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NIQUITIN is a brand name for Nicotine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NiQuitin patches Nicotine Replacement Therapy (NRT) reduces craving and withdrawal symptoms in people with nicotine dependence from smoking tobacco, or from the inhalation of nicotine-containing vapour (vaping/e-cigarettes), and heat-not-burn tobacco/heated tobacco products. NiQuitin patches are indicated to assist in…
Verbatim from this product's MHRA label. Tap a section to expand.
NiQuitin patches should be applied once a day, at the same time each day and preferably soon after waking to a different non-hairy, clean, dry skin site and worn continuously for 24 hours. NiQuitin patch should be applied promptly on removal from its protective sachet.
It should be pressed firmly on the skin with the palm of hand for 10 seconds. Areas where the skin creases should be avoided. Avoid applying to any skin which is broken, red or irritated. After 24 hours the used patch should be removed, and a new patch applied to a fresh skin site.
The patch should not be left on for longer than 24 hours. Skin sites should not be reused for at least seven days. Only one patch should be worn at a time. The patch should be kept sealed in its protective sachet until ready to use. The user should wash hands with water after handling the patch and avoid contact with eyes and nose.
Patches may be removed before going to bed if desired. However use for 24 hours is recommended to optimize the effect against morning cravings. Water will not harm the nicotine transdermal patch if it has been applied properly. The user can bathe, swim or shower for short periods while wearing the nicotine transdermal patch.
Concurrent behavioral support is recommended, as such programs have been shown to be beneficial for smoking cessation. Adults 18 years and over Abrupt cessation of smoking or vaping e-cigarettes and heat -not-burn tobacco/heated tobacco: During a quit attempt every effort should be made to stop smoking or vaping with NiQuitin patches.
g. 6%) are recommended to start at Step 2 (14 mg) for 6 weeks and decrease the dose to NiQuitin 7 mg for the final 2 weeks. Patients on NiQuitin 21 mg who experience excessive side-effects (please refer to precautions), which do not resolve within a few days, should change to NiQuitin 14mg.
This strength should then be continued for the remainder of the 6-week course before stepping down to NiQuitin 7mg for two weeks. If the symptoms persist the patient should be advised to seek the advice of a healthcare professional.
For optimum results, the 10-week treatment course (8 weeks for light smokers or low strength vapers as above), should be completed in full. Treatment with NiQuitin patch may be continued beyond 10 weeks if needed to stay cigarette or vape -free, however, those who have quit smoking or vaping use, but have difficulty discontinuing using the patches are recommended to seek additional help and advice from a healthcare professional.
NRT may cause adverse reactions similar to those associated with nicotine administered by other means, including smoking. These may be attributable to the pharmacological effects of nicotine, some of which are dose dependent. At recommended doses, NiQuitin patches have not been found to cause any serious adverse effects.
Excessive use of NiQuitin patches by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness, or headaches. Subjects quitting smoking or vaping by any means could expect to suffer from asthenia, headache, dizziness, sleep disturbance, coughing or influenza-like illness.
Certain symptoms which have been reported such as depression, irritability, nervousness, restlessness, mood lability, anxiety, drowsiness, impaired concentration, insomnia, and sleep disturbances may be related to withdrawal symptoms associated with cessation of smoking or vaping.
Application site reactions are the most frequent adverse reaction associated with NiQuitin patches. NiQuitin patches can cause other adverse reactions related to the pharmacological effect of nicotine or withdrawal effects related to smoking.
The following undesirable effects have been reported in clinical trials or spontaneously post- marketing. Immune System Disorders Uncommon>1/1000; <1/100: hypersensitivity NOS* Very rare <1/10000: anaphylactic reactions Psychiatric Very common >1/10: sleep disorders including abnormal dreams and insomnia Common >1/100; <1/10: nervousness Nervous system disorders Very Common >1/10: headache, dizziness Common >1/100; <1/10: tremor Not known: seizures Cardiac disorders Common >1/100; <1/10: palpitations Uncommon >1/1000; <1/100: tachycardia NOS Respiratory, Thoracic and Mediastinal Disorders Common >1/100; <1/10: dyspnoea, pharyngitis, cough Gastrointestinal Disorders Very Common >1/10: nausea, vomiting Common >1/100; <1/10: dyspepsia, abdominal pain upper, diarrhea NOS, dry mouth, constipation Skin and Subcutaneous Tissue Disorders Common >1/100; <1/10: sweating increased Very rare > 1/100000; <1/10000: dermatitis allergic*, dermatitis contact*, photosensitivity Musculoskeletal and Connective Tissue Disorders Common >1/100; <1/10: arthralgia, myalgia General Disorders and Administration Site Conditions Very Common >1/10: application site reactions NOS* Common >1/100; <1/10: chest pain, pain in limb, pain NOS, asthenia, fatigue Uncommon >1/1000; <1/100 malaise, influenza-like illness * see below Application site reactions, including transient rash, itching, burning, tingling, numbness, swelling, pain and urticaria are the most frequent undesirable effects of NiQuitin patch.
The risks associated with the use of NRT are substantially outweighed in virtually all circumstances by the well-established dangers of continued smoking. NRT provides controlled doses of nicotine to people dependent on high nicotine consumption from vaping nicotine-containing liquids and heat-not-burn tobacco/heated tobacco products.
This allows them to use NRT to reduce and quit their dependence on nicotine in a structured way. Patients hospitalised for myocardial infarction, severe dysrhythmia or cerebrovascular accident who are considered to be hemodynamically unstable should be encouraged to stop smoking with non- pharmacological interventions.
If this fails, NiQuitin patches may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Once patients are discharged from hospital, they can use NRT as normal.
If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the nicotine patch dose should be reduced or discontinued. Nicotine replacement therapy may exacerbate symptoms in persons suffering from active oesophagitis, oral and pharyngeal inflammation, gastritis, gastric ulcer, or peptic ulcer.
Diabetes:
Blood glucose levels may be more variable when stopping smoking or vaping with or without NRT as catecholamines released by nicotine can affect carbohydrate metabolism, so it is important for diabetics to monitor their blood glucose levels more closely than usual while using this product.
Allergic reactions:
Susceptibility to angioedema and urticaria. g. g. urticaria, hives or generalized skin rashes), users should be instructed to discontinue use of NiQuitin and contact their physician.
Contact sensitization:
NiQuitin patches are contraindicated in: • Patients with hypersensitivity to the system, the active substance, or any of the excipients. • Children under 12 years. • Non-smokers or non-vapers or occasional and in-frequent smokers or vapers.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Further courses may be used at a later time, for NiQuitin patch users who continue or resume smoking, or vaping . Gradual Cessation of smoking or vaping e-cigarettes and heat-not-burn tobacco/heated tobacco: For smokers or vapers who are unwilling or unable to quit abruptly.
The 21 mg patch can be used daily for 2-4 weeks while the user continues to smoke or vape as needed. At the end of the 2-4 weeks the user should quit completely and continue using Step 1 21 mg patch for 6 weeks daily without smoking or vaping.
Thereafter following the Step 2 and 3 directions for abrupt cessation above. Should the patient feel able to quit completely before their designated quit date they can do so. Reduction in smoking or vaping e-cigarettes and heat-not-burn tobacco/heated tobacco: For smokers or vapers who wish to cut down with no immediate plans to quit.
A patch can be used while the user continues to smoke or vape as needed. The user should reduce the number of cigarettes smoked or use of vape (e-cigarettes/heat-not-burn tobacco/heated tobacco) products as far as possible and to refrain from smoking or vaping as long as possible.
Users should be encouraged to stop smoking, vaping or heat-not-burn tobacco/heated tobacco use completely as soon as possible. If users are still feeling the need to use the patches on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.
Temporary Abstinence Apply a patch to control troublesome withdrawal symptoms including craving during the period when smoking or vaping is being avoided. Users should be encouraged to stop smoking or vaping completely as soon as possible.
If users are still feeling the need to use the patches on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.
Combination Nicotine Replacement Treatment (NRT):
In some instances, it may be beneficial to utilise more than one form of NRT concurrently. For example, combination therapy may be used by smokers or vapers who have relapsed with NRT monotherapy in the past, or who experience breakthrough cravings or have difficulty controlling cravings for cigarettes or vape (e-cigarettes/heat-not-burn tobacco/heated tobacco) products using single therapy.
). The combination of transdermal patches and oral forms of nicotine gives better effectiveness than using transdermal patches alone. The initial treatment should begin with the determination of the dose of the patch - according to the same rules as the monotherapy - in combination with a dose of oral nicotine.
The daily intake of oral preparations, when combined with patches, should be around 5 to 6 pieces. When used in combination, the maximum daily dose for 4 mg oral forms is 10 pieces […]
The majority of these topical reactions are minor and resolve quickly following removal of the patch. g. chest) may be reported. Hypersensitivity reactions, including contact dermatitis and allergic dermatitis have also been reported.
g. g. urticaria, hives or generalized skin rashes) users should be instructed to discontinue use of NiQuitin and contact their physician. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the NiQuitin dose should be reduced or discontinued.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Patients with contact sensitization should be cautioned that a serious reaction could occur from exposure to other nicotine-containing products or smoking. A risk benefit assessment should be made by an appropriate healthcare professional 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 with the potential for increased adverse effects.
• Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines. • Seizures: Potential risks and benefits of nicotine should be carefully evaluated before use in subjects taking anti-convulsant therapy or with a history of epilepsy as cases of convulsions have been reported in association with nicotine.
• Cardiovascular disease: The pre-cessation regimen should not be used in people with known cardiovascular disease without evaluation of the risk/benefit by a healthcare professional.
Danger in small children:
Doses of nicotine tolerated by adult and adolescent smokers or vapers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled, or ingested by children.
After removal, the patch should be folded in half, adhesive side innermost, and placed inside the opened sachet, or in a piece of aluminium foil. The used patch should then be disposed of with care. Patches should be kept out of the sight and reach of children.
Stopping smoking:
Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.
Transferred dependence:
Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.
Safety on handling:
NiQuitin is potentially a dermal irritant and can cause contact sensitization. Care should be taken during handling and in particular contact with the eyes and nose avoided. After handling, wash hands with water alone as soap may increase nicotine absorption.
9) should discontinue smoking or vaping and if the symptoms persist remove the patch. If symptoms improve after smoking cessation or vaping cessation, the user may resume using the patch.