Niquitin 7mg/24h - 7 transdermal patches

Product Description

NiQuitin Patches Phase 3 are indicated for the last two weeks of treatment after Phase 1 and Phase 2 as part of Nicotine Replacement Therapy.

Indications

NiQuitin is indicated to relieve nicotine withdrawal symptoms, including cravings, as an aid to smoking cessation. If possible, when quitting smoking, NiQuitin should be used in conjunction with a behavioral support program. NiQuitin transdermal patches are indicated for adults and adolescents aged 12 years and over.

Composition

Active ingredients

Each 7 cm² transdermal patch contains 36 mg of nicotine, equivalent to 5.1 mg/cm² of nicotine and releases 7 mg of nicotine in 24 hours.

Excipients

Active substance depot: ethylene vinyl acetate copolymer. Backing: polyethylene/aluminum/polyethylene terephthalate/ethylene vinyl acetate. Permeable membrane: polyethylene film. Adhesive layer and protective liner: polyisobutylene adhesive laminate. Printing ink: FGN-7214 NT20 Brown ink 465.

Directions for use and Dosage

Dosage Adults (18 years and over)

The patches should be used as follows. Before starting therapy, subjects who are candidates for transdermal nicotine must wish to stop smoking. During a quit attempt, every effort should be made to refrain from smoking while taking NiQuitin. Using NiQuitin in conjunction with behavioral therapy has been shown to be beneficial in smoking cessation therapy. NiQuitin should be applied once daily, at the same time, preferably upon awakening, and left in place for 24 hours. NiQuitin therapy typically begins with one 21 mg patch per 24 hours and is then tapered according to the following treatment schedule:

Moderate smokers (smoking less than 10 cigarettes a day) are recommended to start therapy with the second phase (14 mg) for 6 weeks and taper to the 7 mg/24 hour patch for the final 2 weeks. People using NiQuitin 21 mg/24 hour who experience excessive side effects that do not resolve within a few days should switch to the 14 mg/24 hour patch. This dosage should be maintained for the remaining 6 weeks before switching to NiQuitin 7 mg/24 hour for 2 weeks. If symptoms persist, seek medical advice. For optimal results, treatment should be completed over 10 weeks (8 weeks for moderate smokers or those who have reduced their dosage as above). Treatment with NiQuitin can be The duration of NRT may be extended beyond 10 weeks if necessary to maintain smoking cessation. However, anyone using the patches for more than 9 months should consult their healthcare professional. Individuals who continue or start smoking again may undergo further treatment with NiQuitin. Paediatric population Adolescents (12 to 17 years) should follow the adult treatment schedule above for phases 1, 2, and 3, but as data are limited, the duration of NRT for this age group should not exceed 12 weeks. If an extension is required, consult your healthcare professional. NiQuitin is contraindicated in children under 12 years. Method of administration A new NiQuitin transdermal patch should be applied to a different area of ​​clean, dry, hairless skin. The patch should be applied immediately after removing the protective sachet. The patch should be kept sealed in its protective sachet until use. The patch should be pressed firmly onto the skin with the palm of the hand for 10 seconds. Areas with skin folds should be avoided. Avoid application to broken, inflamed, or irritated skin. After 24 hours, the used patch should be removed and a new patch applied to a different area of ​​skin. The patch should not be left on for more than 24 hours. The same area of ​​skin can be reused after at least 7 days. Use only one patch at a time. Patches can be removed before bed if desired. However, continuous use for 24 hours is recommended to optimize the effect against morning cravings. Special care should be taken when using the patch to avoid contact with the eyes or nose. Wash your hands with water only after application, as soap can irritate the skin. increase nicotine absorption.

Warnings

It is important to know that, regarding NiQuitin phase 3 nicotine patches 7 mg/24 h:

The well-established dangers of smoking far outweigh the risks associated with the use of NRT (Nicotine Replacement Therapy) in virtually all circumstances. Patients hospitalized for myocardial infarction, severe arrhythmia, or cardiovascular disorders who are deemed haemodynamically unstable should be encouraged to stop smoking using non-pharmacological interventions. If this is not possible, NiQuitin may be used, but, as safety data are limited for this patient group, initiation of therapy should only occur under medical supervision. Once discharged from hospital, patients can use NRT as normal. If a clinically significant increase in cardiovascular or other effects attributable to nicotine occurs, the dosage of nicotine patches should be reduced or their use discontinued.

Gastrointestinal disorders: NRT may exacerbate symptoms in people with active esophagitis, oral and pharyngeal inflammation, gastritis, gastric ulcers, or peptic ulcers.

Diabetes: Blood glucose levels may be subject to greater variability when smoking cessation, with or without NRT. This is because the release of catecholamines due to nicotine can interfere with carbohydrate metabolism. Therefore, it is important for patients with diabetes to monitor their blood glucose levels more frequently. than usual when using this medicine.

Allergic reactions: Susceptibility to angioedema and urticaria.

Atopic or eczematous dermatitis (due to local sensitization caused by the patch): In case of severe or persistent local reactions at the application site (e.g. severe erythema, pruritus or swelling) or generalized skin reaction (e.g. urticaria or generalized skin rash), patients should be advised to stop therapy with NiQuitin and inform their doctor.

Contact sensitization: People with contact sensitization should be advised that serious reactions may occur following the use of other nicotine-containing products or smoking.

A benefit-risk assessment should be made by a specialist for patients with the following conditions:

• Renal insufficiency and Hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment, as the clearance of nicotine or its metabolites may be decreased, potentially increasing adverse effects.
• Pheochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma, as nicotine causes the release of catecholamines.
• Seizures: Use with caution in subjects taking anticonvulsant therapy or with a history of epilepsy, as cases of seizures have been reported in association with nicotine.

Danger for small children: The amount of nicotine tolerated by adult smokers and adolescents can cause serious toxicity in small children, with possible fatal outcome. Nicotine-containing products should be kept out of the reach of children to prevent misuse or ingestion. Patches should be folded in half with the adhesive side facing inward and carefully discarded.

Quitting smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce drug metabolism catalyzed by CYP 1A2 (and possibly CYP 1A1). Stopping smoking may result in a slowing of metabolism, resulting in increased plasma levels of these drugs.

NRT dependence: Addiction to nicotine replacement therapy is rare and, at the same time, less harmful and easier to break than that caused by smoking.

Safety in handling: NiQuitin is a potential skin irritant and may cause allergic reactions. cause contact sensitization.

Interactions

No clinically relevant interactions between nicotine replacement therapy and other drugs have been demonstrated, however, nicotine may increase the haemodynamic effect of adenosine. Healthcare professionals are reminded that smoking cessation itself may require adjustment of some drug therapies.

Contraindications

NiQuitin should not be used by:

• children under 12 years;
• occasional smokers;
• non-smokers.

Undesirable effects

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥ 1/100 to <1>

Overdose

The minimum lethal dose of nicotine in a man who has not developed tolerance has been estimated to be between 40 and 60 mg. In children, even small amounts of nicotine can be dangerous and prove fatal. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately. Symptoms The signs and symptoms of a nicotine patch overdose are expected to be the same as those of acute nicotine poisoning, with pallor, cold sweats, salivation, nausea, vomiting, abdominal pain, diarrhoea, headache, dizziness, hearing and vision disturbances, tremor, mental confusion and weakness. With large overdoses, fatigue, hypotension, respiratory failure, rapid, weak or irregular pulse may occur. circulatory collapse and convulsions (including terminal convulsions). Treatment Overdose by topical exposure Immediately remove the transdermal patch or patches in case of overdose or if the patient shows signs of overdose. The user should seek medical attention immediately. The affected skin area should be washed with water and dried. Avoid using soap, which can increase nicotine absorption. After removal of the patch, nicotine will continue to be released into the blood for several hours as it is deposited in the skin. Overdose by ingestion Any type of nicotine intake should be stopped immediately. The patient should seek medical attention immediately and be treated symptomatically. If necessary, artificial respiration with oxygen should be performed. Activated charcoal reduces the gastrointestinal absorption of nicotine.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, or are breastfeeding. Consult your doctor before taking Niquitin Phase 3 nicotine patches 7 mg/24 h.

Pregnancy: Smoking during pregnancy is associated with risks such as intrauterine growth retardation, premature birth, or perinatal mortality. Quitting smoking is the only truly effective intervention to improve both the health of the smoking mother and her baby. The sooner abstinence is achieved, the better. Ideally, it would be possible to quit smoking during pregnancy without the aid of NRT. However, women who are unable to quit on their own may be recommended by their healthcare provider to use NRT to help them in their attempt to quit. The risk associated with the use of NRT for the fetus is lower than that associated with tobacco smoking, thanks to a lower maximum plasma nicotine concentration and the absence of exposure to polycyclic hydrocarbons and carbon monoxide. In any case, since nicotine passes to the fetus by altering respiratory movements and has a dose-dependent effect on the circulation Placenta/fetus: The decision to use NRT should be made as early as possible during pregnancy. The goal is to use NRT for only 2-3 months. Products that deliver nicotine in a discontinuous manner are preferable as they generally provide a lower daily dose of nicotine than patches. However, patches are recommended for women who experience nausea during pregnancy. If patches are used, they should be removed before going to bed.

Breastfeeding: Nicotine from smoking and NRT is found in breast milk. However, the concentration of nicotine in the infant following exposure to NRT is relatively low and less harmful than the secondhand smoke to which the infant would otherwise be exposed. The use of discontinuous-dose NRT preparations, compared to patches, may minimize the concentration of nicotine in breast milk since the time between NRT administration and breastfeeding is longer. can be more easily prolonged.

Fertility: There are no relevant data available.

Format

Pack of 7 patches