Nicorette Microtab Lemon : per tablet: Nicotine 2 mg
(as nicotine bitartrate dihydrate)
Excipients :mannitol, microcrystalline cellulose, povidone 90, methylcellulose, silicified microcrystalline cellulose, magnesium stearate, lemon flavour (containing maltodextrin), aspartam E 951, sweet flavour (containing maltodextrin).
Aspartam content : 0,68 mg/cp.
INDICATIONS
Treatment of tobacco dependence in order to relieve nicotine withdrawal symptoms, particularly irresistible cravings, in subjects wishing to stop smoking.
Appropriate management increases the success rate of smoking cessation.
DOSAGE AND ADMINISTRATION
Dosage :
Children and adolescents: Nicorette Microtab and Nicorette Microtab Citron should not be administered to subjects under 18 years of age without a medical prescription. There are no data evaluating treatment with Nicorette Microtab or Nicorette Microtab Citron sublingual tablets in subjects under 18 years of age. The patient should stop smoking completely while taking Nicorette Microtab or Nicorette Microtab Citron.
Adults and elderly subjects:Nicorette Microtab and Nicorette Microtab Citron will be placed under the tongue, where they dissolve slowly (about 30 minutes).The initial dosage is individual and will depend on the patient's dependence on nicotine.It is recommended that smokers with a low level of dependence (cf. Fagerström test or smoking less than 20 cigarettes per day) use the 2 mg tablets.In highly dependent smokers (cf. Fagerström test or smoking more than 20 cigarettes a day) or in patients who have already failed in their attempt to stop smoking with the 2 mg tablets, it is recommended to use the 4 mg tablets.The initial dosage is 1 tablet every 1-2 hours up to 8-12 tablets per day.2 mg tablets may be used in place of 1 4 mg tablet.Do not exceed 30 2 mg sublingual tablets per day.The duration of treatment is individual, but is usually at least 2-3 months. The daily number of tablets will then be gradually reduced. The treatment will be stopped when the dosage is reduced to 1 to 2 tablets per day. It is recommended not to use Nicorette Microtab or Nicorette Microtab Citron regularly for more than 6 months. Some "ex-smokers" may however require a longer treatment period to avoid a relapse.
CONTRAINDICATIONS
- Hypersensitivity to nicotine or to one of the components of the sublingual tablet.
- Recent myocardial infarction (within the last three months).
- Unstable or progressive angina.
- Prinzmetal's angina.
- Severe heart rhythm disorder.
- Recent cerebrovascular accident.
WARNINGS and PRECAUTIONS
Nicorette Microtab and Nicorette Microtab Citron sublingual tablets should be used with caution in patients with severe cardiovascular disease (obliterative peripheral arterial disease, stroke, angina, decompensated heart failure), vasospasm, uncontrolled hypertension, severe or moderate hepatic insufficiency, severe renal insufficiency, or evolving gastric or duodenal ulcers. Nicotine from replacement therapy as well as nicotine inhaled with cigarette smoke causes the release of catecholamines by the adrenal medulla. Therefore, Nicorette Microtab and Nicorette Microtab Lemon should be used with caution in patients with hyperthyroidism or pheochromocytoma. Smoking cessation may require a reduction in insulin doses in diabetic patients. The doses of nicotine tolerated by adult smokers during treatment may lead to acute intoxication which may be fatal in young children (see Overdose). Nicorette Microtab Lemon contains aspartam (see Composition), a source of phenylalanine. This may be harmful to patients with phenylketonuria.
INTERACTIONS
Drug Interactions: Smoking (but not nicotine) may result in enzymatic induction of cytochrome CYP1A2. Upon cessation of smoking, the clearance of substrates of this enzyme may be decreased. With products with a narrow therapeutic range, such as theophylline, tacrine, clozapine and ropinirole, increased plasma levels may be observed which may have clinical consequences. It is possible that plasma levels of other products partially metabolized by cytochrome CYP1A2, such as imipramine, olanzapine, clomipramine, and fluvoxamine, may also be increased when smoking is stopped. However, there are no data evaluating this effect and its clinical impact. Smoking appears to increase the metabolism of flecainide and pentazocine.
FERTILITY/PREGNANCY/BREASTFEEDING
Pregnancy:
Smoking during pregnancy is associated with risks such as intrauterine growth retardation, premature birth, or stillbirth, which appear, however, to be correlated with the amount of cigarettes smoked and the period of pregnancy. Indeed, these effects were observed when smoking continued into the third trimester. Smoking cessation is the only effective way to improve the health of both mother and child, and the most important thing is to succeed in quitting smoking before the first trimester of pregnancy. The earlier you quit, the better the outcome.
Nicotine crosses the placental barrier and affects the cardiovascular system and chest movements of the fetus. The effects on the circulatory system are dose-dependent.
Therefore, in pregnant women, complete cessation of smoking should always be recommended, without nicotine replacement therapy. However, the risk to the fetus from continued smoking during pregnancy is much greater than that expected from controlled nicotine replacement therapy as part of comprehensive management. Therefore, in case of pregnancy in a highly dependent smoker, the use of sublingual tablets should only be considered on medical prescription.
Breastfeeding :
Nicotine passes easily into breast milk. The levels of nicotine reached can, even at therapeutic doses, have an impact on the infant. Therefore, this treatment should be avoided during lactation.
However, if smoking cessation fails, sublingual tablets should be used in breastfeeding women only on medical advice. If nicotine replacement therapy is used during breastfeeding, sublingual tablets should be taken immediately after breastfeeding and not during the two hours preceding it.
DRIVING AND USE OF MACHINES
Nicorette Microtab and Nicorette Microtab Citron have little or no effect on the ability to drive and use machines.
ADVERSE REACTIONS
Nicorette Microtab and Nicorette Microtab Citron may cause adverse reactions similar to those seen with nicotine administered by other means; these reactions are dose-dependent. Most of the reported adverse events occur within the first 3 to 4 weeks after the start of treatment. In the first few days of treatment, irritation of the mouth or throat may occur. In most cases, patients quickly get used to these effects after a few days. Some symptoms such as dizziness, headache and insomnia may be related to smoking cessation. An increase in the occurrence of mouth ulcers may occur after smoking cessation. The causal relationship is not clearly established. Very common (>= 1/10); common (>= 1/100, < 1/10); uncommon (>= 1/1000, < 1/100); rare (>= 1/10,000, < 1/1000); very rare (< 1/10,000); frequency unknown (cannot be estimated from available data).
Central nervous system:
Common: dizziness, headache.
Gastrointestinal System:
Common: nausea, vomiting (Nicorette Microtab Lemon), digestive discomfort, hiccups.
Respiratory System:
Common: cough.
Local effects:
Common: Sore throat and mouth irritation, dry mouth, mouth burning sensation, rhinitis.
Cardiovascular System:
Common: palpitations.Rare: reversible atrial fibrillation.
OVERDOSAGE
Symptoms of nicotine overdose may occur in patients previously treated with very low nicotine intakes or if they are concomitantly using other smoking cessation therapies. Symptoms of overdose are those of acute nicotine intoxication including nausea, hypersalivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing impairment and general weakness. At high doses, hypotension, weak and irregular pulse, respiratory distress, prostration, cardiovascular collapse and convulsions may occur. The doses of nicotine tolerated by adult smokers during treatment may lead to acute intoxication which may be fatal in young children. Action in case of overdose: Nicotine administration should be discontinued immediately and symptomatic treatment should be instituted. Activated charcoal reduces gastrointestinal absorption of nicotine. The minimum lethal dose of nicotine administered orally in humans is in the range of 40 to 60 mg.
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