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Nicorette Invisipatch 25 Mg/16 H Transdermal Patch Nicorette Invisipatch 15 Mg/16 H Transdermal Patch Nicorette Invisipatch 10 Mg/16 H Transdermal Patch

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Nicorette Invisipatch 25 Mg/16 H Transdermal Patch Nicorette Invisipatch 15 Mg/16 H Transdermal Patch Nicorette Invisipatch 10 Mg/16 H Transdermal Patch Package leaflet: Information for the user Nicorette invisipatch 25 mg/16 h transdermal patch Nicorette invisipatch 15 mg/16 h transdermal patch Nicorette invisipatch 10 mg/16 h transdermal patch (nicotine) Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you have not been able to stop smoking after 6 months of treatment with Nicorette Invisipatch. What is in this leaflet: 1. What Nicorette invisipatch is and what it is used for 2. What you need to know before you use Nicorette invisipatch 3. How to use Nicorette invisipatch 4. Possible side effects 5 How to store Nicorette invisipatch 6. Contents of the pack and other information 1. What Nicorette invisipatch is and what it is used for Nicorette invisipatch is a medicinal product helping you to stop smoking. Nicorette invisipatch is used to treat tobacco dependence, to relieve cravings for smoking (nicotine) and nicotine withdrawal symptoms, which helps the motivated smokers to stop smoking. When you stop smoking and providing your body with nicotine from tobacco, you can experience unpleasant feelings called withdrawal symptoms. By using Nicorette invisipatch you can prevent or reduce these unpleasant feelings - by using Nicorette invisipatch patches you continue to provide your body with small amount of nicotine in its pure form, which does not bring about health risks associated with smoking. Health risks associated with smoking are caused by toxins contained in tobacco. Counselling advice and support usually improve your chances to quit smoking. If possible, use the medicine as a part of a smoking withdrawal program. If used as recommended, Nicorette invisipatch helps you to control potential rise in your weight after you stop smoking. 2. What you need to know before you use Nicorette invisipatch Do not use Nicorette invisipatch - If you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6). - If you are under 18 years of age. - If you are non-smoker. 1/10 Warnings and precautions Talk to your doctor or pharmacist before taking Nicorette invisipatch if you: - have ever suffered from a serious cardio-vascular event or were hospitalized within the last 4 weeks due to abnormal heart condition (e.g. stroke, myocardial infarction, arrhythmia (heart rhythm disorder), unstable angina pectoris) - have had cardio-vascular bypass surgery or angioplasty (surgery on arteries) - suffer from high blood pressure which is not being controlled by medicines - suffer from liver disease and/or severe kidney disease - have diabetes, as when you stop smoking you may need to lower insulin dosage - have an overactive thyroid gland (hyperthyroidism) or a tumour of the adrenal gland (phaeochromocytoma) - have stomach or duodenal ulcers Children and adolescents Nicorette invisipatch is not to be used in patients under 18 years of age. Doses of nicotine that are well tolerated by adult smokers during treatment may cause serious symptoms of poisoning in children and may prove fatal. Even if already used, patches contain enough nicotine to do harm to children. Keep both used and unused patches out of sight and reach of children. Other medicines and Nicorette invisipatch Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important if you take medicines containing: theophylline to treat asthma tacrine for Alzheimer’s disease clozapine for schizophrenia ropinirole to treat Parkinson’s disease Nicorette invisipatch with food and drink Food and drink intake has no influence on the effect of this medicine. Pregnancy and breast-feeding Before using any medicine, consult your doctor or pharmacist. As smoking can cause severe damage to foetus or your infant, you should stop smoking during pregnancy and breast-feeding, if possible you should do so without using medicines containing nicotine. Nicotine is found in breast milk in the amounts that may harm infants. Do not use Nicorette invisipatch during breast-feeding. If you cannot stop smoking without using medicines that contain nicotine, use Nicorette products only after consulting your doctor. Driving and using machines No effects on the ability to drive cars or use machines have been observed. 3. How to use Nicorette invisipatch Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not exceed the maximum dose. You should try your best to stop smoking completely during the treatment with Nicorette invisipatch. Nicorette invisipatch may be used alone or in combination with either [insert local name for Nicorette 2 mg gum] or [insert local name for Nicorette oromucosal 1 mg / spray]. 2/10 Use in children and adolescents Safety and efficacy in children and adolescents have not been assessed. Nicorette invisipatch must not be used by children and adolescents under 18 years of age. Adults (elderly included) Treatment with patch alone: Treatment with Nicorette invisipatch usually takes 12 weeks. The amount of nicotine in a patch is usually high at the beginning and smaller later during the treatment, which means gradual decreasing of nicotine needed and eventual stop of smoking. Treatment with Nicorette invisipatch imitates fluctuation of plasma nicotine level observed in smokers without nicotine intake during sleep. Nicotine excreted from Nicorette patches, that are used only during the active part of a day (effect lasts 16 hours), does not cause sleep disorders observed in patients who get nicotine during sleep. Smokers with high level of nicotine dependence (Fagerström test for nicotine dependence corresponding to or higher than 6, or smoking more than 20 cigarettes a day) are recommended to start their treatment with Nicorette invisipatch 25 mg/16 h (one patch a day), see Table 1. The initial treatment should last 8 weeks. After 8 weeks, the dose of nicotine contained in patches should be decreased gradually. Therefore, Nicorette invisipatch 15 mg/16 h should be used for 2 weeks (one patch a day), followed by Nicorette invisipatch 10 mg/16 h used for 2 weeks as well (one patch a day). Smokers with lower level of nicotine dependence (Fagerström test for nicotine dependence lower than 6, or smoking less than 20 cigarettes a day) are recommended to start their treatment with Nicorette invisipatch 15 mg/16 h (one patch a day), see Table 2. The initial treatment should last 8 weeks. After 8 weeks, the dose of nicotine contained in patches should be decreased gradually. Therefore, Nicorette invisipatch 10 mg/16 h should be used for 4 weeks (one patch a day – step 3, see Table 2). Table 1) Dosage scheme in smokers with high level of nicotine dependence Dosage Treatment period Step 1 Nicorette invisipatch 25 mg/16 h one patch a day first 8 weeks – initial phase Step 2 Nicorette invisipatch 15 mg/16 h one patch a day following 2 weeks Step 3 Nicorette invisipatch 10 mg/16 h one patch a day last 2 weeks Table 2) Dosage scheme in smokers with lower level of nicotine dependence Dosage Treatment period Step 1 Nicorette invisipatch 15 mg/16 h one patch a day first 8 weeks – initial phase Step 2 Nicorette invisipatch 10 mg/16 h one patch a day last 4 weeks Using patches longer than 6 months is generally not recommended. If you need to use the product longer than recommended to prevent taking up smoking again, consult your doctor. 3/10 Treatment with patch in combination with either [insert local name for Nicorette 2 mg gum] or [insert local name for Nicorette oromucosal 1 mg / spray]. If you feel that nicotine craving occurs despite the use of nicotine medications, you can use Nicorette patch in combination with either [insert local name for Nicorette 2 mg gum] or [insert local name for Nicorette oromucosal 1 mg / spray]. Read the leaflet for the Nicorette product you use with the patch before taking it. The leaflet is enclosed in each package. Smokers with high level of nicotine dependence (Fagerström test for nicotine dependence corresponding to or higher than a score of 6, or smoking more than 20 cigarettes a day) are recommended to start their treatment with Nicorette invisipatch 25 mg/16 h (one patch a day) in combination with either [insert local name for Nicorette 2 mg gum] or [insert local name for Nicorette oromucosal 1 mg / spray] as described in Table 3. The initial treatment should last 8 weeks. After 8 weeks, the dose of nicotine contained in patches should be decreased gradually. Therefore, Nicorette invisipatch 15 mg/16 h should be used for 2 weeks (one patch a day), followed by Nicorette invisipatch 10 mg/16 h used for 2 weeks as well (one patch a day). The dose of [insert local name for Nicorette 2 mg gum] or [insert local name for Nicorette oromucosal 1 mg / spray] to use in combination with the patches are described in Table 3. Smokers with lower level of nicotine dependence (Fagerström test for nicotine dependence lower than a score of 6, or smoking less than 20 cigarettes a day) are recommended to start their treatment with Nicorette invisipatch 15 mg/16 h (one patch a day) in combination with either [insert local name for Nicorette 2 mg gum] or [insert local name for Nicorette oromucosal 1 mg / spray] as described in Table 4.
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