The patch is ideal for tackling. Nicorette Invisi 10mg Patch - Summary of Product Characteristics (SPC) by McNeil Healthcare (Ireland) Ltd. Higher dosage nicotine patches increase on-year smoking cessation rates: results from the European CEASE trial. Eur Resp J 1999; 13:238-246 3 NICORETTE Nicorette 4mg Gum - Summary of Product Characteristics (SPC)Chewing Gum containing 4mg nicotine, as nicotine resinate. For excipients see section 6. Nicorette 4 mg Gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is 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 around them. Nicorette 4 mg Gum is indicated in pregnant and lactating women making a quit attempt. In general, if the patient smokes 2. Smokers aiming to reduce cigarettes should use Nicorette 4mg Gum, as needed, between smoking episodes to prolong smoke- free intervals and with the intention to reduce smoking as much as possible. As soon as they are ready smokers should aim to quit smoking completely. Maximum daily dose: 1. When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking, but are having difficulty discontinuing Nicorette 4mg Gum are recommended to contact their pharmacist or doctor for advice. For those using the 4mg gum, switching to the 2mg gum may be helpful when stopping treatment or reducing the number of gums used each day. The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. Doctors give trusted answers on uses, effects, side-effects, and cautions: Dr. Weixel on nicotine patch dosage calculator: Nicoderm has nicotine dissolved into the glue, so it is possible to 'hack' the patches. Nicoderm CQ Dosage for Smoking Cessation The recommended initial Nicoderm CQ dosage for people who smoke more than 10 cigarettes per day is one 21-mg patch per day for six weeks (weeks 1 through 6). After six weeks, you should. However dependent smokers currently hospitalised as a result of myocardial infarction, unstable or worsening angina including Prinzmetal's angina, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable and/or who suffer with 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. Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism. GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported. 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. Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotine gum should be disposed of with care. 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 1. A2 (and possibly by CYP 1. A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e. Denture warning: Smokers who wear dentures may experience difficulty in chewing this product . The chewing gum may stick to, and may in rare cases damage dentures. However nicotine may possibly enhance the haemodynamic effects of adenosine i. Ideally smoking cessation during pregnancy should be achieved without NRT. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the fetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but if this is not achievable this product may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine- free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the fetus would not normally be exposed to nicotine. Lactation. The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second- hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest. Fertility. In females tobacco smoking delays time to conception, decreases in- vitro fertilization success rates, and significantly increases the risk of infertility. In males tobacco smoking reduces sperm production, increases oxidative stress, and DNA damage. Spermatozoa from smokers have reduced fertilizing capacity. The specific contribution of nicotine to these effects in humans is unknown. This product has no or negligible influence on the ability to drive and use machines. 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 and decreased heart rate. Increased frequency of aphthous ulcer may occur after abstinence from smoking. At recommended doses this product has not been found to cause any serious adverse effects. Most of the undesirable effects reported by the patients occur during the first 3- 4 weeks after start of treatment. Excessive consumption of this product by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches. Excessive swallowing of dissolved nicotine may, at first, cause hiccupping. Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and may also cause increased salivation. Frequencies are defined in accordance with current guidance, as: Very common (> 1/1. Not known - cannot be estimated from the available data. System Organ Class. Reported Adverse Event. Incidence. Immune System Disorders. Hypersensitivitya. Anaphylactic reactiona. Common. Psychiatric disorders. Abnormal dreams*Uncommon. Nervous System Disorders. Headachea#Burning sensationc Dizziness. Dysgeusia Paraesthesiaa. Very Common. Common Common. Eye Disorders. Blurred Vision Lacrimation increased. Cardiac Disorders. Palpitationsa Tachycardiaa. Reversible atrial fibrillation. Vascular Disorders. Flushinga. Hypertensiona. Uncommon Uncommon. Respiratory, Thoracic and Mediastinal Disorders. Sore mouth or throat. Throat irritation. Bronchospasm Dysphonia Dyspnoeaa Nasal Congestion. Sneezing Throat tightness. Very Common. Very Common Uncommon Uncommon Uncommon Uncommon Uncommon. Gastrointestinal Disorders. Nauseaa. Hiccups. Abdominal pain. Diarrhoea***Dry mouth. Salivary hypersecretion. Vomitinga. Dyspepsia. Oral mucosal blistering and exfoliation. Paraesthesia oral***Dysphagia. Hypoaesthesia oral***Retching. Gastrointestinal discomforta. Lip pain. Very Common. Common Common. Skin and Subcutaneous Tissue Disorders. Urticariaa. Hyperhidrosisa. Pruritusa. Rasha. Erythemaa. Uncommon Uncommon Uncommon Uncommon Not known. Musculoskeltal and Connective Tissue Disorders. Pain in jawb. Muscle tightnessb. Uncommon. General Disorders and Administration Site Conditions. Fatiguea. Astheniaa. Chest discomfort and paina. Malaisea. Allergic reactions including angioedema. Systemic effects; b Tightness of jaw and pain in jaw with nicotine gum formulationc At the application site*Identified only for formulations applied during the night**Higher frequency observed in clinical studies with inhaler formulation.***Reported the same or less frequently than placebo# 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www. Symptoms: The minimum lethal dose of nicotine in a non- tolerant man has been estimated to be 4. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions. Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro- intestinal absorption of nicotine. Pharmacotherapeutic group: Drugs used in nicotine dependence. ATC code: N0. 7B A0. The pharmacological effects of nicotine as well documented. Clinical trials have demonstrated that Nicotine Replacement Therapy can help control weight following a quit attempt. Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes.
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