QUITT 4 mg MEDICATED CHEWING GUM LEMON FLAVOR

Introduction

Package Leaflet: Information for the Patient

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

Contents of the pack and additional information

1. What Quitt 4 mg Medicinal Chewing Gum Lemon 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 a day before treatment.

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

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2. What you need to know before starting to use Quitt 4 mg Medicinal Chewing Gum Lemon 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 a 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 (in 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 medication 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 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 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 may 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 may persist with the use of nicotine replacement therapy; however, the use of 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 attached 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 may need to take any other medication.

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

• 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 may 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 before consuming Quitt medicinal chewing gum.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, 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.

Breast-feeding

Quitt medicinal chewing gum should be avoided during breast-feeding, as nicotine is excreted in breast milk and may affect your baby. If your doctor has recommended that you use Quitt medicinal chewing gum while breast-feeding, you should take the gum immediately after breast-feeding your baby and not in the 2 hours before or while doing so.

Fertility

Smoking may have adverse effects on male and female 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 may 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 Lemon Flavor

Follow the instructions for use of this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Adults and Elderly Patients

For highly dependent smokers (if you smoke your first cigarette within 20 minutes of waking up and smoke more than 20 cigarettes a day) and for smokers who have not been able to quit smoking with the lower dose of this medication, 2 mg, a Quitt 4 mg medicinal chewing gum is recommended per hour, with a maximum of 16 pieces per day, and generally, 8 to 12 chewing gums per day are sufficient.

This medication should be used whenever 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 chewing gums than the number of cigarettes they previously smoked 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 chewing gum only when recommended by a doctor. Experience with the use of nicotine chewing gum in children and adolescents under 18 years is limited.

Method of Administration

A Quitt chewing 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. You can then start chewing again. To increase the chances of success, it is essential to avoid excessively low dosing. You should chew a sufficient amount of medicated chewing gums daily.

1. .

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 chewing gums per day are sufficient.
• 4 to 6 weeks after starting treatment, the number of gums per day should be gradually reduced by chewing Quitt 4 mg at intervals of more than 1 hour.
• The first attempt to stop taking this medication should be made when the average daily consumption during the last week has been 1-2 gums.

However, the gum should always be on hand for a certain period after the end of treatment to counteract a new urge to smoke.

Treatment for more than 6 months is not recommended. 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 of 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 whenever 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 whenever 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 may 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

Toxicological Information Service (telephone 91 562 04 20), indicating 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 may 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.

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

4. Possible Adverse Effects

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

Quitt medicinal chewing gum can cause adverse reactions similar to those experienced when nicotine is administered through other routes. Most of the adverse effects that occur during treatment and generally depend on the dose.

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 decreased 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 medicinal chewing 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 medicinal chewing 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 for 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 that contains nicotine. If you are prone to stomach sensitivity, Quitt medicinal chewing 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
• Oppression in the throat
• 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):

• 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

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 Medicinal Chewing Gum Lemon 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 will help protect the environment.

6. Package Contents and Additional Information

Composition of Quitt Medicinal Chewing Gum

• The active ingredient is nicotine.
• Each medicinal chewing gum contains 4 mg of nicotine (which corresponds to 26.5 mg of nicotine resinate).
• The other components are: Chewing gum core:gum base (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 Package Contents

Quitt medicinal chewing gum is a rectangular, slightly convex, white/white-broken medicinal 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 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 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 medicinal chewing gum lemon flavor

Poland: NICCOREX LEMON

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/ "