Niquitin Clear 14 mg/24 hours transdermal patch

Patient Information Leaflet

Introduction

Patient Information Leaflet

NiQuitin Clear 14 mg/24 h Transdermal Patches

Nicotine

Contents of the leaflet

1. What NiQuitin Clear is and what it is used for
2. What you need to know before using NiQuitin Clear
3. How to use NiQuitin Clear
4. Possible side effects
5. Storage of NiQuitin Clear
6. Contents of the pack and other information

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

NiQuitin Clear are nicotine patches designed to help people stop smoking by releasing nicotine into the body. This type of treatment is known as Nicotine Replacement Therapy (NRT).

NiQuitin Clear patches are available in three strengths: 21 mg, 14 mg, and 7 mg/24 hours. Individuals who wish to stop smoking should start with the highest strength patch and gradually switch to lower strengths (see section 3: How to use NiQuitin Clear). Each strength comes in its own packaging.

Nicotine from cigarettes is what makes them addictive. NiQuitin Clear helps you quit smoking by replacing some of the nicotine your body receives from cigarettes. Each patch releases nicotine slowly into the body, helping to relieve some of the unpleasant symptoms smokers may experience when trying to quit. It reduces cigarette cravings and helps you resist the urge to smoke.

NiQuitin Clear patches may be used in combination with any NiQuitin oral product (such as lozenges or chewing gum) if you have relapsed after trying to quit smoking with NRT, if one NiQuitin product alone is not sufficient to control your cravings, or if you are a heavy smoker (for example, if you smoke more than 10 cigarettes per day) (see section 3: How to use NiQuitin Clear).

NRT does not carry the health risks associated with tobacco because it does not contain tar, carbon monoxide, or other toxins found in cigarette smoke. Some people are concerned that they might become dependent on the nicotine from NRT. This is very rare, but if it were to happen, it would be less harmful than continuing to smoke. In addition, such dependence is easier to overcome.

Your chances of success improve if you participate in a support programme. For further information, please consult a healthcare professional.

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

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

Do not use NiQuitin Clear

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

Warnings and precautions

Consult your healthcare professional before starting to use NiQuitin Clear:

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

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

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

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

• if you have stomach or duodenal ulcers, or inflamed oesophagus or throat (the passage between the mouth and stomach). 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 wish to use NiQuitin Clear patches in combination with NiQuitin tablets or chewing gum.

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

• if you have uncontrolled hyperthyroidism or phaeochromocytoma (a tumour of the adrenal gland that can affect blood pressure). Nicotine may worsen your symptoms.

• if you have any concerns about becoming dependent on this product, or if you believe you are already dependent on it.

Consult a healthcare professional before using NiQuitin Clear if any of the above apply to you.

Children (under 12 years of age)

Nicotine levels in NRT are not suitable for children under 12 years of age. Nicotine affects children more than adults and could cause severe poisoning, which may result in death.

Use of NiQuitin Clear with other medicines

Inform your healthcare professional if you are taking, have recently taken, or might need to take any other medicines.

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

Pregnancy and Breast-feeding

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

Ideally, if you are pregnant, you should stop 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, as it is better for your baby than continuing to smoke. You should use NRT as early as possible during pregnancy and ideally only for 2–3 months. Remember, the most important thing is to stop smoking. Oral NRT, such as lozenges, may be preferable to nicotine patches because you do not receive nicotine continuously. However, patches may be better if you experience nausea or vomiting.

If you are breastfeeding, tobacco smoke can cause breathing difficulties and other problems in babies and children. You should try to quit without using NRT first. If you need NRT, the amount of nicotine your baby may receive is small but present. It is far less harmful to the baby than exposure to tobacco smoke. Products such as lozenges are better than patches because you do not receive nicotine continuously.

It is also advisable to breastfeed immediately before using NRT to minimize the amount of nicotine the baby receives.

Do not use NiQuitin patches in combination with NiQuitin tablets or chewing gum if you are pregnant or breastfeeding, unless considered necessary by a healthcare professional. This is because this combination has not been studied in pregnant or breastfeeding women.

Driving and using machines

There are no known effects of NiQuitin Clear on your ability to drive or operate machinery. However, quitting smoking may cause behavioural changes that could affect your ability in this regard.

3. How to use NiQuitin Clear

Follow exactly the administration instructions for this medicine provided in this leaflet or those indicated by your healthcare professional. If in doubt, consult your healthcare professional.

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

To increase your chances of success, it is important to complete the full step-down program.

Apply one new patch each day. Each patch should be used only once and worn for 24 hours. Do not use more than the recommended dose.

Patches for adults (18 years and over)

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

Table 2: Low-dependence smokers (fewer than 10 cigarettes per day)

*The patches may be continued beyond the recommended 8 or 10 weeks if you need them to remain smoke-free. However, if you continue using them beyond 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 further courses of NRT.

Use in children and adolescents

Adolescents (12–17 years inclusive) should follow the instructions in Tables 1 and 2, but should only use the patches for a total of 12 weeks. If you feel you need to use Niquitin Clear for longer than 12 weeks, consult a healthcare professional. NiQuitin patches must not be used in combination with NiQuitin tablets or chewing gum. Do not exceed the recommended dose.

Children under 12 years of age must not use Niquitin Clear

Combining NiQuitin Clear patches with oral NiQuitin products (tablets or chewing gum)

NiQuitin Clear patches alone may not always be sufficient. Using oral forms of NiQuitin at the same time as the patches may help control sudden cravings and increase your chances of quitting smoking compared to using patches alone. Oral forms of NiQuitin are available as tablets or chewing gum.

Combining patches with oral NiQuitin may help:

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

Follow the same step-down process with the patches, but take oral NiQuitin when you experience a sudden craving; around 5–6 tablets or pieces of chewing gum per day are recommended. Refer to Tables 3 and 4 on the reverse of this leaflet for further details.

When using NiQuitin Clear patches and oral NiQuitin together:

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

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

Table 3: Combination therapy for heavily dependent smokers (10 or more cigarettes per day)

Table 4: Combination therapy for low-dependence smokers (fewer than 10 cigarettes per day)

How to apply the patches

Choose a clean, dry, and hair-free area of skin to apply the patch, to ensure it adheres properly. Avoid cracked skin (such as over a joint) or areas that fold when moving. Also avoid red, damaged, or irritated skin.

• Do not remove the patch from its pouch until you are ready to use it. Do not use if the pouch is damaged.

• Cut along the dotted line with scissors, taking care not to damage the patch inside.

• Carefully remove the patch. A transparent protective layer covers the adhesive side of the patch, which is the side placed on the skin.

• Remove the patch from its pouch and peel off the transparent protective layers by folding it, taking care not to touch the inner adhesive surface.

• With the adhesive side facing you, remove half of the protective layer starting from the middle. Hold the patch by the outer edge (touching the adhesive side as little as possible), and then remove the other half of the protective layer.

• Immediately apply the adhesive side of the patch to your skin. Press firmly with the palm of your hand for at least 10 seconds. Make sure it adheres well, especially around the edges.

• When applying the patch, avoid touching your eyes or nose. After application, always wash your hands with water only. Do not use soap, as it may increase the absorption of nicotine.

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

NiQuitin Clear generally adheres well to the skin of most people. However, occasionally a patch may come loose. If the patch falls off, apply a new patch immediately, making sure to choose a different skin site. Then, continue changing patches at your usual time.

How to change the patches

A new patch should be applied once daily, at approximately the same time each day, preferably shortly after waking up. Leave the patch in place for 24 hours, and always choose a different skin site when applying a new patch. Do not reuse the same skin area for at least 7 days.

Disposal of patches

When removing a patch, fold it in half with the adhesive side facing inward and place it inside the pouch from which you just removed your new patch, or wrap it in aluminum foil. Dispose of it carefully, ensuring it is out of the reach of children and pets.

If desired, you may remove the patch before going to bed (after approximately 16 hours) and apply a new one in the morning. However, removing it before sleep may 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 begin to feel nausea, dizziness, and discomfort. Remove all patches and wash and dry your skin with water only (without soap). In case of overdose or accidental ingestion, contact your doctor, pharmacist, go to the nearest hospital, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the product name and amount used.

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

If a child has applied or swallowed a patch, remove any patch from the skin and wash the area with water only (without soap), 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:

As soon as you remember, apply a patch immediately. You may continue changing patches at your usual time.

If you stop treatment with NiQuitin Clear

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

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

4. Possible adverse effects

Like all medicines, NiQuitin Clear may cause adverse effects, although not everyone experiences them. At the recommended doses, NiQuitin Clear has not been found to cause any serious adverse effects.

The process of quitting smoking itself may produce certain symptoms such as weakness, dizziness, headache, cough, and symptoms similar to those of flu.

Other symptoms that may also be related to withdrawal symptoms associated with quitting smoking include mood changes, insomnia, sleep disturbances, difficulty concentrating, feelings of depression, irritability, anxiety, drowsiness, restlessness, or nervousness.

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

• Skin reactions at the site 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

• Breathing difficulty

  • Sore throat or throat inflammation
  • Cough
  • Indigestion, stomach ache, diarrhoea, constipation, dry mouth

• Sweating

• Joint pain, 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 symptoms of allergic reactions, which may include wheezing (whistling sounds) or tightness in the chest, rash, and feeling faint.

Not known (frequency cannot be estimated from the available data):

• Seizures (fits)

You may experience mild redness, itching, burning, or tingling on the skin where the 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 occurs, stop using the patch and inform your doctor.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide 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 expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
• Store below 30 °C. Keep all patches in the box, inside their protective pouches until ready to use.
• Do not use NiQuitin Clear patches if the pouch is open or damaged.

Dispose of the container responsibly. Medicines should not be disposed of via wastewater or household waste. Deposit unused medicines and their containers at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of NiQuitin Clear patches.

The active substance is nicotinе.

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, colorless, rectangular patches for skin application.

Each stage (dose) comes in its own package and each package contains 7, 14, 21, 28, or 42 patches. Not all pack 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 certain European Economic Area countries 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 parches transdérmicos

Ireland: Niquitin Clear 14mg/24 hrs Transdermal Patch

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

Portugal: Niquitin Clear 14mg/24 h sistemas Transdermicos

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

Date of the most recent review of this leaflet: May 2021

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