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NICOTINELL TTS is a brand name for Nicotine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Nicotinell patches relieve and/or prevent cravings and nicotine withdrawal symptoms associated with tobacco dependence. They are indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those…
Verbatim from this product's MHRA label. Tap a section to expand.
Method of administration The patch should be used as soon as it has been removed from the child-resistant pouch. ) and held in position for 10-20 seconds with the palm of the hand. It should not be applied to skin that is red, broken or irritated.
Each patch should be removed after 24 hours and disposed of safely and kept out of the sight and reach of children (see “Warnings”). A different site of application should be chosen each day and 7 days should be allowed to elapse before a new patch is applied to the same area of skin.
The dosage must not be adjusted by cutting a patch. 6) During handling, avoid contact with the eyes and nose and wash your hands after application. Adults over 18 years and the elderly Abrupt cessation of smoking Users should stop smoking completely during treatment with nicotine patches.
Sizes of 30cm2, 20cm2 and 10cm2 are available to permit gradual withdrawal of nicotine replacement, using treatment periods of 3-4 weeks (for each size).
For smokers of more than 20 cigarettes a day:
Dose Duration Step 1 Nicotinell TTS 30 (21mg/24h) First 3-4 weeks Step 2 Nicotinell TTS 20 (14mg/24h) Next 3-4 weeks Step 3 Nicotinell TTS 10 (7mg/24h) Last 3-4 weeks For smokers of less than 20 cigarettes a day: Dose Duration Step 2 Nicotinell TTS 20 (14mg/24h) Next 3-4 weeks Step 3 Nicotinell TTS 10 (7mg/24h) Last 3-4 weeks The strength of patch may be adjusted according to individual response, maintaining or increasing the dose if abstinence is not achieved or if withdrawal symptoms are experienced.
Total treatment periods of more than 3 months and daily doses above 30cm2 have not been evaluated. The treatment is designed to be used continuously for 3 months but not beyond. However, if abstinence is not achieved at the end of the 3 month treatment period, further treatments may be recommended.
Nicotine transdermal patch should not be used for more than 12 months unless the potential benefit outweighs the potential risk to the smokers.
Children and Adolescents (aged 12-17 years of age):
Adolescents (12-17 years) should seek medical advice before using the product. Adolescents should follow the schedule of treatment for abrupt cessation of smoking as given above but as data are limited in this age group, medical advice should be obtained should it be found necessary to use the patch beyond 10 weeks.
In principle, the Nicotinell TTS can cause adverse reactions similar to those associated with nicotine administered by other means (including smoking) and these are mainly dose dependent. Since the maximum plasma concentrations of nicotine that are produced by the patch are lower than those produced by smoking and fluctuate less, nicotine-related adverse reactions occurring during treatment with the patch can be expected to be less marked than during smoking.
Clinical trial experience has shown that skin reactions at the application sites are the most frequent adverse reactions. This led to the premature discontinuation of Nicotinell transdermal patch in approximately 6% of clinical trial participants.
These reactions include application site burning, oedema, erythema, irritation, pruritus, rash, urticaria and vesicles. The majority of these reactions were mild. Most of the skin reactions resolved within 48 hours, but in more severe cases the erythema and infiltration lasted from 1 to 3 weeks.
The time of onset of significant skin reactions was between 3 and 8 weeks from the start of therapy. In isolated cases the skin reactions extended beyond the application sites. Isolated cases of urticaria, angioneurotic oedema and dyspnoea were reported.
Upper respiratory tract infection and cough reported as adverse reactions may be linked to a chronic bronchitis induced by long term smoking in the past. Aphthous stomatitis may develop in connection with smoking cessation, but any relation with the nicotine treatment is unclear.
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 smoking cessation.
Subjects quitting smoking by any means could expect to suffer from asthenia, headache, dizziness, coughing or influenza-like illness. Clinical trial data and Post Marketing data The following convention has been utilised for the classification of adverse reactions: Adverse reactions are listed below by system organ class and frequency.
4 Transferred Dependence) because of its slow onset of action, low fluctuations in blood concentrations, inability to produce high blood concentrations of nicotine, and the infrequent (once daily) use. Moreover, gradual weaning from the patches is instituted within the treatment schedule, and the risk of dependence after therapy is minimal.
The effects of abrupt withdrawal from Nicotinell TTS are likely to be similar to those observed with tobacco withdrawal from comparable nicotine concentrations. 3 Contraindications Nicotinell TTS should not be administered to non-smokers or occasional smokers.
1. 4 Special warnings and precautions for use Any risks that may be associated with nicotine replacement therapy are substantially outweighed by the well-established dangers of continued smoking.
Precautions:
Users should be informed that if they continue to smoke while using the patches, they may experience increased adverse effects due to the hazards of smoking, including cardiovascular effects. 2). In the event of a severe or persistent skin reaction, discontinue treatment and use another pharmaceutical form of nicotine replacement therapy.
Cardiovascular disease In stable cardiovascular disease Nicotinell TTS presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalized as a result of a recent myocardial infarction, unstable or worsening angina pectoris including Prinzmetal’s angina, severe cardiac arrhythmias, uncontrolled hypertension or recent cerebrovascular accident and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions (such as counselling).
If this fails, Nicotinell TTS may be considered but as data on safety in this patient group are limited, initiation should only be under medical supervision. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the nicotine patch dose should be reduced or discontinued.
Nicotinell TTS should not be administered to non-smokers or occasional smokers. 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nicotine in United Kingdom.
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The use of NRT in adolescents should only be used when the benefits of abstinence outweigh the risks of continued smoking.
Children below 12 years of age:
Nicotine patches are not recommended for use in children under 12 years.
Elderly:
Experience in the use of these patches in smokers over the age of 65 years is limited. Nicotinell TTS does not appear to pose safety problems in this age group.
Hepatic and Renal Impairment:
Use with caution in patients with moderate to severe hepatic or renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.
Potential for abuse and dependence:
Transdermal nicotine is likely to have a very low abuse potential (see also section
Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), or not known (can not to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The following undesirable effects have been reported in clinical trials and/or spontaneous post-marketing reports. System Organ Class Adverse Reaction Frequency allergic reactions such as urticaria, rash and pruritus; angioedema and anaphylactoid reaction Not Known Hypersensitivity* Uncommon Immune system disorder Anaphylactic reactions Very Rare Sleep disorders including insomnia, abnormal dreams Very Common agitation, anxiety, nervousness Common Psychiatric disorders* disturbance in attention, somnolence, affect lability, irritability, depressed mood and confusional state Uncommon headache, dizziness Very Common motor dysfunction, tremor Common paraesthesia, dysgeusia and blurred vision Uncommon Nervous system disorders* palpitations Common tachycardia Uncommon Cardiac disorders chest pain** and arrhythmia Rare Vascular disorders hypertension and hot flush Uncommon cough, pharyngitis, dyspnoea CommonRespiratory, thoracic and mediastinal disorders upper respiratory tract infections Uncommon nausea, vomiting Very Common abdominal pain upper, dyspepsia, diarrhoea, dry mouth, constipation Common Gastrointestinal disorders* flatulence Uncommon Skin and subcutaneous Sweating increased Common skin discoloration, cutaneous vasculitis Rare tissue disorders allergic dermatitis *, contact dermatitis*, photosensitivity Very Rare myalgia, arthritis CommonMusculoskeletal, connective tissue and bone disorders arthralgia, muscle cramp and back pain Uncommon application site reactions** Very Common application site pain, asthenia, fatigue Common General disorders and administration site conditions malaise, influenza type illness, asthenic conditions, pain and discomfort Uncommon *Symptoms may be ascribed also to withdrawal symptoms in connection with smoking cessation and may be due to insufficient replacement of nicotine **The majority of topical reactions are minor and resolve quickly following removal of the patch.
g. chest) may be reported. 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.
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Dermatitis Patients with a history of dermatitis are more likely to experience generalised skin reactions or localized erythema, swelling or rash. In this case a decision must be made whether to discontinue and another pharmaceutical form of nicotine replacement therapy should be considered.
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.
Diabetes mellitus Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when nicotine replacement therapy is initiated as catecholamines released by nicotine can affect carbohydrate metabolism and the blood glucose levels may be more variable during smoking cessation, with or without NRT.
Allergic reactions Discontinuation of treatment may be advisable in cases of severe or persistent allergic reactions. Angioedema and urticaria have been reported. Contact sensitisation was reported in a few patients using transdermal nicotine in clinical trials.
Patients who develop contact sensitisation to nicotine should be cautioned that a severe reaction could occur from smoking or exposure to other nicotine containing products. Renal and or hepatic impairment Should be used in caution in patients with moderate to severe hepatic impairment and/or severe impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects (See Dosage and Administration).
Gastro-Intestinal disease Nicotinell TTS should be used with caution in patients suffering from active oesophagitis, oral and pharyngeal inflammation, gastritis, gastric ulcer or peptic ulcers as their symptoms may be exacerbated. Pheochromocytoma and uncontrolled hyperthyroidism Nicotinell TTS should be used with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma as nicotine causes release of catecholamines.
Transferred dependence Transferred dependence is rare and is both less harmful and easier to break than smoking dependence. Danger in small children Nicotine is a toxic substance. 9). Both before and after use, the patch contains a significant amount of nicotine.
Subjects must be cautioned that the patches must not be handled casually or left where they might be inadvertently misused or consumed by children. Used patches must be disposed of with care by folding them in half with the adhesive sides inwards, and ensuring that they do not fall into the hands of children under any circumstances.
Patches should be kept out of the sight and reach of children. Nicotinell TTS contains aluminium. The patch should therefore be removed prior to undergoing any MRI (Magnetic Resonance Imaging), defibrillation or cardioversion procedures.
Stopping smoking When a smoker stops, this may result in slower metabolism and a consequent rise in blood levels of such drugs.