Nicotinell 2 mg Red Fruit Flavored Gum

Nicotinell Red Fruits 2 mg Chewing Gum Overview

Nicotinell Red Fruits 2 mg Chewing Gum is a nicotine-based medication designed to help people quit smoking by managing nicotine withdrawal symptoms. It contains nicotine and serves as a substitute for tobacco.

What's in it?

• Main Ingredient: 2 mg of nicotine in the form of nicotine-polacriline (10.00 mg)
• Other Ingredients: gum base (containing butylated hydroxytoluene), calcium carbonate, sorbitol, glycerol, anhydrous sodium carbonate, sodium bicarbonate, polacirline, levomenthol, Tutti Frutti flavor, acesulfame potassium, saccharin, sodium saccharin, carnauba wax, talc, purified water, xylitol, mannitol, gelatin, and titanium dioxide.

Package Size: You can buy it in boxes of 96 or 204 chewing gum pieces.

Dosage and Usage

Nicotinell Red Fruits chewing gum is available in a 2 mg dosage. The recommended dose depends on your smoking habits and is reserved for adults aged 18 and over. Medical advice is required for those under 18. The chewing gum should be chewed until the taste becomes strong and then placed between the gum and the cheek. Once the taste fades, chewing can be resumed for a total duration of approximately 30 minutes.

The starting dose is 1 gum every 1 to 2 hours, which amounts to 8 to 12 gums per day. The maximum daily intake should not exceed 25 pieces of gum.

Treatment Duration

The treatment with Nicotinell Red Fruits chewing gum should last for a minimum of 3 months. After this period, you should gradually reduce the number of gums chewed per day until you reach 1 to 2 pieces of gum. Treatment beyond 6 months is generally not recommended, except for those who need longer assistance to prevent relapses. If the treatment is unsuccessful, consult a healthcare professional. If you find it difficult to stop the treatment after 9 months, seek advice from a healthcare professional.

Warnings

Excessive intake of Nicotinell Red Fruits 2 mg chewing gum can result in nicotine overdose symptoms, including weakness, sweating, throat irritation, nausea, vomiting, diarrhea, abdominal pain, visual and hearing disturbances, headaches, palpitations, shortness of breath, and circulatory problems. If a child accidentally ingests the gum, seek immediate medical attention, as even small amounts of nicotine can be dangerous for children.

Who Shouldn't Use It?

Non-smokers and individuals allergic to nicotine or any of the ingredients should not take this medication. Consult your doctor before using Nicotinell Red Fruits 2 mg if you have cardiovascular disease, a history of stroke, high blood pressure, circulation problems, liver or kidney failure, diabetes, thyroid disease, pheochromocytoma, inflammation of the mouth or throat, esophagitis, gastritis, stomach or duodenal ulcers. Additionally, inform your doctor if you are taking other medications, as adjustments may be necessary. Avoid consuming coffee, acidic, and carbonated drinks 15 minutes before taking the chewing gum.

Pregnancy and Breastfeeding

Nicotine substitutes, including Nicotinell 2 mg chewing gum, are not recommended during pregnancy. However, in cases where other measures have failed, a specialist may prescribe them if the risk to the fetus is considered lower than that of continued smoking. Nicotine passes into breast milk and should be avoided during breastfeeding. If you need assistance with smoking cessation during this time, consult your doctor for appropriate guidance.

Please read full disclosure:

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Updated on: 22/11/2021

1. NAME OF THE MEDICINAL PRODUCT

NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Nicotine ......................................................................................................................... 2.00 mg

In the form of nicotine polacrilex (1:4) ........................................................................ 10.00 mg

Per medicated chewing gum.

Excipients with known effect: Sorbitol (0.2 g), and butylhydroxytoluene (E 321).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Medicated chewing gum.

White rectangular gum.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

This medicine is indicated in the treatment of tobacco dependence to relieve symptoms of nicotine withdrawal in subjects who want to quit smoking.

Appropriate support improves the chances of successfully quitting smoking.

4.2. Posology and method of administration

Posology

Adults over 18 years and elderly individuals

Patients must completely stop smoking during treatment with this medicine.

Chewing gums containing 2 mg are not recommended for heavily or very heavily nicotine-dependent smokers.

If adverse effects occur when using 4 mg chewing gums, switch to 2 mg chewing gums.

The initial dosage choice should be determined based on individual needs according to nicotine dependence.

Chew one gum whenever the urge to smoke arises.

The usual consumption of 2 mg chewing gums is generally 8 to 12 gums per day and should not exceed 24 gums per day. Do not use more than one gum per hour.

The characteristics of this pharmaceutical form can lead to different nicotine blood levels in different individuals. The administration frequency should be adjusted accordingly, based on individual needs within the maximum dosage limit.

The duration of treatment is individual. Normally, this treatment should be continued for at least three months.

After three months, the patient should gradually reduce the number of gums per day until complete cessation of treatment.

Treatment should be discontinued when consumption is reduced to 1 to 2 gums per day.

It is generally recommended not to use the chewing gums beyond 6 months. However, some "ex-smokers" may require longer treatment to avoid relapse. Patients who have used a nicotine substitute for more than 9 months are advised to seek advice from a healthcare professional.

Advice from a healthcare professional can help a smoker quit smoking.

This medicine does not contain sugar.

Children and adolescents

NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum should not be administered to individuals under 18 years of age without medical advice. There is no experience with the use of this medicine in individuals under 18 years of age.

Renal and hepatic impairment:

This medicine should be used with caution in patients with moderate to severe renal impairment and/or moderate to severe hepatic impairment, as the clearance of nicotine or its metabolites may be reduced, leading to an increased potential for adverse effects.

Mode of administration:

· Chew the gum until the taste becomes strong.

· Place the gum between the gum and cheek.

· When the taste fades, chew the gum again.

· Alternate chewing and resting for 30 minutes.

Consumption of acidic beverages such as coffee or soda can decrease nicotine absorption through the oral mucosa. These beverages should be avoided within 15 minutes before taking a chewing gum.

4.3. Contraindications:

· Hypersensitivity to nicotine, licorice, or any of the excipients listed in section 6.1.

· NICOTINELL FRUIT 2 mg SUGAR-FREE, medicated chewing gum should not be used by non-smokers.

4.4. Special warnings and precautions for use:

In the case of recent myocardial infarction, unstable or worsening angina (including Prinzmetal's angina), severe cardiac arrhythmias, unstable hypertension, or recent stroke, which are considered hemodynamically unstable, complete cessation of tobacco consumption using non-pharmacological treatments should always be recommended.

If these nicotine-dependent smokers fail to quit with non-pharmacological methods, the use of NICOTINELL FRUIT 2 mg SUGAR-FREE chewing gum may be considered; however, clinical safety data in these patients are limited, and initiation of treatment should only occur under medical supervision. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the dosage of NICOTINELL FRUIT 2 mg should be reduced or the medication discontinued.

Use NICOTINELL chewing gums with caution in patients with hypertension, stable angina, cerebrovascular disease, occlusive peripheral arterial disease, congestive heart failure, severe hepatic impairment, and/or moderate to severe renal impairment, hyperthyroidism, pheochromocytoma, and diabetes mellitus. Blood glucose levels may be more variable when quitting smoking, with or without nicotine replacement therapy. Therefore, it is important for diabetics to closely monitor their blood glucose levels when using this product.

Seizures: Use with caution in subjects taking anticonvulsant treatment or with a history of epilepsy as cases of seizures have been reported in association with nicotine.

In these patients, complete cessation of tobacco consumption without nicotine replacement therapy (e.g., healthcare professional advice) should be recommended first.

Swallowed nicotine can exacerbate symptoms in patients with esophagitis, oral or pharyngeal inflammation, gastritis, or gastric ulcer.

Nicotine doses tolerated by adult smokers can cause severe or fatal intoxication in young children (see section 4.9).

Keep out of sight and reach of children.

Wearers of dental prostheses may have difficulty chewing the gums; in this case, it is recommended to use another form of nicotine replacement therapy.

NICOTINELL FRUIT, medicated chewing gum may loosen dental fillings or dental implants.

Special warnings related to excipients:

This medicine contains sorbitol. Therefore, patients with rare hereditary fructose intolerance should not take this medicine.

NICOTINELL FRUIT 2 mg SUGAR-FREE chewing gums contain sweeteners, including 0.2 g/gum of sorbitol (E420), a source of fructose at 0.04 g/gum. The caloric content of each gum is 1.0 kcal/gum.

This medicine contains less than 1 mmol (23 mg) of sodium per chewing gum, meaning it is essentially sodium-free.

This medicine contains butylhydroxytoluene (E321), which may cause local irritation of the oral mucosa.

4.5. Interactions with other medicinal products and other forms of interaction

There are no relevant clinical data on potential interactions between nicotine-containing chewing gums and other medications.

Smoking cessation itself may require certain therapeutic adjustments. Smoking, but not nicotine, is associated with increased activity of the CYP1A2 enzyme. Smoking cessation may result in decreased clearance of substrates of this enzyme and increased plasma levels of certain drugs metabolized by CYP1A2, especially molecules with a narrow therapeutic range such as theophylline, tacrine, olanzapine, and clozapine.

In addition, the increased subcutaneous absorption of insulin that may occur upon smoking cessation may require a reduction in the insulin dose.

4.6. Fertility, pregnancy, and lactation

Pregnancy

Smoking and nicotine during pregnancy are associated with reproductive risks and intrauterine growth retardation. It is initially recommended to advise pregnant women to quit smoking without the use of nicotine replacement therapy. If unsuccessful, the use of nicotine replacement therapy may be considered. However, the use of oral nicotine replacement therapy can only be considered after assessing that the benefits for the mother outweigh the potential risks to the fetus.

Breastfeeding

Nicotine passes into breast milk in quantities that may affect the child even at therapeutic doses.

Therefore, NICOTINELL gum, like smoking, should be avoided during breastfeeding.

If smoking cessation is not achieved, the use of the gum during breastfeeding should only be decided upon medical advice. Please consult your doctor or medical professional.

If this medicine is used during breastfeeding, chew the gum immediately after breastfeeding and do not take it for two hours before the next feeding. The use of oral nicotine replacement therapy can only be administered after assessing that the benefits for the mother outweigh the potential risks to the child by a medical professional.

Fertility

Smoking increases the risk of infertility in both women and men. In both humans and animals, it has been shown that nicotine can impair sperm quality. A decrease in fertility has been demonstrated in animals.

4.7. Effects on the ability to drive and use machines

There is no evidence of risk regarding the ability to drive vehicles or operate machinery when using the gum at the recommended doses. However, it should be taken into consideration that smoking cessation may cause behavioral changes.

4.8. Undesirable effects

Nicotine from chewing gums can cause side effects similar to those of nicotine absorbed through smoking due to the pharmacological effects of nicotine, which are dose-dependent.

The non-dose-dependent undesirable effects include jaw pain, hives, hypersensitivity, angioedema, and anaphylactic reactions.

Most reported side effects occur during the first 3 to 4 weeks of treatment.

The nicotine provided by the gums can sometimes cause slight throat irritation and hypersalivation at the beginning of treatment.

Swallowing too much nicotine can cause hiccups.

Individuals with digestive disorders may experience mild signs of dyspepsia or gastric burning at the beginning of treatment. Symptoms can be relieved by chewing the gum more slowly.

Excessive consumption of chewing gums by individuals who did not inhale tobacco smoke can cause nausea, dizziness, and headaches.

The occurrence of aphthous ulcers may be more frequent when quitting smoking.

In rare cases, if adhered to dental work, the gums may cause alterations to dentures or dental amalgams.

The following adverse reactions detailed in Table 1 are related to all oral forms of nicotine. The adverse effects are listed below by organ system and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000).

Some symptoms such as dizziness, headaches, and insomnia may be related to smoking cessation and may be due to inadequate nicotine administration.

Herpes labialis may occur when quitting smoking, but its relationship to nicotine replacement therapy is not established.

The patient may remain nicotine-dependent after quitting smoking.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

4.9. Overdose

In case of overdose, symptoms corresponding to heavy tobacco consumption may be observed.

The acute oral lethal dose is approximately 0.5 to 0.75 mg of nicotine per kg of body weight, which corresponds to 40 to 60 mg in an adult.

Even low doses of nicotine are toxic to children and can cause symptoms of intoxication that can be fatal. In case of suspected intoxication in a child, immediate medical attention should be sought.

An overdose with nicotine-based gums can only occur if multiple gums are chewed simultaneously. Generally, the toxicity of nicotine after ingestion is minimized by the occurrence of early nausea and vomiting.

The risk of intoxication from swallowing the gum is low. The release of nicotine from the gum is slow, and the amount of nicotine absorbed by the stomach and intestine is very low. If any nicotine were absorbed, it would be inactivated in the liver.

Signs and symptoms of an overdose should be the same as those of acute nicotine poisoning, including general weakness, sweating, pallor, hyperhidrosis, hypersalivation, sore throat, nausea, vomiting, diarrhea, abdominal pain, auditory and visual disturbances (sensory disorders), headaches, dizziness, tremors, confusion, and fatigue. Prostration, hypotension, cardiovascular collapse, coma, respiratory failure, and terminal convulsions may occur in cases of significant overdose.

Treatment of overdose:

In case of overdose (e.g., excessive chewing of gums), immediate medical assistance is required. Nicotine intake should be stopped immediately, and the patient should be treated symptomatically and monitored for vital signs.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic class: MEDICINE USED IN NICOTINE DEPENDENCE, ATC code: N07BA01

Mechanism of action

Nicotine, the principal alkaloid of tobacco-derived products, is a natural substance that acts on the autonomic nervous system. It is an agonist of nicotinic receptors in the central and peripheral nervous systems, exerting pronounced effects on the central nervous system and cardiovascular system. When consumed through tobacco, nicotine creates dependence, resulting in a sense of withdrawal and other symptoms upon cessation of administration. These withdrawal symptoms include strong craving to smoke, dysphoria, insomnia, irritability, frustration or anger, anxiety, difficulty concentrating, restlessness, and increased appetite or weight gain. Chewing gums replace some of the nicotine that would have been administered through tobacco and reduce the intensity of withdrawal symptoms and the strong urge to smoke.

5.2. Pharmacokinetic properties

Absorption

When the gum is chewed, nicotine is regularly released in the mouth and quickly absorbed through the buccal mucosa. Due to the swallowing of saliva containing nicotine, a certain amount of nicotine reaches the stomach and intestines, where it is inactivated.

Distribution

The peak plasma concentration after a single administration of a 2 mg gum is approximately 6.4 ng/mL (after 45 minutes) (the average nicotine concentration in plasma after smoking a cigarette is 15 to 30 ng/mL).

Elimination

Nicotine is primarily eliminated through hepatic metabolism. Small amounts of nicotine are excreted unchanged in the urine. The plasma half-life is approximately 3 hours.

Nicotine crosses the blood-brain barrier, placenta, and is detectable in breast milk.

5.3. Preclinical safety data

Nicotine has shown positive results in certain in vitro genotoxicity tests; however, negative results have also been obtained with the same tests. Nicotine has shown negative results in in vivo tests.

Animal experiments have shown that nicotine causes post-implantation loss and decreases fetal growth.

The results of carcinogenicity tests have not provided clear evidence of a carcinogenic effect of nicotine.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Chewing gum base (containing butylhydroxytoluene (E321)), calcium carbonate, sorbitol (E420), glycerol (E422), anhydrous sodium carbonate, sodium bicarbonate, polacrilin, levomenthol, tutti frutti flavor, potassium acesulfame, saccharin, sodium saccharin, carnauba wax, talc, purified water, xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171).

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

30 months

6.4. Special precautions for storage

Store at a temperature not exceeding 25°C.

6.5. Nature and contents of the pack

2 or 12 chewing gums in a blister pack (PVC/PVDC/Aluminium).

Boxes of 2, 12, 24, 36, 48, 60, 72, 96, 120, or 204.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and handling

Disposal of used gums should be done with caution.