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NICORETTE INVISI is a brand name for Nicotine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Nicorette Invisi Patch relieves and/or prevents craving and nicotine withdrawal symptoms in nicotine dependence, such as those arising from the use of tobacco or electronic cigarettes. It is indicated to aid quitting or reduction prior to quitting, to assist those who are unwilling or unable to use such products, and…
Verbatim from this product's MHRA label. Tap a section to expand.
When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. It is intended that the patch is worn through the waking hours (approximately 16 hours) being applied on waking and removed at bedtime.
Smoking/Vaping Cessation Adults (over 18 years of age) For best results, most smokers/vapers are recommended to start on 25 mg / 16 hours patch (Step 1) and use one patch daily for 8 weeks. Gradual weaning from the patch should then be initiated.
One 15 mg/16 hours patch (Step 2) should be used daily for 2 weeks followed by one 10 mg/16 hours patch (Step 3) daily for 2 weeks. e. g. vape infrequently or use low strength e-liquid) are recommended to start at Step 2 (15 mg) for 8 weeks and decrease the dose to 10 mg for the final 4 weeks.
Those who experience excessive side effects with the 25 mg / 16 hours patch (Step 1), which do not resolve within a few days, should change to a 15 mg / 16 hours patch (Step 2). This should be continued for the remainder of the 8 week course, before stepping down to the 10 mg / 16 hours patch (Step 3) for 4 weeks.
If symptoms persist the advice of a healthcare professional should be sought. Adolescents (12 to 18 years) The dose and method of use are as for adults however as data are limited in this age group, the recommended treatment duration is 12 weeks.
If longer treatment is required, advice from a healthcare professional should be sought. Smoking/Vaping Reduction/Pre-Quit Smokers/vapers are recommended to use the patch to prolong smoke/vape- free intervals and with the intention to reduce smoking/vaping as much as possible.
e. g. e. g. vape infrequently or use low strength e- liquid) are recommended to start at Step 2 (15 mg). Smokers/vapers starting on 25 mg patch (Step 1) should transfer to 15 mg patch (Step 2) as soon as cigarette consumption reduces to less than 10 cigarettes per day or vaping dependency decreases.
A quit attempt should be made as soon as the smoker/vaper feels ready. When making a quit attempt patients who have reduced to less than 10 cigarettes per day are recommended to continue at Step 2 (15 mg) for 8 weeks and decrease the dose to 10 mg (Step 3) for the final 4 weeks.
g. vape infrequently or use low strength e- liquid), they should continue at Step 2 (15 mg) for 8 weeks and then step down to 10 mg (Step 3) for the final 4 weeks. Temporary Abstinence Use a Nicorette Invisi Patch in those situations when you can’t or do not want to smoke/vape for prolonged periods (greater than 16 hours).
Effect of Smoking Cessation Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance, decreased heart rate, dizziness, presyncopal symptoms, cough, constipation, gingival bleeding or nasopharyngitis.
Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear. Effects of Vaping Cessation The nicotine withdrawal effects of vaping cessation have not been established; however it is anticipated that many of the effects relating to nicotine withdrawal will be the same as those seen with tobacco smoking cessation.
Adverse Drug Reactions (ADRs) This product may cause adverse reactions similar to those associated with nicotine given by other means, including smoking and vaping, and these are mainly dose-dependent. At recommended doses this product has not been found to cause any serious adverse effects.
Excessive use of this product by those who have not been in the habit of inhaling tobacco smoke or vaping could possibly lead to nausea, faintness or headaches. Most of the undesirable effects reported by the subjects occur during the early phase of treatment and are mainly dose dependent.
About 20% of Nicorette Invisi Patch users experience mild local skin reactions, during the first weeks of treatment. g. 4). Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of this product. Adverse events observed in patients treated with nicotine patch formulations during clinical trials and post-marketing surveillance are listed below by system organ class (SOC).
*Frequencies are defined in accordance with current guidance, as: *very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1 000, <1/100); rare (≥1/10 000, <1/1 000); very rare (<1/10 000), not known - cannot be estimated from the available data.
Any risks that may be associated with NRT are substantially outweighed by the well-established dangers of continued smoking. The risks of continued vaping are not yet established. A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions: Underlying cardiovascular disease: In stable cardiovascular disease this product presents a lesser hazard than continuing to smoke.
However dependent smokers currently hospitalised as a result of myocardial infarction, unstable or worsening angina including Prinzmetal angina, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable and/or who have uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions.
If this fails, this product may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. The risks of continued vaping are not yet established.
Diabetes mellitus:
Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when quitting and NRT is initiated as reductions in nicotine induced catecholamine release can affect carbohydrate metabolism.
Renal or hepatic impairment:
This product should be used 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.
Seizures:
Potential risks and benefits of nicotine should be carefully evaluated before use in subjects with a history of epilepsy as cases of convulsions have been reported in association with nicotine.
Nicorette Invisi Patches should not be administered to patients with known hypersensitivity to nicotine or any component of the patch.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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g. Nicorette inhalator or gum). g. vape frequently or use high strength e-liquid) are recommended to use 25 mg patch. e. g. vape infrequently or use low strength e-liquid) are recommended to use 15 mg patch. How to apply the patches Nicorette Invisi Patch should be applied to clean, dry intact areas of hairless skin, for example on the hip, upper arm, or chest.
These areas should be varied each day, and the same site should not be used on consecutive days. 1. Wash your hands before applying the patch. 2. Cut open the pouch with scissors along the side, as indicated. Select a clean, dry, hairless intact area of skin, such as the hip, upper arm or chest.
3. Peel one part of the silvery aluminium backing away. Avoid touching the sticky surface of the patch with your fingers. 4. Apply the sticky part of the patch carefully onto the skin and peel off the remaining half of the silvery aluminium backing.
5. Press the patch firmly onto the skin with your palm or fingertips. 6. Rub your fingers firmly round the edge to ensure that the patch sticks firmly. Use of skin oils or talc can prevent proper adhesion of the patch. After removal, used patches should be disposed of carefully.
** Frequency category estimated using the “Rule of 3” Body System Reported adverse event (Preferred Term) Incidence* Body System Reported adverse event (Preferred Term) Incidence* Hypersensitivitya# UncommonImmune system disorders Anaphylactic reactiona Rare** Dizziness Headachea§ Common Paraesthesiaa# Uncommon Nervous system disorders Seizures Not known Palpitationsa Tachycardiaa UncommonCardiac disorders Reversible atrial fibrillation Very rare Vascular disorders Flushinga Hypertensiona Uncommon Respiratory, Thoracic and Mediastinal Disorders Dyspnoeaa Uncommon Nauseaa§ Vomitinga CommonGastrointestinal disorders Gastrointestinal discomforta Rare** Pruritus Very common Rasha Urticariaa Common Hyperhidrosisa Uncommon Skin and subcutaneous tissue disorders Angioedemaa Erythemaa Rare** Myalgiab UncommonMusculoskeletal and Connective Tissue Disorders Pain in extremity Rare** Body System Reported adverse event (Preferred Term) Incidence* General disorders and administration site conditions Application site reactions Astheniaa Chest discomfort and paina Malaisea Fatiguea#§ Uncommon a Systemic effects; b In vicinity/region of patch # Although the frequency is <1% the PT occurred at a frequency ≥1% in another formulation in which the PT was identified as a systemic ADR.
§ Although the frequency in the active group is less than that of the placebo group, the frequency in the specific formulation in which the PT was identified as a systemic ADR was greater in the active group than the placebo group.
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.
Danger in children:
Doses of nicotine tolerated by adult and adolescent smokers or vapers can produce severe toxicity in 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 carefully, away from the reach of children or animals.
Phaeochromocytoma and uncontrolled hyperthyroidism:
As nicotine causes release of catecholamines, this product should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.
Transferred dependence:
Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.
Stopping smoking:
Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs.
g. theophylline, clozapine and ropinirole.
Gastrointestinal Disease:
Nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and NRT preparations should be used with caution in these conditions.
Generalised dermatological disorders:
Patients with chronic generalised dermatological disorders such as psoriasis, chronic dermatitis or urticaria should not use this product. Angioedema and urticaria have been reported. Erythema may occur. If it is severe or persistent, treatment should be discontinued.
8). If skin reactions become more severe or more generalized, patients should be advised to discontinue use of patches and seek further medical help regarding nicotine replacement therapy. This product should be removed prior to undergoing any Magnetic Resonance Imaging (MRI) procedures to prevent the risk of burns.