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Nicotinell TTS 10 Patch 7mg (pack of 7) |
Nicotinell TTS patches keep working around the clock to help give you a smoke free life! The patch is designed to supply your body with decreasing amounts of Nicotine as you go from step 1, to 2 and then to 3, helping you become smoke free.
Nicotinell patches can help you stop smoking. When you apply the patch, nicotine passes through your skin and into the body, replacing the nicotine you would normally get from smoking. The patches come in three sizes. As your body adjusts to not smoking you should gradually reduce the size of the patch over a period of up to 12 weeks until you no longer need to use them.
Consult your doctor or pharmacist if you have an underlying medical condition, are taking any other medication or complementary therapy, or if symptoms persist. Seek advice before using if you are breast feeding, pregnant, planning to become pregnant, or suffer from allergies. Keep all medicines out of the reach of children.
Dosage:
Adults over 18 years and elderly: for those smoking 20 plus cigarettes per day, initially 1 TTS30 patch daily for 3-4 weeks. Patch size can be reduced depending upon response. Maximum use period 3 months. For those smoking less than 20 cigarettes a day, start with 1 TTS20 patch daily.
Adolescents under 18 years and pregnant and lactating women: not to be used without medical advice. TTS 30sq cm/average absorption 21mg/24 hours, TTS20sq cm/average absorption 14mg/24 hours, TTS10sq cm/average absorption 7mg/24 hours
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Each Nicotinell TTS 10 patch contains 17.5mg S(-)-nicotine which provides an average absorption rate of 7 mg nicotine in 24 hours.
Transdermal patch.
The Nicotinell TTS patch is a transdermal therapeutic system, consisting of a round, flat, matrix-type self-adhesive, yellowish-ochre coloured patch. It is protected by a rectangular metallic release liner backing to be discarded before application.
Nicotinell TTS 10 patch 7mg/24 hour has a drug releasing area of 10 cm2 and is printed CG CWC on the patch surface.
Relief of nicotine withdrawal symptoms as an aid to smoking cessation.
Concurrent counselling/behavioural support is recommended as it is likely to increase the chances of a successful quit attempt
Route of administration: transdermal.
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Adults:
Users should stop smoking completely during treatment with Nicotinell TTS patch.
For individuals smoking 20 cigarettes or more a day, it is recommended that treatment be started with Nicotinell TTS 30 (Step 1) once daily, applied to a dry non-hairy area of the skin on the trunk or upper arm. Those smoking less than this are recommended to start with Nicotinell TTS 20 (Step 2). 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). The size 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.
Those who use nicotine replacement therapy beyond 9 months are recommended to seek additional help and advice from a healthcare professional.
The dosage must not be adjusted by cutting a patch.
The patch should be used as soon as it has been removed from the child-resistant pouch. Following removal of the metallic backing, the patch should be applied to the skin and held in position for 10-20 seconds with the palm of the hand. Each patch should be removed after 24 hours and disposed of safely (see “Warnings”). A different site of application should be chosen each day and several days should be allowed to elapse before a new patch is applied to the same area of skin.
Use for 24 hours optimizes the effect against morning cravings but in pregnant patients, it is recommended that the patch is removed before going to bed (see section 4.6)
Children and young adults:
The above recommendation can be used for adolescences between 12 and 18 years of age. As data are limited in this age group, medical advice should be obtained should it be found necessary to use the patch beyond 12 weeks.
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.
Potential for abuse and dependence:
Transdermal nicotine is likely to have a very low abuse potential (see also section 4.4 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.
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Nicotinell TTS should not be administered to non-smokers or occasional smokers. The system is contraindicated in diseases of the skin which may complicate patch therapy, and known hypersensitivity to nicotine or any of the components of the patch.
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Any risks that may be associated with nicotine replacement therapy are substantially outweighed by the well established dangers of continued smoking.
Precautions: Users should stop smoking completely during therapy with Nicotinell TTS. They 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.
Underlying 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, severe dysrhythmia or recent cerebrovascular accident and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. 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.
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.
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.
Gastro-Intestinal disease
Nicotinell TTS should be used with caution in patients with peptic ulcers.
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
Doses of nicotine that are tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. 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.
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 slower metabolism and a consequent rise in blood levels of such drugs.
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