Nicorama Fruitmint

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

Nicorama Fruitmint, 2 mg, chewing gum, medicinal

Nicorama Fruitmint, 4 mg, chewing gum, medicinal

Nicotine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 6 months you are still using Nicorama Fruitmint gum, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Nicorama Fruitmint and what is it used for
• 2. Important information before taking Nicorama Fruitmint
• 3. How to take Nicorama Fruitmint
• 4. Possible side effects
• 5. How to store Nicorama Fruitmint
• 6. Contents of the pack and other information

1. What is Nicorama Fruitmint and what is it used for

Nicorama Fruitmint belongs to a group of medicines used to help stop smoking. The nicotine in Nicorama Fruitmint relieves nicotine craving and withdrawal symptoms that occur when you stop smoking, thereby preventing the return to smoking in smokers who are determined to quit. The goal of treatment is to completely stop using tobacco. When nicotine from cigarettes is suddenly no longer supplied to the body, various symptoms may appear, called withdrawal symptoms. Using Nicorama Fruitmint chewing gum can prevent these symptoms and nicotine craving or weaken them by providing the body with small doses of nicotine during the transition period. During chewing, nicotine is slowly released and absorbed in the mouth. Unlike cigarettes, Nicorama Fruitmint does not contain harmful tar substances or carbon monoxide. Nicorama Fruitmint is best used in combination with a smoking cessation program. Advice and support usually increase the chances of success in quitting smoking.

2. Important information before taking Nicorama Fruitmint

When not to take Nicorama Fruitmint:

• if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6),
• in children under 12 years of age,
• in non-smokers.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse if you have any of the following conditions:

• recently (within the last 3 months) had a heart attackor stroke;
• chest pain(unstable angina) or angina at rest;
• heart diseasethat affects heart rate or rhythm;
• uncontrolled high blood pressure;
• severe or moderate liver disease;
• severe or moderate kidney disease;
• diabetes;
• epilepsy;
• overactive thyroid gland;
• adrenal gland tumor(pheochromocytoma);
• stomach ulceror duodenal ulcer;
• esophagitis.

However, the risk of continuing to smoke is always a greater threat than using Nicorama Fruitmint. The chewing gum may stick to dental prostheses and bridges, and in some cases, cause damage to them.

Children and adolescents

The dose suitable for adults may cause severe poisoning or be fatal in children. Therefore, it is essential to always keep Nicorama Fruitmint out of sight and out of reach of children. Adolescents between 12 and 17 years old may use Nicorama Fruitmint only on the advice of a doctor. Nicorama Fruitmint should not be used in children under 12 years of age.

Nicorama Fruitmint and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take. Quitting smoking may require adjusting the dosage of these medicines. There is no available information on interactions between Nicorama Fruitmint gum and other medicines. However, apart from nicotine, other substances in cigarettes may affect some medicines. Quitting smoking may affect the action of some medicines, such as:

• theophyllineused to treat asthma,
• tacrineused to treat Alzheimer's disease,
• olanzapine and clozapineused to treat schizophrenia,
• insulinused to treat diabetes. It may be necessary to adjust the insulin dose.

Nicorama Fruitmint with food and drink

Do not eat or drink while chewing the gum. Drinking coffee, juices, or carbonated beverages while using Nicorama Fruitmint chewing gum may reduce its effectiveness. Avoid these beverages for 15 minutes before using the chewing gum.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. Pregnancy It is very important to quit smoking during pregnancy, as it can negatively affect the development of the child. It can also lead to premature birth or stillbirth. It is recommended to quit smoking without using nicotine-containing medicines. If you are unable to quit, you may use Nicorama Fruitmint only after consulting your doctor, obstetrician, or a doctor specializing in the treatment of tobacco addiction. Breastfeeding While breastfeeding, you should avoid using Nicorama Fruitmint chewing gum, as nicotine passes into breast milk and may affect the baby. If your doctor has recommended using Nicorama Fruitmint chewing gum, you should chew it immediately after breastfeeding. Fertility Smoking increases the risk of infertility in women and men. The effect of nicotine on fertility is unknown.

Driving and using machines

No effect on the ability to drive and use machines has been found.

Nicorama Fruitmint contains xylitol, butylhydroxytoluene, butylhydroxyanisole, and sodium

Nicorama Fruitmint contains xylitol, which may have a laxative effect. Energy value: 2.4 kcal/g xylitol, which corresponds to 0.8 kcal per piece of gum (Nicorama Fruitmint 2 mg and 4 mg). Nicorama Fruitmint contains butylhydroxytoluene and butylhydroxyanisole, which may cause local skin reactions (e.g., contact dermatitis) or irritate the eyes and mucous membranes. Nicorama Fruitmint contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Nicorama Fruitmint

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse.

Method of treatment with Nicorama Fruitmint chewing gum

Choose a chewing gum with the appropriate strength depending on the degree of nicotine addiction. People smoking more than 20 cigarettes a day or previously using Nicorama Fruitmint 2 mg without effect should choose a 4 mg dose. In other cases, a 2 mg dose should be used. Nicorama Fruitmint chewing gums should be used when you would normally reach for a cigarette, or when you feel the urge to smoke. At the beginning of treatment, you can use 1 piece of gum every 1-2 hours. You should use the appropriate number of pieces of gum per day. The dosage is individual and depends on the degree of nicotine addiction. In most cases, 8-12 pieces of gum per day are sufficient. To increase the chances of success, you should not use too small a dose. Maximum daily dose: Nicorama Fruitmint 2 mg: 24 pieces of gum per day, which corresponds to 48 mg of nicotine per day. Nicorama Fruitmint 4 mg: 16 pieces of gum per day, which corresponds to 64 mg of nicotine per day. The duration of treatment is individual. Treatment should usually last at least 3 months. Then, the nicotine dose should be gradually reduced. Treatment should be stopped when the dose is reduced to 1-2 pieces of gum per day. Regular use of Nicorama Fruitmint chewing gum for longer than 6 months is not usually recommended. In some cases, longer treatment may be necessary to avoid returning to the habit. The remaining pieces of gum should be kept in case of sudden nicotine craving. Counseling and support can increase the chances of success.

Chewing technique

Proper chewing technique is important. Nicorama Fruitmint gum should be chewed slowly, with pauses. Otherwise, you may be at risk of heartburn or hiccups:

• Chew the gum until you feel a strong taste. Stop chewing when you feel a slight burning sensation.
• Hold the gum between your cheek and gum until the taste disappears and the burning sensation stops.
• Start chewing slowly again until you feel a strong taste or a slight burning sensation.
• Repeat these steps for 30 minutes.

The effect of nicotine will be felt after a few minutes. Therefore, you should not expect to feel a sense of satisfaction as quickly as when smoking.

Taking a higher dose of Nicorama Fruitmint than recommended

In case of taking too much medicine or, for example, accidental ingestion by a child, contact a doctor or go to the hospital for assessment of the risk and advice. Nicotine overdose can occur when you smoke while using Nicorama Fruitmint chewing gum. Nicotine doses tolerated by adult smokers during treatment may cause severe poisoning symptoms in children, which can lead to death. Symptoms of overdose include: nausea, vomiting, excessive salivation, abdominal pain, diarrhea, excessive sweating, headache, dizziness, hearing disturbances, and significant weakness. At high doses, these symptoms may be accompanied by low blood pressure, weak and irregular heartbeat, breathing difficulties, exhaustion, circulatory collapse, and generalized convulsions. If you have any further doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Nicorama Fruitmint may cause the same side effects as nicotine administered in other ways. Side effects depend on the dose taken. Mouth and throat irritation may occur, but most users get used to it during treatment.

Stop using Nicorama Fruitmint and contact your doctor immediately if you experience any of the following rare symptoms of a serious allergic reaction

(angioedema or anaphylactic reaction):

• swelling of the face, tongue, or throat;
• difficulty swallowing;
• hives, rash, and breathing difficulties.

Other side effects that may occur:

Very common side effects(may affect more than 1 in 10 users):

• headache;
• cough, throat irritation;
• hiccups, nausea;

Common side effects(may affect up to 1 in 10 users):

• local reactions, such as burning, mouth inflammation, altered taste;
• dry mouth or increased salivation;
• stomach problems or abdominal pain;
• vomiting, gas, or diarrhea;
• fatigue;
• hypersensitivity (allergy);
• tingling sensation.

Uncommon side effects(may affect up to 1 in 100 users):

• nasal congestion, sneezing;
• wheezing (bronchospasm), breathing difficulties (dyspnea), throat tightness;
• skin redness (on the face), excessive sweating;
• tingling sensation in the mouth, tongue inflammation, mouth ulceration, voice change, mouth and throat pain, belching;
• palpitations (altered heart rhythm), rapid heartbeat, high blood pressure;
• rash (including hives) or itching;
• vivid dreams;
• discomfort and chest pain;
• feeling weak, malaise;
• jaw muscle pain.

Rare side effects(may affect up to 1 in 1,000 users):

• difficulty swallowing, oral hypoesthesia;
• retching;
• heart rhythm disturbances (atrial fibrillation).

Reported(occurs in an unknown number of users):

• blurred vision, increased tearing (lacrimation);
• throat dryness, stomach discomfort, lip pain;
• skin redness;
• jaw stiffness.

Withdrawal symptoms(withdrawal symptoms) Some side effects that occur after quitting smoking may be withdrawal symptoms, which are caused by reduced nicotine intake

• irritability, anger, impatience, or frustration;
• feeling anxious, restlessness, or difficulty concentrating;
• waking up at night or sleep disturbances;
• increased appetite or weight gain;
• depressed mood (depression);
• craving for a cigarette;
• decreased heart rate;
• gum bleeding or mouth ulcers;
• dizziness or feeling faint;
• cough, sore throat, stuffy nose, or cold;
• constipation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C PL-02 222 Warsaw Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nicorama Fruitmint

Keep the medicine out of sight and out of reach of children. There are no special precautions for storing the medicine. Do not use this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nicorama Fruitmint contains

Nicorama Fruitmint chewing gums do not contain sugar and are available in two strengths: 2 mg and 4 mg. Nicorama Fruitmint 2 mg

• The active substance is nicotine. One piece of gum contains 2 mg of nicotine in the form of nicotine cation exchange resin.
• Other ingredients are: chewing gum base (containing butylhydroxytoluene [E 321]), xylitol (E 967), colloidal silica, magnesium stearate, sodium carbonate, hypromellose, cooling flavor, peppermint flavor, sodium bicarbonate, citrus flavor (containing butylhydroxyanisole [E 320]), levomenthol, macrogol 6000, glycerol, titanium dioxide (E 171), talc, acesulfame potassium (E 950), sucralose (E 955), xanthan gum.

Nicorama Fruitmint 4 mg

• The active substance is nicotine. One piece of gum contains 4 mg of nicotine in the form of nicotine cation exchange resin.
• Other ingredients are: chewing gum base (containing butylhydroxytoluene [E 321]), xylitol (E 967), colloidal silica, magnesium stearate, sodium carbonate, hypromellose, cooling flavor, peppermint flavor, sodium bicarbonate, citrus flavor (containing butylhydroxyanisole [E 320]), levomenthol, macrogol 6000, glycerol, titanium dioxide (E 171), talc, acesulfame potassium (E 950), sucralose, yellow iron oxide (E 172), xanthan gum.

What Nicorama Fruitmint looks like and contents of the pack

2 mg:white or almost white, round, biconvex, coated chewing gums that are smooth on both sides. Diameter: 15 mm and thickness: 8 mm. 4 mg:light yellow, round, biconvex, coated chewing gums that are smooth on both sides. Diameter: 15 mm and thickness: 8 mm. 30, 96, 105, and 204 pieces of gum in blisters. Not all pack sizes may be marketed

Marketing authorization holder and manufacturer

Marketing authorization holder Enorama Pharma AB Södra Förstadsgatan 1 211 43 Malmö Sweden Manufacturer ABF Pharmaceutical Services GmbH Brunner Straße 63/18-19 1230 Vienna Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark Nicochew Fruitmint France Nicorama Fruitmint Greece Nicobright Fruitmint Spain Nicorama Fruitmint Germany Nicorama Fruitmint Sweden Nicorama Fruktmint United Kingdom Nicorama Fruitmint

Date of last revision of the leaflet:

2024-March-18