Leaflet: information for the user

Nicotinell Cool Mint 4 mg medicated chewing gum

Nicotine

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

This medicine can be obtained without a prescription. However, to achieve the best results,

you should use Nicotinell Cool Mint 4 mg medicated chewing gum properly.

Follow exactly the administration instructions contained in this

leaflet or those indicated by your doctor or 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.

- You should consult a doctor if you continue to need to use Nicotinell after 6 months.

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

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

3. How to take Nicotinell Cool Mint

4. Possible side effects

5. Storage of Nicotinell Cool Mint

6. Contents of the pack and additional information

Nicotinell belongs to a group of medications used as aid to quit smoking.

Nicotinell contains the active ingredient nicotin.

When chewing the lozenges, the nicotin is released slowly and is absorbed through the mucosa of the mouth.

It is indicated to relieve the symptoms of nicotine withdrawal syndrome in nicotine dependence, as aid to quit smoking.

Patient advice and support normally improve the chances of success.

Do not take Nicotinell Cool Mint

• If you are allergic (hypersensitive) to nicotine or any of the other components of this medication (listed in section 6).
• If you are not a smoker.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nicotinell if you have:

• Any heart problem, consult a healthcare professional before using any nicotine replacement product. If you experience an increase in heart problems while using a nicotine replacement therapy product, reduce or discontinue use of the product,
• Recently had a heart attack or stroke, or suffers from severe heart rhythm problems or chest pain, try to quit smoking without using any nicotine replacement therapy product, unless your doctor advises you to use it,

• Heart failure, angina, Prinzmetal's angina, or uncontrolled high blood pressure (hypertension),
• Circulation problems,
• Diabetes, monitor your blood sugar levels more frequently when starting to use nicotine gum. Your need for insulin or medication may be altered,
• Hyperactive thyroid gland (hyperthyroidism),
• Hyperactive adrenal glands (pheochromocytoma),
• Renal or hepatic insufficiency,
• Stomach or duodenal ulcers, or inflammation of the esophagus or throat (the passage between the mouth and stomach) as nicotine replacement therapy may worsen your symptoms,
• Fructose intolerance,
• If you have ever experienced seizures.

Keep all medications out of the sight and reach of children.

People with jaw joint problems and some people with dentures may have difficulty chewing the gum. If this is your case, it is recommended to use a different form of nicotine replacement therapy. Consult your doctor or pharmacist.

Children and adolescents

Even small amounts of nicotine in children are hazardous and can cause severe symptoms

or death. If you suspect poisoning in a child, consult a healthcare professional immediately. For this reason, it is essential to keep Nicotinell out of the sight and reach of children at all times.

Taking Nicotinell Cool Mint with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Quitting smoking may alter the effect of other medications you are taking. If you have any questions or concerns, consult a healthcare professional.

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

Quitting smoking may modify 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.

Taking Nicotinell Cool Mint with food and drinks

The consumption of coffee, acidic beverages (e.g. fruit juices) or soft drinks may decrease the

absorption of nicotine, so they should be avoided during the 15 minutes before chewing Nicotinell because they may affect nicotine absorption.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, you should quit smoking without using nicotine replacement therapy. However, if you have tried and failed, nicotine replacement therapy should only be used to help you quit smoking under the advice of a healthcare professional.

Breastfeeding

If you are breastfeeding, nicotine replacement therapy should only be used under the advice of a healthcare professional because nicotine may pass into breast milk.

Fertility

Smoking increases the risk of infertility in women and men.

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 Cool Mint contains sorbitol, butylhydroxytoluene, and sodium

This medication contains sorbitol, which is a source of fructose. If your doctor has told you that you have a condition that affects your ability to tolerate certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the person cannot break down fructose, consult with them before taking this medication. If you do not tolerate sorbitol, do not use this product.

This medication may cause local skin reactions (such as contact dermatitis) or

irritation of the eyes and mucous membranes because it contains butylhydroxytoluene.

Each Nicotinell Cool Mint 4 mg gum contains 0.1 g of sorbitol, as a sweetener, which is a source of 0.02 g of fructose. The caloric value is 1.2 kcal/gum.

This medication contains less than 23 mg of sodium (1mmol) per medicated gum; it is essentially "sodium-free".

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

To improve the possibility of success in quitting smoking, you must not smoke at all when starting the use of Nicotinell or during the complete treatment.

Nicotinell is available in two dosages: 2 and 4 mg. The appropriate dose depends on your previous smoking habits. You should take Nicotinell 4 mg if:

• You are a smoker with high or very high nicotine dependence.
• You have not been able to quit smoking previously using Nicotinell 2 mg.
• Your symptoms resulting from quitting smoking are so intense that you relapse and start smoking again.

In any other case, you should use Nicotinell 2 mg.

Select the appropriate dosage for you from the following table:

If any adverse event is observed when starting treatment with a high dosage form (Nicotinell 4 mg), it should be replaced by a lower dosage form (Nicotinell 2 mg).

Administration form:

Start using this product on the day you quit smoking. To quit smoking successfully with this treatment, you must quit smoking completely.

Chew 1 lozenge when you feel like smoking. Do not use more than 1 lozenge at a time. Do not use more than 1 lozenge per hour.

1. Chew slowly a lozenge until its flavor becomes intense. Do not eat or drink while you have a lozenge in your mouth.

2. Place the lozenge between your cheek and gum.

3. As the flavor decreases, start chewing the lozenge again.

4. Repeat this operation for 30 minutes to release the nicotine gradually.

Medicated lozenges should not be swallowed.

Adults over 18 years:

Chew a lozenge when you start feeling the need to smoke. In general, you should chew 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 chew an extra lozenge. Do not take more than 15

lozenges of Nicotinell 4 mg per day.

The duration of treatment is individual. Normally, treatment should be continued for 3 months. After 3 months, the number of daily lozenges will be reduced gradually. The

treatment should be completed when the consumption of lozenges has been reduced to 1 or 2 per day.

It is not recommended to use Nicotinell for more than 6 months. However, some ex-smokers may need a longer treatment with medicated lozenges to avoid relapsing.

If you are still using Nicotinell after 6 months, you should consult your doctor or

pharmacist.

Patient advice and support usually improve the chances of success.

Use in children and adolescents

Nicotinellshould not be used by minors under 18 years without a doctor's recommendation.

If you take more Nicotinell Cool Mint than you should

Chewing too many lozenges of Nicotinell can cause symptoms similar to those that occur when smoking a large amount of tobacco. If you use too many lozenges of nicotine, you may start to feel sick, dizzy, and unwell. Stop using the lozenges and consult a healthcare professional immediately. The general symptoms of nicotine overdose

include: weakness, pale skin, increased sweating, involuntary muscle contractions, increased salivation, dizziness, burning sensation in the throat, nausea,

vomiting, diarrhea, abdominal pain, visual and auditory disturbances, headache, alteration of heart rhythm (tachycardia), shortness of breath, confusion, lethargy, circulation problems, coma, and terminal convulsions.

With very high overdoses, it may cause exhaustion, convulsions, low blood pressure leading to circulatory collapse or respiratory failure.

Consult your doctor or pharmacist if you experience any problems.

If you suspect poisoning in a child, you should consult a doctor immediately. Even

small amounts of nicotine are hazardous and potentially fatal for children and may lead to severe symptoms or death.

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

If you forget to use Nicotinell

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

If you stop using Nicotinell

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some of the effects you may notice in 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.

They are grouped according to the probability with which they may occur:

Very common(may affect 1 in 10 patients)

• feeling unwell (nausea).

Common(may affect between 1 and 10 in 100 patients):

• The lozenges may cause mild pain or irritation in the mouth or tongue
• throat pain or inflammation
• feeling sick
• stomach discomfort
• diarrhea
• indigestion/heartburn
• flatulence
• hiccups
• excessive salivation
• constipation
• difficulty swallowing

• dizziness and headache
• vomiting
• insomnia
• cough
• dry mouth
• and jaw muscle pain, especially as a result of intense chewing. Chewing the lozenge more slowly can help solve these problems.

Uncommon(may affect between 1 and 10 in 1,000 patients):

• feeling the heartbeat (palpitations)
• itching of skin protrusions (urticaria).

Rare(may affect between 1 and 10 in 10,000 patients):

• rapid or irregular heartbeat
• difficulty breathing
• severe allergic reaction symptoms that include sudden wheezing or chest tightness, skin rash, and feeling faint

• heart rhythm disturbances (faster heartbeat) and allergic reactions. Allergic reactions can be severe in very few cases and with the following symptoms:

• skin swelling;
• inflammation of the face and mouth;
• drowsiness, dizziness, and fainting (symptoms of low blood pressure);
• difficulty breathing.

If you experience any of these symptoms, STOP taking Nicotinell medicated lozenge and seek medical help immediately.

Ulcers in the mouth may occur, which may be related to quitting smoking, not the treatment.

In rare cases, Nicotinell may adhere to and damage dentures or other dental prostheses.

If you consider that any of the side effects you experience are severe or if you notice any other side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 Pharmacovigilance of Medicines for Human Use. Website: 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 Nicotinell after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Do not dispose of the medication through the drains or in the trash. Deposit the packaging and the

medications that you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask

your pharmacist how to dispose of the packaging and the medications that you do not need. In this

way, you will help to protect the environment.

Composition of Nicotinell Cool Mint

• The active ingredient is nicotine. Each medicated chewing gum contains 4 mg (corresponding to 20 mg of nicotine-polacrilex).
• The other components are: sorbitol (E420), gum base (contains butylhydroxytoluene (E321)), calcium carbonate, anhydrous sodium carbonate, sodium hydrogen carbonate, polacrilex, glycerol (E422), purified water, levomenthol, natural peppermint aroma, peppermint oil, sucralose, potassium acesulfame, xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171), carnauba wax, and talc. See section 2 “Nicotinell Cool Mint contains sorbitol, butylhydroxytoluene, and sodium”.

Appearance of the product and contents of the package

Nicotinell medicated chewing gum is available in two doses (2 and 4 mg) and three flavors (Nicotine, Fruit, and Cool Mint). This leaflet corresponds to Nicotinell Cool Mint 4 mg medicated chewing gum.

Nicotinell 4 mg is presented in the form of medicated chewing gum with a white matte color and rectangular shape.

Nicotinell 4 mg is available in packaging of 2, 12, 24, 36, 48, 60, 72, 96, 120, or 204 medicated chewing gum pieces in blister packaging. Some package sizes may only be marketed.

Marketing Authorization Holder

Haleon Spain, S.A.

Parque Tecnológico de Madrid, Calle de Severo Ochoa, 2

28760 Tres Cantos, Madrid – Spain

Responsible for manufacturing

FAMAR S.A.

48thkm National Road Athens-Lamia,

19011, Avlonas, Attiki – Greece

This medicinal product is authorized in the member states of the European Economic Area with the following names:

GermanyNicotinell Kaugummi 4 mg Cool Mint

AustriaNicotinell MintFrisch 4 mg - Kaugummi

BelgiumNicotinell Cool Mint, 4 mg, kauwgom

DenmarkNicotinell Mint

SpainNicotinell Cool Mint 4 mg medicated chewing gum

EstoniaNicotinell Cool Mint

GreeceNicotinell Cool Mint 4 mg medicated chewing-gum

FinlandNicotinell Mint 4 mg lääkepurukumi

FranceNICOTINELL MENTHE FRAICHEUR 4 mg SANS SUCRE, medicated chewing gum

IrelandNicotinell Cool Mint 4mg Medicated Chewing Gum

IcelandNicotinell Mint 4 mg lyfjatyggigúmmí

LithuaniaNicotinell Mint 4 mg medicated chewing-gum

LuxembourgNicotinell Cool Mint, 4 mg, medicated chewing gum

LatviaNicotinell Cool Mint 4 mg medicated chewing gum

NorwayNicotinell medicated chewing gum with peppermint flavor

NetherlandsNicotinell Cool Mint, 4 mg, kauwgom

PortugalNicotinell Freshmint 4 mg

United KingdomNicotinell Ice Mint 4mg Medicated Chewing Gum

SwedenNicotinell Mint 4 mg

This leaflet has been revised in November 2021

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/