Nicorette Freshfruit Gum

Package Leaflet: Information for the Patient

Nicorette FreshFruit Gum, 2 mg, Chewing Gum, Medicinal

Nicorette FreshFruit Gum, 4 mg, Chewing Gum, Medicinal

Nicotine

Read the 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 directed by a doctor or pharmacist.

• Keep this 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 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 FreshFruit Gum, you should contact your doctor.

Table of Contents of the Leaflet:

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

1. What is Nicorette FreshFruit 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 FreshFruit Gum, these can be prevented or weakened by delivering small doses of nicotine to the body in a short time. The nicotine contained in Nicorette FreshFruit Gum is administered in its pure form. Unlike cigarettes, Nicorette FreshFruit Gum does not release harmful tar substances or carbon dioxide, which appear during tobacco combustion.

Indications for Use

Nicorette FreshFruit 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 FreshFruit Gum

When Not to Use Nicorette FreshFruit 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 FreshFruit Gum, you should discuss it with your doctor in case of:

• recently having 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 disease,
• hyperthyroidism,
• insulin-dependent diabetes (smaller doses of insulin may be required as a result of quitting smoking),
• proven pheochromocytoma,
• severe or moderate liver disease,
• severe kidney disease,
• esophagitis,
• a history of epilepsy or seizures.

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

Nicorette FreshFruit 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 bronchial inflammation), tacrine (a medicine used in Alzheimer's disease), ropinirole (a medicine used in Parkinson's disease), flecainide (a medicine used for arrhythmias, paroxysmal atrial fibrillation, heart rhythm disorders), pentazocine (a pain reliever), insulin, you should consult your doctor before using Nicorette FreshFruit 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. To minimize exposure to the child, the medicine should be used immediately after breastfeeding.

Driving and Using Machines

The medicine does not affect or has a negligible effect on the ability to drive and use machines. Nicorette FreshFruit Gum contains butylhydroxytoluene (E 321). The medicine may cause irritation of the mucous membranes. 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 FreshFruit Gum

Children and Adolescents
Without a doctor's recommendation, Nicorette FreshFruit Gum should not be used in people under 18 years of age. Data on the treatment of people in this age group with Nicorette FreshFruit Gum are limited.
Adults and the Elderly
The initial dose should be determined individually depending on the degree of nicotine dependence. Usually, 8-12 gums 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 gums per day.
Quitting Smoking
Nicorette FreshFruit Gum helps people quit smoking who are determined to quit the habit. The 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 FreshFruit Gum helps reduce smoking in people who do not want to or are unable to quit the habit. To prolong the intervals between smoking and maximize the reduction in the number of cigarettes smoked, the gum should be used during periods between cigarettes when the desire to smoke appears. If after 6 weeks, a reduction in the number of cigarettes smoked per day is not achieved, you should consult your doctor. You should consider trying to quit smoking as soon as possible, but no later than 6 months after starting treatment. If within 9 months of starting treatment, it is not possible to make a serious attempt to quit smoking, you should consult your doctor. Usually, 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 tobacco. Unused gums should be kept in case of sudden nicotine craving.
Temporary Abstinence
Nicorette FreshFruit Gum helps smokers temporarily abstain from smoking. The 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 FreshFruit 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 FreshFruit Gum 2 mg should be chewed when a strong desire to smoke appears, not exceeding the maximum daily dose of 15 gums. The gum can be used in this way for a period of 12 weeks, then the use of the gum should be gradually reduced. The maximum duration of gum use is 12 months.
How to Chew Nicorette FreshFruit Gum
The gum should be chewed when you feel the need to smoke a cigarette. The gum is chewed to release nicotine, and then chewing is stopped to allow nicotine to be absorbed through the oral mucosa. Nicotine swallowed with saliva has no beneficial effect and in excess can irritate the throat or stomach, causing, for example, hiccups. Nicorette FreshFruit Gum should not be chewed like regular gum in a continuous and energetic manner, as nicotine is released too intensely. Therefore, Nicorette FreshFruit Gum should be chewed slowly, making regular breaks.

• 1. Chew the gum slowly until you feel the taste.
• 2. Then stop chewing and hold the gum between your cheek and gum.
• 3. Start chewing again when the taste disappears.
• 4. Repeat this process for 30 minutes.

Using a Higher Than Recommended Dose of Nicorette FreshFruit Gum

Overuse of nicotine, both from nicotine replacement products and (or) as a result of smoking cigarettes, 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, 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 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, nicotine administration should be stopped immediately and medical help should be sought. 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 gum is chewed or swallowed by a child, 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 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 desire to smoke. Most reported side effects occur within the first few weeks of starting treatment. Mouth and throat irritation may occur, but most patients get used to it during treatment. The chewing gum may stick, and in rare cases, cause damage to dental prostheses. During the use of Nicorette FreshFruit Gum, allergic reactions (including severe allergic reactions) may rarely occur.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Nicorette FreshFruit Gum

The medicine should be stored in a place out of sight and reach of children. Store in a temperature below 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 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 Pack and Other Information

What Nicorette FreshFruit 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 cationic exchange resin.
• The other ingredients are: core - chewing gum base, xylitol (E 967), peppermint oil, sodium carbonate anhydrous, sodium bicarbonate (only 2 mg dose), acesulfame potassium (E 950), levomenthol, magnesium oxide, quinoline yellow, lake (E 104) (only 4 mg dose); coating - tuttifrutti QL 84441, hypromellose, sucralose (E 955), polysorbate 80, xylitol (E 967), gum arabic (E 414), titanium dioxide (E 171), carnauba wax (E 903), quinoline yellow, lake (E 104) (only 4 mg dose).

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

What Nicorette FreshFruit Gum Looks Like and What the Pack Contains

The pack contains 12, 15, 24, 30, 48, 90, 96, 105, 204, or 210 gums 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, Norrbroplatsen 2, SE-251 09 Helsingborg, Sweden.
To obtain more detailed information, please contact:
email: [email protected]
Date of last revision of the leaflet: June 2023