QUITT 4 mg MEDICATED CHEWING GUM MINT FLAVOR

Introduction

Package Leaflet: Information for the Patient

Quitt 4 mg Medicinal Chewing Gum Mint Flavor

Nicotine

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

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

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

Contents of the Package Leaflet

1. What Quitt 4 mg Medicinal Chewing Gum Mint Flavor is and what it is used for
2. What you need to know before starting to use Quitt 4 mg Medicinal Chewing Gum Mint Flavor
3. How to use Quitt 4 mg Medicinal Chewing Gum Mint Flavor
4. Possible side effects
5. Storage of Quitt 4 mg Medicinal Chewing Gum Mint Flavor

Contents of the Pack and Additional Information

1. What Quitt 4 mg Medicinal Chewing Gum Mint Flavor is and what it is used for

Quitt is a medicinal chewing gum that contains active ingredients to help quit smoking.

Quitt Medicinal Chewing Gum is used to treat tobacco addiction by relieving nicotine withdrawal symptoms, which helps to quit smoking. Even smokers who currently cannot quit smoking completely immediately can use this medication first to reduce their cigarette consumption (smoking reduction) with the goal of quitting smoking.

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

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

2. What you need to know before starting to use Quitt 4 mg Medicinal Chewing Gum Mint Flavor

Do not use Quitt Medicinal Chewing Gum

• if you are allergic to nicotine, levomenthol, maltitol (E965), butylhydroxytoluene (E321), or any of the other components of this medication (listed in section 6)
• if you do not smoke
• if you are an occasional smoker and smoke one cigarette per day or less

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Quitt Medicinal Chewing Gum.

You may be able to take Quitt Medicinal Chewing Gum, but you must discuss it with your doctor first:

• if you have recently (within the last 3 months) had a heart attack or stroke;
• if you have chest pain (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 medications to control it;
• if you have had allergic reactions that have caused swelling of 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 or duodenal ulcer;
• if you have esophagitis.

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 can occur if you smoke soon after chewing Quitt. Consider situations where you are at particular risk of reaching for a cigarette without thinking.

Pre-existing nicotine dependence caused by tobacco can 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 loose when chewing Quitt.

Danger to Children

Doses of nicotine tolerated by adult smokers and adolescents can cause severe poisoning in children, which can be fatal. Quitt should therefore be kept out of the reach of children at all times (see the section "If you use more... than you should").

Children and Adolescents

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

Children and adolescents under 18 yearsshould not take Quitt Medicinal Chewing Gum unless they have a medical prescription.

The correct dose for adults could severely poison and even be lethal in small children. Therefore, it is essential that Quitt Medicinal Chewing Gumbe kept away from children at all times (see section 3 "If you use more Quitt Medicinal Chewing Gum than you should")..

Using Quitt Medicinal Chewing Gum with other Medications

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

When you quit smoking, the change in your body can increase the effect of insulin. Your doctor may reduce your insulin dose.

The effectiveness of the following medications may also increase:

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

Using Quitt Medicinal Chewing Gum with Food and Drinks

You should not eat or drink while chewing the gum, as it can reduce the effect of Quitt Medicinal Chewing Gum.

Acidic drinks (e.g., fruit juices, coffee, or soft drinks) affect the absorption of nicotine in the oral cavity. To ensure you get the maximum effect, you should not take these drinks during the 15 minutes prior to using Quitt Medicinal Chewing Gum.

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy

It is very important to quit smoking during pregnancy, as it can lead to premature births, fetal death, and growth deficiencies in the baby. Ideally, you should try to quit smoking without using nicotine-containing medications. If this is not possible, Quitt Medicinal Chewing Gum should only be used after consulting the medical professional treating you during pregnancy, your family doctor, or a doctor at a specialized smoking cessation center.

Breastfeeding

Quitt Medicinal Chewing Gum should be avoided during breastfeeding, as nicotine is excreted in breast milk and can affect your baby. If your doctor has recommended that you use Quitt Medicinal Chewing Gum while breastfeeding, you should take the gum immediately after breastfeeding your baby and not in the 2 hours before or while doing so.

Fertility

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

Driving and Using Machines

No effects on the ability to drive and use machines are known.

Quitt Medicinal Chewing Gum contains Maltitol (E965), Butylhydroxytoluene (E321), and Sodium

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

Butylhydroxytoluene can cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes in the mouth

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

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3. How to use Quitt 4 mg Medicinal Chewing Gum Mint Flavor

Follow the instructions for using this medication exactly as indicated 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 up and smoke more than 20 cigarettes per day) and for smokers who have not been able to quit smoking with the low dose of Quitt 2 mg Medicinal Chewing Gum, one Quitt 4 mg Medicinal Chewing Gum per hour is recommended, with a maximum of 16 pieces per day, and generally, 8 to 12 gum pieces per day are sufficient.

This medication should be used every time you would normally smoke a cigarette or when you feel the urge to smoke. To increase the chances of success in quitting smoking and avoiding relapse, it is essential to chew a sufficient amount of Quitt 4 mg every day.

Experience has shown that smokers who want to quit smoking need fewer gum pieces than the number of cigarettes smoked previously per day.

Children and Adolescents

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

Adolescents (from 12 years to less than 18 years) should use nicotine gum only when recommended by a doctor. Experience with the use of nicotine gum in children and adolescents under 18 years is limited.

Method of Administration

A Quitt gum should be chewed for about 30 minutes with pauses to release the nicotine from the chewing 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 quickly from the chewing base.

To do this, you should chew the gum until you notice a strong taste. Then, it is essential to push the gum into the cheek until the taste disappears. After that, you can start chewing again. To increase the chances of success, it is crucial to avoid excessive underdosing. You should chew a sufficient amount of medicated gum pieces daily.

Quitting Smoking:

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

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

However, the gum should always be at hand for some time after the end of treatment to counteract a new urge to smoke.

Treatment with this medication is not recommended for more than 6 months. For some ex-smokers, a longer treatment period may be necessary to avoid relapse.

Smoking Reduction followed by Quitting:

You should quit 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.

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 gum piece every time you feel the urge to smoke. Try to reduce your cigarette consumption to half by the end of the 6th week, or even sooner if possible.

• Step 2: Within 4 months

Continue to reduce your cigarette consumption until you quit smoking completely. Chew a gum piece every time you feel the urge to smoke to avoid relapse. Try to quit smoking within 4 months, or sooner if possible.

• Step 3 - Within 6 months: Quit Smoking!

If you use more Quitt Medicinal Chewing Gum than you should

Symptoms of a nicotine overdose can occur due to excessive use of this medication and/or smoking. The risk of poisoning by swallowing the gum is very low because nicotine is poorly absorbed in the body without chewing. The symptoms of a Quitt overdose are similar to those of acute nicotine poisoning: nausea, vomiting, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing disorders, and pronounced weakness. At high doses, these symptoms can be followed by low blood pressure, weak and irregular pulse, breathing difficulties, extreme fatigue, circulatory collapse (due to very low blood pressure), and convulsions.

Doses that are well-tolerated by adult smokers can 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), stating the name and amount used. It is recommended to carry the packaging and package leaflet of the medication with you.

Overdose Management

In case of symptoms of nicotine overdose, you should temporarily stop taking nicotine. Then, you should reduce your nicotine intake, either by reducing the frequency of use or using a lower strength. In case of symptoms of nicotine poisoning, nicotine intake should 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 can reduce the absorption of nicotine from the gastrointestinal tract.

If you forget to use this medication

Do not take a double dose to make up for forgotten doses

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

Effects Related to Quitting Smoking (Nicotine Abstinence)

Some of the side effects you may experience when you quit smoking may be symptoms of abstinence due to the decrease in nicotine intake.

These side effects include:

• Irritability, frustration, impatience, or anger
• Anxiety, restlessness, or difficulty concentrating
• Waking up during the night or sleep disorders
• Increased appetite or weight gain, constipation
• Feeling of discouragement
• Cravings to smoke (urges)
• Decreased heart rate
• Bleeding in the mouth
• Dizziness or feeling of fainting
• Cough, sore throat, congestion, or nasal secretion

Stop taking Quitt medicated gum and consult a doctor immediately if you experience any of the following symptoms or allergic reactions, which can 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;

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

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

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

Very Common Adverse Effects(may affect more than 1 in 10 people):

• Headache
• Cough
• Hiccup
• Nausea
• Irritation of the mouth or throat

Common Adverse Effects(may affect 1 in 10 people):

• Hypersensitivity;
• Dizziness;
• Taste disorders;
• Pins and needles;
• Diarrhea;
• Indigestion;
• Dry mouth;
• Increased salivation;
• Inflamed mouth;

• Nausea;
• Vomiting;
• Burning sensation;
• Flatulence;
• Fatigue;
• Stomach pain

Uncommon Adverse Effects(may affect 1 in 100 people):

• Abnormal dreams
• Hives
• Palpitations (rapid heart rate)
• Hot flashes
• High blood pressure
• Sudden constriction of the small airways in the lungs
• Loss or damage to the voice
• Difficulty breathing
• Nasal congestion
• Pain in the mouth and throat
• Sneezing
• Throat tightness
• Belching
• Tongue inflammation
• Ulceration and inflammation of the mouth mucosa
• Numbness of the mouth
• Weakness
• Discomfort and pain in the chest
• General discomfort
• Excessive sweating
• Itching
• Urticaria
• Jaw muscle pain

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

• Atrial arrhythmias (changes in heart rate).
• Difficulty swallowing
• Decreased sensitivity in the mouth
• Belching

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Quitt 4 mg Medicated Gum, Mint Flavor

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

Do not use this medicine after the expiration date that appears on the box and 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 thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Quitt Medicated Gum

• The active ingredient is nicotine.
• Each medicated gum contains 4 mg of nicotine (which corresponds to 26.5 mg of nicotine resinate).
• The other components are: Gum base:gum base (contains butylhydroxytoluene [E 321]), xylitol, calcium carbonate, anhydrous sodium carbonate, mint flavor mixture of fresh flavors, levomenthol, acesulfame potassium (E 950), sucralose. Gum coating:maltitol (E 965), maltitol liquid, mint flavor, titanium dioxide (E 171), mixture of fresh flavors, levomenthol, sucralose

Appearance of the Product and Package Contents

Quitt medicated gum is a rectangular medicated gum, slightly convex, white/white broken in color, with an approximate size of 19 × 12 mm.

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

Only some package sizes may be marketed.

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 medicine is authorized in the Member States of the European Economic Area 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 medicated gum, mint flavor

Poland: NICCOREX MINT

Date of the Last Revision of this Leaflet:October 2023.

"Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)"http://www.aemps.gob.es/ "