuitin formats at the same time as patches can help control sudden nicotine cravings and increase your chances of quitting smoking compared to using patches alone. Oral NiQuitin formats come in the form of tablets or gum.

The combination of patches and oral NiQuitin can help:

• if you have relapsed after trying to quit smoking with TSN.

• if a NiQuitin product is not enough to control your nicotine cravings.

• if you are a heavy smoker (for example, smoke 10 or more cigarettes per day).

• only if you are 18 years or older and any of the above situations apply.

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

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

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

• do not take more than 10 units of NiQuitin oral format 4 mg in 24 hours

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

Table 3: Combined therapy for very dependent smokers (10 cigarettes or more per day)

Table 4: Combined therapy for less dependent smokers (less than 10 cigarettes per 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 skin that is cracked (such as over a joint), or where it folds when moving. Also avoid skin that is red, raw, or irritated.

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

• With the adhesive side facing you, remove the middle of the protective layer of the patch starting from the middle. Hold the patch by the outer edge (touching as little as possible the adhesive side), 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. When you have finished, always wash your hands only with 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 of time while wearing the patch.

NiQuitin Clear usually sticks well to the skin of most people. However, it is possible that a patch may occasionally fall off.If the patch falls off, put a new patch on, making sure to choose a different area of skin. Then, you can 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 for a new patch. Do not reuse the same area of skin for at least 7 days.

Removing the patches

When removing a patch, fold it in half with the adhesive side facing inwards and put it inside the sachet from which you removed your new patch or wrap it in aluminum foil. Dispose of it carefully, making sure it is out of reach of children and pets.

If you want to, you can remove the patch before going to bed (after approximately 16 hours) and put a new one on in the morning. However, removing it before sleeping will reduce its effectiveness in relieving morning cravings.

If you use more NiQuitin Clear than you should:

If you use too many patches at the same time, you may start to feel nausea, dizziness, and discomfort. Remove all the patches and wash and dry your skin only with water (no soap).In case of overdose or accidental ingestion, consultimmediately a doctor, pharmacist, go to the nearest hospital or call the Toxicological Information Service (phone91 562 04 20), indicating the name and amount used.

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

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

If you forget to use NiQuitin Clear:

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

If you interrupt the treatment with Niquitin Clear

If you interrupt the use of this medication before the recommended time, you may feel the urge to smoke again.

If you have any other questions about the use of this medication, ask your healthcare professional.

Like all medications,NiQuitin Clearmay cause side effects, although not everyone will experience them. At the recommended doses, no serious side effects have been found with NiQuitin Clear.

Stopping smoking itself can cause some symptoms, such as weakness, dizziness, headaches, cough, and flu-like symptoms.

Other symptoms that may be related to withdrawal symptoms associated with quitting smoking are mood changes, insomnia, sleep disturbances, lack of concentration, feelings of depression, irritability, anxiety, drowsiness, 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

-Headaches

-Dizziness

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

-Restlessness

-Trembling

-Difficulty breathing

-Throat pain or inflammation

-Cough

-Indigestion, stomach pain, diarrhea, constipation, dry mouth

-Sweating

-Joint or muscle pain, chest pain, limb pain

-Weakness or fatigue

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

-Allergic reaction

-Increased heart rate

-Flu-like symptoms

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

-Skin reactions, skin sensitivity to sunlight

-Severe allergic symptoms, which may include wheezing, chest tightness, skin rash, and feeling of fainting.

Unknown(frequency is unknown):

-Seizures (attacks)

You may experience a mild redness, itching, burning, and tingling sensation on the skin where the patch has been applied. This usually disappears quickly after the patch is removed. 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 of 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 prospectus. 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 about the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears 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 sachets until you are going to use one.
• Do not use the Niquitin Clear patches if the sachet is open or damaged.

Dispose of the packaging responsibly. Medications should not be thrown down the drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of NiQuitin Clear patches.

The active ingredient is nicotin.

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

Appearance and contents of the NiQuitin Clear packaging.

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

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

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 European Economic Area member states with the following names:

Germany: Niquitin Clear 14mg/24 Stunden transdermal Pflaster

Austria: Niquitin Clear 14mg/24 Stunden transdermal Pflaster

Spain: Niquitin 14 mg/24 h transdermal patches

Ireland: Niquitin Clear 14mg/24 hrs Transdermal Patch

Italy: Niquitin 14mg/24 ore transdermal patches (nicotine)

Portugal: Niquitin Clear 14mg/24 h transdermal systems

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

Last review date of this leaflet : May 2021

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