Label: information for the patient

Quitt 4 mg chewing gum with peppermint flavor

Nicotine

Read this label 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 label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if you cannot stop smoking after 6 months of treatment with Quitt 4 mg chewing gum with peppermint flavor.

Contents of the package and additional information

Quittmedicated chewing gumhelps to quit smoking.

The nicotine in Quittmedicated chewing gumrelieves nicotine withdrawal symptomsand 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 nicotine withdrawal symptoms, may occur. With Quittmedicated chewing gum, these symptoms can beprevented 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 Quittchewing gum medicamentoso.

You may be able to take Quittchewing gum medicamentosobut 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 itchy rashes (urticaria). Sometimes, nicotine replacement therapies can trigger these types of reactions;
• 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 (inflammation of the esophagus).

Thechewing gumsmay stick to dentures and dental bridges and, inrareoccasions, damage them.

Children and adolescents

Children and adolescentsunder 18 yearsshould not take Quittchewing gum medicamentosounless prescribed by a doctor.

The correct dose for adults could be fatal in small children. Therefore, it is essential to keepQuittchewing gum medicamentosoout of reach of children at all times.

Use of Quittchewing gum medicamentosowith other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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 Quittchewing gum medicamentosowith food and drinks

Do not eat or drink while chewing the gum, as it may reduce the effect of Quittchewing gum 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 before consuming Quittchewing gum 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 essential to quit smoking during pregnancy, as it may 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, Quittchewing gum medicamentososhould only be used after consulting your treating doctor, your family doctor, or a doctor at a specialized center for helping smokers quit.

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

Driving and operating machinery

No effects on the ability to drive and operate machinery have been reported.

Quitt chewing gum 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 chewing gum 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 nicotine dependence of the person.

Quitt 4 mg medicated chewing gum, mint 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 reduced gradually. 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, mint flavor, is used to prolong the periods in which one does not smoke 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 since the start 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, in 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 arise suddenly.

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

Oral route

Do not chew Quitt medicated chewing gum like a normal chewing gum. If Quitt medicated chewing gum is chewed very quickly and without pauses, nicotine is released very quickly, 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 slight 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 a 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.

Chewing gum containing nicotine may cause side effects similar to those experienced when nicotine is administered through other routes. Generally, side effects depend on the dose.

Stop taking the chewing gum containing nicotine and 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;
• Rashes and difficulty breathing;

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

• Dizziness;
• Headache;
• Gastrointestinal discomfort;
• Low blood pressure;
• Nausea;
• Vomiting;
• Mandibular muscle pain;
• Irritation of the mouth or throat;

Infrequent(may affect 1 in 100 people):

• Palpitations (rapid or irregular heart rhythm);
• Redness of the skin, urticaria.

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

• Atrial arrhythmias (changes in heart rhythm).

Some symptoms, such as dizziness, headache, or sleep disturbances, may be symptoms of nicotine withdrawal associated with the cessation of tobacco consumption and 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 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 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Quitt Medicinal Chewing GumQuitt Medicinal Chewing Gum

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

Appearance of the product and contents of the packaging

Quitt medicinal chewing gum is a rectangular, slightly convex medicinal chewing gum, white / white speckled in color, 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 medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Nicolex mitPfefferminzgeschmack 4 mgwirkstoffhaltiges Kaugummi

France:NICOPASSMENTHE 4 mgSANS SUCRE, gomme à mâcher médicamenteuse édulcorée au xylitol, à l''acésulfame potassique, au sucralose et au maltitol

Italy:Nicotina Fertin

Spain:Quitt 4 mg medicinal chewing gum with peppermint flavor

Poland:NICCOREX MINT

Date of the last review of this prospectus:April2014.

“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/”