Leaflet: information for the user

NiQuitin 4 mg chewing tablets, peppermint flavour

Nicotine

1. What NiQuitin is and what it is used for

2. What you need to know before you start taking NiQuitin

3. How to take NiQuitin

4. Possible side effects

5. Storage of NiQuitin

6. Contents of the pack and additional informationl

NiQuitin is used to help quit smoking.This type of treatment is called Nicotine Replacement Therapy or NRT. NiQuitin 4 mg chewing tablets, mint flavor, is suitable for smokers who smoke more than 20 cigarettes per day.

The nicotine in cigarettes is what can physically make you addicted to them.

• NiQuitin helps quit smoking by substituting some of the nicotine provided by cigarettes.

• This nicotine alleviates some of the unpleasant symptoms that smokers may experience when trying to quit smoking, including feeling unwell or irritable.

• Nicotine also helps alleviate your anxiety for a cigarette and helps you resist the urge to smoke.

NiQuitin does not present the same health risks as tobacco. This is because it does not contain tar, carbon monoxide, or other toxins found in cigarette smoke. Some people worry that after quitting smoking, they may become dependent on nicotine gum. This is very rare, and if it happens, it is less harmful than continuing to smoke. In any case, it is a habit that is easier to break.

The chances of quitting smoking will improve if you participate in a support program. These "quit smoking programs" are known as behavioral support. For information on quit smoking programs, please consult a healthcare professional.

Smoking has no health benefits..It is always better to quit smoking.The use of Nicotine Replacement Therapy (NRT), such as NiQuitin, can help quit smoking. In general, any possible side effects associated with NRT are compensated by the well-known dangers of continuing to smoke.

Do not take NiQuitin:

• If you are allergic (hypersensitive) to nicotine or any of the components of this medication (See section 6).
• If you are a non-smoker or under 12 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take NiQuitin:

• if you have recently had a heart attack or stroke, or you suffer from severe heart rhythm problems, unstable angina or worsening chest pain (chest pain) or angina at restYou should try to quit smoking without using any nicotine replacement therapy (NRT) unless your doctor tells you to use them.
• if you have diabetesYou should monitor your blood sugar levels more frequently when starting to use NiQuitin. The amount of insulin or your medication may change.
• If you have a history of epilepsy (seizures)..
• if you have ever had allergic reactionsthat include swelling of the lips, face, and throat (angioedema) or itching on the skin (urticaria). The use of NRT may sometimes trigger this type of reaction.

Do not interchange the use between NiQuitin chewing tablets and nicotine gum during the attempt to quit smoking.

Seek help and advice from a healthcare professional if you have:

• serious or moderate liver problems or serious kidney problemsbecause you may be more likely to experience side effects
• if you have uncontrolled hyperactivity of the thyroid gland or phaeochromocytoma(a tumor of the adrenal gland that can affect blood pressure) - your doctor will have told you that nicotine can worsen your symptoms.
• ulcer of the stomach or duodenum or esophagus or glottis (the passage between the mouth and stomach) inflamed,since the nicotine you swallow can make your symptoms worse. This treatment can also cause mouth ulcers. If your symptoms worsen, consult your doctor. You may want to use a non-oral form of NRT, such as patches.
• any concern about being dependent on this product or if you think you are dependent on this product.

Children and adolescents

This medication should not be used by children under 12 years old. A normal dose for an adult smoker could severely poison or even cause death in a child. It is therefore essential to keep NiQuitin out of sight and reach of children at all times.

Other medications and NiQuitin

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Smoking during pregnancy poses risks to the baby. These include fetal growth retardation, premature birth, or fetal death. Quitting smoking is the best way to improve both your health and that of your baby. The sooner you quit smoking, the better. Ideally, if you are pregnant, you should quit smoking without using nicotine replacement therapy (NRT). However, if you have tried and it has not worked, NRT may be recommended by a healthcare professional to help you quit smoking, because it is better for your baby's development than if you continue to smoke. The decision to use NRT should be made as soon as possible during pregnancy. You should only use the product for 2-3 months. Remember, the most important thing is to quit smoking. Products such as chewing tablets may be preferable to nicotine patches, because with chewing tablets, nicotine is not continuously provided. However, if you have nausea or dizziness, patches may be preferable.

If you arebreastfeeding, cigarette smoke causes respiratory difficulties and other problems in the baby and children. The ideal is to quit smoking without the use of nicotine replacement therapy (NRT). However, if you have already tried and it has not worked, NRT may be recommended by a healthcare professional. If you need to use NRT to quit smoking, the amount of nicotine that can reach your baby is small. This is much less harmful than inhaling cigarette smoke. It is better to use NRT products that are taken at specific times of the day (such as gum or chewing tablets), rather than patches. It is also better to breastfeed just before taking the medication, which helps your baby receive the smallest amount of nicotine possible.

Driving and operating machinery

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

NiQuitin chewing tablets contain:

Sodium:This medication contains less than 1mmol (23mg) per chewing tablet, which is essentially "sodium-free".

Use NiQuitin exactly as indicated in this leaflet. You should consult a healthcare professional if you are unsure how to use it.

Insert a lozenge into your mouth and occasionally move it from one side of your mouth to the other until it dissolves completely. It may take around 10 minutes. Do not chew the lozenge or swallow it whole.

Do not use more than 15 lozenges a day.

If you need treatment with this medication for more than 9 consecutive months, you should consult a healthcare professional.

Adults (18 years and older)

After you have successfully stopped smoking, you may suddenly feel the desire to smoke again. If this happens, you can use 1 lozenge again.

Use in children and adolescents

Adolescents (12 to 17 years inclusive)

Only use NiQuitin under the guidance of a healthcare professional.

Do not exceed the recommended dose. Follow the instructions carefully and do not take more than

15 lozenges a day (24 hours).

Children under 12 years old should not use NiQuitin.

This medication is for oral use. This means that the nicotine from the lozenges is released slowly in the mouth, where it is absorbed and passes into the body.

If you are tempted to smoke again

If you are concerned about smoking again or have difficulty stopping completely using the lozenges, you should consult a healthcare professional.

If you start smoking again, they may be able to advise you on how to achieve better results with subsequent treatments with TSN.

If you take more NiQuitin than you should:

If you take more NiQuitin than you should, you may start to feel unwell, dizzy, or

indisposed. Stop using the lozenges and consult a doctor immediately or go to the emergency department of a hospital. If possible, bring the medication package or this leaflet.

Lozenges are not suitable for children under 12 years old or non-smokers. If children or non-smokers use lozenges, they may show signs of nicotine overdose. These include headaches, nausea, stomach pain, and diarrhea. If a child has used or eaten any lozenge, consult their doctor immediately or go to the nearest hospital emergency department. If possible, show them the medication or this leaflet.

If you have any doubts about using this medication, ask your healthcare professional.

Like all medicines, NiQuitin can have side effects, although not everyone will experience them. At the recommended doses, NiQuitin has not been found to cause any serious side effects.

Quitting smoking can cause symptoms such as dizziness, headaches, sleep disturbances, coughing, and symptoms similar to a cold. Symptoms like depression, irritability, anxiety, restlessness, increased appetite, and insomnia may also be related to withdrawal symptoms associated with quitting smoking.

Other side effects are listed below, grouped by the frequency with which they may occur:

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

• It may cause pain or irritation in the mouth or tongue. It is also possible to feel nauseous.

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

• Throat pain
• Feeling nauseous
• Gastrointestinal discomfort
• Diarrhea
• Indigestion/heartburn
• Flatulence
• Hiccup
• Pharyngitis

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

• Nervousness
• Depression
• Palpitations (feeling the heartbeat)
• Increased heart rate
• Chest pain
• Dermatological eruption
• General fatigue and discomfort

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

• Severe allergic reactions, including sudden onset of wheezing or chest tightness (breathing sounds), skin eruption, and feeling of fainting.

Frequency not known (frequency cannot be estimated with available data):

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 leaflet. You can also report them directly to the Spanish System of 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.

If any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform a healthcare professional.

• Keep this medication out of the sight and reach of children.

• Do not use the tablets for sucking after the expiration date shown on the

container and on the box. The expiration date refers to the last day of the month indicated.

• Store in the original container to protect it from moisture.

• Do not store above 25 ° C.

• Do not reuse the container for anything due to the possibility that it may contain powder from the tablet.

• Dispose of the container responsibly. Medications should not be thrown down the drain or in the trash. Deposit the containers and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

NiQuitin Composition

The active ingredient is nicotine. Each lozenge contains 4 mg (in the form of a resin complex called polacrilex nicotine).

The other components are: mannitol (E421), sodium alginate (E401), xanthan gum (E415), potassium bicarbonate (E501), calcium polycarbophil, anhydrous sodium carbonate (E500), potassium acesulfame (E950), peppermint powder flavor, sucralose (E955), magnesium stearate (E470b).

Appearance of NiQuitin and packaging contents

White oval-shaped lozenges with convex surfaces.

The 4 mg lozenges have a “NIC4” on one side.

Each package of lozenges contains 20 lozenges, and each presentation may contain 1, 3, or 5 packages of lozenges.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Perrigo España, S.A.

Xavier Cugat Square, 2 Edif. D Pl. 1st Floor

08174 Sant Cugat del Vallès (Barcelona)

Responsible manufacturer:

Omega Pharma International NV

Venecoweg 26, Nazareth

9810 Belgium

Perrigo Supply Chain International DAC

The Sharp Building

10-12 Hogan Place

Dublin 2

Ireland

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

Belgium: Niquitin Minilozenge 4 mg

Netherlands: Niquitin Mini 4 mg Lozenges

Italy: Niquitin 4 mg pastiglie

Luxembourg: Niquitin Mini Mint cpr. a sucer 4 mg

Poland: Niquitin Mini

Portugal: Niquitin Menta 4 mg Lozenges

United Kingdom: Nicabate Mini 4 mg compressed lozenge

Sweden: Niquitin Komprimerad sugtablett 4 mg

This leaflet was revised in March 2019

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