Nicorama mint

Package leaflet: Information for the user

Nicorama Mint, 2 mg, medicated chewing gum
Nicorama Mint, 4 mg, medicated chewing gum
Nicotine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always take this medicine exactly as described in this patient leaflet or as your doctor,
pharmacist, or nurse has advised.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If you continue using Nicorama Mint gum beyond 6 months, you should contact your doctor.

Contents of the leaflet

1. What Nicorama Mint is and what it is used for
2. What you need to know before using 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 Nicorama Mint is and what it is used for

Nicorama Mint belongs to a group of medicines used to help people stop smoking.
The nicotine contained in Nicorama Mint helps relieve nicotine cravings and withdrawal symptoms that occur when you stop smoking, thereby helping prevent relapse in smokers who are determined to quit. The aim of treatment is complete cessation of tobacco use.
When nicotine from cigarettes suddenly stops entering the body, various symptoms may appear, known as withdrawal symptoms. Nicorama Mint chewing gum can help prevent or reduce these symptoms and nicotine cravings by providing the body with small doses of nicotine during the transition period. While chewing Nicorama Mint gum, nicotine is slowly released and absorbed through the oral mucosa. Unlike cigarettes, Nicorama Mint does not contain harmful tar substances or carbon monoxide.
Nicorama Mint works best when used in combination with a smoking cessation programme. Advice and support usually increase the chances of successfully quitting smoking.

2. Important information before taking Nicorama Mint

When not to take Nicorama Mint:

• 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 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 tumour (pheochromocytoma);
• peptic ulcer or duodenal ulcer;
• oesophagitis.

However, the risk of continuing to smoke is always greater than the risk associated with using Nicorama Mint.
The chewing gum may stick 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 Mint out of sight and reach of children.
Adolescents aged 12 to 17 years may use Nicorama Mint only on medical advice.
Nicorama Mint must not be used in children under 12 years of age.

Nicorama Mint and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. Stopping smoking may require dose adjustments of these medicines.
There is no available information on interactions between Nicorama Mint chewing gum and other medicines. However, apart from nicotine, other substances in cigarettes may also affect certain medicines.
Stopping smoking may influence the effect of certain 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. Insulin dosage adjustment may be necessary.

Nicorama Mint with food and drink
Do not eat or drink while chewing the gum. Drinking coffee, fruit juices, or carbonated beverages during use of Nicorama Mint 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 the child's development and may lead to premature birth or stillbirth. Stopping smoking without using nicotine-containing medicines is recommended. If the patient is unable to quit smoking, she may use Nicorama Mint only after consultation with her obstetrician, family doctor, or a physician specialising in treating tobacco addiction.

Breastfeeding
Avoid using Nicorama Mint chewing gum during breastfeeding, as nicotine passes into breast milk and may affect the infant. If a doctor recommends using Nicorama Mint 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 effects on the ability to drive or operate machinery have been observed.

Nicorama Mint contains xylitol, butylated hydroxytoluene, and sodium
Nicorama Mint 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 Mint 2 mg and 4 mg).
Nicorama Mint contains butylated hydroxytoluene, 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 unit, meaning the medicine is considered "sodium-free".

3. How to take Nicorama Mint

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

Treatment method with Nicorama Mint chewing gum

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

Use Nicorama Mint chewing gum whenever you would normally reach for a cigarette or when experiencing nicotine craving. At the beginning of treatment, one piece of chewing gum may be used every 1–2 hours. An adequate 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 of chewing gum per day are sufficient. To maximize the chance of success, the dose should not be too low.

Maximum daily dose:
Nicorama Mint 2 mg: 24 pieces per day, corresponding to 48 mg of nicotine/day.
Nicorama Mint 4 mg: 64 pieces per day, corresponding 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. Discontinue treatment when the dose has been reduced to 1–2 pieces of chewing gum per day.

Regular use of Nicorama Mint chewing gum for longer than 6 months is generally not recommended. In some cases, longer treatment may be necessary to prevent relapse. Remaining pieces of chewing gum should be kept for possible sudden nicotine cravings.
Counseling and support may increase the likelihood of success.

Chewing technique

Proper chewing technique is important. Nicorama Mint chewing gum should be chewed slowly and intermittently. Otherwise, there is a risk of developing heartburn or hiccups.

• Chew the gum slowly until a distinct taste is perceived. Stop chewing when a mild tingling sensation occurs.
• Place the gum between the cheek and gum and leave it there until the taste fades and the tingling sensation subsides.
• Begin chewing slowly again when a distinct taste or mild tingling is felt.
• Repeat these steps for approximately 30 minutes.

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

Taking more than the recommended dose of Nicorama Mint

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

Nicotine overdose may occur when a patient continues to smoke while using Nicorama Mint chewing gum. Doses of nicotine tolerated by adult smokers during treatment may cause severe poisoning symptoms in children, which may lead to death.

Symptoms of overdose include: nausea, vomiting, excessive salivation, abdominal pain, diarrhea, 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 regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

You should stop using Nicorama Mint and contact your 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 effects:
Very common adverse effects (may affect more than 1 in 10 users):

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

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

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

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

• nasal congestion, sneezing;
• wheezing (bronchospasm), breathing difficulties (dyspnoea), throat tightness;
• skin redness (on the face), excessive sweating;
• tingling sensation in the mouth, tongue inflammation, oral mucosal damage, voice changes, belching;
• palpitations (altered perception of heartbeat), increased heart rate, hypertension;
• rash (including urticaria) or itching;
• unusual dreams;
• discomfort and chest pain;
• jaw muscle pain.

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

• swallowing difficulties, oral hypoesthesia;
• vomiting reflex;
• cardiac arrhythmias (atrial fibrillation).

Reported cases (frequency unknown):

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

Symptoms associated with stopping smoking (withdrawal symptoms)
Some adverse effects occurring after stopping smoking may be withdrawal symptoms 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;
• low mood (depression);
• craving for a cigarette;
• decreased heart rate;
• bleeding gums or oral ulcers;
• dizziness or feeling faint;
• cough, sore throat, blocked nose or catarrh;
• constipation.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nicorama Mint

Keep this medicine out of sight and reach of children.
No special storage instructions are required for this 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Nicorama Mint contains
Nicorama Mint sugar-free chewing gums are available in two strengths: 2 mg and 4 mg.
Nicorama Mint 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 butylhydroxytoluene [E 321]), xylitol (E 967), colloidal anhydrous silica, magnesium stearate, peppermint flavour, cooling effect flavour, sodium carbonate, hypromellose, sodium bicarbonate, levomenthol, titanium dioxide (E 171), macrogol 6000, glycerol, potassium acesulfame (E 950), talc, sucralose (E 955), xanthan gum.

Nicorama Mint 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 butylhydroxytoluene [E 321]), xylitol (E 967), colloidal anhydrous silica, magnesium stearate, peppermint flavour, cooling effect flavour, sodium carbonate, hypromellose, sodium bicarbonate, levomenthol, titanium dioxide (E 171), macrogol 6000, glycerol, potassium acesulfame (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 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 blisters.
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 European Economic Area member states 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
2024-Mar-18