NICORETICY 20PAST 2MG

NICORETTEICY 2 MG TABLETS IS NOT RECOMMENDED

active ingredients

Each lozenge contains 2 mg nicotine (in the form of nicotine resinate).For a full list of excipients, see section 6.1.

Excellent

Pastel core: Mannitol (E421) Winterfresh RDE4–149 Spray died (Arabic rubber (E414) peppermint, menthol and eucalyptus aromas) Anidro sodium carbonate (E500)(i) Sucralosio (E955) Potassium Acesulphame (E950) Magnesium stearate (E470b) Coating: Ipromellose (E464) Winterfresh RDE4–149 (pepiterate, menthol and eucalyptus) Titanium Dioxide (E171) Sucralose (E955) Sepifilm Gloss (Ipromellose (E464), Microcrystalline Cellulose (E460), Aluminium– Potassium Sylicate (E55Esulphase)

Therapeutic indications

Nicoretteicy 2 mg tablets are used to treat tobacco dependence by relief from symptoms of nicotine withdrawal and desire in smokers at least 18 years of age. The final goal is the permanent cessation of tobacco use. Nicoretteicy 2 mg tablets should be used preferably in conjunction with a behavioral support program.

Contraindications

• Hypersensitivity to nicotine or one of the excipients of the pastilla. • Children under 18. Non-smoking

Population

Population The dose of tablets to administer will depend on the smoking habits of individuals. Adults Nicoretteicy 2 mg tablets are suitable for smokers who have a low dependence on nicotine, for example those who smoke the first cigarette of the day more than 30 minutes after awakening or smoke less than 20 cigarettes per day. Meals should not be used for a period of more than 6 months. If users still feel the need for treatment, consult a doctor. Behavioral counseling and support will improve the success rate. Pediatric population Children and teenagers Nicoretteicy tablets 2 mg are not recommended for use in subjects under the age of 18. Method of administration Use oromucosal Place a batter in your mouth and let it dissolve. From time to time move the batter to one side of the mouth, until it is completely dissolved (about 16–19 minutes). Do not chew or swallow the whole batter. Do not take food or beverages at the same time as the pastel. Liquids lowering oral pH such as coffee, juices and carbonated beverages can reduce nicotine absorption in the mouth. To obtain an optimal absorption of nicotine, do not take such liquids in the 15 minutes prior to the intake of the batter. The patient must stop smoking completely during treatment with Nicoretteicy tablets. The tablets should be used whenever you feel the desire to smoke. Take a sufficient amount of tablets every day; most smokers usually need 8–12 pads, for up to 15. The duration of treatment varies from one individual to another, but we recommend a maximum treatment of 6 weeks to stop smoking. The dose of nicotine must be reduced gradually, decreasing the total number of tablets taken per day. When daily consumption is less than 1–2 tablets, stop treatment. Take a pill every time you feel the desire to smoke to maintain full abstinence from smoking. Store all the remaining tablets for hiring in case of sudden desire to smoke. If you take pills for more than 6 months you should contact a doctor to obtain additional support and assistance.

Conservation

Polypropylene container: Store the pads in the original container sheltered from moisture. Blister: This medicine does not require special conditions of conservation.

Warnings

Usually, the advantages of quitting smoking are far higher than the risk associated with a replacement therapy with nicotine administered properly. An assessment of the risks and benefits of a medical practitioner with the following conditions is required: • Dependent smokers with a recent myocardial infarction, unstable or worsening angina, Prinzmetal's angina, severe cardiac arrhythmias, uncontrolled hypertension, recent cerebrovascular accident and/or subjects considered haemodynamically unstable should be encouraged to stop smoking through non-pharmacological interventions (such as advice). If the latter have a negative outcome, it is possible to consider taking Nicoretteicy tablets 2 mg, but since the data on safety in this group of patients are limited, treatment should only be started under strict medical supervision. • Stable cardiovascular disease as hypertension, stable angina pectoris, cerebrovascular pathologies, peripheral occlusive arterial disease and heart failure. • Diabetes mellitus. Patients with diabetes mellitus need to check blood glucose levels more closely than usual in the event of a smoke break and start of nicotine replacement therapy, as the reduction of catecholamine induced by nicotine can affect the metabolism of carbohydrates. • Allergic reactions: susceptibility to angioedema and hives. • Renal and hepatic failure: Carefully use in patients with moderate to severe liver failure and/or severe kidney failure as a decrease in nicotine clearance or its metabolites may occur, with the possibility of an increase in unwanted effects. • Uncontrolled phochromocytoma and hyperthyroidism: Use carefully in case of uncontrolled hyperthyroidism or feocromocytoma as nicotine causes the release of catecholamines. • Gastrointestinal pathology: Ingested nicotine can exacerbate symptoms in patients suffering from esophagitis, gastric or peptic ulcers; preparations of replacement therapy with oral nicotine should be used with caution in these conditions. Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers may produce serious toxicity in young children, with even fatal outcomes.Nicotine-containing products should not be left in places where they could be misused, handled or ingested by children, see section 4.9 Overdose. Smoking intervention: Polycyclic aromatic hydrocarbons present in tobacco smoke induce the metabolism of CYP1A2 metabolized drugs (and probably CYP1A1). When a smoker stops smoking, a slowdown in metabolism could occur, resulting in increased levels of such drugs in the blood. The potentially significant drugs from the clinical point of view are indicated in the section 4.5. Transmitted dependence: The transmitted dependence is unusual, less harmful and easier to interrupt than smoking addiction.

Interactions

The cessation of smoking, with or without nicotine substitutes, may alter the response to the concomitant drug in former smokers. It is possible that an adjustment of the dose of these drugs is necessary and, for drugs with a narrow therapeutic margin, such as theophylline, the interruption of smoking must be accompanied by rigorous clinical and laboratory monitoring; the patient must also be informed about the risks of overdose. When smoking is stopped, it may be necessary to adjust the dose for the following drugs:

It may be necessary decrease of the dose at the cessation of smoking	Possible mechanism of action
Caffeine, theophylline, imipramine, pentazocin, phenacetin, phenylbutazone, tacrine, chlomipramine,	Reduced induction of CYP1A2
olanzapine, fluvoxamine, flecainide, ropinirole.
Insulin	Increase in absorption of subcutaneous insulin
Antagonists adrenergic, e.g. prazosin, propanol.	Decrease in circulation
You may need a increase of the dose at the cessation of smoking	Possible mechanism of action
Agonists adrenergic, e.g. isoprenaline, salbutamolo	Decrease in circulation

Effects

Replacement therapy with nicotine can cause undesirable effects similar to those associated with nicotine administered in other ways, including smoking. These can be attributed to the pharmacological effects of nicotine, some of which depend on the dose. The excessive consumption of the tablets Nicoretteicy 2 mg by individuals who do not have the habit of inhaling tobacco smoking may result in nausea, weakness or headache. Some symptoms that have been reported, such as depression, irritability, anxiety, increased appetite and insomnia, may be related to withdrawal symptoms associated with smoking cessation. Subjects who interrupt the usual use of tobacco in any way, may suffer from an associated nicotine withdrawal syndrome that includes at least four of the following symptoms: dysphoria or mood; insomnia; irritability; frustration or anger; anxiety; difficulty of concentration; restlessness or impatience; decrease in heart rate; increased appetite or weight. Also the desire for nicotine and the urgency of smoking are recognized as clinically relevant symptoms and an important additional element in nicotine abstinence after the cessation of smoking. Nicoretteicy 2 mg tablets cause undesirable reactions similar to those associated with nicotine taken in other ways and these mainly depend on the dose. After abstinence from smoking, an increased frequency of aftous ulcer may occur. Cases are not clear. Within each frequency group, the unwanted effects are presented in descending order of gravity: very common (≥1/10), common (from ≥1/100 to non-common (from ≥1/1.000 to rare (≥1/10.000, very rare (

Overdosing

It is believed that the acute minimum lethal dose of nicotine in humans is between 40 and 60 mg. Direct symptoms of nicotine overdose can occur in patients with a low pre-treatment nicotine intake or if it simultaneously takes nicotine from multiple sources. Nicotine doses that are tolerated by adult smokers during treatment can produce severe symptoms of poisoning in small children with also fatal outcomes. Suspect nicotine poisoning in a child must be treated as a medical emergency requiring immediate intervention. Overdose symptoms coincide with those from acute nicotine poisoning and include nausea, vomiting, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing disorders and marked weakness. At high doses, such symptoms can be followed by hypotension, weak and irregular beat, respiratory difficulties, prostration, circulatory collapse and terminal convulsions. Overdose Management: Interrupt nicotine administration immediately and treat the patient symptomaticly. Active carbon reduces gastrointestinal absorption of nicotine.

Women in fertile age/contraception in males and females

Unlike the well-known side effects of tobacco smoking on conception and pregnancy in humans, the effects of treatment with therapeutic nicotine are not known. As a result, although today it has not been considered necessary to give specific advice on female contraception, the most prudent condition for a woman looking for a pregnancy is to be non-smoker and not to make use of substitute therapies with nicotine. Smoking may have side effects on male fertility, but it has not been shown that special contraceptive measures are necessary during nicotine replacement therapy in male subjects.

Pregnancy

The harmful effects of tobacco smoking on the health of the mother and fetus or child were widely demonstrated. These effects include reduced birth weight, increased risk of miscarriage and increased perinatal mortality. The interruption of smoking is the only effective intervention to improve the health of the smoker in pregnancy and the fetus and the less time to reach abstinence, the better the outcomes will be. Nicotine passes to the fetus and can cause changes depending on the dose in placentare/fetal circulation and respiratory movements. The use of the Nicoretteicy tablets by a highly dependent pregnant smoker should only take place after medical indication, following the assessment of the relationship between risks and benefits. The decision to resort to nicotine replacement therapy must be taken at the early stage of pregnancy as soon as possible. The goal is to use nicotine replacement therapy for only 2–3 months. Intermittent dosing products may be preferable since, usually, they provide a lower nicotine daily dosage compared to patches. However, if the woman suffers from nausea during pregnancy, patches may be preferable. Food Nicotine passes freely in breast milk in quantities such as to affect the child, even at therapeutic doses; therefore, patients should ideally stop smoking without the use of nicotine replacement therapy. If this is not possible, the use of Nicoretteicy pills to assist nursing women in an attempt to quit must only happen after a doctor's indication, following an assessment of the relationship between risks and benefits. To minimize the nicotine content in breast milk, when using nicotine replacement therapy, women must try to breastfeed just before taking the product and allow to spend the greatest amount of time possible (recommended time: 2 hours) between taking a pastry and breastfeeding later. Nicotine and fertility In women's subjects, tobacco smoke delays conception time, decreases the success rates of in vitro fertilization and significantly increases the risk of infertility. In male subjects, tobacco smoke reduces sperm production, increases oxidative stress and DNA damage. Smoking sperm has a reduced fertilizer capacity. The specific contribution of nicotine to these effects in humans is unknown.

Source: Farmadati