INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
NICORETTE® PATCH 5 mg 10 mg 15 mg

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form)

NICORETTE^® PATCH 5 mg 10 mg 15 mg
(Transdermal Delivery System)

COMPOSITION:
Each patch contains nicotine equivalent to 8,3 mg per 10 cm².
The following systems are available:

	NICORETTE Patch 5 mg	NICORETTE Patch 10 mg	NICORETTE Patch 15 mg
Content of nicotine per patch	8,3	16,6	24,9
Average dose of Nicotine delivered during 16 hours	5 mg	10 mg	15 mg
Drug releasing area	10 cm²	20 cm²	30 cm²

The amount of nicotine released from each cm² of the patch is constant and therefore the dose administered is determined by the size of contact area of the system.

PHARMACOLOGICAL CLASSIFICATION:
A 34 Other

PHARMACOLOGICAL ACTION:
Nicotine has both stimulant and depressant phases of action effected by binding to and acting on a variety of neuro-effector and chemosensitive sites, i.e. peripheral nervous system, central nervous system, cardiovascular system, gastro-intestinal tract and exocrine glands.
Nicotine is readily absorbed from the respiratory tract, buccal membranes and skin.
Tolerance develops to some of the effects of nicotine.
Cessation of the use of tobacco may be followed by a withdrawal syndrome that varies in intensity from person to person.

INDICATIONS:
NICORETTE is indicated to be used as part of a smoking cessation programme as a temporary aid to the cigarette smoker seeking to give up the smoking habit.

CONTRA-INDICATIONS:
Known hypersensitivity of the skin or allergy to nicotine, and generalised skin disorders.
NICORETTE should not be used in children.
NICORETTE is contra-indicated in non-smokers or occasional smokers.
The nicotine in NICORETTE may cause foetal harm when administered to pregnant women and is therefore contra-indicated in women who are or who may become pregnant. Female patients should be advised to take adequate precautions to avoid becoming pregnant. The doctor may wish to consider a pregnancy test before instituting therapy with NICORETTE.
Nicotine is found in breast milk and therefore NICORETTE is contra-indicated during lactation or breastfeeding.
NICORETTE is contra-indicated in patients during the immediate post-myocardial infarction period, in patients with life-threatening arrhythmia’s, and patients with severe or worsening angina pectoris.

WARNINGS:
NICORETTE must be kept out of reach of children at all times i.e. before and after use.
Non-smokers should not use NICORETTE as they may experience adverse reactions similar to those associated with nicotine administration.
Patients should not smoke whilst using NICORETTE. If the NICORETTE is being used to supplement a behavioural tobacco withdrawal programme, the dosage should be adapted accordingly, in order to avoid intoxication and presentation of the side effects of nicotine.

DOSAGE AND DIRECTIONS FOR USE:
One NICORETTE patch should be applied once daily and left on the skin for 16 hours. Twelve weeks’treatment is recommended with the 15 mg/16 hour patch. After this period consumption should be reduced by using the 10 mg/16 hour patches for 2-3 weeks and then the 5 mg/16 hour patches for about the same period.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
NICORETTE is to be used by normally healthy smokers.
NICORETTE can cause adverse reactions similar to those associated with nicotine administration, as in smoking. If the user continues to smoke whilst applying the NICORETTE patch, the central nervous system adverse effects may become more frequent and more pronounced, and become indistinguishable from the tobacco withdrawal symptoms. The most commonly reported adverse or withdrawal symptoms include systemic and local effects.
Central Nervous System:
Sleep disturbances, nervousness, irritability, tremor, dysphoria, aggressiveness, anxiety, headache, tiredness, dizziness, light-headedness, and vivid dreams.
Gastro-intestinal:
Nausea, heartburn, gastric discomfort, constipation.
Autonomic Nervous System:
Increased sweating.
Miscellaneous:
Dryness of the mouth and throat, burning sensation of the tongue.
Skin:
Reddening and itching. This is usually mild and disappears rapidly. The best way to avoid it is to regularly alternate the position where you apply the patch.

The following adverse reactions occur less frequently:
Vomiting, diarrhoea, feeling unwell, muscle cramps in the legs, muscular pain in extremities, taste or smell of nicotine, and increased salivation.

Special Precautions:
In view of the pharmacological effects of nicotine in patients with the following conditions, NICORETTE should only be used after carefully weighing up the risks against the benefits:

•	severe hypertension
•	stable angina pectoris
•	cerebrovascular insufficiency
•	occlusive peripheral arterial diseases
•	heart failure
•	hyperthyroidism and diabetes mellitus
•	renal and hepatic insufficiency

In cases of severe or persistent skin reaction, treatment should be discontinued.

Drug Interactions:
Smoking cessation, with or without nicotine substitutes, may alter response to concomitant medication in ex-smokers. Smoking is considered to increase metabolism and thus lower blood levels of drugs such as phenacetin, caffeine, theophylline, imipramine and pentazocine, through enzyme induction. Cessation of smoking may result in increased levels of these drugs. Absorption of glutethimide may be decreased and the “first pass” metabolism of propoxyphene decreased by smoking cessation. Other reported effects of smoking which do not involve enzyme induction, may also relate to the hormonal effects of nicotine, these include reduced diuretic effects of furosemide and, decreased cardiac output and increased blood pressure with propranolol. Smoking cessation may reverse these actions.
Both smoking and nicotine can increase circulating cortisol and catecholamines. Therapy with adrenergic agonists or with adrenergic blockers may need to be adjusted according to changes in nicotine therapy or smoking status.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage of NICORETTE can only occur if more than one patch is applied simultaneously. The fatal oral dose of nicotine in man is probably about 60 mg.
Symptoms of overdosage include nausea, salivation, abdominal pain, vomiting, diarrhoea, cold sweat, headache, dizziness, disturbed hearing and vision, mental confusion and marked weakness, faintness and prostration may ensue and hypotension may occur, breathing is difficult, the pulse may be rapid, weak and irregular. Collapse may be followed by terminal convulsions. Death may result within a few minutes from respiratory failure caused by paralysis of the muscles of respiration.
Nicotine is excreted four times more rapidly in acid than alkaline urine.
Prompt treatment is essential. If patient shows signs of overdosage, the patch is to be removed immediately.
Artificial respiration with oxygen should be instituted if needed and continued for as long as necessary.
Other therapy, including treatment of shock, is purely symptomatic.

IDENTIFICATION:
Transdermal multilaminate system:
Beige, flexible, rectangular shape. Matt-finish backing, patterned silver to yellow/orange adhesive middle layer with a clear, partial-cut release liner which is removed prior to use.

PRESENTATION:
Cartons containing 7 sealed, childproof pouches of NICORETTE 5 mg, 10 mg or 15 mg.

STORAGE INSTRUCTIONS:
KEEP OUT OF REACH OF CHILDREN BOTH BEFORE AND AFTER USE. Store below 25°C.

REGISTRATION NUMBERS:

Nicorette 5 mg:	29/34/0150
Nicorette 10 mg:	29/34/0151
Nicorette 15 mg:	29/34/0152

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Ltd
Alphen West G
George Street
MIDRAND
1685
RSA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
25 October 1995

Registered Trademark
NICORETTE^®

New addition to this site: February 2005
Source: Pharmaceutical Industry
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