Prospect: Information for the user

NiQuitin Mint 2 mg medicated chewing gum

Nicotina

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

2. What you need to know before starting to take NiQuitin Mint

3. How to take NiQuitin Mint

4. Possible adverse effects

5. Storage of NiQuitin Mint

6. Contents of the package and additional information

NiQuitin Mint is used to help people stop smoking. This type of treatment is called Nicotine Replacement Therapy or NRT.

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

• NiQuitin gum 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 stop smoking. These symptoms include feeling unwell or irritable.

• Nicotine can also relieve your anxiety for a cigarette and help you resist the urge to smoke.

NiQuitin Mint 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 stopping smoking, they may become dependent on nicotine gum. This is very rare, and if it happens, it is less harmful than continuing to smoke. Additionally, it is a habit that is easier to suspend.

Your chances of stopping smoking will improve if you participate in a support program. These "stop smoking programs" are known as behavioral support. For information on stop smoking programs, please consult with a healthcare professional such as a pharmacist.

Smoking does not benefit health. It is always better to stop smoking. The use of NRT, such as NiQuitin Mint, can help you stop smoking. In general, any possible side effects associated with NRT are compensated by the well-known risks of continuing to smoke.

Do not take NiQuitin Mint:

• If you are allergic to nicotine or any of the components of this medication (including those listed in section 6)
• If you are under 12 years old.
• If you do not smoke or are an occasional smoker.

Warnings and precautions

Consult your healthcare professional before starting to take NiQuitin Mint:

• 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), uncontrolled high blood pressure, or resting angina, you must try to quit smoking without using any TSN products unless your doctor tells you to use them.

• If you have diabetes, you must control your blood sugar levels more frequently when starting to use NiQuitin Mint. The amount of insulin or medication you need to take may change.

• If you have ever had allergic reactions that include swelling of the lips, face, and throat (angioedema) or itching on the skin (urticaria). The use of TSN may sometimes trigger this type of reaction.

• If you use dental prostheses, as you may have difficulty chewing.

• The nicotine gum may loosen fillings or dental implants.

• If you have a history of epilepsy (seizures).

• The Nicotine Replacement Therapy (TSN) is not suitable for children under 12 years old. The effects of nicotine affect children more than adults. It can cause severe poisoning that can be fatal.

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

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

• Severe or moderate liver problems or severe or moderate kidney problems, as you may be more likely to experience side effects

• If you have uncontrolled hyperthyroidism or phaeochromocytoma (a tumor of the adrenal gland that can affect blood pressure) - your doctor will have told you - because nicotine can worsen your symptoms.

•Stomach ulcers, or duodenal ulcers, or inflammation of the esophagus or throat (connection between the mouth and stomach), as the nicotine you swallow can worsen your symptoms. This treatment may also cause mouth ulcers. If your symptoms worsen, consult your doctor. You may want to use a non-oral form of TSN, such as patches.

Children (under 12 years)

The suitable dose for adults may cause poisoning or be fatal in small children. Therefore, it is essential to keep NiQuitin Mint out of the sight and reach of children at all times.

Use of NiQuitin Mintwith other medications:

Inform your healthcare professional if you are using, have used recently, or may need to use any other medication.

Quitting smoking may alter the effect of other medications you are taking. If you have any doubts, speak with your healthcare professional.

This is especially important if you use other medications that contain:

- theophylline (for the treatment of asthma)

- tacrine (for Alzheimer's disease)

- clozapine (for schizophrenia)

- ropinirole (for the treatment of Parkinson's disease).

Use ofNiQuitin Mintwith food and drinks

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

Acidic beverages (such as fruit juice, coffee, or soda) affect the absorption of nicotine in the oral cavity. To ensure the best effect, avoid such beverages approximately 15 minutes before using NiQuitin Mint.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your healthcare professional 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 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 (TSN). However, if you have tried and it has not worked, TSN may be recommended by a healthcare professional to help you quit smoking, as it is better for your baby's development than if you continue smoking. The decision to use TSN 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 gum may be preferred to patches, as the nicotine delivery is not continuous. However, if you experience nausea or dizziness, patches may be preferred.

If you are breastfeeding, cigarette smoke causes respiratory difficulties and other problems in babies and children. Ideally, quit smoking without using nicotine replacement therapy (TSN). However, if you have tried and it has not worked, TSN may be recommended by a healthcare professional. If you need to use TSN to quit smoking, the amount of nicotine that may reach your baby is small. It is better to use TSN 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 medication, which helps your baby receive the smallest amount of nicotine possible.

Driving and operating machinery

There are no known effects of NiQuitin Mint on your ability to drive and operate machinery. However, you should be aware that quitting smoking may cause behavioral changes that may affect your ability to drive and operate machinery.

NiQuitinMintcontains:

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

• Sorbitol: This medication contains 148.65 mg of sorbitol in each medicated gum. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

Butilhydroxytoluene: This medication may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxytoluene.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your healthcare professional. In case of doubt, ask your healthcare professional.

When attempting to quit smoking using NiQuitin Mint, it is essential to make the maximum effort to quit smoking completely. However, if you smoke a cigarette during the use of TSN, continue with your attempt to quit smoking. If you continue to have difficulties quitting smoking, it may help to talk to your doctor, nurse, smoking cessation counselor, or pharmacist.

NiQuitin Mint 2 mg chewing gum is used for smokers who smoke fewer than 20 cigarettes per day.

Do not chew NiQuitin Mint like regular gum. If NiQuitin gum is chewed too quickly and without pauses, the nicotine is released too rapidly. This may cause discomfort (such as stomach acid and hiccups).

You must use NiQuitin Mint by removing the paper and pushing the gum outwards. Then, insert a gum into your mouth and chew slowly until the flavor becomes strong (around 1 minute). Then, stop chewing and leave the gum in your cheek. When the flavor disappears, chew several times until the flavor becomes strong and leave the gum still again. After 30 minutes of using the gum in this way, the gum will be finished. Do not eat or drink while you have a gum in your mouth, as this may reduce the absorption of nicotine. Do not use more than 15 gums per day. If you need to use NiQuitin Mint for more than 9 months in total, you must consult with a healthcare professional.

NiQuitin Mint can be used according to the following table, which is designed to gradually reduce the number of gums you must use.

Adults (18 years and older)

• Start using 8 to 12 gums per day. Chew a gum each time you have a craving to smoke.
• Continue this way until a maximum of 3 months, then gradually reduce the number of gums you use per day (see table below).
• When you use only 1 or 2 gums per day, stop using them.

After you have successfully quit smoking, you may suddenly feel the desire to smoke again. If this happens, you can go back to using a gum.

Use in children and adolescents

Adolescents (12-17 years inclusive)

Adolescents can only use NiQuitin Mint with the recommendation of a doctor.

Do not exceed the indicated dose. Do not smoke or use any other nicotine-containing product at the same time. Follow the instructions carefully and do not use more than 15 gums per day (24 hours).

Children under 12 years:

Children under 12 years cannot use NiQuitin Mint.

If you are tempted to smoke again

If you are concerned about smoking again or have difficulties quitting completely using the gums, you must consult with a healthcare professional. If you start smoking again, they may advise you on how to get the best results from subsequent treatments with TSN.

If you take more NiQuitin Mint than you should:

If you take too many gums NiQuitin Mint, you may start to feel unwell, dizzy, or nauseous. Stop using the gums and consult a doctor immediately or go to the emergency service of a hospital. If possible, bring the medication package or this leaflet.

The gums are not suitable for children under 12 years. If children use the gums, they may show signs of nicotine overdose. These include headaches, nausea, stomach pain, and diarrhea. If a child has used or eaten any gum, consult a doctor or go to the emergency service of the nearest hospital immediately, as this can be very dangerous and even fatal.If possible, show them the medication or this leaflet.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. At the recommended doses, no serious side effects have been found with NiQuitin Mint.

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

Stop using NiQuitin Mint and seek medical attention immediately if you experience any of the following allergic reaction symptoms, which may be severe:

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

• Swollen face, tongue, or throat
• Difficulty swallowing
• Hives and difficulty breathing
• Irregular heartbeat
• Severe allergic reaction symptoms that include sudden wheezing or chest tightness, hives, and feeling faint.

Other side effects are listed below, grouped by how often they may occur:

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

• Feeling dizzy

Common (may affect up to 1 in 10 people)

• Gastrointestinal discomfort
• Sore throat, mouth pain or dry mouth, mouth irritation or ulcers, sore throat, cough
• Sleep disturbances, headache, irritability, dizziness
• Feeling sick, hiccups, indigestion, flatulence, diarrhea, constipation

• Jaw pain

None of the mentioned side effects are serious and often disappear after a few days of treatment.

Rare (may affect up to 1 in 100 people)

• Increased heart rate or awareness of heartbeat
• Difficulty breathing, chest pain
• Changes in sense of taste
• Redness of the skin, hives, increased sweating
• Muscle or joint pain or swelling
• Inflammation of the mucous membrane of the mouth
• Trembling
• Feeling unwell

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

• Seizures (attacks), difficulty swallowing, belching, increased salivation, asthenia (lack of energy), fatigue (tiredness), flu-like illness (symptoms similar to the flu), hypersensitivity, abnormal dreams, itching or hives, numbness or tingling in the mouth.

Reporting side effects

If you experience any type of side effect, consult your healthcare professional, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

• Do not use the lozenges after the expiration date that appears on the packaging and on the box after CAD. The expiration date refers to the last day of the month indicated.

• Do not store at a temperature above 25°C.

• Store in the original packaging to protect from humidity.

• Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of NiQuitin Mint

• The active ingredient is nicotine. Each piece of chewing gum contains 2 mg of nicotine (in the form of a resin complex called nicotine resinate).
• The other components are:
• • butylhydroxytoluene (E321), sorbitol (E420), xylitol (E967), calcium carbonate (E170), anhydrous sodium carbonate (E500), glycerol (E422), potassium acesulfame (E950), sucralose (E955), mannitol (E421), acacia (E414), titanium dioxide (E171), and flavors: optacool, eucalyptol, and levomenthol.

Appearance of the product and contents of the package

White to off-white rectangular chewing gum.

Each package contains 4 or 10 pieces of chewing gum.

Each box contains 4, 10, 30, 100, or 200 pieces of chewing gum.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

PERRIGO ESPAÑA, S.A.

Parque de Oficinas Sant Cugat Nord - Pza. Xavier Cugat,2 - Edif. D, 1st Floor - San Cugat

del Valles (Barcelona) - 08174 - Spain

Manufacturer responsible:

Fertin Pharma A/S

Dandyvej 19

7100 Vejle

Denmark

Logiters, Logistica Portugal, S.A.

Estrada dos Arneiros, 4,

Azambuja, 2050 – 544

Portugal

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

BelgiumNiQuitin freshmint 2 mg Gomme à mâcher médicamenteuse

CroatiaNiQuitin GUM Icy Fresh Mint 2 mg ljekovita guma zažvakanje

EstoniaNiQuitgum Mint medicinsk tyggegummi 2 mg

HungaryNiQuitin Menthol Fresh 2 mg gyógyszeres rágógumi

IrelandNiQuitin Fresh Mint 2mgMedicated Chewing Gum

LithuaniaNiQuitin Mint 2 mg vaistine kramtomoji guma

LuxembourgNiQuitin freshmint 2 mg Gomme à mâcher médicamenteuse

NetherlandsNiQuitin Mint 2 mg Kauwgom

PolandNiQuitin Extra Fresh 2mg guma do zucia, lecznicza

PortugalNiQuitin Mint 2mg gomas para mascar medicamentosas

SlovakiaNiQuitin Freshmint 2 mg liecivé žuvacky

SpainNiQuitin Mint2 mg chicles medicamentosos

SwedenNiQuitin Mint 2 mg medicinskt tuggummi

United KingdomNicabate Extra Fresh Mint 2 mg Medicated Chewing Gum

(Northern Ireland)

Date of thelast review of this leaflet: December 2021

Other sources of information

The 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/