Nicorette Invisi 15mg Patch

PA Transfer from McNeil Healthcare (Ireland) Ltd to Johnson & Johnson (Ireland) Ltd. Change in PA number. Note the address and contact details remain the same.

Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.

Remove patch and rinse application site with water. Oral activated charcoal reduces gastrointestinal absorption of nicotine. Tachycardia causing circulatory impairment may require treatment with a b blocker. Excitation and convulsions may be treated with diazepam. Mechanically assisted ventilation should be instituted if necessary.

10.       Date of (Partial) Revision of the Text

10^th August 2016

Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.

Remove patch and rinse application site with water. Oral activated charcoal reduces gastrointestinal absorption of nicotine. Tachycardia causing circulatory impairment may require treatment with a b blocker. Excitation and convulsions may be treated with diazepam. Mechanically assisted ventilation should be instituted if necessary.

10.       Date of (Partial) Revision of the Text

10^th August 2016

Section 4.1 added text "or Nicorette 15mg Inhaler"

Section 4.2 added text "heavy"
"(more than 20 cigarettes a day) or smokers"
Replaced "and" with "may be combined with"
Replaced "may be combined" with "or Nicorette 15mg Inhaler"
Added "or Nicorette 15mg Inhaler"
Replaced "felt" with "feels"
Added "of gum or 6 inhaler cartridges"
"or Nicorette 15mg Inhaler"
Replaced "felt" with "feels"
Added "of gum or 6 inhaler cartridges"
"or Nicorette 15mg Inhaler"
Added "or Nicorette Inhaler" three times

Section 10 replaced date with "March 2016"

Section 4.1 added text "or Nicorette 15mg Inhaler"

Section 4.2 added text "heavy"
"(more than 20 cigarettes a day) or smokers"
Replaced "and" with "may be combined with"
Replaced "may be combined" with "or Nicorette 15mg Inhaler"
Added "or Nicorette 15mg Inhaler"
Replaced "felt" with "feels"
Added "of gum or 6 inhaler cartridges"
"or Nicorette 15mg Inhaler"
Replaced "felt" with "feels"
Added "of gum or 6 inhaler cartridges"
"or Nicorette 15mg Inhaler"
Added "or Nicorette Inhaler" three times

Section 10 replaced date with "March 2016"

Section 4.3 – QRD updates

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.

Patients with chronic dermatological disorders such as psoriasis, chronic dermatitis or urticaria should not apply Nicorette Invisi Patch to the affected areas. Erythema may occur.  If it is severe or persistent, treatment should be discontinued.

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.

Transferred dependence: Transferred dependence can occur but is unusual and both less harmful and easier to break than smoking dependence.

Nicorette Invisi Patch should be removed prior to undergoing any Magnetic Resonance Imaging (MRI) procedures to prevent the risk of burns.

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 Invisi Patch 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 Patch should therefore be avoided  during breast-feeding.

Should smoking cessation not be achieved, use of the Nicorette Invisi Patch 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 4.7 – QRD updates

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

SNAS 1293

Section 4.3 – QRD updates

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.

Patients with chronic dermatological disorders such as psoriasis, chronic dermatitis or urticaria should not apply Nicorette Invisi Patch to the affected areas. Erythema may occur.  If it is severe or persistent, treatment should be discontinued.

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.

Transferred dependence: Transferred dependence can occur but is unusual and both less harmful and easier to break than smoking dependence.

Nicorette Invisi Patch should be removed prior to undergoing any Magnetic Resonance Imaging (MRI) procedures to prevent the risk of burns.

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 Invisi Patch 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 Patch should therefore be avoided  during breast-feeding.

Should smoking cessation not be achieved, use of the Nicorette Invisi Patch 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 4.7 – QRD updates

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

SNAS 1293