Consumer medicine information

1 Name of Medicine

Nicotine.

2 Qualitative and Quantitative Composition

Nicorette Lozenge contains nicotine, added as nicotine polacrilex and is available as icy mint and fruit flavoured lozenges in 2 mg and 4 mg strengths.
Nicorette Lozenge also contains sucralose and mannitol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nicorette Lozenge is an oval, white to off-white film-coated lozenge with a size of about 14 x 9 x 7 mm, imprinted with "n" on one side and "2" on the other side of the 2 mg lozenge, and "4" on the other side of the 4 mg lozenge.

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 lozenge is very small, as absorption in the absence of sucking 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.
Management of overdose. In the event of overdose or poisoning activated charcoal should be given as soon as possible.
The administration of nicotine should be stopped immediately and the patient should be treated symptomatically. Activated charcoal reduces gastrointestinal absorption of nicotine.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Literature reports indicate that nicotine is neither an initiator nor a tumour promoter in mice.
Neither nicotine nor cotinine was mutagenic in the Ames Salmonella test.
Carcinogenicity. There is inconclusive evidence to suggest that cotinine, an oxidised metabolite of nicotine, may be carcinogenic in rats.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

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/NICODRST.gif