NIQUITIN 2 MG LOZENGES MINT FLAVOR

Introduction

Package Leaflet: Information for the User

NiQuitin 2 mg Mint Flavor Lozenges

nicotine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you cannot reduce your tobacco consumption or quit smoking or using NiQuitin. See section 3.
• In this leaflet, NiQuitin 2 mg lozenges are referred to as NiQuitin.

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 stop smoking. This type of treatment is called Nicotine Replacement Therapy (NRT). NiQuitin is indicated for adults and adolescents (12-17 years, after consulting a healthcare professional).

NiQuitin 2 mg is suitable for smokers of 20 cigarettes or less per day.

The ultimate goal is permanent cessation of the smoking habit. NiQuitin can also be used to help you gradually stop smoking for those who do not want or cannot stop smoking abruptly. Preferably, NiQuitin should be used in conjunction with a behavioral support program. See section 3 "How to take NiQuitin" for more details.

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

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

NiQuitin does not pose the same health risks as tobacco. NiQuitin does not contain tar, carbon monoxide, or other toxins found in cigarette smoke. Some people may be concerned that after quitting smoking, they may become dependent on NiQuitin. 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.

Your chances of quitting smoking will improve if you participate in support programs. For information on these programs, please consult a healthcare professional.

Smoking has no health benefits. It is always better to quit smoking. The use of NRT, such as NiQuitin, can help you quit smoking. In general, any potential side effects associated with NRT are outweighed by the risks of smoking.

2. What you need to know before taking NiQuitin

Do not take NiQuitin:

• if you are allergic to nicotine or any of the components of this medicine (see section 6)
• if you are under 12 years old
• if you are a non-smoker

Warnings and precautions

Consult your doctor or pharmacist before starting to take NiQuitin:

• if you have recently had a heart attack or stroke, or if you suffer from severe heart rhythm problems, unstable angina, or worsening chest pain (angina pectoris) or chest pain at rest, you should try to quit smoking without using any NRT product unless your doctor tells you to use them.
• If you are pregnant or breastfeeding.

Do not switch between using NiQuitin and nicotine gum during any attempt to quit smoking.

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

• heart or circulatory problems, including heart failure, stable angina, high blood pressure, or peripheral arterial occlusive disease
• diabetes, as you may need to monitor your blood sugar levels more frequently than usual when starting to use NiQuitin. The amount of insulin or medication you need to take may change.
• if you have ever had allergic reactionsthat include swelling of the lips, face, and throat (angioedema) or skin itching (urticaria). The use of NRT can sometimes trigger this type of reaction.
• severe or moderate liver or severe kidney problems- as 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 condition.
• stomach or duodenal ulcer or esophagus or glottis (the passage between the mouth and stomach) inflammation, as the nicotine you swallow can worsen your symptoms. 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.
• if you have a history of epilepsy(seizures)
• any concerns about becoming 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. Adolescents (12-17 years) should only use NiQuitin under the guidance of a healthcare professional. Adolescents should not quit smoking with combined NRT.

Other medicines and NiQuitin

Tell a healthcare professional if you are using or have recently used any other medicine. Nicotine may possibly increase some effects of medicines for irregular or fast heartbeat (adenosine), such as increased blood pressure and heart rate, and also a painful response.

Quitting smoking can alter the effects of other medicines you are taking. If you have questions or concerns, talk to a healthcare professional. The following may require a dose adjustment when quitting smoking: asthma medication (theophylline), pain relievers (pentazocine), medications to restore normal heart rhythm (flecainide), antipsychotics (clozapine, olanzapine), dopamine agonists (ropinirole), and caffeine.

Using NiQuitin with food and drinks

Do not eat or drink while you have NiQuitin in your mouth.

Acidic drinks, such as coffee, fruit juice, or non-alcoholic beverages, can make the nicotine less effective. You should avoid these types of drinks for about 15 minutes before using NiQuitin.

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.

Combined therapy is not recommended during pregnancy or breastfeeding unless a healthcare professional considers it necessary.

Pregnancy

Smoking during pregnancyposes risks to the baby, including 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). If you have tried and failed, NRT may be recommended by a healthcare professional because it is better for your baby than if you continue smoking.

Breastfeeding

Second-hand smoke causes respiratory problems and other issues for the baby and children. Nicotine from tobacco and NRT passes into breast milk. You should quit smoking without using NRT. If you have tried and failed, NRT may be recommended by a healthcare professional. If you need NRT to quit smoking, the amount of nicotine that can reach your baby is small, but this is much less harmful than breathing in second-hand smoke. It is also better to breastfeed just before taking NRT so that your baby receives 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, quitting smoking can cause changes in behavior that may affect your ability to drive or use machines.

NiQuitin contains sodium

This medicine contains less than 1 mmol (23 mg) per lozenge, which is essentially "sodium-free".

3. How to take NiQuitin

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

This medicine is for oral use. This means that the nicotine from the lozenge is released slowly in the mouth from where it is absorbed into the body.

Place a NiQuitin 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.

The instructions for using NiQuitin depend on whether you want to:

(a) quit smoking abruptly

(b) quit smoking gradually

Adults (over 18 years old)

Monotherapy

1. Quit smoking abruptly
   • Take one lozenge whenever you feel the urge to smoke (taking 8-12 lozenges per day) for up to 6 weeks. Then gradually reduce the number of lozenges you take per day.
   • When you are taking 1 or 2 lozenges per day, stop taking them altogether.

After you have managed to quit smoking, you may suddenly feel the urge to smoke again. If this happens, you can take one lozenge again.

1. Quit smoking gradually

When you feel a strong urge to smoke, take a NiQuitin lozenge instead of smoking a cigarette. Reduce the number of cigarettes you smoke per day as much as possible. If you have not been able to reduce the number of cigarettes you smoke per day after 6 weeks, talk to a healthcare professional.

As soon as you feel able, quit smoking completely. Follow the instructions "a) Quit smoking abruptly" indicated above as soon as possible. If you do not quit smoking completely within 6 months of starting to use NiQuitin, talk to a healthcare professional.

Do not exceed the recommended dose. Follow the instructions for use in detail and do not take more than 15 lozenges per day (24 hours).

If you need to take NiQuitin for more than 9 months in a row, you should consult a healthcare professional.

Combined therapy

For smokers who have relapsed after NRT, or when lozenges alone are not enough to control the urge to smoke, or as a first-line treatment in smokers with a high level of dependence.

Smokers can combine patches and oral NRT (nicotine gum, lozenges, etc.). The combination provides greater efficacy than using patches alone.

Initial treatment should begin by determining the patch dose, which depends on the patient's previous smoking habit, in combination with NiQuitin. It is recommended that the daily intake of NiQuitin 2 mg lozenges in combination with patches be 5 to 6 units. The maximum daily dose for all oral forms is 15 units. Only one type of NiQuitin oral product (either lozenges or nicotine gum) should be used in combination with patches.

You should continue using NiQuitin orally for 2 to 3 months, then start reducing the use gradually as you experience less craving for nicotine. When daily use is reduced to 1-2 doses, stop using it.

For more information, consult the NiQuitin patches leaflet.

Consult your doctor if symptoms persist.

Use in children and adolescents

Adolescents (12 to 17 years old)

Adolescents can only use NiQuitin under the guidance of a healthcare professional.

Children under 12 years old

Children under 12 years old should not use NiQuitin.

• Talk to a healthcare professional if:you are concerned about smoking again
• you are having trouble quitting lozenges completely.

If you start smoking again, they can advise you on how to get better results with additional 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 immediatelyor go to the emergency department of a hospital. If possible, take the medicine package or this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

The lozenges are not suitable for children under 12 years old or for non-smokers. If children or non-smokers use them, 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 or go to the emergency department of the nearest hospital immediately.If possible, show them the medicine or this leaflet.

4. Possible Adverse Effects

Like all medicines, NiQuitin can cause adverse effects, although not everyone will experience them.

Stopping smokingcan cause symptoms such as dizziness, headache, sleep disturbances, cough, and cold-like symptoms. Other symptoms (withdrawal symptoms) such as depression, irritability, anxiety, restlessness, increased appetite, and insomnia may also be related.

If you notice any of the following serious side effects, stop taking NiQuitinand contact a doctor immediately, as they may be a sign of a severe allergic reaction:

• Severe allergic reaction, whose symptoms include sudden wheezing or chest tightness, skin rash, and feeling of fainting (very rare frequency).
• Swelling of the skin or mucous membranes, face, tongue, and throat that cause breathing difficulties (unknown frequency).

Other adverse effects that may appear are:

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

• Nausea, vomiting
• Sleep disturbance

Frequent (may affect up to 1 in 10 people)

• Nervousness, dizziness, headache
• Diarrhea
• Tremor
• Constipation
• Indigestion/stomach acidity
• Flatulence
• Hiccup
• Sore throat
• Cough
• Difficulty breathing, feeling of shortness of breath
• Pain in the upper abdomen
• Dry mouth
• Mouth ulcers
• Discomfort in the mouth
• Fatigue (tiredness)
• Feeling of general discomfort
• Flu-like symptoms
• Lack of energy

Infrequent (may affect up to 1 in 100 people)

• Difficulty swallowing
• Palpitations (feeling the heartbeat)
• Increased heart rate

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

• Hypersensitivity

Unknown frequency (frequency cannot be estimated with available data)

• Seizures (attacks)
• Abnormal dreams, depression, irritability, anxiety, altered/distorted taste, rash
• Itching
• Redness of the skin
• Increased sweating
• Urticaria
• Tingling in the mouth, belching
• Excessive salivation

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of NiQuitin

• Keep this medicine out of the sight and reach of children.
• Do not use NiQuitin after the expiration date shown on the packaging and carton. The expiration date refers to the last day of the indicated month.
• Do not store above 25°C.
• Keep in the original packaging to protect it from moisture.
• Do not reuse the packaging for anything due to the possibility of it containing dust from the tablet.
• Dispose of the packaging responsibly. Medicines should not be thrown down the drain or into the trash. Deposit the packaging and unused medicines in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

NiQuitin Composition

Each lozenge contains nicotine resin equivalent to 2 mg of 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 flavor (racemic menthol, peppermint oil, acacia), magnesium stearate (E470b), sucralose.

Appearance of NiQuitin and Package Contents

The size of the lozenges (to the nearest mm) is: L: 10mm x A: 5mm.

Lozenges, white to off-white in color, oval in shape with convex surfaces. The 2 mg lozenges have "NIC2" printed on one side.

The presentations may contain 1 (including a total of 20 lozenges), 3 (including a total of 60 lozenges), or 5 (including a total of 100 lozenges) packages of lozenges.

Only some package 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)

Spain

Perrigo Supply Chain International DAC

The Sharp Building

10-12 Hogan Place

Dublin 2

Ireland

Manufacturer:

Omega Pharma International NV

Venecoweg 26

Nazareth

9810 Belgium

This medicine is authorized in some Member States of the European Economic Area under the following names:

Sweden: NiQuitin 2mg compressed lozenge

Belgium: NiQuitin Minilozenge 2 mg zuigtabletten – comprimés à sucer – Lutschtabletten, gepresst

Luxembourg: NiQuitin Minilozenge 2 mg

Netherlands: NiQuitin minizuigtablet 2 mg, zuigtabletten

Poland: NiQuitin MINI

Portugal: Niquitin Menta 2mg compressed lozenge

Ireland: Niquitin Mini 2 mg Mint Lozenges

Czech Republic: Nicotine Omega

Estonia: NiQuitin Mini Mint

Hungary: NiQuitin Minitab 2 mg préselt szopogató tabletta

Slovakia: NiQuitin mini mint 2 mg

This prospectus was revised in:February 2022.

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