NICORETTE INVISI Transdermal patch Ref.[9897] Active ingredients: Nicotine

Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.

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

Underlying cardiovascular disease: In stable cardiovascular disease this productpresents a lesser hazard than continuing to smoke. 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 have 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 smoking is stopped and NRT is initiated as reductions in nicotine induced catecholamine release can affect carbohydrate metabolism.

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 children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. After removal, the patch should be folded in half, adhesive side innermost, and placed inside the opened sachet, or in a piece of aluminium foil. The used patch should then be disposed of carefully, away from the reach of children or animals.

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 1A2 (and possibly by CYP 1A1). 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, clozapine and ropinirole.

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.

Generalised dermatological disorders: Patients with chronic generalised dermatological disorders such as psoriasis, chronic dermatitis or urticaria should not use this product..

Angioedema and urticaria have been reported.

Erythema may occur. If it is severe or persistent, treatment should be discontinued.

Minor skin reactions are seen at the patch application site in a proportion of patients when commencing treatment (see also section 4.8). If skin reactions become more severe or more generalized, patients should be advised to discontinue use of patches and seek further medical help regarding nicotine replacement therapy.

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

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 increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. Ideally smoking cessation during pregnancy should be achieved without NRT. Nicotine passes to the foetus and affects its breathing movements and circulation. The effect on the circulation is dose-dependent. 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 Nicorette Invisi Patch 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.

Use of nicotine by the pregnant smoker should only be initiated after advice from a health care professional.

Lactation

Nicotine should be avoided during breast-feeding. 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.

Use of the nicotine 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.

This product has no or negligible influence on the ability to drive and use machines.

Effect of Smoking Cessation

Some symptoms may be related to nicotine withdrawal associated with stopping smoking. 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,decreased heart rate, dizziness, presyncopal symptoms, cough, constipation, gingival bleeding or nasopharyngitis.

Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.

Adverse Drug Reactions (ADRs)

This product may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose-dependent. At recommended doses this product has not been found to cause any serious adverse effects. Excessive use of this product by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Most of the undesirable effects reported by the subjects occur during the early phase of treatment and are mainly dose dependent.

About 20% of Nicorette Invisi Patch users experience mild local skin reactions, during the first weeks of treatment. In some patients the skin reactions may become more severe e.g. skin blistering or burning sensation or may be more generalized (see section 4.4).

Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of this product.

Adverse events observed in patients treated with nicotine patch formulations during clinical trials and post-marketing surveillance are listed below by system organ class (SOC).

Frequencies are defined in accordance with current guidance, as: Very common (>≥1/10); common (>≥1/100, <1/10); uncommon (>≥1/1 000, <1/100); rare (>≥1/10 000, <1/1 000); very rare (<1/10 000), Not known – cannot be estimated from the available data.

Immune system disorders

Uncommon: Hypersensitivity^a#

Rare**: Anaphylactic reaction^a

Nervous system disorders

Common: Dizziness, Headache^a§

Uncommon: Paraesthesia^a#

Cardiac disorders

Uncommon: Palpitations^a, Tachycardia^a

Very rare: Reversible atrial fibrillation

Vascular disorders

Uncommon: Flushing^a, Hypertension^a

Respiratory, Thoracic and Mediastinal Disorders

Uncommon: Dyspnoea^a

Gastrointestinal disorders

Common: Nausea^a§, Vomiting^a

Rare**: Gastrointestinal discomfort^a

Skin and subcutaneous tissue disorders

Very common: Pruritus

Common: Rash^a, Urticaria^a

Uncommon: Hyperhidrosis^a

Rare**: Angioedema^a, Erythema^a

Musculoskeletal and Connective Tissue Disorders

Uncommon: Myalgia^b

Rare**: Pain in extremity

General disorders and administration site conditions

Uncommon: Application site reactions, Asthenia^a, Chest discomfort and pain^a, Malaise^a, Fatigue^a#§

** Frequency category estimated using the "Rule of 3"
^a Systemic effects; b In vicinity/region of patch
^# Although the frequency is <1% the PT occurred at a frequency ≥1% in another formulation in which the PT was identified as a systemic ADR.
^§ 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.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.