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Nicorette Invisi Transdermal Patch & Nicorette Icy Mint Medicated Chewing Gum: Before the patient starts to use it: Talk to a doctor or pharmacist if the patient has the following conditions: Cardiovascular disease. Dependent smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetal's angina, severe cardiac arrhythmias, recent cerebrovascular accident, and/or who suffer from uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, Nicorette Invisi Transdermal Patch/Nicorette Icy Mint Gum may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision.
Diabetes mellitus. Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when smoking is stopped, and NRT is initiated as reductions in nicotine-induced catecholamine release can affect carbohydrate metabolism.
Renal and hepatic impairment. Use 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.
Phaeochromocytoma and uncontrolled hyperthyroidism. Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines.
Gastrointestinal disease. Nicotine may exarcebate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers. Nicotine Replacement Therapy (NRT) preparations should be used with caution in these conditions.
Epilepsy and seizures. Caution should be exercised in patients with a history of epilepsy or seizures during introduction of nicotine replacement therapy. Tobacco smoke contains substances - including nicotine - which act on brain receptors, and the changes in intake of these when switching from smoked tobacco to nicotine replacement therapy during quitting may affect seizure threshold.
Transferred dependence: Transferred dependence can occur but is unusual 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 CYP1A2. 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.g. theophylline, tacrine, clozapine and ropinirole.
If the patient notices side effects, any other unwanted effects not listed in this monograph, or have any other questions on the use of this product, stop use and consult a doctor or pharmacist.
Effects on ability to drive or use machines: Nicorette Invisi Transdermal Patch/Nicorette Icy Mint Gum has no or negligible influence on the ability to drive and use machines.
Women of childbearing potential/Contraception in males and females: In contrast to the well-known adverse effects of tobacco smoking on human conception and pregnancy, the effects of therapeutic nicotine treatment are unknown. Thus, whilst to date no specific advice regarding the need for female contraception has been found to be necessary, the most prudent state for women intending to become pregnant to be in is to be both non-smoking, and not using NRT.
Whilst smoking may have adverse effects on male fertility, no evidence exists that particular contraceptive measures are required during NRT treatment by males.
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.
Use in Pregnancy: Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature birth or stillbirth. Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby. The earlier abstinence is achieved the better. Nicotine passes to the foetus and affects its breathing movements and circulation. The effect on the circulation is dose-dependent. Therefore, the pregnant smoker should always be advised to stop smoking completely without using nicotine replacement therapy. The risk of continued smoking may pose greater hazard to the foetus as compared with the use of nicotine replacement products in a supervised smoking cessation programme. Use of Nicorette Invisi Transdermal Patch/Nicorette Icy Mint Gum by the pregnant smoker should only be initiated after advice from a health care professional.
Use in Lactation: Nicotine passes freely into breast milk in quantities that may affect the child even with therapeutic doses. Nicotine should therefore be avoided during breast-feeding. Should smoking cessation not be achieved, use of the Nicorette Invisi Transdermal Patch/Nicorette Icy Mint Gum by breast feeding smokers should only be initiated after advice from a health care professional.
Women should take the product as soon as possible after breastfeeding (Nicorette Icy Mint Medicated Chewing Gum).
Use in Children: Danger in children: Doses of nicotine tolerated by smokers can produce severe toxicity in children that may be fatal. Products containing nicotine should not be left where they may be handled or ingested by children.
Nicorette Invisi Transdermal Patch: Nicorette Invisi Transdermal Patch should be removed prior to undergoing any Magnetic Resonance Imaging (MRI) procedures to prevent the risk of burns.
Nicorette Icy Mint Medicated Chewing Gum: Smokers who wear dentures may experience difficulty in chewing nicotine gum. The chewing gum may stick to, and may in rare cases damage dentures.
Nicorette QuickMist Mouth Spray: Take special care with Nicorette QuickMist: Contact a doctor if the patient suffers from the following. The patient may be able to have Nicorette QuickMist, but need to discuss with the doctor first if they have: Recently (within 3 months) had a heart attack or stroke; Chest pain (unstable angina), or resting angina; A heart condition that effects the heart rate or rhythm; High blood pressure which is not being controlled by medicines; Ever had allergic reactions that involve swelling of the lips, face and throat (angioedema) or itchy skin rash (urticaria). Using NRT can sometimes trigger this type of reaction; Severe or moderate liver disease; Severe kidney disease; Diabetes; An overactive thyroid gland; A tumour of the adrenal gland (phaeochromocytoma); Stomach ulcer; Oesophagitis; Ever experienced seizure (fits).
Nicorette QuickMist should not be used by non-smokers.
Driving and using machines: No effects on the ability to drive cars or use machines have been observed.
Important information about some of the ingredients in Nicorette QuickMist: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per spray.
Use in Pregnancy and Lactation: It is very important to stop smoking during pregnancy because it can result in poor growth of the baby. It can also lead to premature births or stillbirths. It is best if the patient can give up smoking without the use of medicines containing nicotine. If the patient cannot manage this, Nicorette QuickMist should only be used after consulting the healthcare professional who is managing the pregnancy, the family doctor, or a doctor in a centre that is specialised in helping people quit smoking.
Nicorette QuickMist should be avoided during breast-feeding as nicotine is found in breast milk and may affect the child. If the doctor has recommended the patient to use Nicorette QuickMist, the spray should be taken just after breast-feeding.
