Nicorette Icy White 2mg Chewing Gum

PA Transfer from McNeil Healthcare (Ireland) Ltd to Johnson & Johnson (Ireland) Ltd.

Section 4.8 added “Psychiatric Disorders – Abnormal Dreams* – Uncommon” to ADR table, and added text “*Identified only for formulations applied during the night”

Section 4.9 added text “Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately” and “If excessive amount of nicotine is swallowed, activated charcoal reduces the gastrointestinal absorption of nicotine”

Section 10 replaced date with “April 2016”

Section 4.8 added “Psychiatric Disorders – Abnormal Dreams* – Uncommon” to ADR table, and added text “*Identified only for formulations applied during the night”

Section 4.9 added text “Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately” and “If excessive amount of nicotine is swallowed, activated charcoal reduces the gastrointestinal absorption of nicotine”

Section 10 replaced date with “April 2016”

4.2 – the following information was added

Administration of nicotine should be stopped temporarily if any symptoms of nicotine excess occur. Nicotine intake should be decreased by lowering dosing frequency if nicotine excess symptoms persist (see Section 4.9).

Section 4.4 – additional warnings added:

The benefits of quitting smoking outweigh any risks associated with correctly administered nicotine replacement therapy (NRT).

A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:

·         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 with uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, Nicorette Invisi Patch 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 exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and NRT preparations should be used with caution in these conditions.

·         Smokers who wear dentures may experience difficulties in chewing Nicorette Gum. The chewing gum may stick to, and may in rare cases damage dentures.

Transferred dependence:  Nicotine in any dose form is capable of inducing a dependence syndrome after chronic use and is highly toxic after acute use. However, dependence with Nicorette 2mg Gum is a rare side-effect and is both less harmful and easier to break than smoking dependence.

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, see section 4.9 Overdose.

Section 4.5 – information on possible interaction with adenosine added:

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.

Section 4.6 – information updated:

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 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.

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 pregnant smoker and her baby. The earlier abstinence is achieved the better.

Nicotine passes freely 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 the use of nicotine replacement therapy.  The risk of continued smoking may pose a greater hazard to the foetus as compared with the use of nicotine replacement therapy products in a supervised cessation programme. Use of Nicorette Gum should only be initiated after advice from a physician. 

Lactation:

Nicotine passes freely into breast milk in quantities that may affect the child even in therapeutic dose.   Nicorette Gum should therefore be avoided during breast-feeding.

Should smoking cessation not be achieved, use of the Nicorette Gum by breast feeding smokers should only be initiated after advice from a health care professional.

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.

Section 4.8 – additional AEs added, please refer to the SPC for full details

SNAS 1352

4.2 – the following information was added

Administration of nicotine should be stopped temporarily if any symptoms of nicotine excess occur. Nicotine intake should be decreased by lowering dosing frequency if nicotine excess symptoms persist (see Section 4.9).

Section 4.4 – additional warnings added:

The benefits of quitting smoking outweigh any risks associated with correctly administered nicotine replacement therapy (NRT).

A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:

·         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 with uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, Nicorette Invisi Patch 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 exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and NRT preparations should be used with caution in these conditions.

·         Smokers who wear dentures may experience difficulties in chewing Nicorette Gum. The chewing gum may stick to, and may in rare cases damage dentures.

Transferred dependence:  Nicotine in any dose form is capable of inducing a dependence syndrome after chronic use and is highly toxic after acute use. However, dependence with Nicorette 2mg Gum is a rare side-effect and is both less harmful and easier to break than smoking dependence.

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, see section 4.9 Overdose.

Section 4.5 – information on possible interaction with adenosine added:

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.

Section 4.6 – information updated:

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 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.

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 pregnant smoker and her baby. The earlier abstinence is achieved the better.

Nicotine passes freely 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 the use of nicotine replacement therapy.  The risk of continued smoking may pose a greater hazard to the foetus as compared with the use of nicotine replacement therapy products in a supervised cessation programme. Use of Nicorette Gum should only be initiated after advice from a physician. 

Lactation:

Nicotine passes freely into breast milk in quantities that may affect the child even in therapeutic dose.   Nicorette Gum should therefore be avoided during breast-feeding.

Should smoking cessation not be achieved, use of the Nicorette Gum by breast feeding smokers should only be initiated after advice from a health care professional.

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.

Section 4.8 – additional AEs added, please refer to the SPC for full details

SNAS 1352