Consumer medicine information

1 Name of Medicine

Nicotine.

2 Qualitative and Quantitative Composition

Nicorette Chewing Gum contains nicotine, added as nicotine polacrilex. They are available in 2 mg and 4 mg strengths and are available in five flavours: classic, icy mint, freshmint, spearmint and freshfruit.
Nicorette Classic Chewing Gum also contains: sodium and sorbitol.
Nicorette freshfruit, icy mint and spearmint chewing gum also contains: sucralose, sodium and xylitol.
Nicorette freshmint chewing gum also contains: sodium and xylitol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nicorette chewing gums are square, coated pieces of gum.
Nicorette 2 mg classic chewing gums are beige in colour.
Nicorette 2 mg icy mint, freshfruit, spearmint and freshmint chewing gums are white in colour.
Nicorette 4 mg classic chewing gums are yellow in colour.
Nicorette 4 mg icy mint, freshfruit, spearmint and freshmint chewing gums are cream in colour.

4 Clinical Particulars

4.9 Overdose

Excessive use of nicotine from either NRT and/or smoking might cause symptoms of an overdose. The risk of poisoning as a result of swallowing the gum is very small, as absorption in the absence of chewing is slow and incomplete.
Symptoms of overdosage are those of acute nicotine poisoning and include nausea, salivation, vomiting, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. At high doses, these symptoms may be followed by hypotension, weak and irregular pulse, breathing difficulties, prostration, circulatory collapse and general convulsions.
Overdosage with nicotine can occur if the patient has a very low pretreatment nicotine intake or uses other forms of nicotine. The acute minimum lethal oral dose of nicotine in nonsmokers is believed to be 40-60 mg.
Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in small children and may prove fatal. The lethal dose of nicotine in a small child is approximately 10-15 mg. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
If chewing gum is ingested, activated charcoal should be given as soon as possible. Contact the Poisons Information Centre (131126) for advice on treatment.
The administration of nicotine should be stopped immediately and the patient should be treated symptomatically. Activated charcoal reduces gastrointestinal absorption of nicotine.

5 Pharmacological Properties

5.3 Preclinical Safety Data

In vitro and in vivo genotoxicity testing of nicotine has yielded predominantly non-genotoxic results. Some positive findings from in vitro and in vivo genotoxicity tests have been reported but investigations using regulatory accepted assays and protocols have shown no evidence of genotoxic activity at therapeutic doses.
Analysis of the results from long-term carcinogenicity assays data with nicotine or cotinine, major nicotine metabolite, predominately indicate nicotine does not have any significant or relevant carcinogenic activity.
General toxicology. Nicotine has oral and dermal LD₅₀ in the range of 70 mg/kg. The general toxicity of repeated administration of nicotine is well known. Observations in chronic 2 year dosed feeding study in rats (5 mg/kg/day) showed no evidence of toxicity or overt behavior and health including any tumor responses.
Genotoxicity. Nicotine showed negative results in in vitro tests but few in vitro and in vivo genotoxicity studies examining strand-breaking activity assessed by the comet assay, chromosome aberration or micronucleus formation gave positive results. However, the tested range is beyond the systemic nicotine levels achieved in humans by using nicotine products.
Carcinogenicity. Long term animal studies with nicotine suggest that nicotine does not have any significant or relevant carcinogenic activity.
Teratogenicity. In animal experiments nicotine induced maternal toxicity, fetal toxicity including post-implantation loss and growth retardation.
Fertility. In animal experiments, nicotine adversely affected spermatogenesis. To which extent female fertility is affected is not known.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

The chemical name for nicotine is (S)-3-(1-methyl-2-pyrrolidinyl) pyridine.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSNICOTI.gif CAS number. 54-11-5.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/NCOGUMST.gif