Quitt 4 mg medicated chewing gum, peppermint flavour

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Quitt 4 mg medicated chewing gum, peppermint flavour

nicotine

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

Always follow exactly the instructions for use of this medicine as described in this leaflet or as advised by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Quitt 4 mg medicated chewing gum, peppermint flavour is and what it is used for
2. What you need to know before using Quitt 4 mg medicated chewing gum, peppermint flavour
3. How to use Quitt 4 mg medicated chewing gum, peppermint flavour
4. Possible side effects
5. How to store Quitt 4 mg medicated chewing gum, peppermint flavour

Pack contents and additional information

1. What Quitt 4 mg medicated mint-flavour chewing gum is and what it is used for

Quitt is a medicated chewing gum containing active substances to help stop smoking.

Quitt chewing gum is used to treat nicotine addiction by relieving nicotine withdrawal symptoms, thereby helping you to stop smoking. Even smokers who are currently unable to quit smoking completely and immediately may use this medicine initially to reduce their cigarette consumption (smoking reduction) with the aim of quitting smoking.

Quitt 4 mg is indicated for highly dependent smokers or those who smoked more than 20 cigarettes per day before starting treatment.

Smoking advice and support normally improve the chances of success.

2. What you need to know before using Quitt 4 mg medicated chewing gum, peppermint flavour

Do not use Quitt medicated chewing gum

• if you are allergic to nicotine, levomenthol, maltitol (E965), butylated hydroxytoluene (E321), or any of the other components of this medicine (listed in section 6)
• if you are a non-smoker
• if you are an occasional smoker who smokes one cigarette per day or fewer

Warnings and precautions

Consult your doctor or pharmacist before starting to use Quitt medicated chewing gum.

You may still be able to use Quitt medicated chewing gum, but you should inform your doctor if you:

• have recently (within the last 3 months) suffered a myocardial infarction or stroke;
• have chest pain (unstable angina) or angina at rest;
• have a heart condition affecting your heart rate;
• have untreated high blood pressure;
• have ever had allergic reactions causing swelling of the lips, face, or throat (angioedema), or itchy skin rashes (urticaria). Nicotine replacement therapies may sometimes trigger such reactions;
• have moderate or severe liver disease;
• have severe kidney disease;
• have diabetes;
• have an overactive thyroid gland (hyperthyroidism);
• have a tumour of the adrenal medulla (pheochromocytoma);
• have gastric or duodenal ulcer;
• have inflammation of the oesophagus (oesophagitis).

Your doctor will carefully consider the risks of using nicotine replacement therapy against the benefits of quitting smoking.

Side effects due to high blood concentrations of nicotine may occur if you smoke shortly after chewing Quitt. Consider situations in which you are at particular risk of smoking without thinking.

Pre-existing nicotine dependence caused by tobacco may persist with the use of nicotine replacement therapy; however, using nicotine alone is less harmful than smoking tobacco.

Users with dentures may experience difficulty chewing due to the stickiness of Quitt; in some cases, therefore, may be unable to use Quitt. Poorly fixed dental fillings or inlays may become further loosened by chewing Quitt.

Danger in children

Nicotine doses tolerated by adult and adolescent smokers may cause severe poisoning in children, which may be fatal. Quitt must therefore always be kept out of the reach of children (see section "If you use more... than you should").

Children and adolescents

Nicotine chewing gums should not be used in children under 12 years of age.

Children and adolescents under 18 years of age should not use Quitt medicated chewing gum unless under medical supervision.

The correct dose for adults could severely poison or even be lethal in young children. It is therefore essential that Quitt medicated chewing gum is always kept away from children (see section 3 “If you use more Quitt medicated chewing gum than you should”).

Using Quitt medicated chewing gum with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

When you stop smoking, changes in your body may increase the effect of insulin. Your doctor may need to reduce your insulin dose.

The effectiveness of the following medicines may also increase:

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

Using Quitt medicated chewing gum with food and drinks

Do not eat or drink while chewing the gum, as this may reduce the effect of Quitt medicated chewing gum.

Acidic drinks (e.g. fruit juices, coffee, or soft drinks) affect the absorption of nicotine in the oral cavity. To ensure maximum effectiveness, do not consume these drinks within 15 minutes before using Quitt medicated chewing gum.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

It is very important to stop smoking during pregnancy, as smoking can lead to premature births, fetal death, and impaired fetal growth. Ideally, you should try to stop smoking without using nicotine-containing medicines. If this is not possible, Quitt medicated chewing gum should only be used after consulting the healthcare professional managing your pregnancy, your family doctor, or a doctor at a specialist smoking cessation clinic.

Breastfeeding

Quitt medicated chewing gum should be avoided during breastfeeding, as nicotine is excreted in breast milk and may affect your baby. If your doctor has advised you to use Quitt medicated chewing gum during breastfeeding, you should take the gum immediately after breastfeeding and not within 2 hours before or during feeding.

Fertility

Smoking may have adverse effects on male and female fertility. The specific contribution of nicotine to these effects is unknown. If possible, women planning to become pregnant should not smoke or use nicotine replacement therapy.

Driving and using machines

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

Quitt medicated chewing gum contains maltitol (E965), butylated hydroxytoluene (E321), and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Butylated hydroxytoluene (E321) may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes in the mouth.

This medicine contains less than 1 mmol of sodium (23 mg) per medicated chewing gum, i.e., essentially “sodium-free”.

3. How to use Quitt 4 mg medicated chewing gum, mint flavour

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and elderly patients

For highly dependent smokers (those who smoke their first cigarette within 20 minutes of waking and smoke more than 20 cigarettes per day) and for smokers who have been unable to quit smoking using the lower dose Quitt 2 mg medicated chewing gum, one piece of Quitt 4 mg medicated chewing gum per hour is recommended, up to a maximum of 16 pieces per day. Generally, 8 to 12 chewing gums per day are sufficient.

This medicine should be used every time you would normally smoke a cigarette or when you have a craving to smoke. To increase the chances of successfully quitting smoking and to prevent relapse, it is important to chew a sufficient number of Quitt 4 mg gums each day.

Experience has shown that smokers who wish to quit require fewer chewing gums than the number of cigarettes previously smoked per day.

Children and adolescents

Nicotine chewing gums should not be used in children under 12 years of age.

Adolescents (from 12 years up to those under 18 years of age) should only use nicotine chewing gums if recommended by a doctor. Experience with the use of nicotine chewing gums in children and adolescents under 18 years of age is limited.

Method of administration

One piece of Quitt chewing gum should be chewed for about 30 minutes, with pauses, to release the nicotine from the gum base. The most important point is to chew the gum slowly. You should avoid chewing the gum quickly and/or vigorously, as this may cause the nicotine to be released too rapidly from the gum base.

To achieve this, chew the gum until you notice a strong taste. Then, it is important to place the gum between your cheek and gum until the taste disappears. After that, you may start chewing again. To increase the chances of success, it is important to avoid excessively low dosing. A sufficient number of medicated chewing gums should be chewed daily.

Quitting smoking:

Quitt 4 mg should be used for at least 3 months.

• One piece of Quitt 4 mg chewing gum per hour, with a maximum of 16 pieces per day; generally, 8 to 12 chewing gums per day are sufficient.
• 4 to 6 weeks after starting treatment, the number of chewing gums per day should be gradually reduced by chewing Quitt 4 mg at intervals longer than 1 hour.
• The first attempt to stop using this medicine should be made when the average daily consumption over the past week has been 1–2 chewing gums.

However, the chewing gum should remain readily available for some time after the end of treatment to counteract any renewed urge to smoke.

Treatment with this medicine is not recommended for longer than 6 months. For some former smokers, a longer treatment period may be necessary to prevent relapse.

Reducing smoking followed by complete cessation:

You should stop smoking completely as soon as you feel able, but no later than 4 months after starting Quitt. However, if this does not occur within 6 months after starting Quitt, you should consult your doctor.

Please follow the appropriate instructions for quitting smoking. For example:

• Step 1 – 0 to 6 weeks: Reduce cigarette consumption by half

Chew a medicated chewing gum each time you feel the need to smoke. Try to reduce your cigarette consumption by half by the end of week 6, or even earlier if possible.

• Step 2: within 4 months

Continue reducing your cigarette consumption until you stop smoking completely. Chew a chewing gum each time you feel the urge to smoke, to prevent relapse. Try to quit smoking within 4 months, or earlier if possible.

• Step 3 – within 6 months: Quit smoking!

If you use more Quitt medicated chewing gum than you should

Symptoms of nicotine overdose may occur due to excessive use of this medicine and/or continued smoking. The risk of poisoning from swallowing the gum is very low because nicotine is poorly absorbed in the body when not chewed. Symptoms of Quitt overdose are similar to those of acute nicotine poisoning: nausea, vomiting, increased salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, auditory disturbances and marked 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.

Doses well tolerated by adult smokers may cause severe poisoning in children, which can be fatal. Suspected nicotine poisoning in a child should be considered a medical emergency.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the

Toxicology Information Service (telephone 91 562 04 20), stating the name of the medicine and the amount taken.

It is recommended to bring the medicine’s packaging and leaflet with you.

Management of overdose

If symptoms of nicotine overdose occur, you should temporarily stop taking nicotine. Then, reduce your nicotine intake either by decreasing the frequency of use or by switching to a lower strength. In case of symptoms of nicotine poisoning, nicotine intake must be stopped immediately. Contact your doctor or the hospital emergency department. If necessary, you will be treated symptomatically. If excessive amounts of nicotine are ingested, activated charcoal may reduce nicotine absorption from the gastrointestinal tract.

If you forget to use this medicine

Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Quitt medicated chewing gum may cause adverse reactions similar to those experienced when nicotine is administered by other routes. Most of the adverse effects that occur during treatment are generally dose-dependent.

Effects related to quitting smoking (nicotine withdrawal)

Some of the side effects you may experience when quitting smoking may be withdrawal symptoms due to reduced nicotine intake.

These side effects include:

• Irritability, frustration, impatience, or anger
• Anxiety, restlessness, or difficulty concentrating
• Waking during the night or sleep disturbances
• Increased appetite or weight gain, constipation
• Feeling low or down
• Cravings to smoke (urges)
• Decreased heart rate
• Bleeding in the mouth
• Dizziness or feeling faint
• Cough, sore throat, nasal congestion, or nasal discharge

Stop taking Quitt medicated chewing gum and consult a doctor immediately if you experience any of the following symptoms or allergic reactions, which may be serious, such as angioedema. These are rare adverse effects (may affect up to 1 in 1,000 people):

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

Mouth ulcers may appear when you stop smoking. The reason for this is not clear. However, it can be assumed that the side effects during treatment with Quitt medicated chewing gum are less pronounced than those from smoking, because the maximum concentrations of nicotine in the blood are lower. In addition to the effects of nicotine, smoking poses additional risks for smokers and passive smokers due to the well-known harmful effects of carbon monoxide, tar, and other toxic substances.

Irritation of the throat, increased salivation, and occasional damage to the oral mucosa may occur. Hiccups may also occur at the beginning of treatment due to frequent swallowing of saliva containing nicotine. If you are prone to stomach sensitivity, Quitt medicated chewing gum may cause mild stomach discomfort or heartburn. Chewing slowly with longer pauses may help overcome this.

Levomenthol may trigger hypersensitivity reactions (including difficulty breathing) in sensitized patients.

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

• headache
• cough
• hiccups
• nausea
• irritation of the mouth or throat

Common adverse effects (may affect 1 in 10 people):

• hypersensitivity;
• dizziness;
• taste disturbances;
• pins and needles;
• diarrhea;
• indigestion;
• dry mouth;
• increased salivation;
• mouth inflammation;
• nausea;
• vomiting;
• burning sensation;
• flatulence;
• tiredness (fatigue);
• stomach pain

Uncommon adverse effects (may affect 1 in 100 people):

• abnormal dreams
• rashes
• palpitations (rapid heartbeat)
• hot flushes
• high blood pressure
• sudden constriction of the small airways in the lungs
• loss or damage to voice
• difficulty breathing
• nasal congestion
• pain in the mouth and throat
• sneezing
• tightness in the throat
• burping
• swelling of the tongue
• ulceration and inflammation of the oral mucosa
• numbness in the mouth
• weakness
• discomfort and chest pain
• general malaise
• excessive sweating
• itching
• hives
• jaw muscle pain

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

• atrial arrhythmias (changes in heart rhythm)
• difficulty swallowing
• decreased sensitivity in the mouth
• retching

Adverse effects with unknown frequency:

• allergic reactions (anaphylaxis)
• blurred vision
• increased tear production
• dry throat
• gastrointestinal discomfort
• lip pain
• swelling of the face, tongue, or throat (angioedema)
• redness of the skin
• muscle tension
• a fast and irregular heartbeat (atrial fibrillation)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Quitt 4 mg medicated mint-flavored chewing gum

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

Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quittchicle medicamentoso

• The active substance is nicotine.
• Each medicated chewing gum contains 4 mg of nicotine (equivalent to 26.5 mg of nicotine resinate).
• Other components are: Chewing gum core: gum base (contains butylated hydroxytoluene [E 321]), xylitol, calcium carbonate, anhydrous sodium carbonate, peppermint flavour, fresh flavour blend, levomenthol, potassium acesulfame (E 950), sucralose. Coating of the chewing gum: maltitol (E 965), liquid maltitol, peppermint flavour, titanium dioxide (E 171), fresh flavour blend, levomenthol, sucralose.

Appearance of the product and contents of the pack

Quittchicle medicamentoso is a rectangular, slightly convex medicated chewing gum, white/ivory in colour, with approximate dimensions of 19 × 12 mm.

Quittchicle medicamentoso is packaged in blisters within a cardboard box containing 12, 20, 24, 30, 36, 48, 50, 80, 96, 108 or 204 medicated chewing gums.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 - Barcelona

(Spain)

Manufacturer

Fertin Pharma A/S

Dandyvej 19

DK-7100 Vejle

Denmark

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

Germany: Nicolex mit Pfefferminzgeschmack 4 mg wirkstoffhaltiges Kaugummi

France: NICOPASS MENTHE 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 chicle medicamentoso sabor menta

Poland: NICCOREX MINT

Date of the most recent review of this leaflet: November 2025

"Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/"