BOOTS NICASSIST ICE MINT 2 MG GUM

Active substance: NICOTINE RESINATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Nicorette Icy White 2mg Gum
Boots NicAssist Ice Mint 2 mg Gum

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Chewing Gum containing 2mg nicotine, as nicotine resinate.
For excipients, see 6.1.

3.

PHARMACEUTICAL FORM
Medicated Chewing Gum
A square, coated, white coloured piece of gum

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Nicorette Icy White 2 mg Gum relieves and/or prevents craving and nicotine
withdrawal symptoms associated with tobacco dependence. It is indicated to aid
smokers wishing to quit or reduce prior to quitting, to assist smokers who are
unwilling or unable to smoke, and as a safer alternative to smoking for smokers and
those around them.
Nicorette Icy White 2 mg Gum is indicated in pregnant and lactating women making
a quit attempt.

4.2

Posology and method of administration
Adults and Children over 12 years of age
Nicorette Icy White 2 mg Gum should be chewed slowly according to the
instructions.
The strength of gum to be used will depend on the smoking habits of the individual.
In general, if the patient smokes 20 or less cigarettes a day, 2 mg nicotine gum is

indicated. If more than 20 cigarettes per day are smoked, 4 mg nicotine gum will be
needed to meet the withdrawal of the high serum nicotine levels from heavy smoking.
Nicorette Icy White 2 mg Gum should be used whenever the urge to smoke is felt or
to prevent cravings in situations where these are likely to occur.
Smokers willing or able to stop smoking immediately should initially replace all their
cigarettes with the Gum and as soon as they are able, reduce the number of gums used
until they have stopped completely.
Smokers aiming to reduce cigarettes should use Nicorette Icy White 2 mg Gum, as
needed, between smoking episodes to prolong smoke-free intervals and with the
intention to reduce smoking as much as possible.
As soon as they are ready smokers should aim to quit smoking completely.
Maximum daily dose: 15 pieces per day.
When making a quit attempt behavioural therapy, advice and support will normally
improve the success rate. Those who have quit smoking, but are having difficulty
discontinuing Nicorette Icy White 2 mg Gum are recommended to contact their
pharmacist or doctor for advice.
For those using the 4mg gum, switching to the 2 mg gum may be helpful when
stopping treatment or reducing the number of gums used each day.
The chewing gums 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. Absorption of nicotine is through the buccal mucosa,
any nicotine, which is swallowed being destroyed by the liver.

4.3

Contraindications
Hypersensitivity to nicotine or any component of the chewing gum.
Nicorette Icy White 2 mg Gum is contraindicated in children under the age of 12
years.

4.4

Special warnings and precautions for use
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
Icy White 2 mg 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 nonpharmacological interventions. If this fails, Nicorette Icy White 2 mg 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.
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.
Renal or hepatic impairment: Nicorette Icy White 2 mg 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. Nicotine gum should be disposed of with
care.
Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes
release of catecholamines, Nicorette Icy White 2 mg 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.
Excipients: Nicorette Icy White 2 mg Gum also contains butylated hydroxyl
toluene (E321); this may cause irritation to the mucous membranes.
Denture warning: Smokers who wear dentures may experience difficulty in
chewing Nicorette Icy White 2 mg Gum. The chewing gum may stick to, and
may in rare cases damage dentures.
4.5.

Interactions with other medicinal products and other forms of interaction
No clinically relevant interactions between nicotine replacement therapy and
other drugs has definitely been established. However nicotine may possibly
enhance the haemodynamic effects of adenosine i.e. increase in blood pressure

and heart rate and also increase pain response (angina-pectoris type chest pain)
provoked by adenosine administration.

4.6

Pregnancy and lactation
Pregnancy
Stopping smoking is the single most effective intervention for improving the health of
both the pregnant smoker and her baby, and the earlier abstinence is achieved the
better. Ideally smoking cessation during pregnancy should be achieved without NRT.
However, if the mother cannot (or is considered unlikely to) quit without
pharmacological support, NRT may be used as the risk to the fetus is lower than that
expected with smoking tobacco. Stopping completely is by far the best option but if
this is not achievable Nicorette Icy White 2 mg Gum may be used in pregnancy as a
safer alternative to smoking. Because of the potential for nicotine-free periods,
intermittent dose forms are preferable, but patches may be necessary if there is
significant nausea and/or vomiting. If patches are used they should, if possible, be
removed at night when the fetus would not normally be exposed to nicotine.
Lactation
The relatively small amounts of nicotine found in breast milk during NRT use are less
hazardous to the infant than second-hand smoke. Intermittent dose forms would
minimize the amount of nicotine in breast milk and permit feeding when levels were
at their lowest.

4.7.

Effects on ability to drive and use machines
Not applicable.

4.8

Undesirable effects
Some symptoms may be related to nicotine withdrawal associated with
stopping smoking. These can include; irritability/aggression,
dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased
appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep
disturbance and decreased heart rate.
Increased frequency of aphthous ulcer may occur after abstinence from
smoking. The causality is unclear.
Nicorette Icy White 2 mg Gum may cause adverse reactions similar to those
associated with nicotine given by other means, including smoking, and these
are mainly dose-dependent. At recommended doses Nicorette Icy White 2 mg
Gum has not been found to cause any serious adverse effects. Most of the
undesirable effects reported by the patients occur during the first 3-4 weeks
after start of treatment.

Excessive consumption of Nicorette Icy White 2 mg Gum by those who have
not been in the habit of inhaling tobacco smoke could possibly lead to nausea,
faintness or headaches. Excessive swallowing of dissolved nicotine may, at
first, cause hiccupping.
Nicotine from the gum may sometimes cause a slight irritation of the throat at
the start of treatment and may also cause increased salivation.
Those who are prone to indigestion may suffer initially from minor degrees of
indigestion or heartburn if the 4mg nicotine gum is used; slower chewing and
the use of the 2mg nicotine gum (if necessary more frequently) will usually
overcome this problem.
The chewing gum may stick to, and may in rare cases damage dentures.
Reported adverse events associated with Nicorette 2mg and 4mg gum include:
Body System
Nervous system
disorders:
Cardiac disorders:

Gastrointestinal
disorders:

Skin and subcutaneous
tissue disorders:
General disorders and
administration site
conditions:

Incidence*
Very common:

Reported adverse event
Headache

Common:
Uncommon:
Very rare:

Dizziness
Palpitations
Reversible atrial
fibrillation
Gastrointestinal
discomfort, hiccups,
nausea
Vomiting
Erythema, urticaria

Very common:

Common:
Uncommon:
Very common:

Sore mouth or throat, jawmuscle ache

Rare:

Allergic reactions
including angioedema

* Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000,
<1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), including isolated
reports.
4.9.

Overdose
Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has
been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning
include nausea, salivation, abdominal pain, diarrhoea, sweating, headache,
dizziness, disturbed hearing and marked weakness. In extreme cases, these
symptoms may be followed by hypotension, rapid or weak or irregular pulse,
breathing difficulties, prostration, circulatory collapse and terminal
convulsions.

Management of an overdose: All nicotine intake should stop immediately and
the patient should be treated symptomatically. Artificial respiration should be
instituted if necessary. Activated charcoal reduces the gastro-intestinal
absorption of nicotine.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Drugs used in nicotine dependence
ATC code: N07B A01
The pharmacological effects of nicotine are well documented. Those resulting from
chewing Nicorette 2 mg Gum are comparatively small. The response at any one time
represents a summation of stimulant and depressant actions from direct, reflex and
chemical mediator influences on several organs. The main pharmacological actions
are central stimulation and/or depression; transient hyperpnoea; peripheral
vasoconstriction (usually associated with a rise in systolic pressure); suppression of
appetite and stimulation of peristalsis.
The gum contains a number of ingredients that are recognized as having properties for
removal of dental staining. Clinical studies have shown that the gum helps to improve
tooth whiteness.
Increased appetite is a recognised symptom of nicotine withdrawal and post-cessation
weight gain is common. Clinical trials have demonstrated that Nicotine Replacement
Therapy can help control weight following a quit attempt.

5.2.

Pharmacokinetic properties
Nicotine administered in chewing gums is readily absorbed from the buccal
mucous membranes. Demonstrable blood levels are obtained within 5 – 7
minutes and reach a maximum about 30 minutes after the start of chewing.
Blood levels are roughly proportional to the amount of nicotine chewed and
have been shown never to exceed those obtained from smoking cigarettes.

5.3.

Preclinical safety data
Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.
There are no other findings derived from preclinical testing of relevance to the
prescriber in determining the safety of the product which have not been
considered in other relevant sections of this Summary of Product
Characteristics.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Core Gum
Chewing gum base, containing butylated hydroxy toluene (E321)
Xylitol
Peppermint oil
Sodium carbonate, anhydrous
Sodium hydrogen carbonate
Acesulfame Potassium
Levomenthol
Magnesium oxide, light
Talc
Sub coating
Winterfresh
Hypromellose
Sucralose
Polysorbate 80
Hard Coating
Xylitol
Starch
Titanium dioxide (E171)
Winterfresh
Carnauba wax

6.2.

Incompatibilities
Not applicable.

6.3

Shelf life
Blister: 3 Years
Box: 2 Years. Shelf life after opening 3 months.

6.4.

Special precautions for storage
Do not store above 25°C.

6.5

Nature and contents of container

PVC/PVDC/Al Blister packed strips each containing 6, 10 or 15 pieces supplied in
packs of 10, 12, 15, 30, 105 and 210 pieces.
and
Laminated cardboard box, wrapped in a transparent plastic film, containing 25 pieces,
supplied in packs of 25, 100 and 200.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
Dispose of Nicorette Gum sensibly.
Any unused product or waste material should be disposed of in accordance
with local requirements.

7

MARKETING AUTHORISATION HOLDER
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
UK

8.

MARKETING AUTHORISATION NUMBER
PL 15513/0152

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/07/2006

10

DATE OF REVISION OF THE TEXT
20/08/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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