Niquitin Mint 2 mg medicated chewing gum

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

NiQuitin Mint 2 mg chewing gum medicinal product

Nicotine

Package leaflet contents

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

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

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

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

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

NiQuitin Mint does not carry 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 might become dependent on nicotine gum. This is very rare, and if it does occur, it is less harmful than continuing to smoke. In addition, it is easier to stop this habit.

Your chances of quitting smoking will improve if you take part in a support programme. These "quit smoking" programmes are known as behavioural support. For information about smoking cessation programmes, please consult a healthcare professional such as a pharmacist.

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

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

Do not take NiQuitin Mint:

• If you are allergic to nicotine or to any of the ingredients of this medicine (listed in section 6)
• If you are under 12 years of age
• If you do not smoke or if you are an occasional smoker

Warnings and precautions

Consult your healthcare professional before starting to use NiQuitin Mint:

• If you have recently had a heart attack or stroke, or if you suffer from serious heart rhythm problems, unstable angina or worsening angina pectoris (chest pain), uncontrolled high blood pressure, or angina at rest, you should try to quit smoking without using any nicotine replacement therapy (NRT) unless your doctor advises you to use it.

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

• If you have ever had allergic reactions including swelling of the lips, face, and throat (angioedema) or skin itching (urticaria). The use of NRT may sometimes trigger such reactions.

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

• Nicotine gum may loosen dental fillings or dental implants.

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

• Nicotine replacement therapy (NRT) is not suitable for children under 12 years of age. Nicotine affects children more than adults. It may cause severe poisoning that could be fatal.

Do not switch between NiQuitin chewing gum and nicotine lozenges during your 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
• Uncontrolled overactivity of the thyroid gland or pheochromocytoma (a tumor of the adrenal gland that can affect blood pressure) – your doctor will have informed you of this – because nicotine may worsen your symptoms.
• Stomach or duodenal ulcer, or inflammation of the esophagus or throat (the connection between mouth and stomach), as swallowed nicotine may worsen your symptoms. This treatment may also cause mouth ulcers. If your symptoms worsen, consult your doctor. You may wish to use a non-oral form of NRT, such as patches.

Children (under 12 years of age)

The appropriate adult dose could cause poisoning or be fatal in young children. It is therefore essential to keep NiQuitin Mint out of sight and reach of children at all times.

Using NiQuitin Mint with other medicines:

Inform your healthcare professional if you are taking, have recently taken, or might need to take any other medicines.

Stopping smoking may alter the effect of other medicines you are taking. If you have any doubts about this, speak with your healthcare professional.

This is especially important if you are taking other medicines that contain:

• theophylline (for treatment of asthma)
• tacrine (for Alzheimer's disease)
• clozapine (for schizophrenia)
• ropinirole (for treatment of Parkinson's disease)

Using NiQuitin Mint with food and drinks:

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your healthcare professional before using this medicine.

Smoking during pregnancy poses risks to the baby, including 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 earlier you quit, the better.

Ideally, if you are pregnant, you should stop smoking without using nicotine replacement therapy (NRT). However, if you have tried and failed, NRT may be recommended by a healthcare professional to help you quit smoking, as it is better for your baby's development than continuing to smoke. 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 stop smoking. Products such as chewing gum may be preferable to nicotine patches because gum provides intermittent nicotine delivery rather than continuous. However, if you experience nausea or dizziness, patches may be preferable.

If you are breastfeeding, tobacco smoke causes breathing difficulties and other problems in babies and children. Ideally, you should quit smoking without using nicotine replacement therapy (NRT). However, if you have tried and failed, NRT may be recommended by a healthcare professional. If you need to use NRT to quit smoking, the amount of nicotine that reaches your baby is small. It is better to use NRT products that are taken at specific times of day (such as chewing gum or lozenges) rather than patches. It is also preferable to breastfeed just before taking the medicine, as this helps minimize the amount of nicotine your baby receives.

Driving and using machines

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

NiQuitin Mint contains:

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

• Sorbitol: This medicine 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 if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot break down fructose, consult your doctor before taking this medicine.

Butylated hydroxytoluene (BHT): This medicine may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylated hydroxytoluene.

3. How to take NiQuitin Mint

Follow exactly the instructions for use of this medicine as described in this leaflet or as directed by your healthcare professional. If in doubt, consult your healthcare professional.

During any attempt to stop smoking using NiQuitin Mint, it is important that you make every effort to stop smoking completely. However, if you smoke a cigarette while using NRT, you should continue with your attempt to quit smoking. If you continue to have difficulty quitting, it may help to speak with your doctor, nurse, smoking cessation counselor, or pharmacist.

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

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

To use NiQuitin Mint, remove the paper and push the gum out. Then place one piece of gum into your mouth and chew slowly until the taste becomes strong (about 1 minute). Then stop chewing and place the gum between your cheek and gum. When the taste fades, chew several times until the taste becomes strong again, then let the gum rest in your mouth once more. After 30 minutes of using the gum in this way, the gum will be finished. Do not eat or drink while the gum is 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 should consult a healthcare professional.

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

Adults (18 years and older)

• Start by using 8 to 12 gums per day. Chew one gum whenever you feel the urge to smoke.
• Continue in this way for up to 3 months, then gradually reduce the number of gums you use each day (see table below).
• When you are using only 1 or 2 gums per day, stop using them.

After successfully quitting smoking, you may suddenly feel the urge to smoke again. If this happens, you may use another gum.

Use in children and adolescents

Adolescents (12–17 years inclusive)

Adolescents may only use NiQuitin Mint on the advice of a doctor.

Do not exceed the recommended 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 chewing gums per day (24 hours).

Children under 12 years:

NiQuitin Mint must not be used by children under 12 years of age.

If you are tempted to smoke again

If you are worried about starting to smoke again or have difficulties completely stopping the use of the chewing gum, you should consult a healthcare professional. If you start smoking again, they can advise you on how to achieve the best results from future treatments with nicotine replacement therapy (NRT).

If you take more NiQuitin Mint than you should:

If you take too many NiQuitin Mint chewing gums, you may begin to feel unwell, dizzy or nauseous. Stop using the chewing gums immediately and consult a doctor or go to a hospital emergency department straight away. If possible, take the medicine pack or this leaflet with you.

The chewing gums are not suitable for children under 12 years of age. If children use the chewing gums, they may show signs of nicotine overdose. These include headache, nausea, stomach pain and diarrhoea. If a child has used or swallowed any of the chewing gum, consult your doctor or go to the nearest hospital emergency department immediately, as this may be very dangerous and even fatal. If possible, show them the medicine or this leaflet.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. At the recommended doses, NiQuitin Mint has not been found to cause any serious adverse effects.

Stopping smoking may cause symptoms such as dizziness, headache, sleep disturbances, cough, and cold-like symptoms. 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 contact your doctor immediately if you experience any of the following symptoms of allergic reactions, which may be serious:

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

• Swelling of the face, tongue, or throat
• Difficulty swallowing
• Hives and breathing difficulties
• Irregular heartbeat
• Symptoms of severe allergic reaction including sudden wheezing or chest tightness, rash, and feeling faint.

Other adverse effects listed below are grouped according to how frequently 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 ulceration, pharyngitis, cough
• Sleep disturbances, headache, irritability, dizziness
• Feeling unwell, hiccups, indigestion, flatulence, diarrhoea, constipation
• Jaw pain

None of the effects listed above are serious and often disappear within a few days of treatment.

Uncommon (may affect up to 1 in 100 people)

• Increased heart rate or awareness of heartbeat
• Difficulty breathing, chest pain
• Changes in taste sensation
• Skin redness, hives, increased sweating
• Muscle/joint pain or swelling
• Inflammation of the mucous lining of the mouth
• Tremor
• Feeling unwell

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

• Seizures (fits), difficulty swallowing, burping, increased salivation, asthenia (lack of energy), fatigue (tiredness), flu-like illness (flu-like symptoms), hypersensitivity, abnormal dreams, itching or rash, numbness or tingling in the mouth.
• A fast and irregular heartbeat (Atrial fibrillation)

Reporting of adverse effects

If you experience any type of adverse effect, consult your healthcare professional, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of NiQuitin Mint

• Keep this medicine out of the sight and reach of children.
• Do not use the chewing gum after the expiry date stated on the packaging and carton after EXP. The expiry date refers to the last day of the month indicated.
• Do not store above 25°C.
• Store in the original packaging to protect from moisture.
• Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of NiQuitin Mint

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

Appearance of the product and contents of the pack

White to off-white rectangular chewing gums.

Each pack contains 4 or 10 chewing gums.

Each carton contains 4, 10, 30, 100 or 200 chewing gums.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

PERRIGO ESPAÑA, S.A.

Parque de Oficinas Sant Cugat Nord - Pza. Xavier Cugat,2 - Edif. D, 1ª Planta - San Cugat
del Valles (Barcelona) - 08174 - Spain

Manufacturer:

Fertin Pharma A/S
Dandyvej 19
7100 Vejle
Denmark

Logiters, Logistica Portugal, S.A.
Estrada dos Arneiros, 4
Azambuja, 2050 – 544
Portugal

This medicinal product is authorised in certain European Economic Area (EEA) Member States under the following names:

Belgium NiQuitin freshmint 2 mg Gomme à mâcher médicamenteuse
Croatia NiQuitin GUM Icy Fresh Mint 2 mg ljekovita guma za žvakanje
Estonia NiQuitgum Mint medicinsk tyggegummi 2 mg
Hungary NiQuitin Menthol Fresh 2 mg gyógyszeres rágógumi
Ireland NiQuitin Fresh Mint 2mg Medicated Chewing Gum
Latvia NiQuitin Mint 2 mg arstnieciska košļājamā gumija
Lithuania NiQuitin Mint 2 mg vaistinė kramtomoji guma
Luxembourg NiQuitin freshmint 2 mg Gomme à mâcher médicamenteuse
Netherlands NiQuitin Mint 2 mg Kauwgom
Poland NiQuitin Extra Fresh 2mg guma do żucia, lecznicza
Portugal NiQuitin Mint 2mg gomas para mascar medicamentosas
Slovak Republic NiQuitin Freshmint 2 mg liečivé žuvacky
Spain NiQuitin Mint 2 mg chicles medicamentosos
Sweden NiQuitin Mint 2 mg medicinskt tuggummi
United Kingdom Nicabate Extra Fresh Mint 2 mg Medicated Chewing Gum (Northern Ireland)

Date of the most recent revision of this leaflet: November 2025

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/