Nicorama fruitmint

Package leaflet: Information for the user

Nicorama Fruitmint, 2 mg, medicated chewing gum
Nicorama Fruitmint, 4 mg, medicated chewing gum
Nicotine
Please read this leaflet carefully before taking this 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
the doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If after 6 months the patient is still using Nicorama Fruitmint chewing gum, he/she should contact the doctor.

Contents of the leaflet

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

Nicorama Fruitmint belongs to a group of medicines used to help stop smoking.
The nicotine in Nicorama Fruitmint helps relieve nicotine craving and withdrawal symptoms
that occur when stopping smoking, thereby helping prevent relapse in smokers determined to quit.
The aim of treatment is to completely stop tobacco use.
When nicotine from cigarettes is suddenly no longer supplied to the body, various symptoms may appear, known as withdrawal symptoms. Using Nicorama Fruitmint chewing gum can help prevent or reduce these withdrawal symptoms and nicotine cravings by providing the body with small, temporary doses of nicotine. While chewing the gum, nicotine is slowly released and absorbed through the oral mucosa. Unlike cigarettes, Nicorama Fruitmint does not contain harmful tar substances or carbon monoxide.
Nicorama Fruitmint works best when used in combination with a smoking cessation program. Advice and support generally increase the chances of successfully quitting smoking.

2. Important information before using Nicorama Fruitmint

When not to use Nicorama Fruitmint:

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse if the patient has any of the following conditions:

• recent myocardial infarction (heart attack) or stroke (within the past 3 months);
• chest pain (unstable angina) or angina at rest;
• heart disease affecting heart rate or rhythm;
• hypertension not controlled with medication;
• severe or moderate liver disease;
• severe or moderate kidney disease;
• diabetes;
• epilepsy;
• overactivity of the thyroid gland;
• adrenal gland tumor (pheochromocytoma);
• peptic ulcer or duodenal ulcer;
• esophagitis.

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

Children and adolescents
A dose suitable for adults may cause severe poisoning or even be fatal in children. Therefore, it is essential to keep and store Nicorama Fruitmint out of sight and reach of children.
Adolescents aged 12 to 17 years may use Nicorama Fruitmint only on medical advice. Nicorama Fruitmint must not be used in children under 12 years of age.

Nicorama Fruitmint and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take. Stopping smoking may require dose adjustments of certain medicines.
There is limited information available on interactions between Nicorama Fruitmint chewing gum and other medicines. Besides nicotine, other substances in cigarettes may also affect certain medications.
Stopping smoking may influence the effects of some medicines, for example:

• theophylline, used in the treatment of asthma;
• tacrine, used in the treatment of Alzheimer's disease;
• olanzapine and clozapine, used in the treatment of schizophrenia;
• insulin, used in the treatment of diabetes. Adjustment of insulin dosage may be necessary.

Nicorama Fruitmint with food and drink
Do not eat or drink while chewing the gum. Drinking coffee, fruit juices, or carbonated beverages while using Nicorama Fruitmint chewing gum may reduce its effectiveness. These drinks should be avoided for 15 minutes before using the chewing gum.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
It is very important to stop smoking during pregnancy, as smoking may negatively affect fetal development. It may also lead to premature birth or stillbirth. Stopping smoking without using nicotine-containing medicines is recommended. If the patient is unable to quit smoking without assistance, she may use Nicorama Fruitmint only after consulting with her obstetrician, family doctor, or a specialist in tobacco addiction treatment.

Breastfeeding
Nicorama Fruitmint chewing gum should be avoided during breastfeeding, as nicotine passes into breast milk and may affect the infant. If a doctor recommends using Nicorama Fruitmint chewing gum, it should be chewed immediately after breastfeeding.

Fertility
Smoking increases the risk of infertility in both women and men. The effect of nicotine on fertility is unknown.

Driving and operating machinery
No influence on the ability to drive or operate machinery has been observed.

Nicorama Fruitmint contains xylitol, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), and sodium
Nicorama Fruitmint contains xylitol, which may have a laxative effect.
Energy value: 2.4 kcal/g of xylitol, equivalent to 0.8 kcal per chewing gum (Nicorama Fruitmint 2 mg and 4 mg).
Nicorama Fruitmint contains butylated hydroxytoluene (BHT) and butylated hydroxyanisole (BHA), 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 dosage unit; therefore, 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 your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Instructions for using Nicorama Fruitmint chewing gum

Select the appropriate strength of chewing gum based on the degree of nicotine dependence.
Individuals who smoke more than 20 cigarettes per day or who previously used Nicorama Fruitmint 2 mg without success should use the 4 mg dose. In all other cases, the 2 mg dose should be used.

Use Nicorama Fruitmint chewing gum whenever you would normally reach for a cigarette or when experiencing nicotine cravings. At the beginning of treatment, one piece of chewing gum may be used every 1–2 hours. An appropriate number of chewing gums should be used daily. Dosage is individual and depends on the degree of nicotine dependence. In most cases, 8 to 12 pieces per day are sufficient. To maximize the chance of success, the dose should not be too low.

Maximum daily dose:
Nicorama Fruitmint 2 mg: 24 pieces per day, equivalent to 48 mg of nicotine/day.
Nicorama Fruitmint 4 mg: 16 pieces per day, equivalent to 64 mg of nicotine/day.

The duration of treatment is individual. Treatment should usually last at least 3 months. After this period, the nicotine dose should be gradually reduced. Treatment should be discontinued when the dose has been reduced to 1–2 pieces of chewing gum per day.

Regular use of Nicorama Fruitmint chewing gum for longer than 6 months is generally not recommended. However, in some cases prolonged treatment may be necessary to prevent relapse. Remaining pieces of chewing gum should be kept available in case of sudden nicotine cravings. Counselling and support may increase the likelihood of success.

Chewing technique

Proper chewing technique is important. Nicorama Fruitmint chewing gum should be chewed slowly, with pauses. Otherwise, there is a risk of developing heartburn or hiccups:

• Chew the gum slowly until a distinct taste is noticed. Stop chewing when a slight tingling sensation occurs.
• Place the gum between the cheek and gum until the taste fades and the tingling sensation subsides.
• Begin chewing slowly again when a distinct taste or slight tingling returns.
• Repeat these steps for approximately 30 minutes.

The effect of nicotine will be felt after a few minutes. Therefore, do not expect to experience satisfaction as quickly as when smoking.

Taking more Nicorama Fruitmint than recommended

If an excessive dose is taken, or if the medicine is accidentally ingested by a child, contact a doctor immediately or go to a hospital for assessment and advice.

Nicotine overdose may occur when a patient smokes while simultaneously using Nicorama Fruitmint chewing gum. Doses of nicotine tolerated by adult smokers during treatment may cause severe poisoning symptoms in children, which may be fatal.

Symptoms of overdose include: nausea, vomiting, excessive salivation, abdominal pain, diarrhoea, excessive sweating, headache, dizziness, hearing disturbances, and marked weakness. With large doses, these symptoms may be accompanied by hypotension, weak and irregular heartbeat, breathing difficulties, exhaustion, circulatory collapse, and generalized seizures.

If you have any further doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
Nicorama Fruitmint may cause the same adverse reactions as nicotine administered by other means.
Adverse reactions depend on the dose used.
Irritation of the mouth and throat may occur; however, most users become accustomed to this during treatment.

Discontinue use of Nicorama Fruitmint and contact a doctor immediately if any of the following rare symptoms of a serious allergic reaction occur (angioedema or anaphylactic reaction):

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

Other possible adverse reactions:
Very common adverse reactions (may affect more than 1 in 10 users):

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

Common adverse reactions (may affect up to 1 in 10 users):

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

Uncommon adverse reactions (may affect up to 1 in 100 users):

• nasal mucosal congestion, sneezing;
• wheezing (bronchospasm), breathing difficulties (dyspnea), throat tightness;
• facial skin redness, excessive sweating;
• oral tingling sensation, glossitis, oral mucosal damage, voice change, heartburn;
• palpitations (altered perception of heartbeat), increased heart rate, hypertension;
• rash (including urticaria) or itching;
• unusual dreams;
• discomfort and chest pain;
• feeling of weakness, malaise;
• jaw muscle pain.

Rare adverse reactions (may affect up to 1 in 1000 users):

• difficulty swallowing, oral hypoesthesia;
• gag reflex;
• cardiac arrhythmias (atrial fibrillation).

Reported (frequency unknown):

• blurred vision, excessive tear production (lacrimation);
• dry throat, gastric discomfort, lip pain;
• skin redness;
• jaw stiffness.

Symptoms associated with smoking cessation (withdrawal symptoms)
Some adverse reactions occurring after stopping smoking may be withdrawal symptoms caused by reduced nicotine intake:

• irritability, anger, impatience, or frustration;
• feeling restless, motor restlessness, or difficulty concentrating;
• waking up during the night or sleep disturbances;
• increased appetite or weight gain;
• low mood (depression);
• craving for a cigarette;
• decreased heart rate;
• gum bleeding or oral ulcers;
• dizziness or feeling faint;
• cough, sore throat, nasal congestion, or catarrh;
• constipation.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Nicorama Fruitmint

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack following: EXP.
The expiry date refers to the last day of the specified 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 Fruitmint contains
Nicorama Fruitmint sugar-free chewing gums are available in two strengths: 2 mg and 4 mg.
Nicorama Fruitmint 2 mg

• The active substance is nicotine. Each chewing gum contains 2 mg of nicotine in the form of nicotine with cation exchange resin.
• The other ingredients are: chewing gum base (containing butylated hydroxytoluene [E 321]), xylitol (E 967), colloidal anhydrous silica, magnesium stearate, sodium carbonate, hypromellose, cooling flavour, peppermint flavour, sodium bicarbonate, citrus flavour (containing butylated hydroxyanisole [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. Each chewing gum contains 4 mg of nicotine in the form of nicotine with cation exchange resin.
• The other ingredients are: chewing gum base (containing butylated hydroxytoluene [E 321]), xylitol (E 967), colloidal anhydrous silica, magnesium stearate, sodium carbonate, hypromellose, cooling flavour, peppermint flavour, sodium bicarbonate, citrus flavour (containing butylated hydroxyanisole [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, smooth on both sides.
Diameter: 15 mm and thickness: 8 mm.
4 mg: Light yellow, round, biconvex, coated chewing gums, smooth on both sides.
Diameter: 15 mm and thickness: 8 mm.
30, 96, 105 and 204 chewing gums in blister packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised 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
2024-Mar-18