Nicorette Combi Patch and Gum

Nicorette combi patch + gum is indicated for the relief of nicotine withdrawal symptoms as an aid to smoking cessation in adults and children over 12 years of age.

It is used for smokers who smoke 10 or more cigarettes per day, individuals who experience acute or breakthrough cravings, or those who have failed with single treatment. The patch provides background nicotine levels while the gum is used for immediate relief of cravings. Combination treatment has been shown to have greater success rates than either patch or gum alone.

If possible, nicorette combi patch + gum should be used in conjunction with a behavioural support programme.

How to apply the Patch

The invisi patch should be applied to clean dry intact areas of hairless skin, for example on the hip, upper arm, or chest. These areas should be varied each day and the same site should not be used on consecutive days. There is no clinically significant difference in bioavailability of nicotine when the patch is applied to either the hip, upper arm or chest.

1. Wash your hands before applying the invisi patch.

2. Cut open the pouch with scissors along the side, as indicated. Select a clean, dry, hairless intact area of skin, such as the hip, upper arm or chest.

3. Peel one part of the silvery aluminium backing away. Avoid touching the sticky surface of the patch with your fingers.

4. Apply the sticky part of the invisi patch carefully onto the skin and peel off the remaining half of the silvery aluminum backing.

5. Press the invisi patch firmly onto the skin with your palm or finger- tips.

6. Rub your fingers firmly round the edge to ensure that the invisi patch sticks firmly.

Use of skin oils or talc can prevent proper adhesion of the invisi patch.

After removal, used invisi patches should be disposed of carefully.

It is intended that the invisi patch be worn through the waking hours (approximately 16 hours) being applied on waking and removed at bedtime. After 12 weeks the invisi patch should be discontinued.

Gum

The icy white gum should be chewed according to the instructions.

The icy white gum should be used whenever there is an urge to smoke according to the 'chew and rest' technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Use a minimum of four 2mg icy white gums per day; usually 5 – 6 icy white gums will be adequate for effect. Not more than 15 pieces of the icy white chewing gum may be used each day. Absorption of nicotine is through the buccal mucosa, any nicotine that is swallowed being destroyed by the liver.

Any icy white gums which remain following the initial 12 week period should be retained and used during the weaning period.

Invisi 15 mg patch: Each patch is 13.5 sq.cm, containing nicotine 1.75mg/sq.cm, releasing a nominal 15 mg of nicotine per 16 hours.

Icy white 2 mg gum: Chewing gum containing 2mg nicotine, as nicotine resinate.

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

Underlying cardiovascular disease: In stable cardiovascular disease nicorette combi patch + gum presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, nicorette combi patch + gum 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 NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

Renal or hepatic impairment: nicorette combi patch + gum 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 small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small 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 invisi patch should be folded in half, adhesive side innermost, and placed inside the opened sachet, or in a piece of aluminium foil. The used invisi patch should then be disposed of carefully, away from the reach of children or animals. The icy white gum should also be disposed of with care.

Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, nicorette combi patch + gum 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.

Invisi patch only

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

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

Icy white gum only

GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Denture warning: Smokers who wear dentures may experience difficulty in chewing the icy white gum. The chewing gum may stick to, and may in rare cases damage dentures.

Excipients: The icy white gum also contains butylated hydroxytoluene (E321); this may cause irritation to the mucous membranes.

Special warnings and precautions for the combination of nicotine gum with nicotine patch are the same as those for each treatment alone.