INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo NICORETTE®
SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

NICORETTE®

NICORETTE®2mg (gum)
NICORETTE®4mg (gum)
NICORETTE®MINT 2mg (gum)
NICORETTE®MINT 4mg (gum)

COMPOSITION:
NICORETTE 2 mg: each piece contains 10 mg nicotine-resin complex 20%, equivalent to 2 mg nicotine.
NICORETTE 4 mg: each piece contains 20 mg nicotine-resin complex 20%, equivalent to 4 mg nicotine.
NICORETTE MINT 2 mg: each piece contains 10 mg nicotine-resin complex 20%, equivalent to 2 mg nicotine.
NICORETTE MINT 4 mg: each piece contains 20 mg nicotine-resin complex 20%, equivalent to 4 mg nicotine.
NICORETTE IS SUGAR FREE.

PHARMACOLOGICAL CLASSIFICATION:
A 34 Other

PHARMACOLOGICAL ACTION:
When used as directed, the 2 mg strengths produce peak blood nicotine concentrations equivalent to 1/3, and the 4 mg strengths produce peak blood nicotine concentrations equivalent to 2/3 that of smoking a mild cigarette. Owing to the slower rate of absorption of nicotine through the buccal mucosa, it does not reproduce the pleasure of cigarette smoking.
Although one is still supplying the body with nicotine, the blood levels achieved after repeated administration of NICORETTE are less than those achieved after smoking.

INDICATIONS:
NICORETTE is indicated as a temporary aid to the cigarette smoker seeking to give up his or her smoking habit while participating in a behavioural modification programme under professional supervision. The efficacy of NICORETTE use without concomitant participation in a behavioural modification programme has not been established. The benefits of NICORETTE use beyond three months has not been demonstrated.

CONTRA-INDICATIONS:
Safety and effectiveness in children and adolescents who smoke has not been evaluated.
NICORETTE should not be given to children.
NICORETTE is contra-indicated in non-smokers.
NICORETTE is contra-indicated in patients during the immediate post-myocardial infarction period, in patients with life-threatening arrhythmias, and patients with severe or worsening angina pectoris. NICORETTE is also contra-indicated in patients with active temporomandibular joint disease.
NICORETTE may cause foetal harm when administered to a pregnant woman. NICORETTE is therefore contra-indicated in women who are or may become pregnant, and 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. If NICORETTE is used during pregnancy, or if the patient becomes pregnant while taking Nicorette, the patient should be apprised of the potential hazard to the foetus.
NICORETTE should not be used by nursing mothers, as nicotine passes freely into breast milk.

WARNINGS:
The risks of nicotine use in patients with certain cardiovascular and endocrine diseases should be carefully weighed against the benefits of including NICORETTE in a smoking cessation programme in these patients. Specifically, patients with coronary heart disease (history of myocardial infarction and/or angina pectoris), serious cardiac arrhythmias or vasospastic diseases (Buerger’s disease, Prinzmetal variant angina) should be carefully screened and evaluated before NICORETTE is prescribed.
As the action of nicotine on the adrenal medulla (release of catecholamines) does not appear to be affected by tolerance, NICORETTE should be used with caution in patients with hyperthyroidism, phaeochromocytoma or insulin-dependent diabetes.
Cigarette smoking is felt to play a perpetuating role in hypertension and peptic ulcer disease. Therefore, NICORETTE should be used in patients with systemic hypertension or inactive peptic ulcer only when the benefits of including NICORETTE in a smoking cessation programme outweigh the risks.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
1. The patient must give up smoking completely. The gradual cutting down of tobacco consumption will not work.
2. NICORETTE has been prescribed as part of a programme to help the patient stop smoking.
3. Whenever the patient feels the need to smoke, one piece of gum should be placed in the mouth.
4. When the gum is chewed, nicotine is slowly released and is absorbed through the lining of the mouth.
5. The gum should be chewed very slowly until it is tasted or a slight tingling is felt in the mouth. Because of its nicotine content, the gum does not taste like an ordinary chewing gum.
6. As soon as the gum can be tasted, chewing must stop.
7. After the taste or tingling is almost gone (about one minute), the gum should be chewed slowly again until the taste is more pronounced. Then chewing should be stopped again.
8. The gum should be chewed slowly for 30 minutes to release most of the nicotine. The patient should not expect the gum to give the same quick satisfaction that smoking does.
9. Most people find that 10 to 12 pieces per day of NICORETTE 2 mg or 4 mg are enough to control their urge to smoke. If this is not the case, consult your doctor or pharmacist. Do not use more than 15 pieces in 24 hours. Depending on the patient’s needs, the rate of chewing and the time between pieces can be adjusted.
10. Warnings:
  If the gum is chewed too fast, the patient may experience effects similar to those experienced when inhaling cigarette smoke for the first time, or when smoking too fast. These effects include light-headedness, nausea and vomiting, throat and mouth irritation, hiccups and stomach upset. Most of these effects are controlled by chewing more slowly. See instructions above. Some other effects sometimes seen –particularly during the first few days of using gum –include mouth ulcers, jaw muscle ache, headache, heart palpitations and more than the usual amount of saliva in the mouth. There are other side-effects which have been infrequently reported with the use of NICORETTE . Patients should be encouraged to discuss any questions, and to report any disturbing side effects.
11. Do not exceed the recommended dosage.
12. If the patient accidentally swallows a piece of gum, no adverse effects should be experienced. Overdose could occur if many pieces are chewed simultaneously or in rapid succession. IN CASE OF ACCIDENTAL OVERDOSAGE OR IF A CHILD CHEWS OR SWALLOWS ONE OR MORE PIECES OF THE GUM, A DOCTOR OR THE LOCAL POISON CONTROL CENTRE SHOULD BE CONTACTED IMMEDIATELY.
13. As the urge to smoke fades, gradually reduce the number of pieces of gum chewed each day. This may be possible within two or three months. Unless advised otherwise, no attempt to stop using the gum should be made until the craving is satisfied with one or two pieces a day. The gum should not be used for more than 3 months.
14. Patients should remember to carry the gum with them at all times in case they feel the sudden urge to smoke again.
  THEY SHOULD NOT FORGET THAT ONE CIGARETTE IS ENOUGH TO START THE SMOKING HABIT AGAIN.
Children:
Not to be administered to children.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Mechanical effects of gum chewing include traumatic injury to oral mucosa or teeth. Nicotine from NICORETTE may sometimes cause irritation of the throat and mouth and may also cause increased salivation. Excessive swallowing of dissolved nicotine (in the saliva) may cause hiccupping.
Excessive consumption of NICORETTE could lead to nausea, faintness or headaches, diarrhoea, constipation, vomiting, hoarseness, dry mouth, flushing, sneezing, cough, euphoria, insomnia, dizziness, eructation, indigestion, anorexia, jaw muscle ache and atrial fibrillation.
Swallowed nicotine may exacerbate symptoms in patients suffering from gastritis or peptic ulcer.
Smokers who wear dentures may experience difficulty in chewing NICORETTE.
NICORETTE should be used with caution in patients with oral or pharyngeal inflammation and in patients with a history of oesophagitis or peptic ulcer.
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, include reduced diuretic effects of furosemide and decreased cardiac output, and increased blood pressure with propranolol, which may also relate to the hormonal effects of nicotine. 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.
Nursing Mothers:
Because of the potential for serious adverse reactions to nursing infants from nicotine, a decision should be made whether to discontinue the drug.
Paediatric Use:
The possibility of transferance of nicotine dependence to NICORETTE exists.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage of NICORETTE can only occur if many pieces are chewed simultaneously. The fatal 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.
In the event of overdosage, vomiting should be induced with syrup of ipecacuanha or gastric lavage carried out (wide bore tube). A suspension of activated charcoal should then be passed through the tube and left in the stomach.
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:
NICORETTE 2 mg:        A beige, square piece.
NICORETTE 4 mg:        A yellow, square piece.
NICORETTE MINT 2 mg: A square, light beige piece, with a characteristic minty taste and odour
NICORETTE MINT 4 mg: A square, light yellow piece,with a characteristic minty taste and odour.

PRESENTATION:
NICORETTE 2 mg: Cartons of 30 pieces, in the form of 2 blister packed strips each containing 15 pieces.
NICORETTE 4 mg: Cartons of 30 pieces, in the form of 2 blister packed strips each containing 15 pieces.
NICORETTE MINT 2 mg: Cartons of 30 pieces, in the form of 2 blister packed strips each containing 15 pieces.
NICORETTE MINT 4 mg: Cartons of 30 pieces, in the form of 2 blister packed strips each containing 15 pieces.

STORAGE INSTRUCTIONS:
KEEP OUT OF REACH OF CHILDREN. Protect from light. Keep in a cool place (below 25°C).

REGISTRATION NUMBERS:
NICORETTE 2 mg:         P/34/187
NICORETTE 4 mg:         P/34/188
NICORETTE MINT 2 mg:         30/34/0272
NICORETTE MINT 4 mg:         30/34/0273

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:
03 July 1996

Registered Trademark
NICORETTE®


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

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