Package Insert: Information for the Patient

Quitt 4 mg Chewable Medicinal Lozenge, Lemon Flavor

Nicotine

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

Follow exactly the administration instructions for this medication contained in this package insert or those indicated by your doctor or pharmacist.

Keep this package insert, as you may need to refer to it again.

If you need advice or more information, consult your pharmacist.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

You should consult a doctor if you are unable to stop smoking after 6 months of treatment with Quitt 4 mg Chewable Medicinal Lozenge.

Contents of the package and additional information

Quittmedicated chewing gumhelps to quit smoking.

The nicotine in Quittmedicated chewing gumrelieves withdrawal symptomsfrom nicotineand anxiety that appearwhen quitting smoking or reducingtemporarily the consumption of tobacco in order toquit smoking. In this way, it prevents a relapse in those smokers whoare motivated to quit smoking.

Quittmedicated chewing gumis indicated for adult smokers.

When the body stops receiving nicotine from tobacco suddenly, different types of symptoms, known as withdrawal symptoms, may occur. With Quittmedicated chewing gum, these unpleasant symptoms can bereverted or, at leastreduced, as a small amount of nicotine is still provided to the body for ashort period of time.

Advice and support for the smoker usually improve the chances of success.

Consult your doctor if you cannot quit smoking after 6 months of treatment with Quitt medicated chewing gum.

No use chewing gum medicamentosoQuitt

• if you are allergic to nicotine or any of the other components of this medication (listed in section 6)
• if you do not smoke or are an occasional smoker.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Quittchicle medicamentoso.

You may be able to take Quittchicle medicamentoso, but you must tell your doctor before:

• if you have recently (in the last 3 months) had a myocardial infarction or a cerebrovascular accident;
• if you have unstable angina or angina at rest;
• if you have a heart condition that affects your heart rate;
• if you have high blood pressure and are not taking medication to control it;
• if you have had allergic reactions that have caused swelling in the lips, face, and throat (angioedema) or hives with itching (urticaria). Sometimes, nicotine replacement therapies can trigger this type of reaction;
• if you have moderate or severe liver disease;
• if you have severe kidney disease;
• if you have diabetes;
• if you have an overactive thyroid gland (hyperthyroidism);
• if you have a tumor in the adrenal gland (pheochromocytoma);
• if you have a stomach ulcer;
• if you have esophagitis.

Thechicles may stick to dentures and dental bridges and, inrareoccasions, damage them.

Children and adolescents

Children and adolescentsunder 18 yearsshould not take Quittchicle medicamentosounless they have a doctor's prescription.

The correct dose for adults could be severely toxic and even fatal in small children. Therefore, it is essential tokeep Quittchicle medicamentosoout of the reach of children at all times.

Use of Quittchicle medicamentosowith other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

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

Use of Quittchicle medicamentosowith food and drinks

Do not eat or drink while chewing the gum, as it may reduce the effect of Quittchicle medicamentoso.

Acidic beverages (e.g. fruit juices, coffee, or soda) affect the absorption of nicotine in the oral cavity. To ensure maximum effect, do not take these beverages during the 15 minutes prior to consuming Quittchicle medicamentoso.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

It is very important to stop smoking during pregnancy, as it can lead to premature birth, fetal death, and growth deficiencies in the baby. Ideally, you should try to quit smoking without using medications containing nicotine. If this is not possible, Quittchicle medicamentososhould only be used after consulting your treating doctor during pregnancy, your family doctor, or a doctor at a specialized center for helping to quit smoking.

Quittchicle medicamentososhould be avoided during breastfeeding, as nicotineis excreted in breast milkand may affect yourbaby. If your doctor has recommended using Quittchicle medicamentosoduring breastfeeding, you should take the gum immediately afterfeeding your babyand not before or while doing so.

Driving and operating machinery

No effects on the ability to drive and operate machinery are known.

Quitt chicle medicamentoso contains maltitol (E965)

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Quitt chicle medicamentoso contains butylhydroxytoluene (E321)

This medication may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes due to the presence of butylhydroxytoluene.

Follow exactly the instructions for use of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The dosage of the medicated chewing gum should be chosen based on the person's dependence on nicotine.

Quitt 4 mg medicated chewing gum, lemon flavor, is indicated for people who smoke more than 20 cigarettes a day or who have not been able to quit the habit previously with 2 mg medicated chewing gums.

When starting treatment with 4 mg of nicotine (1 medicated chewing gum), one can be taken every 1 or 2 hours, and usually 32 to 48 mg of nicotine (8 to 12 medicated chewing gums) per day are sufficient. Do not take more than 64 mg of nicotine (16 medicated chewing gums) per day.

When used to gradually reduce tobacco consumption with the goal of quitting smoking:

• Do not take more than 48 mg of nicotine (12 medicated chewing gums) per day.

Drastic suppression of tobacco consumption

The duration of treatment is individual; generally, it should be maintained for at least 3 months, and after that time, the nicotine dose should be gradually reduced. Treatment should be interrupted when the dose is reduced to 4-8 mg of nicotine (1 or 2 medicated chewing gums) per day. However, a medicated chewing gum can be taken when feeling the urge to smoke.

Gradual reduction of tobacco consumption

Quitt 4 mg medicated chewing gum, lemon flavor, is used to prolong periods of not smoking and gradually reduce tobacco consumption as much as possible. The number of cigarettes should be gradually replaced by Quitt 4 mg medicated chewing gums. If after 6 weeks, the number of cigarettes smoked per day has not been reduced by at least half, a doctor should be consulted.

A serious attempt to quit smoking should be made as soon as the smoker is motivated, no later than the first 4 months of treatment. After that, the number of medicated chewing gums should be gradually reduced, for example, by using one every 2-5 days. A doctor should be consulted if, after 4 months, a serious attempt to quit smoking has not been made. Generally, it is not recommended to use Quitt 4 mg medicated chewing gum regularly for more than 6 months.

In some cases, a longer treatment may be necessary to avoid relapse. The remaining medicated chewing gums should be stored, as anxiety can appear suddenly.

Advice and support for the smoker usually improve the chances of success.

Oral route

Do not chew Quitt medicated chewing gum like a regular chewing gum. If Quitt medicated chewing gum is chewed very quickly and without pauses, nicotine is released rapidly, and discomfort may occur (e.g., stomach burning and hiccups).

Quitt medicated chewing gum technique:

1. Chew Quitt medicated chewing gum slowly until you perceive a strong flavor or a mild tingling sensation.
2. Hold the medicated chewing gum between the mucosa of the cheek and the gums until the flavor or tingling sensation decreases.
3. Chew again until the flavor intensifies or you feel the tingling sensation.
4. Repeat the process for about 30 minutes.

If you use more Quitt medicated chewing gum than you should:

You may experience nicotine overdose if you smoke at the same time as chewing a medicated chewing gum. Symptoms of overdose include nausea, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, auditory disturbances, and pronounced weakness. At high doses, these symptoms may be followed by low blood pressure, weak and irregular pulse, breathing difficulties, extreme fatigue, circulatory collapse (due to very low blood pressure), and seizures.

If a child takes Quitt medicated chewing gum or if you ingest a large amount of nicotine, contact your doctor or the hospital emergency service immediately.

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

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

Quittchicle medicamentosomay cause side effectssimilar to those experienced when nicotine is administered through other routes. Generally, side effects depend on the dose.

Stop taking Quittchicle medicamentosoand consult a doctor immediately if you experience any of the following symptoms or allergic reactions, which may be severe, such as angioedema.

These are rare side effects (may affect up to 1 in 1,000 people):

• swelling of the face, tongue, and throat;
• difficulty swallowing;
• hives and difficulty breathing;

Frequent side effects(may affect 1 in 10 people):

• dizziness;
• headache;
• gastrointestinal discomfort;
• nausea;
• vomiting;
• jaw muscle pain;
• mouth or throat irritation;

Infrequent(may affect 1 in 100 people):

• palpitations (rapid or irregular heart rhythm);
• skin redness, urticaria.

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

• auricular arrhythmias (changes in heart rhythm).

Some symptoms, such as dizziness, headache, or sleep disturbances, may be symptoms of nicotine withdrawal associated withcessation of tobacco consumptionand may be due to a very low nicotine contribution.

When quitting smoking, mouth ulcers may appear. However, their relationship to nicotine treatment is unclear.

Reporting 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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 this medication after the expiration date that appears on the box and the blister pack. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Quitt chewing gum Medicinal chewing gum

• The active principle is nicotine .
• Each medicinal chewing gum contains 4 mg of nicotine (corresponding to 26.5 mg of nicotine resin) .
• The other components are: Chewing gum core: base gum (contains butylhydroxytoluene [E 321]), xylitol, calcium carbonate, anhydrous sodium carbonate, peppermint flavor, , fresh flavor mixture, levomenthol , acesulfame potassium (E 950) , sucralose. Chewing gum coating: maltitol (E 965), maltitol liquid, lemon flavor, titanium dioxide (E 171), levomenthol , sucralose

Appearance of the product and contents of the packaging

Quitt medicinal chewing gum is a rectangular, slightly convex, white / white speckled chewing gum, with an approximate size of 19 × 12 mm.

Quitt medicinal chewing gum is packaged in blister packs in a cardboard box containing 12, 20, 24, 30, 36, 48, 50, 80, 96, 108, and 204 medicinal chewing gums.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 - Barcelona

(Spain)

Responsible for manufacturing

Fertin Pharma A/S

Dandyvej 19

DK-7100 Vejle

Denmark

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

Germany: Nicolex mit Zitronengeschmack 4 mg wirkstoffhaltiges Kaugummi

France: NICOPASS CITRON 4 mg SANS SUCRE, gomme à mâcher médicamenteuse édulcorée au xylitol, à l''acésulfame potassique, au sucralose et au maltitol

Italy: Nicotina Fertin

Spain: Quitt 4 mg chewing gum medicamentoso sabor limón

Poland: NICCOREX LEMON

Date of the last review of this prospectus: April 2014 .

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es / ”