NIQUITIN MINT 2 MG MEDICATED CHEWING GUMS

2. What you need to know before taking NiQuitin Mint

Do not take NiQuitin Mint:

• If you are allergic to nicotine or any of the components of this medicine (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 if you suffer from serious heart rhythm problems, unstable angina, or worsening angina (chest pain), uncontrolled high blood pressure, or angina at rest, you should try to stop smoking without using any NRT product unless your doctor tells you to use them.

• 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 to take 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 can sometimes trigger this type of reaction.

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

• Nicotine chewing gum can loosen dental fillings or implants.

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

• NRT 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 switch between NiQuitin chewing gum and nicotine lozenges during a quit attempt.

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

• Severe or moderate liver or 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 informed you - because nicotine can worsen the symptoms of your condition.
• Stomach ulcer, duodenal ulcer, or inflammation of the esophagus or throat (connection between the mouth and stomach), 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.

Children (under 12 years old)

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

Using NiQuitin Mint with other medicines:

Tell your healthcare professional if you are using, have recently used, or might use any other medicines.

Stopping smoking can alter the effect of other medicines you are taking. If you have any doubts, talk to your healthcare professional.

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

• Theophylline (for asthma treatment)
• Tacrine (for Alzheimer's disease)
• Clozapine (for schizophrenia)
• Ropinirole (for Parkinson's disease treatment).

Using NiQuitin Mint with food and drinks:

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

Acidic drinks (such as fruit juice, coffee, or soda) affect the absorption of nicotine in the mouth. To ensure you get the best effect, you should avoid these types of drinks about 15 minutes before using NiQuitin Mint.

Pregnancy, breastfeeding, and fertility.

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

Smoking during pregnancy poses risks to the baby. These include delayed fetal growth, premature birth, or fetal death. Stopping smoking is the best way to improve both your health and your baby's health. The sooner you stop smoking, the better.

Ideally, if you are pregnant, you should stop smoking without using NRT. However, if you have tried and it has not worked, NRT may be recommended by a healthcare professional to help you stop smoking, as 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 stop smoking. Products such as chewing gum may be preferable to nicotine patches because the nicotine intake is not continuous. However, if you experience nausea or dizziness, patches may be preferable.

If you are breastfeeding, cigarette smoke causes respiratory problems and other issues in babies and children. Ideally, you should stop smoking without using 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 stop smoking, the amount of nicotine that can reach your baby is small. It is better to use NRT products that are taken at specific times of the day (such as chewing 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 Mint on your ability to drive or operate machinery. However, you should be aware that stopping smoking can cause changes in behavior that can affect your ability to drive and operate machinery.

NiQuitin Mint contains:

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

• Sorbitol: This medicine contains 148.65 mg of sorbitol in each medicinal chewing 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 medicine.

Butylhydroxytoluene: This medicine may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxytoluene.

3. How to take NiQuitin Mint

Follow the instructions for administration of this medicine contained in this leaflet or as indicated by your healthcare professional. In case of doubt, ask your healthcare professional.

During any attempt to stop smoking using NiQuitin Mint, it is essential 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 stop smoking. If you continue to have difficulty stopping smoking, it may help to talk to your doctor, nurse, stop smoking counselor, or pharmacist.

NiQuitin Mint 2 mg medicinal chewing gum is used for smokers who smoke less than 20 cigarettes a day.

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

You should use NiQuitin Mint by removing the wrapper and pushing the gum out. Then, place a piece in your mouth and chew slowly until the flavor becomes strong (about 1 minute). Then, stop chewing and leave the gum in your cheek. When the flavor disappears, chew several times until the flavor becomes strong again and leave the gum still. After 30 minutes of using the gum in this way, the gum will be finished. Do not eat or drink while you have a piece of gum in your mouth, as this can reduce the absorption of nicotine. Do not use more than 15 pieces of gum 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 pieces of gum you need to use.

Adults (18 years and older)

• Start using 8-12 pieces of gum per day. Chew a piece whenever you feel the urge to smoke.
• Continue for up to 3 months, then gradually reduce the number of pieces of gum you use per day (see table below).
• When you are using only 1 or 2 pieces of gum per day, stop using them.

After you have stopped smoking, you may suddenly feel the urge to smoke again. If this happens, you can use a piece of gum again.

Use in children and adolescents

Adolescents (12-17 years inclusive)

Adolescents can only use NiQuitin Mint with a doctor's recommendation.

Do not exceed the recommended dose. Do not smoke or use any other product that contains nicotine at the same time. Follow the instructions carefully and do not use more than 15 pieces of gum per day (24 hours).

Children under 12 years old:

Children under 12 years old cannot use NiQuitin Mint.

If you are tempted to smoke again

If you are worried about smoking again or have difficulty stopping using the gum completely, you should consult a healthcare professional. If you start smoking again, they can advise you on how to get the best results from subsequent NRT treatments.

If you take more NiQuitin Mint than you should:

If you take too many NiQuitin Mint pieces, you may start to feel unwell, dizzy, or nauseous. Stop using the gum 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.

The gum is not suitable for children under 12 years old. If children use the gum, they may show signs of nicotine overdose. These include headache, nausea, stomach pain, and diarrhea. If a child has used or eaten some gum, consult a doctor or go to the emergency department of the nearest hospital immediately, as this can be very dangerous and even fatal. 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, this medicine can cause side effects, although not everyone gets them. At the recommended doses, NiQuitin Mint has not been found to cause any serious side effects.

Stopping smoking can 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 stopping smoking.

Stop using NiQuitin Mint and consult a doctor immediately if you experience any of the following symptoms of allergic reactions, which can be serious:

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

• Face, tongue, or throat swelling
• Difficulty swallowing
• Hives and breathing difficulties
• Irregular heartbeat
• Symptoms of a severe allergic reaction, including sudden wheezing or chest tightness, rash, and feeling of fainting.

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, dry mouth, irritation, or ulcers in the mouth, pharyngitis, cough
• Sleep disturbances, headache, irritability, dizziness
• Feeling sick, hiccups, indigestion, flatulence, diarrhea, constipation

• Jaw pain

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

Uncommon (may affect up to 1 in 100 people)

• Increased heart rate or awareness of heartbeat
• Breathing difficulties, chest pain
• Changes in taste
• Redness of the skin, hives, increased sweating
• Pain in muscles/joints or swelling
• Inflammation of the mucous membrane lining of the mouth
• Tremors
• Feeling unwell

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

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

Reporting side effects

If you experience any side effects, consult your healthcare professional, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 gum after the expiration date stated on the packaging and carton after EXP. The expiration date refers to the last day of the month indicated.
• Do not store above 25°C.
• Keep in the original packaging to protect from moisture.
• Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container contents and additional information

Composition of NiQuitin Mint

• The active ingredient is nicotine. Each piece of 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, eucamentol, and levomentol.

Appearance of the product and container contents

White to off-white rectangular-shaped chewing gums.

Each container contains 4 or 10 pieces of gum.

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

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 - España

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

Belgium NiQuitin freshmint 2 mg Medicated Chewing Gum

Croatia NiQuitin GUM Icy Fresh Mint 2 mg Medicinal Chewing Gum

Estonia NiQuitgum Mint Medicinal Chewing Gum 2 mg

Hungary NiQuitin Menthol Fresh 2 mg Medicinal Chewing Gum

Ireland NiQuitin Fresh Mint 2mg Medicated Chewing Gum

Latvia NiQuitin Mint 2 mg Medicinal Chewing Gum

Lithuania NiQuitin Mint 2 mg Medicinal Chewing Gum

Luxembourg NiQuitin freshmint 2 mg Medicated Chewing Gum

Netherlands NiQuitin Mint 2 mg Chewing Gum

Poland NiQuitin Extra Fresh 2mg Medicinal Chewing Gum

Portugal NiQuitin Mint 2mg Medicinal Chewing Gums

Slovak Republic NiQuitin Freshmint 2 mg Medicinal Chewing Gum

Spain NiQuitin Mint 2 mg Medicinal Chewing Gums

Sweden NiQuitin Mint 2 mg Medicinal Chewing Gum

United Kingdom Nicabate Extra Fresh Mint 2 mg Medicated Chewing Gum

(Northern Ireland)

Date of last revision of this leaflet: December 2021

Other sources of information

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