Quitt 4 mg medicated chewing gum lemon flavour

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Quitt 4 mg medicated chewing gum, lemon flavour

nicotine

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

Follow exactly the instructions for use of this medicine as described in this leaflet or as indicated 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, lemon flavour is and what it is used for
2. What you need to know before using Quitt 4 mg medicated chewing gum, lemon flavour
3. How to use Quitt 4 mg medicated chewing gum, lemon flavour
4. Possible adverse effects
5. How to store Quitt 4 mg medicated chewing gum, lemon flavour

Pack contents and additional information

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

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

Quitt medicated chewing gum is used to treat tobacco addiction by relieving nicotine withdrawal symptoms, thereby helping people 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 eventually.

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

Smoking cessation advice and support normally improve the chances of success.

2. What you need to know before using Quitt 4 mg medicated chewing gum, lemon 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 ingredients of this medicine (listed in section 6)
• if you are a non-smoker
• if you are an occasional smoker who smokes one cigarette a day or fewer

Warnings and precautions

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

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

• if you have recently (within the last 3 months) had a myocardial infarction or stroke;
• if you have chest pain (unstable angina) or angina at rest;
• if you have a heart condition affecting your heart rate;
• if you have high blood pressure and are not taking medication to control it;
• if you have ever had allergic reactions causing swelling of the lips, face, and throat (angioedema) or skin rashes with itching (urticaria). Nicotine replacement therapies may sometimes 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 tumour of the adrenal medulla (pheochromocytoma);
• if you have a gastric or duodenal ulcer;
• if you have inflammation of the oesophagus (oesophagitis).

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

Side effects due to high concentrations of nicotine in the blood may occur if you smoke shortly after chewing Quitt. Consider situations in which you are at particular risk of smoking a cigarette 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 have difficulty chewing due to the stickiness of Quitt; in some cases, therefore, they may not be able to use Quitt. Dental fillings or inlays that are not properly adhered may become further loosened when chewing Quitt.

Danger to children

Nicotine doses tolerated by adult and adolescent smokers may cause severe poisoning in children, which could 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 take Quitt medicated chewing gum unless prescribed by a doctor.

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”).

Use of 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)

Use of 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, you should avoid consuming 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 your healthcare provider during pregnancy, your family doctor, or a doctor at a specialist centre for smoking cessation.

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 breastfeeding.

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 and should not use nicotine replacement therapy.

Driving and using machines

No effects on the ability to drive or use machines 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 with them 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, lemon flavour

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

Unless otherwise prescribed by a physician, the recommended dose is:

Adults and elderly patients

For highly dependent smokers (if you smoke your 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 of this medicine, 2 mg, one Quitt 4 mg medicated chewing gum per hour is recommended, with 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 avoiding relapses, it is important to chew a sufficient number of Quitt 4 mg chewing gums each day.

Experience has shown that smokers who want 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) should only use nicotine chewing gums when 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

A Quitt chewing gum should be chewed for about 30 minutes, with pauses, to release the nicotine from the gum base. The most important thing is to chew the gum slowly. You should avoid chewing the gum quickly and/or intensely, so that the nicotine is not released too rapidly from the gum base.

To achieve this, chew the gum until you notice a strong taste. Then, it is important to press the gum against the inside of your cheek until the taste disappears. Afterwards, 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.

1. .

Quitting smoking

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

• One Quitt 4 mg chewing gum per hour, with a maximum of 16 pieces per day, and 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 taking 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 always remain readily available for a certain period after the end of treatment to counteract any renewed urge to smoke.

Treatment for longer than 6 months is not recommended. For some former smokers, a longer treatment 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 happen within 6 months after starting Quitt, you should consult your doctor.

Please follow the relevant instructions for quitting smoking. For example, do the following:

• 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 need to smoke to prevent relapses. 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 intoxication from swallowing the gum is very low because nicotine is poorly absorbed in the body without chewing. Symptoms of a Quitt overdose are similar to those of acute nicotine poisoning: nausea, vomiting, increased salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, hearing 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, consult your doctor or pharmacist immediately, or call the

Toxicology Information Service (telephone 91 562 04 20), indicating the name of the product and the amount used.

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 the absorption of nicotine from the gastrointestinal tract.

If you forget to use this medicine

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

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

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.

Symptoms related to quitting smoking (nicotine withdrawal)

Some of the side effects you may experience when you stop smoking could 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 (nicotine urges)
• Slowed 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 could 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 associated with smoking, since the maximum nicotine blood concentrations 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 up to 1 in 10 people):

• Hypersensitivity
• Dizziness
• Taste disturbances
• Pins and needles
• Diarrhea
• Indigestion
• Dry mouth
• Increased salivation
• Inflamed mouth
• Nausea
• Vomiting
• Burning sensation
• Flatulence
• Tiredness (fatigue)
• Stomach pain

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

• Abnormal dreams
• Rashes
• Palpitations (fast 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
• Throat tightness
• 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
• Urticaria
• Jaw muscle pain

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

• 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)
• Skin redness
• Muscle tension
• Fast and irregular heartbeat (atrial fibrillation)

Reporting of adverse effects

If you experience any adverse effects, talk to 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 lemon-flavoured 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 pack. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quittchicle medicated chewing gum

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

Nature of the product and contents of the pack

Quitt medicated chewing gum is a rectangular, slightly convex, white/ivory-white medicated chewing gum, approximately 19 × 12 mm in size.

Quitt medicated chewing gum 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 (EEA) Member States under 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 chicle medicamentoso sabor limón

Poland: NICCOREX LEMON

Date of the most recent revision 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 Health Products (AEMPS) http://www.aemps.gob.es/"