- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
- Legal category
Adults: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. 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 an area of dry skin with no skin lesion and little hair (shoulder blade, hip, lateral surface of the arms, etc) 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)During handling, avoid contact with the eyes and nose and wash your hands after application.
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.
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.Nicotinell TTS should be used with caution on diseased skin (see section 4.2). In the event of a severe or persistent skin reaction, discontinue treatment and use another pharmaceutical form of nicotine replacement therapy.
Underlying cardiovascular diseaseIn 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.
Diabetes mellitusPatients 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 reactionsDiscontinuation 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 impairmentShould 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 diseaseNicotinell TTS should be used with caution in patients with peptic ulcers.
Pheochromocytoma and uncontrolled hyperthyroidismNicotinell TTS should be used with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma as nicotine causes release of catecholamines.
Transferred dependenceTransferred dependence is rare and is both less harmful and easier to break than smoking dependence.
Danger in small childrenNicotine is a toxic substance. Doses of nicotine that are tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal (see section 4.9). 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..Nicotinell TTS contains aluminum. The patch should therefore be removed prior to undergoing any MRI (Magnetic Resonance Imaging), defibrillation or cardioversion procedures.
Stopping smokingPolycyclic 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.
|SYSTEM ORGAN CLASS(MedDRA classification)||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)||NOT KNOWN (can not be estimated from available data)|
|Immune system disorders||-||-||-||allergic reactions such as urticaria, rash and pruritus; angioedema and anaphylactoid reaction|
|Psychiatric disorders*||agitation, anxiety, nervousness, insomnia, abnormal dreams||disturbance in attention, somnolence, affect lability, irritability, depressed mood and confusional state||-||-|
|Nervous system disorders*||headache, dizziness, motor dysfunction||paraesthesia, dysgeusia and blurred vision||tremor|
|Cardiac disorders||-||palpitations||chest pain, dyspnea and arrhythmia||-|
|Vascular disorders||-||hypertension and hot flush||-||-|
|Respiratory, thoracic and mediastinal disorders||cough||upper respiratory tract infections||-||-|
|Gastrointestinal disorders*||nausea, abdominal pain, dyspepsia||vomiting, constipation, diarrhea, flatulence, dry mouth||-||-|
|Skin and subcutaneous tissue disorders||-||hyperhidrosis||skin discoloration, cutaneous vasculitis||-|
|Musculoskeletal, connective tissue and bone disorders||myalgia, arthritis||arthralgia, muscle cramp and back pain||-||-|
|General disorders and administration site conditions||application site reactions||asthenic conditions, pain and discomfort||-||-|
SymptomsSymptoms of acute nicotine poisoning include nausea, vomiting, salivation, abdominal pain, diarrhoea, sweating, headache, tachycardia, dizziness, disturbed hearing and vision and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse, coma and terminal convulsions.
Management of overdoseIf the patient shows signs of overdose, the patch should be removed immediately. The skin surface may be washed with water and dried (no soap should be used). The skin will continue to deliver nicotine into the blood stream for several hours after removal of the system, possibly because of a depot of nicotine in the skin. The patient should then be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary.
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