Nicorette Freshmint Gum

Package Leaflet: Information for the Patient

Nicorette FreshMint Gum, 2 mg, chewing gum, medicinal

Nicorette FreshMint Gum, 4 mg, chewing gum, medicinal

Nicotine

Read the package 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 package leaflet or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, 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 consult a doctor.

Table of Contents of the Package 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 package 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 supplied to the body, various withdrawal symptoms occur, including irritability, anxiety, mood disturbances, dizziness, and headaches, as well as sleep disturbances. Nicorette FreshMint Gum can help prevent or alleviate these symptoms by delivering small doses of nicotine to the body quickly.

The 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 occur 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 the patient is allergic to nicotine or any other component of this medicine (listed in section 6).

Warnings and Precautions

Before starting to use Nicorette FreshMint Gum, 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 heart rate or rhythm, 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.

• recently had a stroke or heart attack,
• chest pain or symptoms of angina pectoris,
• heart disease affecting heart rate or rhythm,
• 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,
• a history of epilepsy or seizures.

Chewing gum may stick to and, in rare cases, damage dental prostheses.

Nicorette FreshMint Gum and Other Medicines

Tell your doctor about all medicines you are taking now 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 to treat arrhythmias), pentazocine (a pain reliever), or insulin, 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, consult your doctor before using this medicine.

Use of Nicorette FreshMint Gum in a smoking pregnant woman should only be started after consulting a doctor.

If you cannot quit smoking, use of Nicorette FreshMint Gum by a breastfeeding woman should 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 (E967)

The medicine may have a laxative effect. Energy value 2.4 kcal/g xylitol.

Nicorette FreshMint Gum Contains Butylhydroxytoluene (E321)

The medicine may cause irritation of the mucous membranes.

The 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

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 Elderly

The initial dose should be determined individually based on the patient's degree of nicotine dependence. Usually, 8-12 pieces of gum are used per day with the appropriate nicotine content. 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 pieces of gum per day.

Quitting Smoking

Nicorette FreshMint Gum helps people who are determined to quit smoking.

The gum should be used for at least 3 months. Then, you should start gradually reducing the gum use. Treatment should be completed when the dose is reduced to 1-2 pieces of gum per day.

Reducing Smoking

Nicorette FreshMint Gum helps people who do not want to or cannot quit smoking to reduce their smoking.

To prolong the intervals between smoking and to maximize the reduction in the number of cigarettes smoked, the gum should be used during the periods between cigarettes, when the urge to smoke occurs.

If after 6 weeks, there is no reduction in the number of cigarettes smoked per day, consult a doctor.

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, consult a doctor.

Generally, 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 gum should be kept in case of sudden nicotine craving.

Take advantage of support groups, as they can improve the smoking cessation process and help complete therapy successfully.

Temporary Abstinence

Nicorette FreshMint Gum helps smokers to temporarily abstain from smoking.

The gum should be used during breaks between cigarettes, when the urge to smoke occurs, for example, in places where smoking is prohibited or in other situations where you want to avoid smoking.

Using 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 is beneficial in the case of smokers who have returned to smoking despite previously using monotherapy or who have difficulty controlling the urge 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 a strong urge to smoke occurs, not exceeding the maximum daily dose of 15 pieces of gum.

The gum can be used in this way for a period of 12 weeks, then the use of gum should be gradually reduced.

The maximum duration of gum use is 12 months.

How to Chew Nicorette FreshMint Gum

The gum should be chewed when you feel the need to smoke.

Chew the gum to release the nicotine, and then stop chewing to allow the nicotine to be absorbed through the mucous membranes of the mouth.

Nicotine swallowed with saliva has no beneficial effect and in excess can irritate the throat or stomach, causing, for example, hiccups.

Nicorette FreshMint Gum should not be chewed like regular gum continuously and energetically, as the 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. Start chewing again when the taste disappears.
• 4. Repeat this process for 30 minutes. This is how long it takes for all the nicotine in the gum to be released.

Using More Than the Recommended Dose of Nicorette FreshMint Gum

Overuse of nicotine, both from nicotine replacement products and (or) due to smoking, can cause overdose symptoms.

The risk of poisoning due to swallowing the chewing gum is very low, as the absorption of nicotine without chewing is slow and incomplete.

Overdose symptoms of nicotine include nausea, vomiting, excessive salivation, abdominal pain, diarrhea, excessive sweating, headache, dizziness, and hearing disturbances, as well as 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 severe poisoning in small children and can be fatal.

Keep the medicine out of the 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 swallowing an excessive amount of nicotine, activated charcoal reduces gastrointestinal absorption of nicotine.

In case of using too many pieces of gum or chewing or swallowing the gum by a child, contact a doctor or go to the nearest hospital immediately, taking the packaging of the gum and this package 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 of 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 accompanied by the urge 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 the use of 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 defined according to the following scheme:

Very common (may occur in 1 to 10 out of 10 people)

Common (may occur in 1 to 10 out of 100 people)

Uncommon (may occur in 1 to 10 out of 1,000 people)

Rare (may occur in 1 to 10 out of 10,000 people)

Unknown (frequency cannot be estimated from available data)

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store Nicorette FreshMint Gum

Keep the medicine out of sight and reach of children.

Store in a temperature below 25°C in the original packaging.

Do not use this medicine after the expiry date stated on the packaging.

The expiry date refers to the last day of the month stated.

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 Package and Other Information

What Nicorette FreshMint Gum Contains

• The active substance of the medicine is nicotine.
• One piece of chewing gum contains 2 mg or 4 mg of nicotine, in the form of nicotine with a cation exchanger.
• Other ingredients are: core - chewing gum base, xylitol (E967), peppermint oil, sodium carbonate anhydrous, sodium bicarbonate (only 2 mg dose), quinoline yellow (E104) (only 4 mg dose), acesulfame potassium (E950), levomenthol, magnesium oxide; coating - xylitol (E967), peppermint oil, arabic gum (E414), titanium dioxide (E171), carnauba wax, quinoline yellow (E104) (only 4 mg dose).

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

What Nicorette FreshMint Gum Looks Like and What the Package Contains

2 mg Chewing Gum:

Square-shaped chewing gum with dimensions of 15 x 15 x 6 mm in a white coating.

4 mg Chewing Gum:

Square-shaped chewing gum with dimensions of 15 x 15 x 6 mm in a cream-colored coating.

The package contains 15, 30, 90, 105, or 210 pieces of gum in blisters placed in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:McNeil AB, SE-251 09 Helsingborg, Sweden.

Manufacturer:McNeil AB, Norrbroplasten 2, SE-251 09 Helsingborg, Sweden.