Nicorette freshmint gum

Patient Information Leaflet

Warning! Keep this leaflet! The packaging label is in a foreign language.
Nicorette Freshmint Gum (Nicorette Menthe Fraiche 2 mg Sans Sucre)
2 mg, chewing gum, medicinal
Nicotinum
Nicorette Freshmint Gum and Nicorette Menthe Fraiche 2 mg Sans Sucre are different trade names
for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If after 9 months you still have difficulties refraining from smoking without the help of Nicorette Freshmint Gum, you should contact your doctor.

Contents of the leaflet:

1. What Nicorette Freshmint Gum is and what it is 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 pack and other information

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

Mechanism of action
When you stop smoking, and nicotine is no longer regularly supplied to your body, various withdrawal symptoms begin to appear, including irritability, restlessness, mood disturbances, dizziness and headaches, as well as sleep disturbances. Nicorette Freshmint Gum can help prevent or relieve these symptoms by delivering small doses of nicotine to your body over a short period of time.
The nicotine contained in Nicorette Freshmint Gum is administered in pure form. Unlike cigarettes, Nicorette Freshmint Gum does not release harmful tar substances or carbon monoxide, which are produced during tobacco combustion.

Indications
Nicorette Freshmint Gum is indicated for the treatment of tobacco dependence by reducing nicotine craving and withdrawal symptoms occurring after smoking cessation.

2. Important information before using Nicorette Freshmint Gum

When not to use Nicorette Freshmint Gum

• If the patient is 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, consult your doctor if you have:

• Recently suffered a stroke or heart attack,
• Chest pain or symptoms of angina,
• Heart disease affecting the speed or regularity of the heartbeat,
• Uncontrolled high blood pressure,
• Peptic ulcer of the stomach or duodenum,
• Hyperthyroidism,
• Insulin-dependent diabetes (lower insulin doses may be required as a result of stopping smoking),
• A diagnosed pheochromocytoma,
• Severe or moderate liver disease,
• Severe kidney disease,
• Oesophagitis,
• A history of epilepsy or seizures.

The chewing gum may stick to, and in rare cases cause damage to, dental prostheses.
Some patients may continue using Nicorette Freshmint Gum beyond the recommended treatment period; however, the potential risk of long-term use is considerably lower than the risk associated with returning to smoking.

Nicorette Freshmint Gum and other medicines
Inform your doctor about all medicines you are currently taking, have recently taken, or plan to take. Stopping smoking may require adjustment of dosages of other medicines.
If you are taking imipramine, clomipramine, fluvoxamine (medicines used to treat depression), clozapine, olanzapine (medicines used to treat schizophrenia), theophylline (used to treat bronchial asthma, chronic obstructive pulmonary disease and bronchial inflammation), tacrine (used in Alzheimer's disease), ropinirole (used in Parkinson's disease), flecainide (used e.g. in tachycardia, paroxysmal atrial fibrillation, cardiac arrhythmias), pentazocine (an analgesic), or insulin, consult your doctor before using Nicorette Freshmint Gum.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine.
Use of Nicorette Freshmint Gum in a pregnant woman who smokes should only begin after consultation with a doctor.
If quitting smoking is not successful, use of Nicorette Freshmint Gum by a breastfeeding woman should only begin after consultation with a doctor. To reduce infant exposure, the gum should be used immediately after breastfeeding.

Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery.

Nicorette Freshmint Gum contains xylitol (E 967)
This medicine may have a laxative effect. The caloric value is 2.4 kcal/g of xylitol.

Nicorette Freshmint Gum contains butylated hydroxytoluene (E 321)
This medicine may cause mucosal irritation.

Nicorette Freshmint Gum contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to use Nicorette Freshmint Gum

Children and adolescents
Nicorette Freshmint Gum should not be used in individuals under 18 years of age without medical advice. Data on treatment with Nicorette Freshmint Gum in this age group are limited.
Adults and elderly
The initial dose should be individually determined based on the degree of nicotine dependence. Typically, 8–12 pieces of gum per day containing the appropriate amount of nicotine are used. Smokers with low dependence (smoking ≤ 20 cigarettes/day) should start treatment with the 2 mg dose. Smokers with high dependence should start treatment with the 4 mg dose. Do not use more than 15 pieces of gum per day.
Smoking cessation
Nicorette Freshmint Gum helps individuals determined to quit smoking to stop the habit. The gum should be used for at least 3 months. After this period, gradual discontinuation of the gum should begin. Treatment should be completed when the dose has been reduced to 1–2 pieces per day.
Smoking reduction
Nicorette Freshmint Gum helps reduce smoking in individuals who are unwilling or unable to quit. To extend the intervals between cigarettes and maximally reduce the number of cigarettes smoked, the gum should be used between cigarettes, whenever the urge to smoke arises. If no reduction in daily cigarette consumption is achieved after 6 weeks, consult a physician.
Consider attempting to quit smoking as soon as possible, but no later than 6 months after starting treatment. If a serious attempt to quit smoking is not possible within 9 months of starting treatment, consult a physician.
Generally, regular use of the gum for longer than 12 months is not recommended. However, some former smokers may require longer treatment to prevent relapse. Unused gum should be kept in case of sudden nicotine cravings.
Seek support from counseling or support groups, as they may improve the quitting process and help ensure successful treatment completion.
Temporary abstinence
Nicorette Freshmint Gum helps smokers temporarily refrain from smoking. Use the gum during breaks between cigarettes when the urge to smoke arises, for example, in places where smoking is prohibited or in other situations where one wishes to avoid smoking.
Use of gum in combination with patches
Gum can be used alone or in combination with nicotine patches. Using more than one form of nicotine replacement therapy (NRT) may be beneficial for smokers who have relapsed despite previous monotherapy with NRT or who experience difficulty controlling cigarette cravings during monotherapy. Therefore, if necessary, Nicorette Invisipatch 15 mg/16 h and Nicorette Freshmint Gum 2 mg may be used together.
The Nicorette Invisipatch 15 mg/16 h patch should be applied in the morning upon waking and removed after 16 hours, before going to sleep. It should be used according to the dosing regimen approved for monotherapy. Nicorette Freshmint Gum 2 mg should be chewed whenever a strong urge to smoke occurs, without exceeding the maximum daily dose of 15 pieces. This combined approach may be used for up to 12 weeks, after which gum use should be gradually reduced. The maximum duration of gum use is 12 months.
How to chew Nicorette Freshmint Gum
Chew the gum when you feel the urge to smoke. Chew the gum slowly to release nicotine, then stop chewing to allow nicotine absorption through the oral mucosa. Swallowed nicotine has no beneficial effect and may irritate the throat or stomach, potentially causing hiccups. Nicorette Freshmint Gum should not be chewed continuously and vigorously like regular gum, as this releases nicotine too intensely. Therefore, chew the gum slowly, taking regular breaks.
Chewing technique

1. Chew the gum slowly until you notice the taste.
2. Then stop chewing and place the gum between your gum and cheek.
3. Begin chewing again when the taste fades.
4. Repeat this process for approximately 30 minutes—the time required for all the nicotine in the gum to be released.

Use of a higher than recommended dose of Nicorette Freshmint Gum
Abuse of nicotine, either from nicotine replacement products and/or continued cigarette smoking, may lead to symptoms of overdose. The risk of poisoning following ingestion of the chewing gum is very low, as nicotine absorption without chewing is slow and incomplete.
Symptoms of nicotine overdose include nausea, vomiting, excessive salivation, abdominal pain, diarrhea, profuse sweating, headache, dizziness, hearing disturbances, and marked weakness. After large doses, these symptoms may be accompanied by hypotension, weak and irregular pulse, breathing difficulties, exhaustion, circulatory collapse, and generalized seizures.
Nicotine doses tolerated by adults during treatment may cause severe poisoning in young children and can be fatal.
Keep the medicine out of reach of children. In case of overdose, immediately stop administering nicotine and seek medical help. The physician will provide appropriate symptomatic treatment.
In cases of excessive nicotine ingestion, activated charcoal reduces gastrointestinal absorption of nicotine.
If too many pieces of gum have been used, or if a child has chewed or swallowed the gum, contact a doctor immediately or go to the nearest hospital, bringing the gum packaging and this leaflet with you.

4. Possible adverse effects

Like all medicines, this product may cause adverse effects, although not everyone will experience them.
Some symptoms may occur as a result of stopping smoking. These include low mood, insomnia, irritability, frustration, anger, anxiety, difficulty concentrating, nervousness or impatience. Physical symptoms may also occur, such as reduced heart rate, increased appetite or weight gain, dizziness or pre-syncope symptoms, cough, constipation, gum bleeding, aphthous ulcers or nasopharyngitis, and nicotine craving associated with the desire to smoke.
Most adverse effects reported by patients occur during the first weeks of treatment. Oral and throat irritation may occur, but most patients become accustomed to this during treatment.
The chewing gum may stick to, and in rare cases cause damage to, dental prostheses.
Allergic reactions (including severe allergic reactions) may rarely occur during the use of Nicorette Freshmint Gum.
Adverse effects reported in at least 1% of patients treated with nicotine in clinical trials and post-marketing experience are listed in the table below. Frequency of occurrence is defined according to the following classification:
Very common (may affect up to 1 in 10 people)
Common (may affect up to 1 in 100 people)
Uncommon (may affect up to 1 in 1,000 people)
Rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from available data)

System organ class Adverse effect
Frequency
Cardiac disorders
Uncommon Palpitations (pounding heartbeat)
Uncommon Tachycardia (increased heart rate)
Eye disorders
Not known Blurred vision
Not known Excessive tearing
Gastrointestinal disorders
Common Abdominal pain
Common Dry mouth
Common Dyspepsia
Common Flatulence
Very common Nausea
Common Excessive salivation
Common Stomatitis (inflammation of the mouth)
Common Vomiting
Common Diarrhoea
Not known Dryness of pharyngeal mucous membranes
Rare Dysphagia (difficulty swallowing)
Uncommon Belching
Not known Gastrointestinal discomfort
Uncommon Glossitis (inflammation of the tongue)
Rare Oral hypoesthesia (reduced sensation in the mouth)
Uncommon Blisters and peeling of the oral mucosa
Not known Lip pain
Uncommon Tingling/numbness sensation in the mouth
Rare Gag reflex
General disorders and administration site conditions
Common Burning sensation
Common Fatigue
Uncommon Weakness
Uncommon Chest discomfort and pain
Uncommon Malaise
Immune system disorders
Common Hypersensitivity
Not known Anaphylactic reaction (sudden, severe allergic reaction which may manifest as urticaria, itching, flushing, shortness of breath, hypotension, abdominal pain, diarrhoea or vomiting)
Nervous system disorders
Very common Headache
Common Taste disturbance
Common Sensation of cold, heat and tingling of the skin
Not known Seizures
Musculoskeletal and connective tissue disorders
Not known Jaw muscle stiffness
Uncommon Jaw pain
Psychiatric disorders
Uncommon Unusual dreams
Respiratory, thoracic and mediastinal disorders
Common Cough
Very common Hiccups
Very common Sore throat
Uncommon Bronchospasm
Uncommon Voice disorders
Uncommon Dyspnoea (shortness of breath)
Uncommon Nasal mucosa hyperaemia
Uncommon Mouth and throat pain
Uncommon Sneezing
Uncommon Throat tightness
Skin and subcutaneous tissue disorders
Not known Angioedema (a skin and mucous membrane disorder characterized by localized swelling)
Not known Flushing
Uncommon Excessive sweating
Uncommon Itching
Uncommon Rash
Uncommon Urticaria
Vascular disorders
Uncommon Facial flushing
Uncommon Hypertension

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

5. How to store Nicorette Freshmint Gum

Keep this medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Nicorette FreshMint Gum contains

• The active substance is nicotine. Each chewing gum contains 2 mg of nicotine in the form of nicotine with cationite.
• 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, acacia gum (E 414), titanium dioxide (E 171), Carnauba wax.

Nicorette FreshMint Gum chewing gum does not contain sugar (sucrose) or ingredients of animal origin.
What Nicorette FreshMint Gum looks like and contents of the pack
White or almost white chewing gum.
Packs contain 15, 30, 90, 105 or 210 chewing gums in blisters placed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in France, 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in France, country of export: 3400937631358
Parallel Import Authorisation Number: 369/24