NICORETQUICK SPRAY 1FL 150D

NICORETTEQUICK 1 MG/IRGATION, SPRAY OROMUCOSALE, SOLUTION, AROMA

active ingredients

A free delivery of 1 mg of nicotine in 0.07 ml of solution. 1 ml solution contains 13,6 mg of nicotine. Excipients with known effect: Ethanol 7.1 mg/ dispensing Propilene glycol 12 mg/ dispensing Hydroxytoluene butylated 363 ng/erogration For the full list of excipients, see paragraph 6.1.

Excellent

Propilene glycol (E1520) Ethanol anidro Trometamolo Polossamero 407 Glicerol (E422) Sodium hydrogen carbonate Levomentolo Aroma red fruits Aroma refreshing Sucralosio Acesulfame potassium Hydroxytoluene butylated (E321) Hydrochloric acid (for pH regulation) Purified water

Therapeutic indications

Nicorettequick is used to treat tobacco addiction in adults, by relief of symptoms of nicotine withdrawal, including the desire to smoke during an attempt to break smoke. The final goal is the permanent interruption of tobacco use. The use of Nicorettequick should be preferably flanked by a behavioral support program.

Contraindications

• Hypersensitivity to nicotine or any of the excipients listed in paragraph 6.1. • Children under 18. • Subjects that have never smoked.

Population

Population Subjects must stop smoking completely during treatment with Nicorettequick. Adults and elderly The following graph illustrates the recommended usage timing for oromucosal spray during full treatment (phase I) and in phase III reduction phases. You can use up to 4 issues every hour. Do not exceed 2 dispenses for each dose and 64 dispenses (4 issues per hour within 16 hours) in a 24-hour period. Phase I: weeks from 1 to 6 Use 1 or 2 dispenses when you would smoke a cigarette or if you find the desire to smoke. If only one dispensing does not allow you to control the desire to smoke within a few minutes, provide a second dispensing. If 2 issues are needed, in the future it will be possible to provide 2 consecutive issues. Most smokers will need 1 or 2 dispenses every 30 minutes or 1 hour. Phase II: weeks from 7 to 9 Start reducing the number of daily issues. By the end of the week 9, subjects must have DIMEZZATO the average number of daily issues used in phase I. Phase III: 10 to 12 weeks Continue to reduce the number of daily issues so that, in week 12, subjects do not use more than 4 issues per day. When subjects have reduced the number of dispenses to 2-4 per day, the use of oromucosal spray must be stopped. Example: If you smoke 15 cigarettes per day on average, 1-2 dispenses must be used at least 15 times during the day. As an aid to continue the interruption of smoking after phase III, subjects can continue to use horomucosal spray in situations where they are strongly tempted to smoke. You can use only one dispensing in situations where you feel the urgency of smoking, with a second dispensing if the first did not have any effect within a few minutes. At this stage, you should not use more than four issues per day. Generally we do not recommend the regular use of the oromucosal spray over 6 months. Some ex-smokers may need a longer treatment with oromucosal spray to avoid smoking again. The residual oromucosal spray must be preserved for use in case of sudden desire to smoke. Pediatric population Do not administer Nicorettequick to subjects under the age of 18. You have no experience in treating teenagers under the age of 18 with Nicorettequick. Method of administration After preparation, point the spray spout as close to the mouth as possible. Press firmly the top of the dispenser and release a dispensing within the mouth, avoiding the lips. Subjects should not inhale during delivery, to prevent spray from being sprayed in the airways. For optimal results, do not swallow for a few seconds after delivery. Subjects should not take food or drink at the same time as the intake of the spray. Generally support and behavioral therapy increase the success rate.

Conservation

Do not store at a temperature above 30 °C

Warnings

Nicorettequick should not be used by non-smokers. The benefits of quitting smoking are higher than any risks associated with the proper administration of nicotine substitute therapy (NRT). A risk-benefit assessment must be made by appropriate medical personnel, for patients with the following conditions: • Cardiovascular pathologies: dependent smokers who have recently had myocardial infarction, unstable or aggravated angina, including Prinzmetal angina, severe heart arrhythmias or recent cerebrovascular accidents and/or those suffering from uncontrolled hypertension, should be encouraged to stop smoking through non-pharmacological interventions (e.g. counselling). If the latter have a negative outcome, it is possible to take into account the intake of oromucosal spray but, since the safety data in this group of patients are limited, the treatment should only be started under strict medical supervision. • Diabetes mellitus. Patients with diabetes mellitus should be advised to check blood glucose levels more carefully in the event of a smoke break and start of the NRT, as the reduction in the release of catecholamine induced by nicotine can affect the metabolism of carbohydrates. • Allergic reactions: predisposition to angioedema and hives. • Hepatic kidney damage and impairment: use with caution in patients with moderate to severe liver impairment and/or severe kidney damage, as a decrease in nicotine clearance or its metabolites may occur, with the possibility of an increase in adverse effects. • Phochromocytoma and uncontrolled hyperthyroidism: use with caution in case of uncontrolled hyperthyroidism or feochromocytoma, as nicotine causes the release of catecholamines. • Gastrointestinal pathology: nicotine can exacerbate symptoms in patients with esophagitis, gastric ulcers or peptics; with such conditions NRT preparations should be used with caution. Pediatric population Danger in children: doses of nicotine tolerated by smokers can cause severe toxicity in children, with fatal results. Products containing nicotine should not be left in places where they could be manipulated or ingested by children; see paragraph 4.9 Overdosing. Transmitted dependence: transmitted dependence may occur, but it is less harmful and easier to interrupt than smoking addiction. Smoke break: polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of CYP1A2 metabolized drugs (and probably CYP1A1). When a smoker stops smoking, it can manifest a slowing down of metabolism, resulting in increased levels of such drugs in the blood. This is potentially more clinically relevant for products with a restricted therapeutic window, such as theophylline, tacrine, chlozapine and ropinirol. With the cessation of tobacco use, the plasma concentration of other metabolized medicinal products in part from CYP1A2 (e.g., imipramine, olanzapine, chlomipramine and fluvoxamine) may increase, although the data supporting this theory is poor and the possible clinical significance of such an effect for such unknown medicines. A limited amount of data indicates that smoking can induce the metabolism of flecainide and pentazocin. Excipients: oromucosal spray contains small amounts of ethanol (alcohol), less than 100 mg per dose (1 or 2 dispenses). This medicine contains less than 1 mmol (23 mg) of sodium per dispensing, i.e. it is essentially ‘without sodium’. This medicine contains 12 mg of glycol propylene for each delivery, equivalent to 157 mg/mL. Due to the presence of butylated hydroxytoluene, Nicorettequick can cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucosa. You should be careful to avoid contact of the oromucosal spray with your eyes during administration.

Interactions

No clinically significant interaction has yet been confirmed between nicotine-based replacement therapy and other drugs. However, nicotine can increase the hemodynamic effects of adenosine, i.e. increased blood pressure and heart rate, as well as increased painful response (thoracic pain type angina pectoris) caused by adenosine administration (see paragraph 4.4, Smoke Interruption).

Effects

Effects of nicotine abstinence Regardless of the means used, a variety of symptoms are known to be associated with suspension of the usual use of tobacco. These include emotional or cognitive effects such as discomfort or depressed mood; insomnia; irritability, frustration or anger; anxiety; difficulty of concentration and restlessness or impatience. Physical effects can also occur as a decrease in heart rate; increased appetite or weight, dizziness or precouple symptoms, cough, constipation, gum bleeding or aftous ulceration, or renofaringitis. Besides, and of clinical importance, nicotine desire can cause a deep impulse to fumare.Nicorettequick can cause adverse reactions similar to those associated with nicotine taken in other ways and mainly dependent on dose. In predisposed individuals, allergic reactions such as angioedema, hives or anaphylaxis may occur. The local adverse effects of administration are similar to those observed with other oral forms. In the first days of treatment, mouth and throat irritation may occur; also the hiccups is a particularly common effect. Assumption is normal with prolonged use. The daily collection of data from the subjects of the study showed that the most common adverse events were reported with an onset in the first 2-3 weeks of use of the oromucosal spray, and then decrease. The adverse reactions observed with nicotine formulations for oromucosal use identified by clinical studies and during post-marketing experience are presented below. The frequency category was estimated through clinical trials for adverse reactions identified during the post-marketing experience. Very common (≥1/10); common (≥1/100 a Classification for Systems and Organs References Immune system disorders Town Hypersensitivity Notable Allergic reactions, including angioedema and anaphylaxis Psychiatric disorders Not common Anomalous dreams Diseases of the nervous system Very common Cefa Town Disgeusia, parestesia Pathologies of the eye Notable Offused vision, increased tearing Heart disease Not common Palpitations, tachycardia Notable Atrial fibrillation Vascular diseases Not common Redness, hypertension Respiratory, chest and mediastinic pathologies Very common Sludge, throat irritation Town Tosses Not common Broncospasm, rhyrrhea, dysphony, dysphony, nasal congestion, oropharynx pain, sneezing, throat tension Gastrointestinal diseases Very common Nausea Town Abdominal pain, mouth dryness, diarrhea, dyspepsia, flatulence, salivary hypersecretion, stomatitis, vomiting Not common Eruttations, glossy gum bleeding, bladders and exfoliation of the oral mucosa, oral paresthesia Rare Disphagia, oral hypoesthesia, vomiting Notable Gorgeous dryness, gastrointestinal disorders, lip pain. Pathologies of skin and subcutaneous tissue Not common Hyperhidrosis, itching, rash, hives Notable Eritema Systemic pathologies and conditions for administration Town Feeling of burning, fatigue Not common Astenia, discomfort and chest pain, malaise Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Direct symptoms of nicotine overdose can occur in patients with a reduced intake of pre-treatment nicotine or if they are simultaneously nicotine from multiple sources. 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, fatigue, circular collapse and generalized seizures. Pediatric population Nicotine doses tolerated by adult smokers during treatment can cause severe symptoms of poisoning with fatal outcomes even in children. Suspect nicotine poisoning in a child must be treated as a medical emergency requiring immediate intervention. Overdose management: nicotine administration should be stopped immediately and subject the patient to symptomatic treatment. If an excessive amount of nicotine is ingested, activated charcoal reduces nicotine gastrointestinal absorption. It is believed that the acute minimum lethal dose of nicotine in man is between 40 and 60 mg.

Women in fertile age /Contraception in men and women The adverse effects of tobacco smoking on human conception and pregnancy are known, while the effects of nicotine-based therapeutic treatment are unknown. Therefore, since until today specific recommendations regarding the need for female contraception have not been considered necessary, the most prudent condition for women who intend to start a pregnancy is not smoking and do not make use of NRT. As for men, smoking may cause adverse effects on male fertility, but there are no evidence of the need for particular contraceptive measures by men during NRT treatment.Pregnancy Smoking during pregnancy is associated with risks such as delay in intrauterine growth, premature birth or birth of a dead fetus. The interruption of smoking is the only really effective intervention to improve the health of the smoker in pregnancy and the child. The sooner you reach abstinence, the better the results. The nicotine is transmitted to the fetus, with consequences on the respiratory movements and the circulation of the latter. The effect on the circulation depends on the dose. As a result, the pregnant smoker should always be advised to stop smoking completely without resorting to nicotine-based replacement therapy. The risk of prosecuting smoking may lead to more serious dangers to the fetus than the use of nicotine-based substitute products in a controlled program of cessation of tobacco use. The use of Nicorettequick by a pregnant smoker must be undertaken only on the advice of a health care worker. Food Nicotine passes freely in breast milk in quantities such as to affect the child, even at therapeutic doses. As a result, you should avoid taking Nicorettequick during breastfeeding. If you can't stop smoking, the use of Nicorettequick by nursing smokers should only be undertaken on the advice of a healthcare provider. Women must take the product immediately after breastfeeding and wait as long as possible (it is suggested 2 hours) before the next stern. Fertility Smoking increases the risk of infertility in women and men. In vitro studies have shown that nicotine can negatively affect the quality of human sperm. In rats, reduced fertility and compromised sperm quality has been demonstrated.

Source: Farmadati