Niquitin

Package leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER

NiQuitin 4 mg tablets

Nicotine
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, consult a healthcare professional, such as your doctor, a smoking cessation clinic, or a pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• In this patient information leaflet, the term NiQuitin refers to NiQuitin 4 mg tablets.

Contents of this leaflet:

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

1. What NiQuitin is and what it is used for

NiQuitin is used to help people stop smoking. This type of treatment
is known as Nicotine Replacement Therapy (NRT). NiQuitin 4 mg is indicated for smokers of
more than 20 cigarettes per day.
It is the nicotine in cigarettes that can cause physical dependence on smoking.

• NiQuitin helps you to stop smoking by replacing some of the nicotine you normally absorb from cigarettes.
• Nicotine relieves some of the unpleasant symptoms that smokers may experience when trying to quit, such as discomfort or irritability.
• Nicotine can also reduce cigarette cravings and help you resist the urge to smoke.

NiQuitin does not carry the health risks associated with tobacco, as it contains no tar,
carbon monoxide, or other toxins found in cigarette smoke. Some people are concerned that after
quitting smoking they might become dependent on nicotine tablets instead. This is very rare, and if it
does occur, it is still much less harmful than continuing to smoke. Moreover, it is an easier habit to
overcome.
Your chances of successfully quitting smoking increase if you take part in a support programme.
Such "smoking cessation programmes" are known as behavioural support. For information on
smoking cessation programmes, please consult your doctor or pharmacist.
Smoking provides no health benefits. It is always better to stop smoking. Using Nicotine Replacement Therapy (NRT), such as NiQuitin, can help you. Overall, any potential side effects associated with NRT are far less significant than the well-known risks linked to smoking.

2. What you need to know before using NiQuitin

Do not use NiQuitin:

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

Warnings and precautions
Consult your doctor or pharmacist before using NiQuitin:

• If you have recently had a heart attack or stroke, or if you suffer from severe heart rhythm disorders, unstable or worsening angina (chest pain), or angina at rest, you should try to stop smoking without using NRT unless your doctor specifically recommends it.
• If you have diabetes, when you start using NiQuitin, you should monitor your blood sugar levels more frequently than usual. It may become necessary to adjust your insulin dose or other medications.
• If you have a history of epilepsy (seizures).
• If you have had allergic reactions with swelling of the lips, face, and throat (angioedema) or itchy skin rash (urticaria). Using NRT may sometimes trigger these types of reactions.

Children and adolescents
This medicine must not be used by children under 12 years of age. A normal dose for an adult smoker may cause severe poisoning or be fatal in children. It is therefore essential to always keep NiQuitin out of the sight and reach of children.
Do not alternate NiQuitin with nicotine-containing chewing gum during an attempt to stop smoking.
Ask your doctor for advice and help in the following cases:

• If you have severe or moderate liver problems or severe kidney problems, as you may be more likely to experience side effects.
• If you have uncontrolled hyperthyroidism or phaeochromocytoma (a tumour of the adrenal gland that can affect blood pressure) – your doctor will already have discussed this with you – as nicotine may worsen symptoms.
• If you suffer from gastric or duodenal ulcer or inflammation of the oesophagus (the passage between mouth and stomach), because taking in nicotine may worsen symptoms. It may also cause mouth ulceration. If symptoms worsen, consult your doctor. It may be preferable to use a non-oral form of NRT, such as patches.
• If you are concerned about becoming dependent or think you have become dependent on this product.

Other medicines and NiQuitin
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those not requiring a prescription.
Stopping smoking may alter the effects of other medicines you are taking. If you have any doubts about using this medicine, consult your doctor or pharmacist.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning a pregnancy, seek advice from your doctor or pharmacist before taking this medicine.
Smoking during pregnancy poses risks to the baby, such as poor growth before birth, premature birth, and stillbirth. Stopping smoking is the best thing you can do for your health and your baby’s health. The earlier you stop smoking, the better.
Ideally, if you are pregnant, you should stop smoking without using NRT. However, if you have tried and failed, NRT may be recommended by your doctor as an aid to quitting smoking, as it is considered better for the developing fetus than cigarette smoke.
The decision to use NRT should be made as early as possible during pregnancy. You should aim to use it for only 2–3 months. Remember, the most important thing is to stop smoking.
Products such as lozenges may be preferable to nicotine patches, as lozenges do not deliver nicotine continuously. However, patches may be preferable if you suffer from nausea or vomiting.
If you are breastfeeding, tobacco smoke causes breathing difficulties and other problems in the infant. Ideally, you should stop smoking without using NRT. However, if you have tried and failed, your doctor may recommend using NRT to stop smoking. If you need to use NRT to quit smoking, the amount of nicotine the infant may receive is low and much less harmful than passive smoking. It is better to use NRT products taken several times a day (such as chewing gum or lozenges) rather than patches. In addition, it is best to breastfeed shortly before taking the product, so as to expose the baby to the lowest possible amount of nicotine.

Driving and using machines
There are no known effects of NiQuitin on the ability to drive or operate machinery.
However, you should be aware that quitting smoking may cause behavioural disturbances that could affect your ability to drive or operate machinery.

NiQuitin contains
Sodium – this medicine contains less than 1 mmol of sodium per lozenge (23 mg), and is therefore considered sodium-free.

3. How to use NiQuitin

NiQuitin should always be used exactly as described in this leaflet. If you have any doubts,
consult your doctor or pharmacist.
The tablet should be kept in the mouth and moved from time to time from one side of the mouth
to the other until it has completely dissolved (approximately 10 minutes). The tablet must not be
chewed or swallowed whole. Do not use more than 15 tablets per day. If you feel the need to use
NiQuitin for more than a total of 9 months, consult your doctor or pharmacist.
Adults (18 years and over)

• Begin by taking 8 to 12 tablets per day. Suck one tablet whenever you feel a strong urge to smoke.
• Use the tablets in this way for up to a maximum of 6 weeks, then gradually reduce the number of tablets you take daily.
• When you reach the point of taking only 1 or 2 tablets per day, stop completely.

After quitting, you may occasionally feel a sudden urge to smoke a cigarette. If
this happens, you may take a tablet.
Use in children and adolescents
Adolescents (12 to 17 years inclusive)
Use NiQuitin only on medical advice.
Do not exceed the recommended doses. Follow the instructions carefully and do not take more than 15 tablets
per day (24 hours).
Children under 12 years of age must not use NiQuitin.
This is an oral mucosal product. This means that the nicotine in the tablets is slowly released in the mouth and then absorbed into the body.
If you are tempted to start smoking again
If you are concerned about starting to smoke again, or if you find it difficult to completely stop taking the
tablets,
consult your doctor or pharmacist.
If you start smoking again, they will be able to advise you on how to achieve the best results with
further courses of Nicotine Replacement Therapy (NRT).
If you take more NiQuitin than recommended
If you take too many NiQuitin tablets, you may begin to experience nausea, dizziness, and general malaise. Stop
using the tablets and contact a doctor or hospital emergency department immediately.
If possible, show the pack or this leaflet.
The tablets are not intended for children under 12 years of age or for non-smokers. If the tablets
are taken by children or non-smokers, they may cause symptoms of nicotine overdose. These include
headache, malaise, stomach pain, and diarrhoea. If a child has sucked or eaten one or more tablets, contact a doctor and the nearest hospital emergency department immediately. If possible, show the pack or this leaflet.
If you have any further questions about this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, NiQuitin can cause side effects, although not everyone gets them.
At the recommended doses, NiQuitin has not caused any serious side effects.
Stopping smoking in itself may lead to certain symptoms such as dizziness, headache, sleep disturbances, cough, and cold-like symptoms.
Symptoms such as depression, irritability, anxiety, restlessness, increased appetite, and insomnia may be associated with withdrawal symptoms following smoking cessation.
Other side effects are listed below, grouped according to how likely they are to occur.

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

• The tablets may cause slight pain or irritation of the mouth or tongue. You may also experience nausea.

Common (may affect up to 1 in 10 people)

• Sore throat
• Vomiting
• Stomach discomfort
• Diarrhoea
• Digestive problems / heartburn
• Flatulence
• Hiccups
• Pharyngitis

Uncommon (may affect up to 1 in 100 people)

• Nervousness
• Depression
• Palpitations (awareness of heartbeat)
• Increased heart rate
• Chest pain
• Rash
• Tiredness and general feeling of unwellness

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

• Symptoms of a severe allergic reaction including sudden breathlessness or chest tightness, rash, and feeling faint.

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

• Seizures (convulsions)
• Dysphagia (difficulty swallowing)
• Eructation (a reflex to expel gas from the stomach through the mouth with a sound)
• Increased salivation
• Influenza-like illness (flu-like symptoms)
• Hypersensitivity
• Tremor, dysgeusia (altered taste), oral paraesthesia (numbness or tingling in the mouth)
• Dyspnoea (shortness of breath)
• Itching or rash, swelling of the skin or mucous membranes, skin redness, increased sweating
• A fast and irregular heartbeat (Atrial fibrillation)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NiQuitin

• Keep all medicines out of the sight and reach of children.
• Do not use the tablets after the expiry date stated on the tube and outer packaging. The expiry date refers to the last day of the month.
• Do not store above 25°C.
• Store in the original container to protect the medicine from moisture.
• Do not reuse the packaging for other purposes, as a fine layer of tablet powder may remain in the container.
• Dispose of the packaging responsibly. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NiQuitin contains
The active substance is nicotine. Each tablet contains 4 mg of nicotine (in the form of a complexed resin known as nicotine resinate).
The excipients are mannitol (E421), sodium alginate (E401), xanthan gum (E415), potassium bicarbonate (E501), calcium polycarbophil, anhydrous sodium carbonate (E500), potassium acesulfame (E950), powdered peppermint flavour (E955), sucralose, magnesium stearate (E470b).

Description of the appearance of NiQuitin and the contents of the pack
Mini oval tablets, white to off-white, with convex surfaces.
The 4 mg tablet has "NIC4" impressed on one side.
Each tube contains 20 mini tablets. Packs may contain one, three or five tubes.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Perrigo Italia S.r.l.
Viale dell’Arte, 25 – 00144 Roma
Italy

Responsible manufacturer for batch release
Perrigo Supply Chain International DAC
The Sharp Building
Hogan Place
Dublin 2, D02 TY74
Ireland

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

This leaflet was last approved in: January 2026

Package Leaflet: Information for the User

NiQuitin

7 mg, 14 mg, 21 mg/24 hours Transparent Transdermal Patches
nicotine
Contents of this leaflet: Read this leaflet carefully before using
this medicine as it contains

1. What NiQuitin is and what it is used for important information for you. Always use this medicine exactly as described
2. What you need to know before using NiQuitin in this leaflet or as your healthcare provider has told you to do.
   • Keep this leaflet. You may need to read it again.
   • If you need more information or advice, contact your healthcare provider (for example, a doctor, nurse, smoking cessation advisor, or pharmacist).
3. How to use NiQuitin
4. Possible side effects If you experience any of the side effects, including those not listed in this leaflet, contact your healthcare provider. See section 4.
5. How to store NiQuitin In this patient information leaflet, references are made to
   • Contents of the pack and other information

NiQuitin indicating NiQuitin transparent

transdermal patches

1. What NiQuitin is and what it is used for

NiQuitin are transdermal patches that release nicotine to help people stop smoking. This
type of treatment is known as Nicotine Replacement Therapy (NRT for short).
NiQuitin is available in three dosage strengths: 21 mg, 14 mg, and 7 mg/24 hours. People who wish to stop smoking
start with a stronger patch and gradually switch to lower strengths (see section 3: How to use NiQuitin). Each dosage strength has its own packaging.
It is the nicotine in cigarettes that can make you dependent on them. NiQuitin helps you stop smoking by replacing part of the nicotine absorbed from cigarettes. Each patch releases nicotine slowly into the body. This helps relieve some of the unpleasant symptoms smokers may experience when trying to quit, reduces the craving for a cigarette, and helps you resist the urge to smoke.

• NiQuitin may be used in combination with any NiQuitin oral product / Niquitinmint (mini lozenges) if you have relapsed after attempting to quit with NRT, when one NiQuitin product alone is not sufficient to control your cravings, or if you are a heavy smoker (e.g. more than 10 cigarettes per day) (see section 3). NRT does not carry the health risks associated with tobacco, as it does not contain tar, carbon monoxide, or other toxins present in cigarette smoke. Some people are concerned about becoming dependent on nicotine in NRT instead. This is very rare, but if it were to occur, it would be less harmful than continuing to smoke. Moreover, it is an easier habit to overcome.

If you take part in a support programme, you will increase your chances of quitting successfully. These "smoking cessation programmes" are known as behavioural support. For more information, please consult your doctor or pharmacist.
Smoking provides no health benefits. It is always better to stop smoking. Using a Nicotine Replacement Therapy (NRT) such as NiQuitin can be helpful. In general, the dangers associated with smoking are far greater than any possible side effects related to NRT.

2. What you need to know before using NiQuitin

Do not use NiQuitin

• if you are allergic to nicotine or to any of the excipients of the medicine listed in section 6.
• if you are a non-smoker, an occasional smoker, or if you are under 12 years of age.

Warnings and precautions
Consult your healthcare provider before using NiQuitin:
if you are hospitalized due to a heart attack, serious heart rhythm disorders, or stroke.
You should try to stop smoking without using nicotine replacement therapy (NRT), unless your doctor advises otherwise. After hospital discharge, you may normally use NRT;

• if you have diabetes. You should monitor your blood sugar levels more frequently than usual when starting NiQuitin. It may be necessary to adjust your insulin dose or other antidiabetic medications;
• if you have had allergic reactions with swelling of the lips, face, and throat, or itchy skin rash. NRT may occasionally trigger such reactions;
• if you suffer from allergic eczema or dermatitis. You may experience a reaction to the patches.
• If you have a history of epilepsy (seizures).
• If you have gastric or duodenal ulcers or inflammation of the esophagus (the passage between mouth and stomach). NRT may worsen symptoms.
• If you have a history of cardiovascular disorders (conditions affecting the heart or blood vessels, e.g., heart disease, angina, or high blood pressure) and wish to use NiQuitin patches in combination with NiQuitin mini lozenges.
• If you have severe liver or kidney problems. You may be at higher risk of experiencing side effects.
• If you have uncontrolled hyperthyroidism or a pheochromocytoma (a tumor of the adrenal gland that can affect blood pressure). Nicotine may worsen symptoms.
• If you are concerned about becoming dependent on, or think you have become dependent on, this product. → Talk to your doctor before using NiQuitin if any of these situations apply to you.

Children (under 12 years)
Nicotine levels provided by NRT are not suitable for children under 12 years of age. Nicotine affects children more than adults. In children, nicotine can cause severe poisoning which may lead to death.

Other medicines and NiQuitin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Stopping smoking may alter how your body responds to other medicines taken concomitantly. If you have any doubts, consult your healthcare provider.

Pregnancy and breastfeeding
Smoking during pregnancy poses risks to the baby, such as poor fetal growth before birth, premature births, and stillbirths. Stopping smoking is the best way to benefit both your health and your baby's. The earlier you stop smoking, the better.
Ideally, if you are pregnant, you should stop smoking without using Nicotine Replacement Therapy (NRT). However, if you have tried and failed, Nicotine Replacement Therapy may be recommended by healthcare professionals, because it is better for your baby if you use NRT than if you continue smoking. You should use NRT as early as possible during pregnancy and ideally only for 2–3 months. Remember that the most important goal is to stop smoking.
Oral NRT, such as lozenges, may be preferable to patches, as they do not deliver nicotine continuously. However, patches may be better if you suffer from nausea or vomiting.
If you are breastfeeding, tobacco smoke causes breathing difficulties and other health problems in infants and children. You should try to stop smoking first without using NRT. If you need to use NRT to quit, the amount of nicotine passed to the infant is low, and this is much less harmful than passive smoking. Products such as lozenges may be preferable to patches because they do not deliver nicotine continuously. In addition, it is advisable to breastfeed shortly before taking the NRT dose, so that the infant receives the lowest possible amount of nicotine.
Do not use NiQuitin patches in combination with NiQuitin mini lozenges/NiQuitinmint during pregnancy or breastfeeding unless a doctor considers it necessary. This is because this combination has not been tested in pregnant or breastfeeding women.

Driving and using machines
No known effects of NiQuitin on the ability to drive vehicles or operate machinery have been reported. However, quitting smoking may cause behavioral changes that could affect these abilities.

3. How to use NiQuitin

Use this medicine exactly as described in this leaflet or as directed by your healthcare professional. If you have any doubts, consult your doctor or pharmacist.
As your body adjusts to stopping smoking, reduce the dosage of patches until you no longer need them. This gradual programme allows you to gradually overcome your body's need for nicotine.
To increase your chances of success, the reduction programme should be completed in full.
Apply a new patch each day. Each patch should be used only once, for a maximum of 24 hours. Do not use more than the recommended dose.
Patches for adult smokers (18 years and over)
Table 1: Heavy smokers (more than 10 cigarettes per day)

Table 2: Light smokers (fewer than 10 cigarettes per day)

*Patches can be continued beyond the recommended 8 or 10 weeks if you need them to avoid
smoking. However, if you are still using them after 9 months, consult a doctor.
Talk to a healthcare professional if:

• you are concerned about possibly starting to smoke again
• you are finding it too difficult to stop using the patches. If you start smoking again, they can advise you on how to achieve the best results from further nicotine replacement therapy cycles.

Use in children and adolescents
Adolescents (12–17 years)
Follow the instructions in Table 1 and Table 2, but use the patches for a maximum of 12 weeks total.
If you feel the need to use NiQuitin for longer than 12 weeks, seek advice from healthcare personnel.
You should not use NiQuitin patches in combination with NiQuitin oral tablets/Niquitinmint.
Do not exceed the recommended doses.
Children under 12 years of age must not use NiQuitin.

Combination of patches and oral NiQuitin
NiQuitin patches alone are not always sufficient. Using oral NiQuitin/Niquitinmint
simultaneously with the patches can help control sudden cravings and increase your chances
of quitting smoking compared to using patches alone. Oral NiQuitin/Niquitinmint is available as mini tablets.

Combining patches with oral NiQuitin may help:

• if you have relapsed after attempting to quit with NRT
• if a single NiQuitin product is not enough to control your urge to smoke and you are a heavy smoker (e.g., smoke 10 or more cigarettes per day)
• only if you are at least 18 years old and meet one of the above conditions

Follow the same “step-down” process with the patches, but take oral NiQuitin whenever you experience a sudden craving; approximately 5–6 tablets per day are recommended. See Tables 3 and 4 on the reverse of this leaflet for details.

When using patches together with oral NiQuitin:

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

For further information, read the package leaflet provided with oral NiQuitin.
Table 3: Combination therapy for heavy smokers (more than 10 cigarettes per day)

Table 4: Combination therapy for light smokers (fewer than 10 cigarettes per day)

How to apply the patches
Choose a clean, dry, and hair-free area of skin to ensure proper adhesion of the patch. Avoid skin folds (for example, over joints) or areas where the skin bends when moving.
Avoid areas where the skin is red, injured, or irritated.

• Do not remove the patch from its pouch until you are ready to apply it. Do not use if the seal is broken.
• Cut the pouch along the dotted line, taking care not to damage the patch inside.
• Carefully remove the patch. A transparent protective film covers the adhesive side of the patch, which will be applied to the skin.
• Holding the adhesive side towards yourself, remove half of the protective film starting from the center. Avoid touching the adhesive side as much as possible; hold the patch by the outer edge and remove the other half of the protective film.
• Immediately apply the adhesive side to the skin. Press firmly on the patch with the palm of your hand for at least 10 seconds, ensuring it adheres well, especially around the edges.
• During patch application, avoid touching your eyes and nose. After applying the patch, always wash your hands with water only. Do not use soap, as it may increase nicotine absorption. Water will not damage the correctly applied patch. You may take brief baths, swims, or showers while wearing the patch.

NiQuitin generally adheres well to the skin of most people. However, occasionally a patch may come loose. If the patch detaches, apply a new one, making sure to choose a different application site, then continue changing patches at your usual time.
How to replace the patches
A new patch should be applied once daily, at approximately the same time each day, preferably immediately upon waking. Leave each patch in place for 24 hours. Always choose a different skin area for each new patch. Do not reuse the same skin area until at least 7 days have passed.
How to dispose of used patches
After removing the patch, fold it in half with the adhesive side inward and place it back into the pouch from which you just removed the new patch, or wrap it in a piece of aluminum foil. Dispose of it carefully, ensuring it remains out of reach of children and pets.
If desired, the patch may be removed before going to bed (after about 16 hours) and a new one applied upon waking. However, removing it before bedtime may make it less effective in relieving the urge to smoke upon waking.
If you use more patches than recommended
If you use more than one patch at the same time, you may begin to experience nausea, dizziness, and general discomfort. Remove all patches and wash and dry the skin with water only (without soap). Seek immediate medical advice or go to a hospital emergency department. If possible, show the pack or this leaflet.
The patches are not intended for children under 12 years of age or for non-smokers. If used by children or non-smokers, symptoms of nicotine overdose may occur, such as headache, discomfort, stomach pain, and diarrhea.
If a child has applied a patch or placed it in their mouth, remove the patch from the skin and wash the area with water only (without soap), then dry. Seek immediate medical advice or go to a hospital emergency department. If possible, show the pack or this leaflet.
If you forget to use NiQuitin
If you forget to change the patch at your usual time, replace it as soon as you remember. You may then continue changing patches at your usual time.
If you stop using NiQuitin
If you stop treatment with this medicine before the recommended time, you may feel the urge to smoke again.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
At the recommended doses, NiQuitin has not caused any serious side effects.
Stopping smoking itself may cause some symptoms such as weakness, dizziness, headache, cough, and flu-like symptoms.
Other symptoms may also be related to smoking cessation, such as mood changes, insomnia, sleep disturbances, difficulty concentrating or feeling depressed, 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 1 in 10 people)

• nervousness
• tremor
• shortness of breath
• sore or swollen throat
• cough
• indigestion
• stomach pain
• diarrhoea
• constipation
• dry mouth
• sweating
• joint, muscle, chest or limb pain
• fatigue or weakness
• palpitations (awareness of heartbeat)

Uncommon (may affect 1 in 100 people)

• allergic reaction
• increased heart rate
• flu-like symptoms

Very rare (may affect 1 in 10,000 people)

• skin reactions
• skin sensitivity to sunlight
• severe allergic reaction – symptoms may include breathlessness or tightness in the chest, rash and feeling faint

Not known (frequency not known)

• epileptic seizures (convulsions)

Mild redness, itching, burning or stinging may occur at the application site, which usually disappear quickly after removing the patch. Rarely, a more severe reaction may occur at the site, including redness, swelling or a 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 contact your doctor.

Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NiQuitin Transparent Transdermal Patches

• 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.
• Store below 30°C.
• Keep all patches in their case, inside the protective pouches until the time of use.
• Do not use this medicine if you notice that the pouches are damaged or open.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What NiQuitin contains

• The active substance is nicotine.
• The other components are ethylene vinyl acetate copolymer, polyethylene terephthalate, polyethylene film, polyisobutylene, and printing ink.

Description of the appearance of NiQuitin and package contents
NiQuitin is a transparent, colourless, rectangular transdermal patch to be applied to the skin.
Each stage (dosage) has its own packaging, and each pack contains 7, 14, 21, 28, or 42 patches. It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Perrigo Italia S.r.l.
Viale dell’Arte, 25
00144 Roma
The manufacturer of NiQuitin is:
LTS Lohmann Therapie-Systeme AG, Lohmannstrasse 2, 56626 Andernach, Germany
This leaflet was last approved in January 2025