Nicorette 2 mg - 105 chewable gums for smoking cessation

Product Description

Mint-flavored nicotine-based chewable gum useful for smokers motivated to quit smoking.

Indications

Nicorette 2 mg Gums are used in the treatment of smoking cessation.
With strong>mint flavor.

Composition

Active ingredients
One gum contains 2 mg of nicotine.

Excipients
Chewing gum base, xylitol, pepper mint oil, acesulfame potassium, sodium carbonate, sodium bicarbonate, levomenthol, magnesium oxide, pregelatinized starch, titanium dioxide, carnauba wax, hypromellose, sucralose, polysorbate 80, glacial mint.

How to use and Dosage

The medicine should be taken according to the following doses and methods:
The dosage of Nicorette depends on the number of cigarettes normally consumed by the individual smoker.

In adults and the elderly, it is advisable to start with the 2 mg preparation, identifying, as needed, the optimal dosage, i.e. the number of gums to chew during the day.
The number of gums used must be sufficient to cover the nicotine requirement.
Chew one gum every time you feel the need to smoke.
For most smokers, 10 2 mg gums per day are usually sufficient.
If 15 2 mg gums per day are not sufficient, such as in heavy smokers (more than 20 cigarettes per day), it is preferable to use Nicorette 4 mg chewable gums, or two 2 mg gums at the same time.
Do not use more of 15 4 mg gums per day.

The recommended duration of treatment is 3 months.
After this period, the daily dose should be gradually reduced.
When this has dropped to 1-2 gums, it is advisable to try to completely stop using Nicorette.
However, it is advisable to keep some spare gum on hand in case of a sudden return of the desire to smoke.
For the use of Nicorette gums in diabetics, see paragraph.
It is not advisable to continue the treatment beyond 12 months.

The safety and efficacy in children and adolescents under 18 years of age have not yet been established.
It is important to chew very slowly for at least 30 minutes to obtain the release of nicotine.
Chewing too quickly causes the nicotine to be absorbed too quickly: to avoid this inconvenience, it is advisable to stop occasionally chewing

Warnings

Nicotine administration should be temporarily discontinued if any symptoms of overdose occur.
If symptoms of nicotine overdose persist, nicotine intake should be decreased either by frequency of administration or by lowering the dosage.
A risk-benefit assessment by a competent physician is necessary for patients with the following conditions:

• Severe cardiovascular disease (e.g. peripheral occlusive arterial disease, cerebrovascular disease, cardiac failure), vasospasms and uncontrolled hypertension, as the cardiovascular effects of nicotine can be hazardous.
  Such patients should be encouraged to stop smoking with non-pharmacological interventions (such as counseling); if this is not possible, the patient should be advised to stop smoking. If this is not sufficient, therapy with medicated chewing gum may be considered.
  Since safety data in this patient group are limited, treatment should be initiated only with caution.
• Moderate and severe hepatic impairment and/or severe renal impairment.
  Use with caution in such patients as the clearance of nicotine or its metabolites may be reduced with a potential increase in adverse effects;
• Esophagitis and/or gastric or peptic ulcers.
  Use with caution in such patients as nicotine may worsen the symptoms of these conditions;
• Diabetes mellitus.
  Such patients should be advised to monitor their blood sugar levels more frequently. more frequently than usual because, when smoking is stopped and nicotine replacement therapy (NRT) is started, the release of catecholamines induced by nicotine is reduced and this may affect carbohydrate metabolism;
• Uncontrolled hyperthyroidism or pheochromocytoma, as nicotine causes the release of catecholamines from the adrenal glands.

The use of Nicorette is less risky than smoking.
Smokers who wear dentures may have difficulty chewing Nicorette gum, as chewing gum may cause irritation. stick to dentures and in rare cases damage them.
When using nicotine replacement therapy products to reduce smoking, nicotine from cigarettes is also present in the body.
It is unclear whether the nicotine from cigarettes affects the elimination of nicotine from nicotine replacement therapy products or vice versa.
Although it has been reported that nicotine is eliminated more rapidly in smokers than in non-smokers, suggesting that nicotine itself promotes its own elimination, a more in-depth study has shown that the opposite is also true.
Another study found that cotinine, the main metabolite of nicotine produced by smoking, did not increase or decrease nicotine elimination.
In a more direct test conducted on the same subjects, the elimination of intravenous nicotine was found to be faster than that of non-smokers. 36% slower during a short period of smoking compared to a short period of abstinence.
The medicine contains sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine.

Overdose

If the patient is an occasional smoker or smokes a few cigarettes a day, or chews Nicortette gum at the same time as taking other forms of nicotine (inhaler, patch), you may experience an overdose. Check for an overdose.
Symptoms of overdose present as nicotine poisoning and include nausea, vomiting, excessive salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing impairment, and obvious weakness.
At high doses, these symptoms may be followed by hypotension, a weak and irregular pulse, difficulty breathing, prostration, circulatory collapse, and generalized convulsions.
Doses of nicotine tolerated by adult smokers during treatment can cause severe poisoning symptoms in children and can be fatal.
Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.
The minimum acute lethal oral dose of nicotine in humans is believed to be between 40 and 60 mg.
Nicotine intake should be discontinued immediately and the patient should be treated symptomatically.
Artificial respiration should be administered if necessary. with oxygen.
If an excessive amount of nicotine is taken, activated charcoal reduces the gastrointestinal absorption of nicotine.

Contraindications

• Hypersensitivity to nicotine or to any of the excipients
• Non-smokers
• Recent myocardial infarction
• Unstable or aggravated angina pectoris
• Prinzmetal's angina
• Severe cardiac arrhythmia
• Acute stroke
• Pregnancy and breastfeeding
• Children and adolescents under 18 years of age.

Side effects

Abrupt cessation of tobacco products after a prolonged period of daily use causes a characteristic withdrawal syndrome characterized by the following manifestations: dysphoria or depressed mood; insomnia; irritability, frustration, anger; anxiety; difficulty concentrating, restlessness or impatience; bradycardia; increased appetite or weight gain, dizziness, and headache.
Intense nicotine craving, which is recognized as a relevant clinical symptom, is also an important element in nicotine withdrawal.
Most of the adverse effects experienced by subjects occur during the first phase of treatment and are mainly dose-dependent.
Mouth and throat irritation may occur, however, most subjects adapt with continued use.
The safety of nicotine from clinical studies is based on data from a meta-analysis of randomized clinical trials for smoking cessation treatment.
The list below contains adverse reactions reported with a frequency of >1%, identified from a meta-analysis of data from clinical studies with oral nicotine formulations.

• Gastrointestinal disorders: abdominal pain, dry mouth, dyspepsia, flatulence, nausea, salivary hypersecretion, stomatitis, vomiting.
• Systemic disorders and conditions related to the administration site: burning at the application site, fatigue.
• Immune system disorders: hypersensitivity
• Nervous system disorders: headache, dysgeusia, paraesthesia.
• Respiratory, thoracic and mediastinal disorders: cough, hiccups, throat irritation

Other effects may include: mouth irritation, ulcerative aphthae, anxiety, depression, vomiting, joint pain, heartburn, flatulence, feeling of thirst.
The undesirable effects collected from post-marketing experience are reported according to frequency categories using the following convention:

• Very common (> 1/10).
• Common (> 1/100 and <1/10).
• Uncommon (≥ 1/1,000 and < 1/100).
• Rare (≥ 1/10,000 and
• Very rare (<1/10,000).
• Not known (frequency cannot be estimated from the available clinical data).

Cardiac disorders
Uncommon: palpitations*, tachycardia*.
Eye disorders
Not known: blurred vision, increased lacrimation.
Gastrointestinal disorders
Common: diarrhoea.
Uncommon: eructation, glossitis, oral mucosal blistering, oral paraesthesia.
Rare: dysphagia, hypoaesthesia oral, retching.
Not known: dry throat, gastrointestinal discomfort*, lip pain.
General disorders and administration site conditions
Uncommon: asthenia*, chest discomfort*, chest pain*, malaise*.
Immune system disorders
Not known: anaphylactic reaction*.
Musculoskeletal and connective tissue disorders
Uncommon: jaw pain.
Not known: muscle tension.
Psychiatric disorders
Uncommon: abnormal dreams*.
Respiratory, thoracic and mediastinal disorders
Uncommon: bronchospasm, dysphonia, dyspnoea*, nasal congestion, oropharyngeal pain, sneezing, throat tightness.
/>Skin and subcutaneous tissue disorders
Uncommon: hyperhidrosis*, pruritus*, rash*, urticaria*.
Not known: Angioedema*, erythema*.
Vascular disorders
Uncommon: flushing*, hypertension*.
*Systemic effects.