Nicorette freshmint chewing gum

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging 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 the patient.
This medicine should always be used exactly as described in this patient leaflet or as advised by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, 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 difficulty refraining from smoking without the help of Nicorette FreshMint Gum, you should contact your doctor.

Contents of this leaflet:

1. What Nicorette FreshMint Gum is and what it is used for
2. What you need to know 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 the body, various symptoms of nicotine withdrawal begin to appear, such as irritability, restlessness, mood disturbances, dizziness and headaches, and sleep disturbances. Nicorette FreshMint Gum can help prevent or reduce these symptoms by delivering small doses of nicotine to the body over a short period of time.
The nicotine contained in Nicorette FreshMint Gum is delivered in pure form. Unlike cigarettes, Nicorette FreshMint Gum does not release harmful tar substances or carbon dioxide produced by the burning of tobacco.
Indications
Nicorette FreshMint Gum is indicated for the treatment of tobacco dependence by reducing nicotine craving and withdrawal symptoms occurring after stopping smoking.

2. Important information before using Nicorette FreshMint Gum

When not to use Nicorette FreshMint Gum

• If the patient is allergic to nicotine or to 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,
• A heart condition affecting the speed or regularity of the heartbeat,
• Uncontrolled high blood pressure,
• A stomach or duodenal ulcer,
• Hyperthyroidism,
• Insulin-dependent diabetes (lower insulin doses may be required as a result of stopping smoking),
• A diagnosed phaeochromocytoma,
• Severe or moderate liver disease,
• Severe kidney disease,
• Oesophagitis,
• A history of epilepsy or seizures.

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

Nicorette FreshMint Gum and other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Stopping smoking may require dosage adjustments of certain medications.
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 inflammatory airway conditions), tacrine (used in Alzheimer's disease), ropinirole (used in Parkinson's disease), flecainide (used, among others, in tachycardia, paroxysmal atrial fibrillation, cardiac arrhythmias), pentazocine (a painkiller), or insulin, consult your doctor before using Nicorette FreshMint Gum.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should 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 minimize 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 of xylitol is 2.4 kcal/g.

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

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

3. How to use Nicorette Freshmint Gum

Nicorette Freshmint Gum is available in the following doses: 2 mg, 4 mg.
Children and adolescents
Nicorette Freshmint Gum chewing 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 depending on the degree of nicotine dependence. Typically, 8–12 pieces per day of the appropriate nicotine strength are used. Individuals who smoke with low dependence (smoking ≤ 20 cigarettes/day) should start treatment with the 2 mg dose. Individuals who smoke with high dependence should start treatment with the 4 mg dose. Do not use more than 15 pieces per day.
Smoking cessation
Nicorette Freshmint Gum helps individuals determined to quit smoking overcome their addiction. The gum should be used for at least 3 months. Then, gradual discontinuation of the gum should be initiated. 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 unwilling or unable to quit smoking completely. To extend the intervals between cigarettes and maximally reduce the number of cigarettes smoked, the gum should be used between cigarettes, when the urge to smoke arises. If no reduction in daily cigarette consumption is achieved after 6 weeks, consult a doctor.
Consider attempting smoking cessation 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 doctor.
Generally, regular use of the gum for longer than 12 months is not recommended. Some former smokers may require longer treatment to prevent relapse into smoking. Unused gum should be kept in case of sudden nicotine cravings.
Seek support from counselling 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. The gum should be used 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
The gum can be used alone or in combination with nicotine-containing patches. Using more than one form of nicotine replacement therapy (NRT) is beneficial for smokers who have relapsed despite previous monotherapy with NRT or who have 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 when a strong urge to smoke occurs, without exceeding the maximum daily dose of 15 pieces. The gum may be used this way 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 whenever you feel the urge to smoke. Chew the gum slowly to release nicotine, then stop chewing and place the gum between your gum and cheek to allow nicotine to be absorbed through the oral mucosa. Swallowing nicotine with saliva does not provide therapeutic benefit and may irritate the throat or stomach, potentially causing hiccups. Nicorette Freshmint Gum should not be chewed continuously and vigorously like regular chewing gum, as this releases nicotine too quickly. Therefore, chew Nicorette Freshmint Gum slowly, taking regular breaks.
Chewing technique

1. Chew the gum slowly until you taste the flavour.
2. Then stop chewing and place the gum between your gum and cheek.
3. Start chewing again when the taste fades.
4. Repeat this process for 30 minutes. This is how long it takes for all the nicotine in the gum to be released.

Use of more than the 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, diarrhoea, excessive sweating, headache, dizziness, hearing disturbances, 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 may cause severe poisoning in young children and may be fatal.
Keep the medicine out of reach of children. In case of overdose, stop administering nicotine immediately and seek medical help. The doctor will provide appropriate symptomatic treatment.
In case of ingestion of excessive nicotine, activated charcoal reduces gastrointestinal absorption of nicotine.
If too many pieces have been used, or if a child has chewed or swallowed the gum, contact a doctor immediately or go to the nearest hospital, taking the gum packaging and this leaflet with you.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Some symptoms may occur as a result of stopping smoking. These include mood disturbances, insomnia, irritability, frustration, anger, anxiety, difficulty concentrating, restlessness or impatience.
Physical symptoms may also occur, such as decreased 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 of the adverse reactions reported by patients occur during the first weeks of treatment. Oral and throat irritation may occur, although most patients become accustomed to this during treatment.
The chewing gum may stick to teeth and, in rare cases, may cause damage to dental prostheses.
Allergic reactions (including severe allergic reactions) have been reported rarely during the use of Nicorette Freshmint Gum.
Adverse reactions reported in at least 1% of patients treated with nicotine in clinical trials and after marketing are listed in the table below. The frequencies are defined according to the following classification:
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)
Not known (frequency cannot be estimated from the available data)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. 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, 02-222 Warsaw, phone: + 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 or parallel importer.
By reporting adverse reactions, it is possible to gather 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. This will 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 cation-exchange resin complex.
• The 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 (E 903).

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 coated chewing gum, measuring 15.3 x 15.3 x 6.9 mm.

The pack contains 15, 30, 90, 105 or 210 chewing gums in blisters packed in a cardboard box.

For further detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in France, country of export:
Kenvue France
41 rue Camille Desmoulins
92130 Issy-les-Moulineaux
France

Manufacturer:
McNeil AB
Norrbroplatsen 2
SE-25109 Helsingborg
Sweden

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Numbers in France, country of export: 376 313-5
34009 376 313 5 8
376 314-1
34009 376 314 1 9

Parallel Import Authorisation Number: 381/25