Nicorama Mint

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

Nicorama Mint, 2 mg, chewing gum, medicinal

Nicorama Mint, 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 you continue to use Nicorama Mint gum after 6 months, you should contact your doctor.

Table of contents of the leaflet

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

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

Nicorama Mint belongs to a group of medicines used to help stop smoking. The nicotine in Nicorama Mint relieves nicotine cravings and withdrawal symptoms that occur when you stop smoking, thereby preventing smokers who are determined to quit from returning to smoking. The goal of treatment is to completely stop using tobacco. When nicotine from cigarettes is suddenly no longer supplied to the body, various withdrawal symptoms may occur. Using Nicorama Mint chewing gum can prevent these symptoms and nicotine cravings or weaken them by providing the body with small doses of nicotine during the transition period. While chewing Nicorama Mint gum, nicotine is slowly released and absorbed in the mouth. Unlike cigarettes, Nicorama Mint does not contain harmful tar substances or carbon monoxide. Nicorama Mint 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 Mint

When not to take Nicorama Mint:

• 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

You should 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;
• hyperthyroidism;
• pheochromocytoma(chromaffinoma);
• stomach ulceror duodenal ulcer;
• esophagitis.

However, the risk of continuing to smoke is always a greater risk than using Nicorama Mint. 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 keep Nicorama Mint out of sight and out of reach of children. Adolescents between 12 and 17 years old may use Nicorama Mint only on the advice of a doctor. Nicorama Mint should not be used in children under 12 years of age.

Nicorama Mint and other medicines

Tell your doctor or pharmacist about all the 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 Mint gum and other medicines. However, other substances contained in cigarettes may affect some medicines. Quitting smoking can 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 Mint with food and drink

Do not eat or drink while chewing the gum. Drinking coffee, juices, or carbonated beverages while using Nicorama Mint gum may weaken its effect. Avoid these beverages for 15 minutes before using the 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 Mint only after consulting your doctor, obstetrician, or a doctor specializing in the treatment of tobacco addiction. Breastfeeding While breastfeeding, you should avoid using Nicorama Mint gum, as nicotine passes into breast milk and may affect the baby. If your doctor has recommended using Nicorama Mint 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 observed.

Nicorama Mint contains xylitol, butylhydroxytoluene, and sodium

Nicorama Mint 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 Mint 2 mg and 4 mg). Nicorama Mint contains butylhydroxytoluene, which may cause local skin reactions (e.g., contact dermatitis) or irritate the eyes and mucous membranes. Nicorama Mint contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Nicorama Mint

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

Method of treatment with Nicorama Mint gum

Choose a gum with the appropriate strength based on the degree of nicotine addiction. People who smoke more than 20 cigarettes a day or have previously used Nicorama Mint 2 mg without effect should choose a 4 mg dose. In other cases, use a 2 mg dose. Use Nicorama Mint gum when you would normally reach for a cigarette or when you experience nicotine cravings. Initially, you can use 1 piece of gum every 1-2 hours. Use the appropriate number of pieces of gum daily. The dosage is individual, depending 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 cannot use too small a dose. Maximum daily dose: Nicorama Mint 2 mg: 24 pieces of gum per day, which corresponds to 48 mg of nicotine per day. Nicorama Mint 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 Mint gum for longer than 6 months is not usually recommended. In some cases, longer treatment may be necessary to avoid relapse. Store the remaining gum for sudden nicotine cravings. Counseling and support can increase the chances of success.

Chewing technique

Proper chewing technique is important. Nicorama Mint 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 experience mild tingling.
• Place the gum between your cheek and gum until the taste disappears and the tingling stops.
• Start chewing slowly again until you feel a strong taste or mild tingling.
• 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 Mint 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 an assessment of the risk and advice. Nicotine overdose can occur when smoking while using Nicorama Mint gum. Doses of nicotine tolerated by adult smokers during treatment can cause severe poisoning symptoms in children, which can be fatal. Overdose symptoms 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 using 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 Mint 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 Mint and contact your doctor immediately

if you experience any of the following rare symptoms of a severe 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), tightness in the throat;
• flushing (redness of the skin on the face), excessive sweating;
• tingling sensation in the mouth, tongue inflammation, oral mucosa damage, voice change, mouth and throat pain, belching;
• palpitations (changed heart rhythm), rapid heartbeat, high blood pressure;
• rash (including hives) or itching;
• vivid dreams;
• discomfort and chest pain;
• weakness, malaise;
• jaw muscle pain.

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

• difficulty swallowing, oral hypoesthesia;
• gagging reflex;
• 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 caused by reduced nicotine intake.

• irritability, anger, impatience, or frustration;
• feeling anxious, restless, or having difficulty concentrating;
• waking up at night or sleep disturbances;
• increased appetite or weight gain;
• low 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 Drug Safety, 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 Mint

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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nicorama Mint contains

Nicorama Mint gum does not contain sugar and is available in two strengths: 2 mg and 4 mg. Nicorama Mint 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: gum base (containing butylhydroxytoluene [E 321]), xylitol (E 967), colloidal hydrated silica, magnesium stearate, peppermint flavor, cooling flavor, sodium carbonate, hypromellose, sodium bicarbonate, levomenthol, titanium dioxide (E 171), macrogol 6000, glycerol, acesulfame potassium (E 950), talc, sucralose (E 955), xanthan gum.

Nicorama Mint 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: gum base (containing butylhydroxytoluene [E 321]), xylitol (E 967), colloidal hydrated silica, magnesium stearate, peppermint flavor, cooling flavor, sodium carbonate, hypromellose, sodium bicarbonate, levomenthol, titanium dioxide (E 171), macrogol 6000, glycerol, acesulfame potassium (E 950), talc, sucralose (E 955), yellow iron oxide (E 172), xanthan gum.

What Nicorama Mint looks like and contents of the pack

2 mg:white or almost white, round, biconvex, coated gum that is smooth on both sides. Diameter: 15 mm and thickness: 8 mm. 4 mg:light yellow, round, biconvex, coated gum that is 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 Mint France Nicorama Mint Greece Nicobright Mint Spain Nicorama Mint Germany Nicorama Mint Sweden Nicorama Mint United Kingdom Nicorama Mint

Date of last revision of the leaflet:

2024-March-18