Leaflet: information for the user

Nicotinell Mint 1 mg chewing tablets

nicotine

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

- If symptoms worsen or persist after 6 months, you must consult a doctor.

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

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

3. How to take Nicotinell Mint

4. Possible side effects

5. Storage of Nicotinell Mint

6. Contents of the pack and additional information

Nicotinell Mint belongs to a group of medications used as a help to quit smoking. Nicotinell Mint chewing tablets contain the active ingredient nicotine

.

When chewing the tablets, nicotine is released slowly and absorbed through the mucous membrane of the mouth.

This medication is used to help people quit smoking. The nicotine contained in Nicotinell Mint chewing tablets relieves nicotine withdrawal symptoms and anxiety that occur when quitting smoking or gradually reducing tobacco consumption to facilitate the process of quitting smoking. By relieving nicotine withdrawal symptoms and anxiety, Nicotinell Mint chewing tablets counteracts relapses in motivated smokers trying to quit.

Patient advice and support usually improve the chances of success.

Nicotinell Mint chewing tablets is indicated for smokers 18 years of age or older.

Do not take Nicotinell Mint chewing tablets

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

This medication (including those listed in section 6).

• If you are not a smoker.

Warnings and precautions

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

• Any heart problem, such as having recently had a heart attack, experiencing heart rhythm problems, heart failure, or chest pain (angina, including Prinzmetal's angina). While using this medication, if you experience an increase in heart problems, you should reduce or discontinue use of this medication.cardiac, such as having recently had a heart attack, experiencing heart rhythm problems, heart failure, or chest pain (angina, including Prinzmetal's angina). While using this medication, if you experience an increase in heart problems, you should reduce or discontinue use of this medication.
• Stroke (cerebral apoplexy).
• High blood pressure.
• Circulation problems.
• Diabetes. You should monitor your blood sugar levels more frequently when starting to use nicotine tablets. Your insulin or medication requirements may change.
• Hyperthyroidism.
• Overactive adrenal glands (pheochromocytoma).
• Renal or hepatic insufficiency.
• Esofagitis, inflammation of the mouth or throat, gastritis, or peptic ulcer.
• History of epilepsy (seizures).

Children and adolescents

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

The correct dose for adults could severely or even fatally poison small children. Therefore, it is essential to keep Nicotinell Mint tablets out of the sight and reach of children at all times. Nicotinell Mint should not be used in children under 12 years old.

Use of Nicotinell Mint with other medications

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

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

Quitting smoking may affect the effect of medications 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), whose dose may need to be adjusted

Use of Nicotinell Mint with food and drinks

The consumption of coffee, acidic beverages (such as lemon, orange, etc.), or soft drinks may reduce the absorption of nicotine, so they should be avoided for 15 minutes before taking the tablet. Do not eat or drink while having a tablet 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's development. It may induce premature births and even stillbirths. It would be best to quit smoking without using medications containing nicotine. If you cannot quit smoking without medications, Nicotinell should be used only after consulting a healthcare professional.

Breastfeeding

The 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 breastfeeding, you should take the tablet immediately after breastfeeding, and in no case when there are less than 2 hours 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 operating machinery

Although there are no known effects on the ability to drive or operate machinery at the recommended doses, it should be noted that quitting smoking causes changes in behavior.

Nicotinell Mint contains aspartame, mannitol, and sodium

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

This medication contains maltitol (E965). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. You may experience a mild laxative effect.

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

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

Follow exactly the administration instructions of the medication contained in this leaflet or those 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.

Nicotinell Mint 1mg lozenges can be used alone(a)or in combination with

Nicotinell patches(b).

Adults aged 18 years and over

(a)Treatment with Nicotinell Mint lozenges only

Nicotinell Mint 1mg lozenges are recommended for smokers with low to moderate nicotine dependence. It is not recommended for smokers with high to very high nicotine dependence.

Choose the appropriate dose for you from the following table:

If any adverse event is observed when starting treatment with a high-dose form (2mg lozenges), it should be replaced by a lower-dose form (1mg lozenges).

Dose for adults aged 18 years and over

Take a lozenge when you start to feel the need to smoke. In general, you should take a lozenge every 1-2 hours. In most cases, the amount of 8-12 lozenges per day is sufficient. If you still feel the need to smoke, you can take additional lozenges. Do not take more than 24 lozenges of 1mg per day (both for quitting smoking and for progressive reduction of 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 possibility of success in quitting smoking, you should not smoke at all when starting to use lozenges or during the entire treatment period.

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

Do not use Nicotinell Mint lozenges for more than 6 months. However, some ex-smokers may need a longer treatment with lozenges to avoid relapse.

If you are still using lozenges after 6 months, you should consult your doctor or pharmacist.

Patient advice and support usually improve the chances of success.

Progressive reduction of tobacco consumption:

You should use Nicotinell lozenges to prolong the periods when you do not smoke and 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 managed 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 since 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 within 6 months there has been no serious attempt to quit smoking, you should seek professional help. Do not use Nicotinell lozenges regularly for more than 6 months. Some ex-smokers may need a longer treatment to avoid relapse.

Patient advice can increase your chances of quitting smoking.

Instructions for use:

Lozenges should not be swallowed.

1.Chew a lozenge until its flavor becomes intense.

2.Place the lozenge between the cheek and the gum.

3.As the flavor decreases, go back to chewing the lozenge.

4. Repeat this routine until the lozenge has completely dissolved (approximately 30 minutes).

Avoid taking coffee, acidic drinks, and soda for 15 minutes before sucking the lozenge, as they may reduce nicotine absorption. Do not eat or drink while you have a lozenge in your mouth.

(b)Combined therapy of Nicotinell Mint 1 mg lozenges with Nicotinell transdermal patches

Drastic reduction of tobacco consumption:

If treatment with Nicotinell lozenges only has failed, you can use Nicotinell patches together with Nicotinell 1 mg lozenges.

NOTE: Read the leaflet for Nicotinell transdermal patches before use.

You should stop smoking completely when starting to use lozenges in combination with Nicotinell patches, and during the entire treatment period.

The use of Nicotinell patches together with Nicotinell 1 mg lozenges is recommended for smokers with moderate to very strong nicotine dependence, i.e. more than 20 cigarettes per day. It is strongly recommended that combined therapy be carried out with the advice and support of a healthcare professional.

Combined therapy can only be used for drastic reduction of tobacco consumption.

Initial combined therapy:

Start treatment with a 21 mg/24 h patch combined with Nicotinell 1 mg lozenges. Use at least 4 lozenges (1 mg) per day. In most cases, 5-6 lozenges are sufficient. Do not use more than 15 lozenges per day. In normal cases, treatment can last from 6 to 12 weeks. Then, the dose of nicotine should be gradually reduced.

Place the patch on an intact area of skin, clean, dry, and without hair on the trunk, arms, or legs, and press it against the skin for 10 to 20 seconds.

Alternate between different application sites to minimize the risk of local irritation when applying Nicotinell patches.

Wash your hands thoroughly after applying the patches to avoid irritating your eyes with nicotine from your fingers.

Reduction of the dose of nicotine after the first 6-12 weeks:

It can be done in two ways.

Alternative 1:

Use patches of a lower dose, i.e. 14 mg/24 hours for 3-6 weeks, followed by patches of 7 mg/24 hours for another 3-6 weeks, together with the initial dose of Nicotinell 1 mg lozenges. Then, gradually reduce the number of lozenges. Generally, it is not recommended to use Nicotinell Mint lozenges for more than 6 months. However, some ex-smokers may need a longer treatment to avoid relapse, but it should not be prolonged for more than 9 months.

Alternative 2:

Stop using the patch and gradually reduce the number of Nicotinell 1 mg lozenges. Generally, it is not recommended to use Nicotinell Mint lozenges for more than 6 months. However, some ex-smokers may need a longer treatment to avoid relapse, but it should not be prolonged for more than 9 months.

Recommended dose:

If you are still using lozenges after 6 months, you should consult your doctor or pharmacist.

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, visual and auditory disturbances, headache, increased or any other alteration of heart rate, shortness of breath, dizziness, tremors, and confusion.

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

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

If you suspect poisoning in a child, you should consult a doctor immediately. Even small amounts of nicotine are dangerous, and possibly fatal,for children and may lead to severe poisoning symptoms that can be fatal.

If you forget to take Nicotinell

Do not take a double dose to compensate for the missed doses.

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

Like all medications,this medicationmay cause

side effects, although not everyone will experience 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 underlying symptoms related to quitting smoking, and in some cases, it may be due to insufficient nicotine administration.

Other possible symptoms of withdrawal related to quitting the smoking habit may be insomnia, cough, weakness, fatigue, feeling unwell, and symptoms similar to the flu.

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

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

Other possible 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):

• Mouth mucosa inflammation, oral discomfort.
• Throat pain.
• Vomiting.
• Stomach discomfort, stomach pain.
• Diarrhea.
• Indigestion / stomach acid. Chewing the tablet 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):

• Heart rhythm disturbances and allergic reactions.
• Hypersensitivity reactions.

Frequency not known:

• Hives
• Mouth ulcers.
• Tremor.
• Shortness of breath.
• Difficulty swallowing.
• Belching.
• Increased saliva secretion.
• Weakness.
• Fatigue.
• Feeling unwell and symptoms similar to the flu.

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 type of side effect, consult your doctor or pharmacist, 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 the Pharmacovigilance of Medicinal Products for Human Use. Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date indicated on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging.

Do not dispose of medications through drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Nicotinell Mint Composition

• The active ingredient is nicotine. Each lozenge contains 1 mg (corresponding to 3,072 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.

Appearance of the product and contents of the package

Nicotinell Mint lozenges are white, round, biconvex tablets with a peppermint flavor.

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

Nicotinell Mint is presented in blister packs of 12, 36, 72, 96, 144, 192, or 204 lozenges. Some package sizes may not be commercially available.

Marketing Authorization Holder

Haleon Spain, S.A.

Parque Tecnológico de Madrid, Calle de Severo Ochoa, 2

28760 Tres Cantos, Madrid – Spain

Responsible for manufacturing

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)

or

Haleon-Gebro Consumer Health GmBH

Bahnhofbichl 13, 6391 Fieberbrunn, Austria

This medicine has been authorized in the following Member States of the EEA under the following names:

Trade names:

GermanyNicotinell Lutschtabletten 1 mg Mint

AustriaNicotinell Mint 1 mg Lutschtabletten

DenmarkNicotinell Mint 1 mg Sugetablet

SpainNicotinell Mint 1 mg lozenges

FinlandNicotinell Mint 1 mg Imeskelytabletti

FranceNicotinell Menthe 1 mg, lozenge

IrelandNicotinell Mint 1 mg compressed Lozenge

LuxembourgNicotinell Mint 1 mg, lozenge

NetherlandsNicotinell Mint 1 mg Zuigtablet

PortugalNicotinell Mint 1 mg Pastilhas

United KingdomNicotinell Mint 1 mg lozenge

SwedenNicotinell Mint 1 mg sugtablett

Last review date of this prospectus:March 2020

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/