NIQUITIN 4 mg LOZENGES MINT FLAVOR

Introduction

Package Leaflet: Information for the User

NiQuitin 4 mg lozenges for sucking mint flavor

Nicotine

Contents of the package leaflet

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

1. What is NIQUITIN and what is it used for

NiQuitin is used to help you quit smoking. This type of treatment is called Nicotine Replacement Therapy or NRT. NiQuitin 4 mg lozenges for sucking mint flavor are suitable for smokers who smoke more than 20 cigarettes a day.

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

• NiQuitin helps you quit smoking by replacing some of the nicotine that cigarettes provide.
• This nicotine relieves some of the unpleasant symptoms that smokers may have when trying to quit smoking. These symptoms include feeling unwell or irritable.
• Nicotine can also relieve your craving for a cigarette and help you resist the urge to smoke.

NiQuitin does not pose 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 are concerned that after quitting smoking, they may become dependent on nicotine lozenges. This is very rare, and if it happens, it is less harmful than continuing to smoke. Anyway, it is a habit that is easier to break.

Your 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 you quit smoking. In general, any potential side effects associated with NRT are outweighed by the well-known dangers of continuing to smoke.

2. BEFORE TAKING NIQUITIN

Do not take NiQuitin:

• If you are allergic (hypersensitive) to nicotine or any of the components of this medicine (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:

• you should try to quit smoking without using any NRT product unless your doctor tells you to use them.
• you should monitor your blood sugar levels more frequently than usual when starting to use NiQuitin. The amount you need to take of insulin or your medication may change.
• if you have a history of epilepsy (seizures).
• that include swelling of the lips, face, and throat (angioedema) or skin itching (urticaria). The use of NRT can sometimes trigger this type of reaction.

Do not switch between NiQuitin lozenges and nicotine gum during a quit-smoking attempt.

Ask for help and advice from a healthcare professional if you have:

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

Children and adolescents

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

Other medicines and NiQuitin

Tell your doctor or pharmacist if you are using or have recently used any other medicine, including those obtained without a prescription.

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

Pregnancy and breastfeeding

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

Smoking during pregnancyhas risks for the baby. These include delayed fetal growth, premature birth, or fetal death. 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 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 smoking. The decision to use NRT should be made as early as possible in pregnancy. You should only use the product for 2-3 months. Remember, the most important thing is to quit smoking. Products such as lozenges may be preferable to nicotine patches, because with lozenges, the nicotine intake is not continuous. However, if you have nausea or dizziness, patches may be preferable.

If you are breastfeeding, cigarette smoke causes respiratory problems and other issues for the baby and children. Ideally, 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. 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 breathing in cigarette smoke. It is better to use NRT products that are taken at specific times of the day (such as gum or lozenges), rather than patches. It is also better to breastfeed just before taking the medicine, which helps your baby receive the smallest amount of nicotine possible.

Driving and using machines

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 lozenges contain:

Sodium:This medicine contains less than 1mmol (23mg) per lozenge, i.e., it is essentially "sodium-free".

3. HOW TO TAKE NIQUITIN

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

Put a lozenge in your mouth and from time to time move it from one side of your mouth to the other, until it is completely dissolved. This may take about 10 minutes. Do not chew the lozenge or swallow it whole.

Do not use more than 15 lozenges per day.

If you need treatment with this medicine for more than 9 months in a row, you should consult a healthcare professional.

Adults (over 18 years old)

• Start using 1 lozenge whenever you feel the urge to smoke, up to 8-12 lozenges per day.
• Continue like this for up to 6 weeks, then gradually reduce the number of lozenges you use per day.
• When you use 1 or 2 lozenges per day, stop using them.

After quitting smoking, you may suddenly feel the urge to smoke again. If this happens, you can use 1 lozenge again.

Use in children and adolescents

Adolescents (12 to 17 years old inclusive)

May only use NiQuitin with the advice of a healthcare professional.

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

15 lozenges per day (24 hours).

Children under 12 years old should not use NiQuitin.

This medicine 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 quitting completely, you should consult a healthcare professional.

If you start smoking again, they can advise you on how to get better results with subsequent NRT treatments.

If you take more NiQuitin than you should:

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

nauseous. Stop using the lozenges and consult a doctor immediately or go to the emergency department of a hospital. If possible, take the medicine package or this leaflet with you.

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

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

4. Possible side effects

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

Quitting smoking can cause symptoms such as dizziness, headache, sleep disturbances, cough, symptoms similar to a cold. Symptoms such as 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 frequency:

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

• May cause pain or irritation in the mouth or tongue. You may also feel sick.

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

• Sore throat
• Feeling sick
• Gastrointestinal upset
• Diarrhea
• Indigestion/heartburn
• Flatulence
• Hiccups
• Pharyngitis

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

• Nervousness
• Depression
• Palpitations (feeling your heartbeat)
• Increased heart rate
• Chest pain
• Rash
• Fatigue and general malaise

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

• Serious allergic reaction symptoms including sudden wheezing or chest tightness (wheezing), rash, and feeling of fainting.

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

• Seizures (fits)
• Dysphagia (difficulty swallowing)
• Eructation (a reflex that noisily expels gas from the stomach through the mouth)
• Increased salivation
• Flu-like illness (symptoms similar to the flu)
• Hypersensitivity
• Tremor, dysgeusia (taste disturbance), paresthesia in the mouth (numbness or tingling in the mouth)
• Dyspnea (difficulty breathing)
• Itching or rash, skin or mucous membrane swelling, skin redness, increased sweating.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a side 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 side effects, you can help provide more information on the safety of this medicine.

If any of the side effects you suffer from is serious or if you notice any side effect not mentioned in this leaflet, inform a healthcare professional.

5. Storage of NIQUITIN

• Keep this medicine out of the sight and reach of children.
• Do not use the lozenges after the expiration date stated on the package and carton. The expiration date refers to the last day of the month indicated.

Keep in the original package to protect from moisture.

• Do not store above 25°C.
• Do not reuse the package for anything due to the possibility of it containing dust from the lozenge.
• Dispose of the package responsibly. Medicines should not be thrown down the drain or into the trash. Deposit the packages and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This way, you will help protect the environment.

6. FURTHER INFORMATION

Composition of NiQuitin

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

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

Appearance of NiQuitin and package contents

White oval-shaped lozenges with convex surfaces.

The 4 mg lozenges have "NIC4" on one side.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Perrigo España, S.A.

Pza. Xavier Cugat, 2 Edif. D Pl. 1ª

08174 Sant Cugat del Vallès (Barcelona)

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 Member States of the European Economic Area under the following names:

Belgium: Niquitin Minilozenge 4 mg

Netherlands: Niquitin Mini 4 mg Zuigtabletten

Italy: Niquitin 4 mg pastiglie

Luxembourg: Niquitin Mini Mint cpr. a sucer 4 mg

Poland: Niquitin Mini

Portugal: Niquitin Menta 4 mg comprimidos para chupar

United Kingdom: Nicabate Mini 4 mg compressed lozenge

Sweden: Niquitin Komprimerad sugtablett 4 mg

This leaflet was last revised in March 2019

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