NICOTINELL MINT 2 mg LOZENGES

Introduction

Package Leaflet: Information for the User

Nicotinell Mint 2 mg lozenges

nicotine

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your 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 it is a side effect not listed in this leaflet. See section 4.
• If symptoms worsen or persist after 6 months, you should consult your doctor.

Contents of the package leaflet

1. What is Nicotinell Mint and what is it used for
2. What you need to know before you start taking Nicotinell Mint
3. How to take Nicotinell Mint
4. Possible side effects
5. Storage of Nicotinell Mint
6. Package contents and further information

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

Nicotinell Mint belongs to a group of medicines used as an aid to stop smoking. Nicotinell Mint lozenges contain the active ingredient nicotine

.

When you suck the lozenges, the nicotine is released slowly and absorbed through the mouth mucosa.

This medicine is used to help people stop smoking. The nicotine contained in Nicotinell Mint lozenges alleviates the symptoms of nicotine withdrawal and anxiety that occur when you stop smoking or gradually reduce your tobacco consumption to facilitate the smoking cessation process. By alleviating the symptoms of nicotine withdrawal and anxiety, Nicotinell Mint lozenges counteract relapses in motivated smokers who want to quit.

Patient counseling and support usually improve the chances of success.

Nicotinell Mint lozenges are indicated for smokers over 18 years of age.

2. What you need to know before you start taking Nicotinell Mint

Do not take Nicotinell Mint lozenges

• If you are allergic to nicotine or any of the other components of this medicine (listed in section 6).

If you are a non-smoker.

Warnings and precautions

Consult your doctor or pharmacist before taking Nicotinell Mint lozenges if you have:

• Any heart problems, such as having recently suffered a heart attack, having heart rhythm problems, heart failure, or chest pain (angina pectoris, including Prinzmetal's angina). While using this medicine, if you experience an increase in heart problems, you should reduce or stop using this medicine.
• Stroke (cerebral apoplexy).
• High blood pressure.
• Circulation problems.
• Diabetes. You should check your blood sugar levels more frequently than usual when you start using the nicotine lozenges. Your insulin or medication requirements may change.
• Hyperthyroidism.
• Overactive adrenal glands (pheochromocytoma).
• Kidney or liver failure.
• Esophagitis, mouth or throat inflammation, gastritis, or peptic ulcer.
• History of epilepsy (seizures).

Children and adolescents

Nicotinell should not be used by adolescents between 12 and 17 years without the prescription of a healthcare professional.

The correct dose for adults could seriously harm or even be fatal for young children. Therefore, it is essential to keep Nicotinell Mint lozenges out of sight and reach of children at all times. Nicotinell Mint should not be used in children under 12 years of age.

Using Nicotinell Mint with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. If you want to quit smoking and are taking other medicines, your doctor may need to adjust the dose.

There is no information about interactions between Nicotinell Mint lozenges and other medicines. However, apart from nicotine, other substances in cigarettes may affect some treatments.

Quitting smoking may change the effect of medicines such as:

• Theophylline (used in the treatment of bronchial asthma)
• Tacrine (used in the treatment of Alzheimer's disease)
• Olanzapine and Clozapine (for the treatment of schizophrenia)
• Insulin (used in the treatment of diabetes), which may need to be readjusted

Using Nicotinell Mint with food and drinks

Consuming coffee, acidic drinks (such as lemon or orange), or fizzy drinks may decrease the absorption of nicotine, so they should be avoided for 15 minutes before taking the lozenge. Do not eat or drink while you have a lozenge in your mouth.

Pregnancy, breastfeeding, and fertility

Pregnancy

It is very important to quit smoking during pregnancy because it can be harmful to the fetus. It can cause premature births and even stillbirths. The best option would be to quit smoking without using nicotine-containing medications. If you cannot quit smoking without medication, Nicotinell should only be used after consulting a healthcare professional.

Breastfeeding

Treatment with Nicotinell Mint should be avoided during breastfeeding because nicotine passes into breast milk and may affect your baby. If a healthcare professional recommends continuing treatment during the breastfeeding period, you should take the lozenge immediately after breastfeeding, and in no case when there are less than 2 hours left before breastfeeding your baby again.

Fertility

Smoking increases the risk of infertility in women and men. The effects of nicotine on fertility are unknown.

Driving and using machines

Although there are no known effects on the ability to drive or use machines at the recommended doses, it should be taken into account that quitting smoking causes changes in behavior.

Nicotinell Mint contains aspartame, mannitol, and sodium

This medicine contains 10 mg of aspartame in each lozenge. Aspartame is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medicine contains maltitol (E965). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine. It may have a mild laxative effect.

The caloric value is 2.3 Kcal/g of maltitol. The components of Nicotinell Mint lozenges are suitable for diabetics.

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

3. How to take Nicotinell Mint

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Nicotinell Mint lozenges are available in two dosages: 1 and 2 mg. The appropriate dose depends on your previous smoking habits. You should take Nicotinell Mint 2 mg lozenges if:

• You are a smoker with high or very high nicotine dependence;
• You have not been able to quit smoking previously using 1mg lozenges;
• Your withdrawal symptoms are so intense that you relapse and start smoking again.

In any other case, you should use Nicotinell Mint 1mg lozenges.

Adults over 18 years of age

Select the appropriate dose for you based on the following table:

If you experience any adverse event when starting treatment with a high-dosage form (2mg lozenges), it should be replaced with a lower-dosage form (1mg lozenges).

Dose for adults over 18 years of age

Take a lozenge when you start feeling the need to smoke. In general, you should take a lozenge every 1-2 hours. In most cases, 8-12 lozenges per day are sufficient. If you still feel the need to smoke, you can suck additional lozenges. Do not take more than 15 lozenges of 2mg per day (for both quitting and reducing tobacco consumption). Do not take more than one lozenge per hour.

The primary purpose of Nicotinell lozenges should be to quit smoking.

Drastic reduction of tobacco consumption:

To improve the chances of success when quitting smoking, you should not smoke at all when starting to use the lozenges or during the entire treatment.

The duration of treatment is individual. Normally, treatment should be followed for at least 3 months. After 3 months, the number of lozenges per day will be gradually reduced. Treatment should be finished when the consumption of lozenges has been reduced to 1 or 2 lozenges per day.

It is not recommended to use Nicotinell Mint lozenges for more than 6 months. However, some ex-smokers may need longer treatment with lozenges to avoid relapse. If you are still using the lozenges after 6 months, you should consult your doctor or pharmacist.

Patient counseling and support usually improve the chances of success.

Gradual reduction of tobacco consumption:

You should use Nicotinell lozenges to prolong the periods when you do not smoke and gradually reduce tobacco consumption as much as possible. The number of cigarettes should be gradually replaced by Nicotinell lozenges. If after 6 weeks you have not been able to reduce the number of cigarettes per day by at least half, you should seek professional advice. You should try to quit smoking as soon as you feel ready, but in any case within the first 4 months of starting to use Nicotinell lozenges. Then, you should gradually reduce the number of lozenges, for example, by removing one lozenge every 2-5 days.

If after 6 months you have not made a serious attempt to quit smoking, you should seek professional help. It is not recommended to regularly use Nicotinell lozenges for more than 6 months. Some ex-smokers may need longer treatment to avoid relapse.

Counseling can increase your chances of quitting smoking.

Instructions for use:

Lozenges should not be swallowed.

1. Put the lozenge in your mouth and suck it slowly until the taste becomes intense.
2. Place the lozenge between your cheek and gum.
3. When the taste decreases, suck the lozenge slowly again.
4. Repeat this process until the lozenge has dissolved completely (approximately 30 minutes).

Avoid taking coffee, acidic drinks, and fizzy drinks for 15 minutes before sucking the lozenge because they can decrease nicotine absorption. Do not eat or drink while you have a lozenge in your mouth.

If you take more Nicotinell Mint than you should

You may experience symptoms similar to those that occur when smoking a large amount of tobacco. Symptoms of nicotine overdose include: weakness, pale skin, sweating, increased salivation, burning sensation in the throat, nausea, vomiting, diarrhea, abdominal pain, changes in vision and hearing, headache, increased or altered heart rate, shortness of breath, dizziness, tremors, and confusion.

With large overdoses, these symptoms can be followed by exhaustion, low blood pressure, circulatory collapse, coma, difficulty breathing, and convulsions.

Stop taking the lozenges and contact a doctor or pharmacist immediately to assess the risk and receive advice if you have taken more medicine than you should, or if a child has taken the medicine by mistake.

If you suspect poisoning in a child, you should consult a doctor immediately. Even small amounts of nicotine are dangerous and potentially fatal for children and can cause severe poisoning symptoms, which can be fatal.

If you forget to take Nicotinell

Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some of the effects you may notice during the first few days are dizziness, headache, and sleep disturbances, which can be attributed to the symptoms related to quitting smoking, and sometimes may be due to insufficient nicotine administration.

Other possible withdrawal symptoms related to quitting smoking may be insomnia, cough, weakness, fatigue, feeling unwell, and flu-like symptoms.

Stop taking Nicotinell Mint and contact a doctor immediately if you experience any of the following symptoms of a severe allergic reaction (angioedema or anaphylactic reaction)

• Swelling of the face, tongue, or throat; difficulty swallowing; hives, and breathing difficulties. These side effects are rare.

Other side effects that may occur:

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

• Feeling sick (nausea).

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

• Inflammation of the mouth mucosa, oral discomfort.
• Sore throat.
• Vomiting.
• Stomach upset, stomach pain.
• Diarrhea.
• Indigestion / stomach acid. Sucking the lozenge more slowly usually solves these problems.
• Flatulence.
• Hiccups.
• Constipation.
• Headache and dizziness.
• Cough.
• Dry mouth.
• .

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

• Palpitations.

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

• Changes in heart rhythm and allergic reactions.
• Hypersensitivity reactions.

Frequency not known:

• Hives
• Ulcerative stomatitis.
• Tremors.
• Shortness of breath.
• Difficulty swallowing.
• Belching.
• Increased saliva production.
• Weakness.
• Fatigue.
• Feeling unwell and flu-like symptoms.

When trying to quit smoking, mouth ulcers may occur, but the relationship with nicotine treatment is unclear.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use. Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nicotinell Mint

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging Contents and Additional Information

Nicotinell Mint Composition

• The active ingredient is nicotine. Each lozenge contains 2 mg (corresponding to 6.144 mg of nicotine bitartrate dihydrate).
• The other components are: maltitol (E965), anhydrous sodium carbonate, sodium hydrogen carbonate, polyacrylate, xanthan gum, anhydrous colloidal silica, levomenthol, peppermint essential oil, aspartame (E951), and magnesium stearate.

Product Appearance and Packaging Contents

Nicotinell Mint lozenges are white, round, biconvex lozenges with

a mint flavor.

Nicotinell Mint lozenges are available in two dosages (1 and 2 mg). This

leaflet corresponds to Nicotinell Mint 2 mg lozenges.

Nicotinell Mint is available in packs of 12, 36, 72, 96, 144, 192, or 204 lozenges in blisters. Not all pack sizes may be marketed.

Marketing Authorization Holder

Haleon Spain, S.A.

Parque Tecnológico de Madrid, Calle de Severo Ochoa, 2

28760 Tres Cantos, Madrid – Spain

Manufacturer

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited

980 Great West Road, Brentford

Middlesex TW8 9GS

United Kingdom

or

Haleon Belgium NV

Da Vincilaan 5,

1930 Zaventem,

Belgium

or

Haleon Denmark ApS

Delta Park 37, 2665 Vallensbæk Strand (Denmark)

or

Haleon Germany GmbH

Barthstrasse, 4 - 80339

Munich (Germany)

This medicinal product has been authorized in the following EEA Member States under the

following names:

Germany Nicotinell Lutschtabletten 2 mg Mint

Austria Nicotinell Mint 2 mg Lutschtabletten

Denmark Nicotinell Mint 2 mg Sugetablet

Spain Nicotinell Mint 2 mg lozenges

Finland Nicotinell Mint 2 mg Imeskelytabletti

France Nicotinell Menthe 2 mg, comprimé à sucer

Ireland Nicotinell Mint 2 mg compressed Lozenge

Iceland Nicotinell mint 2 mg Munnsogstafla

Luxembourg Nicotinell Mint 2 mg, comprimé à sucer

Netherlands Nicotinell Mint 2 mg Zuigtablet

Portugal Nicotinell Mint 2 mg Pastilhas

United Kingdom Nicotinell Mint 2 mg Lozenge

Sweden Nicotinell Mint 2 mg sugtablett

Date of the last revision of this leaflet: March 2020

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/