Niquitin 14 mg/24 hours - 7 transparent transdermal patches

People using NiQuitin 21mg/24hours and experiencing excessive side effects that do not resolve within a few days should switch to the 14mg/24hours patch. This dosage should be maintained for the remaining 6 weeks before switching to NiQuitin 7mg/24hours for 2 weeks. If symptoms persist, seek advice from your healthcare professional. For optimal results, treatment should be completed within 10 weeks (8 weeks for moderate smokers or those who have reduced their dosage as indicated above). Treatment with NiQuitin can be extended beyond 10 weeks if necessary to maintain abstinence from smoking; however, those using the patches for more than 9 months should consult their healthcare professional. Individuals who continue or resume smoking may undergo additional courses of NiQuitin treatment.
Combination Therapy: Treatment with NiQuitin clear transdermal patches in combination with NiQuitin mini lozenges and NiQuitinmint. Smokers may combine transdermal patches and oral forms of nicotine. The combination of transdermal patches and oral forms of nicotine provides better efficacy than using transdermal patches alone. Treatment should begin with determining the patch dose, according to the same rules as for monotherapy, in combination with a dose of oral nicotine. The recommended daily dose of oral preparations, when combined with patches, is around 5-6 pieces. When used in combination, the maximum daily dose for the 4 mg oral form is 10 pieces and for the 1.5 mg/2 mg oral form remains 15 pieces.
Paediatric population:Adolescents (12 to 17 years) should follow the adult treatment regimen, but since available 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. Due to the lack of data, adolescents should not discontinue combination NRT therapy.
NiQuitin is contraindicated in children under 12 years of age.
Method of administration: A new NiQuitin clear transdermal patch should be applied to a different area of ​​hairless, clean, and dry skin. The patch should be applied immediately after removing the protective sachet. The patch should be kept sealed in its protective sachet until used. The patch should be pressed firmly onto the skin with the palm of the hand for 10 seconds. Areas where there are 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 skin area can be reused after at least 7 days. Use only one patch at a time. Patches may 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 and nose. Wash your hands with water only after application, as soap can increase nicotine absorption.

Warnings

The well-established dangers of smoking are significantly greater in virtually all circumstances than the risks associated with the use of NRT. Patients hospitalized for myocardial infarction, severe arrhythmia, or cardiovascular disorders deemed haemodynamically unstable should be encouraged to quit smoking using non-pharmacological interventions. If this is unsuccessful, NiQuitin may be used, but as the safety data available for this patient group are limited, initiation of therapy should only occur under medical supervision. Once discharged from the hospital, patients can use NRT normally. If there is a clinically significant increase in cardiovascular or other nicotine-related effects, the dosage of nicotine patches should be reduced or their use discontinued. Gastrointestinal disorders: NRT may accentuate symptoms in people suffering from active esophagitis, oral and pharyngeal inflammation, gastritis, gastric ulcer or peptic ulcer.
Diabetes: Blood glucose levels may be subject to greater variability when smoking cessation, with or without NRT since 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 closely than usual when using this drug.
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 edema) or generalized skin reaction (e.g. If you experience any of the following conditions: urticaria or generalized skin rash, patients should be advised to discontinue NiQuitin therapy and inform their doctor. This may be more likely if there is a history of dermatitis.
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 risk-benefit assessment should be made by a specialist for patients with the following conditions:
Renal 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; this may result in an increase in adverse effects. Pheochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma because nicotine causes the release of catecholamines.
Seizures: Use with caution in subjects taking anticonvulsant therapy or with a history of epilepsy because cases of convulsions have been reported in association with nicotine.
Danger for young children: The amount of nicotine tolerated by adult smokers and adolescents can cause serious toxicity in young children with possible fatal outcome. Nicotine-containing products should be kept out of the reach of children to prevent misuse or ingestion. After removal, the patches should be folded in half with the adhesive side innermost and placed inside the opened sachet or in aluminum foil. The used patch must therefore be carefully disposed of.
Stop smoking: Polycyclic aromatic hydrocarbons contained in tobacco smoke induce drug metabolism catalyzed by CYP 1A2 (and possibly by CYP 1A1). Stopping smoking may cause a slowing of metabolism with consequent increase in plasma levels of these drugs. NRT dependence: Dependence on nicotine replacement therapy is rare and at the same time less harmful and easier to break than that caused by smoking. Safe handling: NiQuitin is a potential skin irritant and may cause contact sensitization. The patches should be kept out of the sight and reach of children. Special warnings and precautions for the use of combination therapy with NiQuitin transparent transdermal patches and oral forms of NiQuitin/Niquitinmint are the same for each individual treatment (see the SPCs for each oral preparation used in combination). Combination TNS therapy should not be used in subjects with known cardiovascular disease without a risk/benefit assessment by a healthcare professional.

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 <1/10);
• uncommon (>=1/1000 to <1/100);
• rare (>=1/10000 to <1/1000);
• very rare (<1/10000).

The most frequent adverse reactions associated with the use of NiQuitin is characterized by skin reactions at the application site. NiQuitin may also cause other side effects related to the pharmacological actions of nicotine or the effects of smoking withdrawal. Some of the reported symptoms, such as depression, irritability, nervousness, agitation, mood swings, anxiety, drowsiness, difficulty concentrating, insomnia, and sleep disturbances, may be related to smoking withdrawal. People who quit smoking by any means may experience fatigue, headache, dizziness, cough, or flu-like symptoms. The undesirable effects listed below have been reported in clinical studies or spontaneously during the post-marketing phase of the product.

Immune system disorders

• Uncommon: hypersensitivity;
• Very rare: anaphylactic reactions.

Psychiatric disorders

• Very common: sleep disturbances, including abnormal dreams and insomnia;
• Common: nervousness;

Nervous system disorders

• Very common: headache, dizziness;
• Common: tremor;
• Not known: seizures.

Cardiac disorders

• Common: palpitations;
• Uncommon: tachycardia.

Respiratory, thoracic and mediastinal disorders

• Common: dyspnoea, pharyngitis, cough.

Gastrointestinal disorders

• Very common: nausea, vomiting;
• Common: dyspepsia, upper abdominal pain, diarrhoea, dry mouth, constipation.

Skin and subcutaneous tissue disorders 

• Common: increased sweating;
• Very rare: allergic dermatitis, contact dermatitis, photosensitivity.

Musculoskeletal and subcutaneous tissue disorders connective tissue

• Common: arthralgia, myalgia.

General disorders and administration site conditions.

• Very common: application site reactions;
• Common: chest pain, pain in limb, pain, asthenia, fatigue/malaise;
• Uncommon: flu-like illness.

Most local reactions are mild and resolve rapidly after removal of the patch. Pain or a feeling of heaviness in the limb or at the area where the patch was applied may occur. Observed in patients taking anticonvulsant therapy or with a history of epilepsy.
If a clinically significant increase in cardiovascular or other effects attributable to nicotine occurs, the dosage of iQuitin should be reduced or its use discontinued.

Paediatric population (12 to 17 years of age): There are no specific data on adverse events for this population. However, the frequency, type, and severity of adverse reactions in adolescents are expected to be the same as in adults, based on a pharmacokinetic study that demonstrated a similar pharmacokinetic profile in the adolescent age group compared to adults. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after the medicinal product has been authorised is important, as it allows for continuous monitoring of the benefit/risk balance of the medicinal product.

Pregnancy and breastfeeding

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 mother who smokes 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. However, since nicotine passes to the fetus by altering respiratory movements and has a dose-dependent effect on placental-fetal circulation, 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 intermittently are preferable as they generally provide a lower daily dose of nicotine than patches. However, the latter are recommended for women who experience nausea during pregnancy. If used, patches should be removed before bedtime. Due to the lack of specific studies, combined therapy with patches and oral forms is not recommended during pregnancy unless the physician deems it necessary to ensure abstinence.

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. Ideally, smoking cessation during breastfeeding should be achieved without NRT. However, for women who are unable to quit on their own, NRT may be recommended by a healthcare professional to assist in a quit attempt. 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 can be more easily prolonged. Women should attempt to breastfeed just before taking the product. Due to the lack of specific studies, combined therapy with patches and oral forms is not recommended during breastfeeding unless a physician deems abstinence necessary.

Fertility
Effects of nicotine on male reproductive tissues have been observed in rats, however, the clinical significance is unknown.

Format

7 Transparent Transdermal Patches