Nicotinell 2 mg Fresh Mint Gum

Nicotinell 2 mg fresh mint is a gum that helps people quit smoking. It has nicotine, the same stuff that's in cigarettes, but instead of smoking, you chew this gum.

Here's how you use it: When you feel like smoking, instead, you chew a gum. You should do this slowly until the taste gets strong. Then, put it between your cheek and gums. Once the taste fades, you can chew it again. This process can last about 30 minutes.

Try to chew a gum every 1 to 2 hours, which is about 8 to 12 gums a day. However, don't chew more than 25 gums in a day. Your treatment should last for at least 3 months, gradually chewing fewer gums each day. When you're down to 1-2 gums a day, you can stop. But don't use it for more than 6 months unless your doctor tells you to.

Be careful not to chew too many gums because you could get nicotine overdose. The symptoms include weakness, sweating, nausea, vomiting, and even seizures which can be deadly. If this happens, contact a doctor.

Also, don't let kids get these gums. Even small amounts of nicotine can be very harmful to them.

This gum is not for you if you're allergic to nicotine or any other ingredients in it, or if you're not a regular smoker. And if you have certain health conditions, like heart problems, high blood pressure, liver or kidney problems, or certain other illnesses, you should ask your doctor before using this gum.

Also, this gum might interact with other medicines you're taking. So, make sure to tell your doctor about any other medicines you're on. And, avoid drinking fizzy, acidic drinks and coffee 15 minutes before chewing the gum.

Pregnant women should avoid smoking as it's harmful to them and their baby. If you're breastfeeding, you shouldn't use the gum within two hours before breastfeeding because nicotine can pass into breast milk.

Lastly, this gum might have some side effects like headaches, dizziness, hiccups, and mouth irritation. If you chew the gum more slowly, these might lessen. If you get serious side effects like heart rhythm problems or allergic reactions, stop using the gum and call a doctor.

Please read the following full disclosure:

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM - Updated on: 22/11/2021

1. NAME OF THE MEDICINE

NICOTINELL FRESH MINT 2 mg SUGAR-FREE, medicated chewing gum

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

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

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

For a medicated chewing gum.

Excipients: Sorbitol (0.1 g), and butylhydroxytoluene (E 321).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Medicated chewing gum.

White rectangular-shaped gum.

4. CLINICAL DATA

4.1. Therapeutic indications

This medicine is indicated in the treatment of tobacco dependence to relieve the symptoms of nicotine withdrawal in people wishing to stop their tobacco consumption.

Appropriate support improves the chances of success in quitting tobacco.

4.2. Dosage and method of administration

Dosage

Adults over 18 years and elderly

Patients must stop smoking completely during treatment with this medicine.

The 2 mg dosage chewing gums are not recommended for smokers who are highly or very highly dependent on nicotine.

The initial dosage will be personalized according to the nicotine dependence of the individual.

In case of side effects when using 4 mg dosage chewing gums, switch to the 2 mg dosage chewing gums.

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

Chew a gum each time the urge to smoke arises.

The consumption of 2 mg dosage chewing gums is generally 8 to 12 gums per day and should never exceed 24 gums per day. Do not use more than one gum per hour.

The characteristics of this pharmaceutical form are such that the nicotine levels obtained can vary from one individual to another. The frequency of administration will be adjusted accordingly, depending on individual needs within the limit of the maximum dosage.

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 the treatment is completely stopped.

Treatment will be stopped 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 need longer treatment to avoid relapses. Patients who have used a nicotine substitute beyond 9 months are advised to seek advice from a health professional.

Advice from a health professional can help a smoker quit tobacco.

This medicine does not contain sugar.

Children and Adolescents

NICOTINELL FRESH MINT 2 mg sugar-free, chewing gum should not be administered to individuals under 18 years of age without medical advice. There is no experience with the administration of this medicine to individuals under 18 years of age.

Renal and Hepatic Insufficiency

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

Method of Administration

· Chew the gum until the taste becomes strong.

· Place the gum between the gum and the cheek.

· When the taste fades, chew the gum again.

· Alternate chewing and pauses for 30 minutes.

The intake of acidic drinks such as coffee or soda can decrease the absorption of nicotine through the oral mucosa. These drinks should be avoided for 15 minutes before taking a chewing gum.

4.3. Contraindications

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

· NICOTINELL FRESH MINT 2 mg sugar-free, chewing gum should not be used by non-smokers.

4.4. Special warnings and precautions for use

In case of recent myocardial infarction, unstable or worsening angina (including Prinzmetal angina), severe heart rhythm disorder, unstable hypertension or recent cerebrovascular accident which are considered hemodynamically unstable, complete cessation of tobacco use with non-pharmacological treatments should always be recommended.

In case of failure in these nicotine-dependent smokers, the use of NICOTINELL FRESH MINT 2 mg chewing gum can be considered; however, as clinical safety data in these patients are limited, treatment initiation should only be under medical supervision. In case of clinically significant increase in cardiovascular or other effects attributable to nicotine, the dosage of Nicotinell FRESH MINT 2 mg should be reduced or the medication stopped.

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

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

In these patients, complete cessation of tobacco use without nicotine replacement therapy should first be recommended.

Swallowed nicotine can exacerbate symptoms in subjects suffering from oesophagitis, oral or pharyngeal inflammation, gastritis or gastric ulcer.

Nicotine doses tolerated in smoking adults can cause serious or even fatal poisoning in young children (see section 4.9).

Keep out of the sight and reach of children.

Wearers of dentures may have difficulty chewing the gums: in this case, it is recommended to use another pharmaceutical form of nicotine replacement.

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

Special warnings related to excipients:

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

NICOTINELL FRESH MINT 2 mg gums contain sweeteners, including 0.1 g/gum of sorbitol (E420), source of fructose at a rate of 0.02 g/gum. The caloric intake of each gum is 1.2 Kcal/gum.

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

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

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