NIQUITIN 7CER TRANSD 14MG/24H

NIQUITIN 14 MG/24

active ingredients

Each 15 cm2 transdermal patch contains 78 mg of nicotine, equivalent to 5,1mg/cm2 of nicotine and which releases 14 mg of nicotine in 24 hours. For the full list of excipients, see paragraph 6.1.

Excellent

Active substance storage: ethylene vinyl acetate copolymer. Dorsal wall: polyethylene/aluminum/polyethylene tereftalate/ethylene acetate vinyl. Permeable member: polyethylene film. Adhesive layer and protective foil: laminate polysobutilene adhesive. Press ink: FGN-7214 NT20 Brown ink 465.

Therapeutic indications

NiQuitin is indicated to alleviate symptoms from nicotine withdrawal including desire, acting as a help to stop smoking. If possible, when you are quitting smoking, NiQuitin must be used together with a behavioral support program. NiQuitin transdermal patches is indicated in adults and adolescents from 12 years on.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. NiQuitin should not be used by: • children under 12 years; • occasional smokers; • non-smoking.

Population

Population Adults (from 18 years up) The patches must be used as indicated below. Before starting the therapy the candidates to use nicotine through transdermal must want to stop smoking. During an attempt to quit, it must be made every effort not to smoke in process with NiQuitin. NiQuitin’s use is recommended along with behavioral support therapy, as this association has shown benefits in the treatment to stop smoking. NiQuitin must be applied once a day, at the same time and preferably just awake and left in the application site for 24 hours continuous. The therapy with NiQuitin normally begins with the application of a 21 mg/24 hours patch and later is reduced according to the following treatment scheme:

	dosage	duration
first phase:	NiQuitin 21 mg/24 hours	for the first 6 weeks
second phase:	NiQuitin 14 mg/24 hours	for the following 2 weeks
third phase:	NiQuitin 7 mg /24 hours	for the last 2 weeks

It is recommended for moderate smokers (who smoke less than 10 cigarettes per day) to start therapy from the second stage (14 mg) for 6 weeks and decrease the dose using the 7 mg/24 hours patch for the 2 final weeks. Subjects using NiQuitin 21 mg/24 hours and suffer from excessive unwanted effects, which do not resolve within a few days, must change plaster and use that from 14 mg/24 hours. This dosage must be maintained for the remaining 6 weeks before switching to NiQuitin 7 mg/24 hours for 2 weeks. If symptoms persist in asking for advice to health care personnel. To optimize the results, the treatment must be completed in 10 weeks (8 weeks for moderate smokers or for those patients who reduced the dosage as indicated above). Treatment with NiQuitin can be extended over 10 weeks if it is necessary to maintain abstention from smoking, however those who use patches over 9 months should consult the health care staff. Persons who continue or recover from smoking may perform additional treatment cycles with NiQuitin. Pediatric population Adolescents (from 12 to 17 years) must follow the adult treatment scheme presented above for the first, second and third phase, but since the available data are limited, for this age group the duration of the TNS it must not exceed 12 weeks. If an extension is required, consult the health care staff. NiQuitin is contraindicated in children under 12 years. Method of administration A new transdermal patch NiQuitin must be applied on a different area of skin glabra, clean and dry. The patch should be applied immediately after removal of the protective bag. The plaster must be kept sealed in its protective bag until its use. The plaster must be pressed strongly on the skin with the palm of the hand for 10 seconds. Areas where skin folds are present should be avoided. Avoid the application on the wounded, inflamed or irritated skin. After 24 hours the used patch must be removed and a new patch applied on a skin area other than the previous one. The patch should not be left applied for more than 24 hours. You can reuse the same skin area after at least 7 days. Use one patch at a time. The patches can be removed before sleeping if you want. However, it is recommended to use for 24 hours, to optimize the effect against the morning smoking desire. Particular care should be used during the use of the plaster to avoid contact with eyes or nose. Wash hands after application only with water since soap can increase the absorption of nicotine.

Conservation

Store at a temperature below 30°C.

Warnings

The well-proven smoke-related hazards have a considerably greater relevance in all circumstances than the risks associated with the use of TNS. . Patients admitted for myocardial infarction, severe arrhythmia or cardiovascular disorders, deemed unstable from the hemodynamic point of view must be encouraged to stop smoking through non-pharmacological interventions. If you do not succeed, you can use NiQuitin, but by limiting the security data available for this group of patients, the start of the therapy should only take place under medical control. Once discharged from the hospital, patients can make use of TNS normally. In case of a clinically significant increase in cardiovascular effects or other effects attributable to nicotine, the dose of nicotine patches must be reduced or the application must be suspended. Gastrointestinal disorders: the TNS can accentuate symptoms in people suffering from active esophagitis, oral inflammation and pharyngeal, gastritis, gastric ulcer or peptic ulcer. Diabetes:blood glucose levels can be subject to increased variability when you quit smoking, with or without TNS since the release of catecholamines due to nicotine can interfere with the metabolism of carbohydrates, so it is important for patients with diabetes to monitor their blood glucose levels more closely than usual when using this drug. Allergic reactions: susceptibility to angioedema and hives. Atopic or eczematous dermatitis (due to local sensitization caused by the plaster): in the case of severe or persistent local reactions in the place of application (e.g. severe erythema, itching or edema) or generalized skin reaction (e.g. urticaria or generalized skin rash) patients should be advised to suspend therapy with NiQuitin and inform their doctor. Contact awareness: contact-sensitivity subjects should be advised that serious reactions may occur as a result of the use of other products containing nicotine or smoke. The risk-benefit ratio assessment must be done by a patient specialist who has the following conditions: • Renal and hepatic insufficiency: use with caution in patients with moderate to severe liver failure and/or severe kidney failure as clearance of nicotine or metabolites can be decreased with potential increase in unwanted effects. • Phochromocytoma and uncontrolled hyperthyroidism: use with caution in patients with uncontrolled hyperthyroidism or feochromocytoma since nicotine causes the release of catecholamines. • Convulsive crisis: use with caution in subjects taking anti-convulsive therapy or with a history of epilepsy as cases of seizures were reported in association with nicotine. Danger for small children: the amount of nicotine tolerated by adult smokers and adolescents can cause severe toxicity in small children with possible fatal outcome. Products containing nicotine must be kept out of the reach of children in order to prevent improper or ingested use. The patches must be folded in two with the adhesive part facing the inside and carefully eliminated. Stop smoking: aromatic polycyclic hydrocarbons contained in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and perhaps by CYP 1A1). Suspension of smoking can cause slowing down metabolism resulting in increased plasma levels of such drugs.Dependency TNS: the addiction to nicotinic replacement therapy is rare and at the same time less harmful and easier to interrupt than that caused by smoking. Safety in handling: NiQuitin is potentially a skin irritant and can cause contact sensitization.

Interactions

No clinically relevant interactions have been demonstrated between nicotinic replacement therapy and other drugs, but nicotine can increase the hemodynamic effect of adenosine. It reminds health care personnel that quitting smoking in themselves may require adaptation of certain drug therapies.

Effects

Adverse reactions are listed below by classification for systems and organs and by frequency. The frequencies are defined as: very common (≥1/10), common (from ≥ 1/100 to Classification for systems and organs and frequency Reaction Adversa / Event Immune system disorders not common Hypersensitivity1 very rare anaphylactic reactions Psychiatric disorders very common sleep disorders, including abnormal dreams and insomnia common nervousness Diseases of the nervous system very common cephalea, chief common tremor Not known Convulsive crisis2 Heart disease common palpitations not common tachycardia Respiratory, chest and mediastinic pathologies common dispnea, pharyngitis, cough Gastrointestinal diseases very common nausea, vomiting common dyspepsia, pains at the top of the abdomen, diarrhea, dry mouth, stipsi Skin pathologies and subcutaneous tissue common increased sweating very rare allergic dermatitis1, contact dermatitis1, photosensitivity Diseases of musculoskeletal system and connective tissue common artralgia, mialgia Systemic pathologies and conditions relating to the site of administration very common reactions to the application site1 common chest pain1, arrhythic pain1, pain, asthenia, fatigue/disease not common simil- flu syndrome 1 The majority of these local reactions are of modest size and are resolved quickly following the removal of the plaster. Pain or feeling of heaviness may occur at the limb or area of application of the patch (p.es. chest). 2 observed in patients taking anti-convulsive therapy or with a history of epilepsy. In case of clinically significant increase in cardiovascular effects or other effects attributable to nicotine, the dosage of NiQuitin must be reduced or the application must be suspended. Pediatric population (from 12 to 17 years of age) There are no specific data of adverse events for this population. However, the frequency, type and severity of adverse reactions in adolescents should be the same as adults, based on a pharmacokinetics study that showed a similar pharmacokinetic profile in the group of adolescents than adults. 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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

The minimum lethal dose of nicotine in a man who did not develop tolerance was estimated between 40 and 60 mg. In children, even small amounts of nicotine can be dangerous and prove fatal. A suspected nicotine poisoning in a child must be considered a medical emergency and should be treated immediately. Synonyms It is expected that the signs and symptoms from overdose of a nicotine patch are the same as those from acute poisoning of nicotine, with pallor, cold sweating, salivation, nausea, vomiting, abdominal pain, diarrhea, headache, dizziness, hearing and sight disorders, tremor, mental confusion and weakness. With high overdose can appear to be moved, hypotension, respiratory failure, accelerated pulse, weak or irregular, circulatory collapse and seizures (including terminal convulsions). Treatment Overdose for topical exposure Remove the transdermal patch or transdermal patches immediately in case of overdose or if the patient shows signs of overdose. The user must contact the doctor immediately. The affected skin surface should be washed with water and dried. Avoid the use of soap that can increase the absorption of nicotine. After removal of the plaster, nicotine will continue to be released in the blood for several hours, as it settles in the skin. Overdosage by ingestion Any type of nicotine intake must be immediately interrupted. The patient must immediately contact the doctor and must be treated symptomaticly. If necessary, you should practice artificial breathing with oxygen. Active carbon reduces nicotine gastrointestinal absorption.

Pregnancy Pregnant smoking is associated with risks such as delay in intrauterine growth, premature birth or perinatal mortality. Smoking cessation is the only effective intervention to improve both the state of health of the smoking mother and her child. First you reach the abstinence better. Ideal would be able to stop smoking during pregnancy without the help of TNS. However, women who cannot quit alone can be recommended by health care staff to resort to TNS to help them in an attempt to stop. The risk related to the use of TNS for the fetus is less than that associated with tobacco smoke, thanks to a maximum plasma concentration of lower nicotine and the absence of exposure to polycyclic hydrocarbons and carbon monoxide. In any case, as nicotine passes to the fetus by altering the respiratory movements and has a dose-dependent effect on the placenta/feto circulation, the decision to resort to the TNS must be taken as soon as possible during pregnancy. The goal is to use the TNS only for 2-3 months. Products that provide nicotine in a discontinuous way are preferable as they generally provide a lower daily dose of nicotine than patches. However, the latter are recommended for women who suffer from nausea during pregnancy. If patches are used, they must be removed before bed. Food The nicotine that comes from smoke and TNS she finds herself in breast milk. However, nicotine concentration in the child following exposure to TNS is relatively low and less harmful than passive smoking to which the same would otherwise be exposed. The use of preparations of TNS at a discontinuous dose, compared to the patches, can minimize the concentration of nicotine in breast milk since the time between the administration of TNS and breastfeeding can be more easily prolonged. Fertility There are no relevant data available. See paragraph 5.3

Source: Farmadati