Nicorette

Nicotine.

Nicorette Invisi Transdermal Patch: Each strength of the patch has a different size: 10 mg: 9.0 cm², 15 mg: 13.5 cm², 25 mg: 22.5 cm², respectively.
Nicorette Icy Mint Medicated Chewing Gum: Each Nicorette Icy Mint Medicated Chewing Gum contains: Nicotine (as resinate) 2 mg or 4 mg, respectively.
Nicorette QuickMist Mouth Spray: The active substance is nicotine. One spray dose contains 1 mg of nicotine.
Each bottle contains 13.2 ml of solution which provides approximately 150 sprays, each containing 1 mg nicotine.
Excipients/Inactive Ingredients: Nicorette Invisi Transdermal Patch: Medium chain triglycerides, basic butylated methacrylate copolymer, polyethylenterephthalate film (PET), acrylic adhesive solution, potassium hydroxide, croscarmellose sodium, aluminium acetylacetonate, siliconized PET release liner with aluminized single side, printing inks.
Nicorette Icy Mint Medicated Chewing Gum: 2mg: Chewing gum base, levomenthol, acesulfame potassium, talc, magnesium oxide (light), xylitol, peppermint oil, sodium carbonate anhydrous, and sodium hydrogen carbonate.
4mg: Chewing gum base, xylitol, levomenthol, Quinoline yellow E104 Al-lake, acesulfame potassium, magnesium oxide (light), peppermint oil, sodium carbonate anhydrous and talc.
Coating: Pregelatinized starch, titanium dioxide, hypromellose, water, xylitol, carnauba wax, polysorbate 80, winterfresh, and sucralose and quinoline yellow E 104 Al-lake (4mg only).
Nicorette QuickMist Mouth Spray: The other ingredients are: propylene glycol, anhydrous ethanol, trometamol, poloxamer 407, butylated hydroxytoluene (BHT), glycerol, sodium hydrogen carbonate, levomenthol, mint flavour, cooling flavour, sucralose, acesulfame potassium, hydrochloric acid and purified water.

Nicorette Invisi Transdermal Patch & Nicorette Icy Mint Medicated Chewing Gum: When the patient stops smoking, the body misses the nicotine that the patient has been absorbing. The patient may experience unpleasant feelings and a strong desire to smoke (craving). This indicates that the patient is dependent on nicotine.
When the patient applies a Nicorette Invisi Transdermal Patch to the skin and chew Nicorette Icy Mint Gum, nicotine is released and passes into the body, and through the lining of the mouth (Nicorette Icy Mint Medicated Chewing Gum). The nicotine released from the patch and gum are sufficient to relieve the unpleasant withdrawal symptoms. It will also help to stop the craving to smoke, but Nicorette Invisi Transdermal Patch and Nicorette Icy Mint Gum will not give the "buzz" the patient gets from smoking a cigarette.
The benefits of quitting smoking outweigh any risks associated with correctly administered nicotine replacement therapy (NRT).
Nicorette Invisi Transdermal Patch and Nicorette Icy Mint Gum are not to be administered to persons under 18 years of age without recommendation from health care professional. There is insufficient clinical data from controlled trials to recommend routine use in adolescents under the age of 18.

Nicorette Invisi Transdermal Patch & Nicorette Icy Mint Medicated Chewing Gum: Nicorette Invisi Transdermal Patch/Nicorette Icy Mint Gum is used to relieve withdrawal symptoms and reduce the cravings for nicotine that the patient gets when trying to stop smoking.
Advice and support normally improve the success rate.
Nicorette QuickMist Mouth Spray: Nicorette QuickMist is used to help stop smoking when the patient wants to quit. This is a type of treatment called Nicotine Replacement Therapy (NRT).
Nicorette QuickMist will give a fast relief of cravings for nicotine and the withdrawal symptoms the patient gets when stopping smoking. When the patient suddenly stops providing nicotine from tobacco to the body, they get hit by different kinds of unpleasant feelings called withdrawal symptoms. By using Nicorette QuickMist, the patient can prevent or reduce these unpleasant feelings and cravings for smoking. This is because the patient continues to provide a small amount of nicotine to the body for a short period of time. Using Nicorette QuickMist does not involve the health dangers of tobacco smoking. This is because it does not contain the tar, carbon monoxide or other toxins in cigarette smoke.
To improve the chances of helping the patient to stop smoking, they should also seek counselling advice and support, if they can.

Nicorette Invisi Transdermal Patch: Monotherapy: How much to use: Use one new patch per day. Apply when the patient wakes up (usually in the morning) and remove 16 hours later (usually at bedtime).
Wash hands before applying the patch.
Each Nicorette Invisi Transdermal Patch comes with a child-resistant sachet which can be opened by cutting along the edge with a pair of scissors.
Remove the patch from its sachet and then peel one part of the silvery aluminum backing away. Avoid touching the sticky surface of the patch with fingers. Carefully apply the sticky part of the patch to the chosen area of skin and then peel off the remaining half of the silvery backing foil.
Press the patch firmly onto the skin with palm or fingertips.
Run fingers around the edge to ensure it sticks firmly.
If the patch comes off, replace with a new one. Use of skin oils or talc can prevent proper adhesion of the patch.
Administration of nicotine should be stopped temporarily if any symptoms of nicotine excess occur. Nicotine intake should be decreased by either lowering dosing frequency or strength if nicotine excess symptoms persist.
How long to use it: Heavy smokers (those smoking 15 or more cigarettes in a 24-hour period) are recommended to start at Step 1 with the 25mg/16 hours patch and use one patch daily for 8 weeks.
Gradual weaning from the patch should then be initiated. One 15 mg/16 hours patch should be used daily for 2 weeks followed by one 10 mg/16 hours patch daily for 2 weeks.
Light smokers (those smoking less than 15 cigarettes in a 24-hour period) are recommended to start at Step 2 (15 mg/16 hours) for 8 weeks and decrease the dose to Step 3 (10 mg/16 hours) for the final 4 weeks. (See Tables 1 and 2.)

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Smokers should stop smoking completely during the course of treatment with Nicorette Invisi Transdermal Patch.
Nicorette Invisi Transdermal Patch is usually not recommended for use over a period in excess of 6 months but some people may need longer treatment in order to avoid getting into a smoking habit again.
While the patient is using it: Things the patients must do: Before applying Nicorette Invisi Transdermal Patch, choose a completely clean, dry area of hairless skin on the front or side of the chest, upper arm or hip.
Things the patients must not do: Do not use more than one patch at a time. If the patient loses a patch while swimming, bathing or showering, the patient can replace it with another patch.
Do not apply oil, lotion or talcum powder to the skin before putting on the patch as this may prevent it from sticking properly.
The patch should not be kept on at night while sleeping as it may cause nicotine-induced sleep disturbance. If the patient forgets to remove the patch the night before, continue treatment the following morning by removing the old patch and applying the new one.
Things to be careful of: Avoid placing the patch onto any area of skin that is red, cut or irritated.
Do not use the same area for two consecutive days to help avoid skin irritation.
Nicorette Icy Mint Medicated Chewing Gum: Monotherapy: How much to use: The initial dosage should be individualized on the basis of the smoker's nicotine dependence. The 4 mg Nicorette Icy Mint Gum is recommended for smokers who are highly dependent (for example smoking 20 cigarettes or more per day or smoking the first cigarette in the morning 30 minutes or less after waking up). Other smokers should begin treatment with the 2 mg dosage strength. (See Table 3.)

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Most people use between 8 to 12 gums per day.
Do not exceed the following quantity in any 24-hour period: 2mg: 30 gums; 4mg: 24 gums.
Chew a piece of chewing gum when feeling the need to smoke. Each piece of Nicorette Icy Mint Chewing Gum should be chewed slowly for approximately 30 minutes, with pauses. The gum should be chewed until a strong taste or mild burning sensation is experienced, then rested between the cheek and gums until the taste and/or sensation have disappeared, then chew again slowly and repeat.
The chewing gum is chewed to release nicotine, then rested so that nicotine can be taken in through the lining of the mouth. Nicotine swallowed in the saliva is not beneficial and in excess may irritate the throat or upset the stomach causing e.g. hiccups.
To avoid this, refer to the Nicorette Chewing Gum Technique as follows.
The Nicorette Chewing Gum Technique: CHEW gum slowly until taste becomes strong (approx-1 min) (10 chews).
REST the gum between the gum and cheek (wait 1 min).
CHEW the gum again when taste has faded (Repeat for 20-30 mins).
When the chewing gum has lost its strength dispose of it carefully, such as back in the hole of the blister.
Administration of nicotine should be stopped temporarily if any symptoms of nicotine excess occur. Nicotine intake should be decreased by either lowering dosing frequency or strength if nicotine excess symptoms persist.
How long to use it: The full course for using Nicorette Icy Mint Gum lasts around 16 weeks, from quitting cigarettes to no longer requiring Nicorette Icy Mint Gum. During that time the patient should gradually reduce the intake of nicotine, until the patient can do without it. It is suggested that the patient should use Nicorette Icy Mint Gum for 12 weeks, reducing the number of pieces used in the next 4 weeks. (See Table 4.)

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Stop smoking completely at the same time in order to increase the chances of success.
To help stay smoke free after treatment, some smokers may need to use the Nicorette Icy Mint Gum in situations when they are strongly tempted to smoke.
Regular use beyond 12 months is generally not recommended.
Nicorette Invisi Transdermal Patch & Nicorette Icy Mint Medicated Chewing Gum: Combination Therapy: Highly dependent smokers, smokers who experience 'breakthrough' cravings or those who have failed with single Nicotine Replacement Therapy (NRT) treatment, can use a flexible smoking cessation format, in combination with the patch for fast relief of cravings.
How to combine the use of Nicorette Invisi Transdermal Patch with Nicorette Icy Mint Gum 2mg: The treatment involves the addition of Nicorette Icy Mint Gum 2mg to the patch.
The Nicorette Invisi Transdermal Patch should be applied daily to an intact area of the skin upon waking and removed at bedtime, and the 2mg Gum should be used as required when cravings occur.
For heavy smokers (more than 15 cigarettes in a 24-hour period): Use one Nicorette Invisi Transdermal Patch 25mg/16 hours per day for 12 weeks plus the Nicorette Icy Mint Gum 2mg. For best results, try to use at least 4 2mg Gums every day. Most people will use 5 - 6 Gums. The maximum number of 2mg Gums that can be taken in conjunction with Nicorette Invisi Transdermal Patch is 12.
The combination of Nicorette Icy Mint Gum 2mg and Nicorette Invisi Transdermal Patch should be used in this way for 12 weeks. After this, the patient should wean off NRT by either: 1) Using the Nicorette Invisi Transdermal Patch 15mg/16 hours for 2 weeks, followed by the Nicorette Invisi Transdermal Patch 10mg/16 hours for 2 weeks, while using the same number of 2mg Gums a day that the patient has routinely used. Then, when a Patch is no longer needed, gradually reduce the number of 2mg Gums until the patient no longer needs them. OR 2) Stop using the Nicorette Invisi Transdermal Patch 25mg/16 hours, then gradually reduce the number of 2mg Gums that the patient uses until the patient no longer needs them.
For light smokers (less than 15 cigarettes in a 24-hour period): Use one Nicorette Invisi Transdermal Patch 15mg/16 hours per day for 12 weeks plus the Nicorette Icy Mint Gum 2mg. For best results, try to use at least 4 2mg Gums every day. Most people will use 5 - 6 Gums. The maximum number of 2mg Gums that can be taken in conjunction with Nicorette Invisi Transdermal Patch is 12.
The combination of Nicorette Icy Mint Gum 2mg and Nicorette Invisi Transdermal Patch should be used in this way for 12 weeks. After this, the patient should wean off NRT by either: 1) Using the Nicorette Invisi Transdermal Patch 10mg/16 hours for 4 weeks, while using the same number of 2mg Gums a day that the patient has routinely used. Then, when a Patch is no longer needed, gradually reduce the number of 2mg Gums until the patient no longer needs them. OR 2) Stop using the Nicorette Invisi Transdermal Patch 15mg/16 hours, then gradually reduce the number of 2mg Gums that the patient uses until no longer need them.
The Nicorette Invisi Transdermal Patch should NOT be used with Nicorette Icy Mint Gum 4mg.
Smokers should stop smoking completely during the course of treatment with Nicorette Icy Mint Gum and Nicorette Invisi Transdermal Patch.
Nicorette QuickMist Mouth Spray: HOW TO TAKE NICORETTE QUICKMIST: Always take Nicorette QuickMist as stated in the monograph. The patient should check with a doctor or pharmacist if not sure.
People under 18 years of age should not use Nicorette QuickMist, unless prescribed by a doctor.
The patient should stop smoking completely during treatment with Nicorette QuickMist.
The following information shows the recommended step by step process for Nicorette QuickMist.
Step 1: Weeks 1-6: Use 1 or 2 sprays when the patient would normally smoke a cigarette or have cravings to smoke. Use one spray first and if the cravings do not disappear within a few minutes use the second spray. If 2 sprays are required, future doses may be delivered as 2 consecutive sprays. For most smokers this means about 1 or 2 sprays every 30 minutes to 1 hour.
For example, if the patient smokes an average of 15 cigarettes per day, they should use 1 or 2 sprays at least 15 times during the day.
The maximum dose is 2 sprays at a time, 3 sprays per hour and 48 sprays per day.
Step 2: Weeks 7-9: Start reducing the number of sprays per day.
By the end of the week 9 the patient should be using HALF the average number of sprays per day that were used in Step 1.
Step 3: Weeks 10-12: Continue reducing the number of sprays per day so that the patient is not using more than 3 sprays per day during week 12. Then stop using Nicorette QuickMist.
The patient may be tempted to smoke again after treatment has stopped. If they have a craving use one or two sprays if one spray dose not help within a few minutes.
Normally the patient should take Nicorette QuickMist for 3 months, though no longer than 6 months. Consult a doctor or pharmacist if the patient needs to use Nicorette QuickMist for longer than 6 months. Save any remaining doses of the spray, as craving for smoking may suddenly occur.

Nicorette Invisi Transdermal Patch & Nicorette Icy Mint Medicated Chewing Gum: Symptoms of overdose with nicotine from Nicorette Invisi Transdermal Patch/Nicorette Icy Mint Gum may occur in smokers who have previously had a low nicotine intake from cigarettes or if other sources of nicotine are used concomitantly with Nicorette Invisi Transdermal Patch/Nicorette Icy Mint Gum.
Acute or chronic toxicity of nicotine in man is highly dependent on mode and route of administration. Adaptation to nicotine (e.g. in smokers) is known to significantly increase tolerability compared with non-smokers. The acute minimum lethal oral dose of nicotine is believed to be 40 to 60 mg in children (oral intake of tobacco from cigarettes) or 0.8 to 1.0 mg/kg in adult non-smokers.
Symptoms of overdose are those of acute nicotine poisoning and include nausea, vomiting, increased salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. At high doses, these symptoms may be followed by hypotension, weak and irregular pulse, breathing difficulties, prostration, circulatory collapse and general convulsions.
Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in children and may prove fatal. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.
Management of overdose: Administration of nicotine must be stopped immediately and the patient should be treated symptomatically.
In the event of overdose, get medical help right away.
Nicorette Invisi Transdermal Patch: Remove patch and rinse application site with water.
Nicorette Icy Mint Medicated Chewing Gum: The risk of poisoning as a result of swallowing the gum is very small, as absorption in the absence of chewing is slow and incomplete.
If excessive amount of nicotine is swallowed, activated charcoal reduces the gastrointestinal absorption of nicotine.
Nicorette QuickMist Mouth Spray: If the patient uses more Nicorette QuickMist than they should: Overdosing of nicotine may occur if the patient smokes at the same time as they take Nicorette QuickMist.
If a child takes Nicorette QuickMist or if the patient has used more Nicorette QuickMist than they should, contact a doctor or go to nearest hospital immediately. Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in small children and may prove fatal.
The symptoms of overdose are feeling sick (nausea), too much saliva, stomach pain, diarrhoea, sweating, headache, dizziness, changed hearing, and feeling very weak. At high doses, these symptoms may be followed by low blood pressure, weak and irregular pulse, difficulty breathing, extreme tiredness, circulatory collapse and general convulsions.
Administration of nicotine should be stopped temporarily if any symptoms of nicotine excess occur. Nicotine intake should be decreased by either lowering dosing frequency or strength if nicotine excess symptoms persist.
If the patient has any further questions on the use of the product, ask a doctor or pharmacist.

Do not use if the patient has an allergy to nicotine or any of the other ingredients.

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.

Nicorette Invisi Transdermal Patch & Nicorette Icy Mint Medicated Chewing Gum: 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.
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.
Breastfeeding: 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 (for Nicorette Icy Mint Medicated Chewing Gum).
Nicorette QuickMist Mouth Spray: Pregnancy and breast-feeding: 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.

Nicorette Invisi Transdermal Patch & Nicorette Icy Mint Medicated Chewing Gum: Like all medicines, Nicorette Invisi Transdermal Patch/Nicorette Icy Mint Gum can cause side effects. As many of the effects are due to nicotine, they can also occur when nicotine is obtained by smoking.
Effects of smoking cessation: Regardless of the means used, a variety of symptoms are known to be associated with quitting habitual tobacco use. These include emotional or cognitive effects such as dysphoria or depressed mood; insomnia; irritability, frustration or anger; anxiety; difficulty concentrating, and restlessness or impatience. There may also be physical effects such as decreased heart rate; increased appetite or weight gain, dizziness or presyncopal symptoms, cough, constipation, gingival bleeding or aphthous ulceration, or nasopharyngitis. In addition, and of clinical significance, nicotine cravings may result in profound urges to smoke.
Adverse Drug Reactions: Most of the undesirable effects reported by the subjects occur during the early phase of treatment and are mainly dose dependent.
Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of nicotine products.
As would be expected, the types of adverse reactions seen for nicotine in clinical trials are similar to those associated with nicotine administered by other means.
Nicorette Invisi Transdermal Patch: About 20% of users experienced mild local skin reactions during the first weeks of treatment.
Nicorette Icy Mint Medicated Chewing Gum: Irritation in the mouth and throat may be experienced, however most subjects adapt to this with ongoing use.
The chewing gum may stick to, and may in rare cases damage dentures.
Clinical Trial Data: The safety of nicotine from clinical trial data is based on data on a meta-analysis of randomized clinical trials (RCTs) for the treatment of smoking cessation.
Adverse Drug Reactions (ADRs) with patch/oromucosal formulations identified from clinical trials are presented as follows.
Nicorette Invisi Transdermal Patch: (See Table 5.)

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Nicorette Icy Mint Medicated Chewing Gum: (See Table 6.)

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Post Marketing Data: Adverse drug reactions (ADRs) first identified during post-marketing experience with nicotine are presented as follows. Frequencies are given according to the following convention: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000, <1/1,000; Very rare <1/10,000; Not known (cannot be estimated from the available data).
Frequency categories are estimated from clinical trials.
Nicorette Invisi Transdermal Patch: Frequency category: Common Undesirable Effects: Rash**, Urticaria** (hives).
Frequency category: Uncommon Undesirable Effects: Palpitations**, Tachycardia**, Application site reactions, Asthenia** (abnormal body weakness), Chest discomfort and pain**, Malaise**, Myalgia* (muscle pain), Abnormal dream**,***, Dyspnoea** (shortness of breath), Hyperhidrosis** (increased sweating), Flushing**, Hypertension** (high blood pressure).
Frequency category: Not known Undesirable Effects: Gastrointestinal discomfort*, Anaphylactic reaction**, Pain in extremity, Angioedema**, Erythema**, Seizure**.
Notes: * In vicinity/region of patch.
** systemic effects.
*** systemic effect, identified only for formulations administered during night.
Nicorette Icy Mint Medicated Chewing Gum: Frequency category: Common Undesirable Effects: Diarrhoea^#.
Frequency category: Uncommon Undesirable Effects: Palpitations**, Tachycardia**, Eructation (belching), Glossitis (inflammation of the tongue), Oral mucosal blistering and exfoliation, Paraesthesia oral^# (prickling/tingling sensation in the mouth), Asthenia**(abnormal body weakness), Chest discomfort and pain**, Malaise**, Pain in Jaw*, Abnormal dream**,***, Bronchospasm, Dysphonia, Dyspnoea** (shortness of breath), Nasal congestion, Oropharyngeal pain, Sneezing, Throat tightness, Hyperhidrosis**, Pruritus**, Rash**, Urticaria**, Flushing**, Hypertension**.
Frequency category: Rare Undesirable Effects: Dysphagia (difficulty in swallowing), Hypoaesthesia oral^# (numbness in the mouth area), Retching.
Frequency category: Not known Undesirable Effects: Blurred vision, Lacrimation increased, Dry throat, Gastrointestinal discomfort**, Lip pain, Anaphylactic reaction**, Muscle tightness*, Angioedema**, Erythema**, Seizure**.
Notes: * Tightness of jaw and pain in jaw with nicotine gum formulation.
** systemic effects.
*** systemic effect, identified only for formulations administered during night.
^# reported the same or less frequently than placebo.

Nicorette QuickMist Mouth Spray: Like all medicines, Nicorette QuickMist can cause side effects, although not everybody gets them.
Nicorette QuickMist can give the same side effects as other forms of nicotine. The side effects generally depend on the dose that the patient takes.
Effects related to stopping smoking (nicotine withdrawal): Some of the unwanted effects that the patient experiences when stopping smoking can be withdrawal symptoms due to decreases in nicotine intake.
These effects include: irritability or aggression; impatience or frustration; feeling low; anxiety; restlessness; poor concentration; increased appetite or weight gain; urges to smoke (craving); night time awakening or sleep disturbance; lowering of heart rate.
If the patient notices any of the following serious rare side effects, stop taking Nicorette QuickMist and contact a doctor immediately (signs of angioedema): swollen face, tongue or pharynx; difficulty to swallow; hive and difficulties to breathe.
Some common unwanted effects the patient may notice when they start to use NICORETTE QuickMist for the first time include headache, nausea, vomiting, tingling/burning sensations, inflammation or pain in the mouth or lips, changes in taste perception, changes in saliva production, dryness of the mouth, indigestion and hiccups. These effects may be due to incorrect use of NICORETTE QuickMist like using too much, or swallowing too much nicotine.
Other commonly reported side-effects include dizziness, vomiting, sore mouth, throat irritation, dry mouth, taste disturbance, tingling or numbness of hands or feet, stomach pain or discomfort, diarrhoea, wind, cough, burning sensation, fatigue, hypersensitivity.
Uncommonly reported side effects include chest palpitations, fast heartbeat, flushing, high blood pressure, redness or itching of the skin, hives, wheezing, shallow breathing, difficulty speaking, nasal congestion, sneezing, tight throat, burping, red tongue, mouth blisters, mouth tingling or numbness, excessive sweating, limb weakness, chest discomfort or pain, general feeling of being unwell, abnormal dreams.
Very rarely, abnormal beating of the heart, swelling of the face, lips, mouth or tongue, difficulty swallowing, blurred vision, watery eyes, dry throat lip pain, retching, muscle tightness and seizure have been reported.
When the patient stops smoking they may also develop mouth ulcers. The reason why this happens is unknown.
If any of the side effects get serious, or if the patient notices any side effects not listed in the monograph, tell a doctor or pharmacist.

Nicorette Invisi Transdermal Patch & Nicorette Icy Mint Medicated Chewing Gum: Taking other medicines: No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established. However, nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increased pain response (angina-pectoris type chest pain) provoked by adenosine administration.
Tell the doctor or pharmacist if the patient is taking or have recently taken other medicines, even those not prescribed. Stopping smoking may require the dose of these medicines to be adjusted.
Nicorette QuickMist Mouth Spray: Using other medicines: Tell the doctor or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription. This is especially important if they take medicines containing: theophylline to treat asthma; tacrine for Alzheimer's disease; clozapine for schizophrenia; ropinirole to treat Parkinson's disease; flecainide for heart problems; pentazocine for severe pain.
Do not eat or drink when administering the mouth spray.

Disposal: Nicorette Invisi Transdermal Patch: After removal, fold the patch into half with sticky side inwards and place inside the opened sachet or a piece of aluminium foil. Dispose the used patch carefully in the household rubbish, away from reach of children and animals. Ask a pharmacist how to dispose of medicines no longer required.
Nicorette Icy Mint Medicated Chewing Gum: Dispose of the Nicorette Gum sensibly.

Nicorette Invisi Transdermal Patch: Store below 30°C.
Nicorette Icy Mint Medicated Chewing Gum: Store at or below 30°C. Protect from light.
Nicorette QuickMist Mouth Spray: Store at temperatures not exceeding 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Nicorette QuickMist Mouth Spray: How to open the dispenser: 1. Use your thumb to slide down the button until it can be pushed lightly inwards. Do not push too hard.
2. While pushing in, slide upwards to unlock the top of the dispenser. Then release the button.
How to load the dispenser: When you use the spray for the first time you must first load the spray pump. Point the spray nozzle safely away from you, any other adults, children or pets near you. Press the top of the QuickMist with your index finger 3 times until a fine spray appears. If you do not use the spray for 2 days, this loading procedure will need to be repeated.
How to use the dispenser: 3. Point the spray nozzle towards your open mouth and hold it as close to your mouth as possible.
4. Press the top of the QuickMist to release one spray into your mouth, avoiding the lips. To avoid getting spray down your throat do not inhale while spraying. For best results, do not swallow for a few seconds after spraying.
How to close the dispenser: 5. Slide the button down until it can be pushed inwards.
6. While pushing in, slide the top of the dispenser downwards. Release the button. The QuickMist spray is now closed.
To take another dose repeat the steps as previously mentioned.
Close the dispenser every time after use to prevent use of the spray by children and accidental spraying.
Care should be taken not to spray the eyes whilst administering the mouth spray. If the spray gets into your eyes, rinse thoroughly with water.

Drugs Used in Substance Dependence

N07BA01 - nicotine ; Belongs to the class of drugs used in the management of nicotine dependence.

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