Nicorette Freshmint Gum

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Nicorette FreshMint Gum(Nicorette Menthe Fraiche 2 mg Sans Sucre)
2 mg,chewing gum, medicinal
Nicotine
Nicorette FreshMint Gum and Nicorette Menthe Fraiche 2 mg Sans Sucre are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 9 months you are still having trouble quitting smoking with the help of Nicorette FreshMint Gum, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Nicorette FreshMint Gum and what is it used for
• 2. Important information before using Nicorette FreshMint Gum
• 3. How to use Nicorette FreshMint Gum
• 4. Possible side effects
• 5. How to store Nicorette FreshMint Gum
• 6. Contents of the packaging and other information

1. What is Nicorette FreshMint Gum and what is it used for

Description of action

When a patient stops smoking cigarettes and nicotine is no longer regularly delivered to the body, various symptoms resulting from nicotine withdrawal begin to appear, including irritability, anxiety, mood disturbances, dizziness, and headaches, as well as sleep disturbances. With the help of Nicorette FreshMint Gum, you can prevent or alleviate these symptoms by delivering small amounts of nicotine to the body quickly.
Nicotine in Nicorette FreshMint Gum is administered in its pure form. Unlike cigarettes, Nicorette FreshMint Gum does not release harmful tar substances or carbon dioxide, which appear during tobacco combustion.

Indications for use

Nicorette FreshMint Gum is indicated for the treatment of tobacco dependence by reducing nicotine craving and withdrawal symptoms that occur after quitting smoking.

2. Important information before using Nicorette FreshMint Gum

When not to use Nicorette FreshMint Gum

• If you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Nicorette FreshMint Gum, you should discuss it with your doctor if you have recently had a stroke or heart attack, chest pain or symptoms of angina pectoris, heart disease affecting the speed or regularity of the heartbeat, uncontrolled high blood pressure, stomach or duodenal ulcer, hyperthyroidism, insulin-dependent diabetes (lower insulin doses may be required as a result of quitting smoking), diagnosed pheochromocytoma, severe or moderate liver disease, severe kidney disease, esophagitis, or a history of epilepsy or seizures.

Chewing gum may stick to and, in rare cases, damage dental prostheses.
Some patients may continue to use Nicorette FreshMint Gum for longer than the recommended treatment period, but the potential risk of long-term use is much lower than the risk of dependence associated with returning to smoking tobacco.

Nicorette FreshMint Gum and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Quitting smoking may require modification of their dosing.
If you are taking imipramine, clomipramine, fluvoxamine (medicines used to treat depression), clozapine, olanzapine (medicines used to treat schizophrenia), theophylline (a medicine used to treat asthma, chronic obstructive pulmonary disease, and bronchitis), tacrine (a medicine used to treat Alzheimer's disease), ropinirole (a medicine used to treat Parkinson's disease), flecainide (a medicine used for arrhythmias, paroxysmal atrial fibrillation, and heart rhythm disorders), pentazocine (a pain reliever), or insulin, you should consult your doctor before using Nicorette FreshMint Gum.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
Using Nicorette FreshMint Gum in a smoking pregnant woman can only be started after consulting a doctor.
If you are unable to quit smoking, using Nicorette FreshMint Gum while breastfeeding can only be started after consulting a doctor. To minimize exposure to the child, the medicine should be used immediately after breastfeeding.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.

Nicorette FreshMint Gum contains xylitol (E 967)

The medicine may have a laxative effect. The energy value is 2.4 kcal/g of xylitol.

Nicorette FreshMint Gum contains butylhydroxytoluene (E 321)

The medicine may cause irritation of the mucous membranes.

Nicorette FreshMint Gum contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Nicorette FreshMint Gum

Children and adolescents
Without a doctor's recommendation, Nicorette FreshMint Gum should not be used in people under 18 years of age. Data on the treatment of people in this age group with Nicorette FreshMint Gum are limited.
Adults and the elderly
The initial dose should be determined individually based on the degree of nicotine dependence. Usually, 8-12 gums per day with the appropriate nicotine content are used. People who smoke with a low degree of dependence (smoking ≤ 20 cigarettes/day) should start treatment with a 2 mg dose. People who smoke with a high degree of dependence should start treatment with a 4 mg dose. Do not use more than 15 gums per day.
Quitting smoking
Nicorette FreshMint Gum helps people who are determined to quit smoking.
Gum should be used for at least 3 months. Then, you should start gradually reducing the gum. Treatment should be completed when the dose is reduced to 1-2 gums per day.
Reducing smoking
Nicorette FreshMint Gum helps reduce smoking in people who do not want to or are unable to quit.
To prolong the intervals between smoking and maximize the reduction in the number of cigarettes smoked, gum should be used during periods between cigarettes, when the desire to smoke appears. If after 6 weeks, there is no reduction in the number of cigarettes smoked per day, you should consult a doctor.
You should consider trying to quit smoking as soon as possible, but no later than 6 months after starting treatment. If after 9 months of treatment, it is not possible to make a serious attempt to quit smoking, you should consult a doctor.
Regular use of gum for a period longer than 12 months is not recommended. Some former smokers may require longer treatment to avoid returning to smoking. Unused gums should be kept in case of sudden nicotine cravings.
You should use support group advice, as they can improve the smoking cessation process and help complete therapy successfully.
Temporary abstinence
Nicorette FreshMint Gum helps smokers temporarily abstain from smoking.
Gum should be used during breaks between cigarettes, when the desire to smoke appears, for example, in places where smoking is prohibited or in other situations where you want to avoid smoking.
Using gum in combination with patches
Gums can be used alone or in combination with nicotine patches. Using more than one form of nicotine replacement therapy is beneficial in the case of smokers who have returned to the smoking habit despite previously using monotherapy or who have difficulty controlling the desire to smoke during monotherapy. Therefore, if necessary, Nicorette Invisipatch 15 mg/16 h and Nicorette FreshMint Gum 2 mg can be used together.
Nicorette Invisipatch 15 mg/16 h should be applied in the morning, after waking up, and removed after 16 hours, before going to bed. It should be used in accordance with the approved dosing for monotherapy. Nicorette FreshMint Gum 2 mg should be chewed when you feel a strong desire to smoke, not exceeding the maximum daily dose of 15 gums. The gum can be used in this way for a period of 12 weeks, then you should gradually reduce the use of the gum. The maximum duration of gum use is 12 months.
How to chew Nicorette FreshMint Gum
Gum should be chewed when you feel the need to smoke. The gum is chewed to release nicotine, and then you stop chewing to allow the nicotine to be absorbed through the mouth mucosa. Nicotine swallowed with saliva has no beneficial effect and in excess can irritate the throat or stomach, causing hiccups, for example. Nicorette FreshMint Gum should not be chewed like regular gum continuously and energetically, as nicotine is released too intensely. Therefore, Nicorette FreshMint Gum should be chewed slowly, making regular breaks.

• 1. Chew the gum slowly until you feel the taste.
• 2. Then stop chewing and keep the gum between your cheek and gum.
• 3. You should start chewing again when the taste disappears.
• 4. This action should be repeated for 30 minutes. This is how long it takes for all the nicotine contained in the gum to be released.

Using a higher dose of Nicorette FreshMint Gum than recommended

Nicotine overdose, both from nicotine replacement products and (or) due to smoking, can cause symptoms of overdose. The risk of poisoning as a result of swallowing chewing gum is very low, as absorption of nicotine without chewing is slow and incomplete.
Symptoms of nicotine overdose include nausea, vomiting, excessive salivation, abdominal pain, diarrhea, excessive sweating, headache, dizziness, and significant weakness. After large doses, these symptoms may be accompanied by hypotension, weak and irregular pulse, breathing difficulties, exhaustion, circulatory collapse, and generalized seizures.
Doses of nicotine tolerated by adults during treatment can cause symptoms of severe poisoning in small children and can be fatal.
The medicine should be stored in a place inaccessible to children. In case of overdose, you should immediately stop administering nicotine and seek medical help. The doctor will provide appropriate symptomatic treatment.
In case of swallowing an excessive amount of nicotine, activated charcoal reduces gastrointestinal absorption of nicotine.
If too many gums are used or if a child chews or swallows gum, you should immediately contact a doctor or go to the nearest hospital, taking the gum packaging and this leaflet with you.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms may occur in connection with quitting smoking. These include worsening mood, insomnia, irritability, frustration, anger, anxiety, concentration problems, nervousness, or impatience. Physical symptoms may also occur, such as decreased heart rate, increased appetite or weight gain, dizziness or hyperventilation symptoms, cough, constipation, gum bleeding, aphthous ulcers, or pharyngitis, as well as nicotine craving associated with the desire to smoke.
Most side effects reported by patients occur within the first few weeks of starting treatment. Mouth and throat irritation may occur, but most patients get used to it during treatment.
Chewing gum may stick to and, in rare cases, damage dental prostheses.
Rarely, allergic reactions (including severe allergic reactions) may occur during treatment with Nicorette FreshMint Gum.
Side effects reported in at least 1% of patients treated with nicotine in clinical trials and after marketing are presented in the table below. The frequency of occurrence is determined according to the following scheme:
Very common (may affect 1 to 10 in 10 people)
Common (may affect 1 to 10 in 100 people)
Uncommon (may affect 1 to 10 in 1,000 people)
Rare (may affect 1 to 10 in 10,000 people)
Unknown (frequency cannot be estimated from available data)

Classification of systems and organs

Frequency of occurrence

Adverse reaction

Cardiac disorders

Uncommon
Uncommon
Palpitations (heart pounding)
Tachycardia (rapid heart rate)

Eye disorders

Unknown
Unknown
Blurred vision
Increased tearing

Gastrointestinal disorders

Common
Common
Common
Common
Very common
Common
Common
Common
Common
Unknown
Rare
Uncommon
Unknown
Uncommon
Rare
Uncommon
Unknown
Uncommon
Rare
Abdominal pain
Dry mouth
Nausea
Bloating
Nausea
Excessive salivation
Oral inflammation
Vomiting
Diarrhea
Dryness of the throat mucosa
Dysphagia (difficulty swallowing)
Belching
Gastrointestinal discomfort
Tongue inflammation
Oral hypoesthesia
Blisters and peeling of the oral mucosa
Lip pain
Oral paresthesia
Gagging

General disorders and administration site conditions

Common
Burning sensation
Common
Uncommon
Uncommon
Uncommon
Fatigue
Weakness
Chest discomfort and pain
Malaise

Immune system disorders

Common
Unknown
Hypersensitivity
Anaphylactic reaction (sudden, severe allergic reaction, which may manifest as hives, itching, redness, shortness of breath, low blood pressure, abdominal pain, diarrhea, or vomiting)

Nervous system disorders

Very common
Common
Common
Unknown
Headache
Change in taste
Feeling of cold, heat, and paresthesia on the skin
Seizures

Musculoskeletal and connective tissue disorders

Unknown
Uncommon
Jaw stiffness
Jaw pain

Psychiatric disorders

Uncommon
Unusual dreams

Respiratory, thoracic, and mediastinal disorders

Common
Very common
Very common
Uncommon
Uncommon
Uncommon
Uncommon
Uncommon
Uncommon
Cough
Hiccup
Throat irritation
Bronchospasm
Voice disorders
Dyspnea
Nasal congestion
Oral and throat pain
Sneezing
Throat tightness

Skin and subcutaneous tissue disorders

Unknown
Unknown
Uncommon
Uncommon
Uncommon
Uncommon
Angioedema (a disease of the skin and mucous membranes, characterized by the occurrence of limited swelling)
Redness
Excessive sweating
Itching
Rash
Hives

Vascular disorders

Uncommon
Uncommon
Flushing
Hypertension

Reporting of side effects

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

5. How to store Nicorette FreshMint Gum

The medicine should be stored in a place out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Nicorette FreshMint Gum contains

• The active substance of the medicine is nicotine. One piece of chewing gum contains 2 mg of nicotine, in the form of nicotine with a cationic exchange resin.
• Other ingredients are: core- chewing gum base, xylitol (E 967), peppermint oil, sodium carbonate, sodium bicarbonate, acesulfame potassium (E 950), levomenthol, light magnesium oxide; coating: xylitol (E 967), peppermint oil, gum arabic (E 414), titanium dioxide (E 171), carnauba wax.

Nicorette FreshMint Gum does not contain sugar (sucrose) or ingredients of animal origin.

What Nicorette FreshMint Gum looks like and what the packaging contains

White or almost white chewing gum.
The packaging contains 15, 30, 90, 105, or 210 gums in blisters placed in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in France, the country of export:

Johnson & Johnson Santé Beauté France
43 rue Camille Desmoulins
92130 Issy-les-Moulineaux
France

Manufacturer:

McNeil AB
Norrbroplatsen 2
SE-25109 Helsingborg
Sweden

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in France, the country of export:3400937631358
3400937631419
Parallel import authorization number:369/24

Date of leaflet approval: 16.05.2025

[Information about the trademark]