BOOTS NICASSIST 4 MG MINT GUM

Active substance: NICOTINE - RESIN COMPLEX

View full screen / Print PDF » Download PDF ⇩

Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Nicorette Mint 4 mg Gum / Boots NicAssist 4 mg mint gum

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Chewing Gum containing 4mg nicotine, as nicotine resinate.
For excipients see section 6.1

3

PHARMACEUTICAL FORM
Chewing Gum

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Nicorette Mint 4mg Gum is indicated for the relief of nicotine withdrawal symptoms
as an aid to smoking cessation in adults and children over 12 years of age. It is also
indicated in pregnant and lactating women (see section 4.6).
In smokers currently unable or not ready to stop smoking abruptly, the gum may also
be used as part of a programme to reduce smoking prior to stopping completely.
If possible, Nicorette Mint 4mg Gum should be used in conjunction with a
behavioural support programme.

4.2

Posology and method of administration
Nicorette Mint 4 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, 2mg nicotine gum is
indicated. If more that 20 cigarettes per day are smoked, 4mg nicotine gum will be
needed to meet the withdrawal of the high serum nicotine levels from heavy smoking.
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. Not more than 15 pieces of the chewing gum may be
used each day. Absorption of nicotine is through the buccal mucosa, any nicotine
which is swallowed being destroyed by the liver.
Behavioural therapy, advice and support will normally improve the success rate.

Smoking cessation
Adults (over 18 years of age)
The patient should make every effort to stop smoking completely during treatment
with Nicorette Mint 4mg Gum.
Use the gum whenever there is an urge to smoke to maintain complete abstinence
from smoking. Sufficient gums should be used, usually 8-12, up to a maximum of 15.
Continue use for up to three months to break the habit of smoking, then gradually
reduce gum use. When daily use is 1-2 gums, use should be stopped.
For those using 4 mg nicotine gum, the 2 mg nicotine gum will be helpful during
withdrawal from treatment.
Any spare gum should be retained, as craving may suddenly return. Adults who use
NRT beyond 9 months for smoking cessation are recommended to seek additional
help and advice from a healthcare professional.
Adolescents (12 to 18 years)
The patient should make every effort to stop smoking completely during treatment
with Nicorette Mint 4mg Gum.
Use the gum whenever there is an urge to smoke to maintain complete abstinence
from smoking. Sufficient gums should be used, usually 8-12, up to a maximum of 15.
Continue use for up to 8 weeks to break the habit of smoking, then gradually reduce
gum use over a 4 week period. When daily use is 1-2 gums, use should be stopped.
For those using 4 mg nicotine gum, the 2 mg nicotine gum will be helpful during
withdrawal from treatment.

As data are limited in this age group, the recommended duration of treatment is 12
weeks. If longer treatment is required, advice from a healthcare professional should
be sought.

Smoking reduction
Adults (over 18 years of age)
Use the gum between smoking episodes to manage the urge to smoke, to prolong
smoke-free intervals and with the intention to reduce smoking as much as possible. If
a reduction in number of cigarettes per day has not been achieved after 6 weeks,
professional advice should be sought.
A quit attempt should be made as soon as the smoker feels ready, but not later than 6
months after start of treatment. If a quit attempt cannot be made within 9 months after
starting treatment, professional advice should be sought.
When making a quit attempt the smoking cessation instructions above can be
followed.
Adolescents (12 to 18 years)
Where adolescents are motivated to stop smoking abruptly, smoking cessation should
be recommended. However, smoking reduction can be considered where adolescents
are not ready or able to stop smoking abruptly. As data are limited in this age group,
and the recommended duration of NRT is 12 weeks, adolescents should consult a
healthcare professional before starting the “smoking reduction prior to stopping”
regimen.
Use the gum between smoking episodes to manage the urge to smoke, to prolong
smoke-free intervals and with the intention to reduce smoking as much as possible. If
a reduction in number of cigarettes per day has not been achieved after 6 weeks,
professional advice should be sought.
A quit attempt should be made as soon as the smoker feels ready, but not later than 6
months after start of treatment. If a quit attempt cannot be made within 9 months after
starting treatment, professional advice should be sought.
When making a quit attempt the smoking cessation instructions for adolescents (12
to 18 years) given above can be followed.

4.3

Contraindications
Hypersensitivity to any component of the chewing gum.

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 Mint
4mg 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 non-pharmacological interventions. If this
fails, Nicorette Mint 4mg 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 Mint 4mg 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 Mint 4mg 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 Mint 4mg Gum also contains butylated hydroxy toluene (E321);
this may cause irritation to the mucous membranes.
Denture warning: Smokers who wear dentures may experience difficulty in chewing
Nicorette Mint 4mg Gum. The chewing gum may stick to, and may in rare cases
damage dentures.

4.5

Interaction 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
NRT is not contraindicated in pregnancy. The decision to use NRT should be made on a riskbenefit assessment as early on in the pregnancy as possible with the aim of discontinuing use
as soon as possible.
Smoking during pregnancy is associated with risks such as intra-uterine growth retardation,
premature birth or stillbirth. Stopping smoking is the single most effective intervention for
improving the health of both pregnant smoker and her baby. The earlier abstinence is
achieved the better.
Ideally smoking cessation during pregnancy should be achieved without NRT. However for
women unable to quit on their own, NRT may be recommended to assist a quit attempt.
Nicotine passes to the fetus affecting breathing movements and has a dose-dependent effect
on placental/fetal circulation. However the risk of using NRT to the fetus is lower than that
expected with tobacco smoking, due to lower maximal plasma nicotine concentration and no
additional exposure to polycyclic hydrocarbons and carbon monoxide.
Intermittent dosing products may be preferable as these usually provide a lower daily dose of
nicotine than patches. However, patches may be preferred if the woman is suffering from
nausea during pregnancy. If patches are used they should be removed before going to bed.
Lactation
NRT is not contraindicated in lactation. Nicotine from smoking and NRT is found in breast
milk. However the amount of nicotine the infant is exposed to is relatively small and less
hazardous than the second-hand smoke they would otherwise be exposed to.
Using intermittent dose NRT preparations, compared with patches, may minimize the amount
of nicotine in the breast milk as the time between administrations of NRT and feeding can be
more easily prolonged.

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 Mint 4mg Gum may cause adverse reactions similar to those associated
with nicotine given by other means, including smoking, and these are mainly dosedependent. At recommended doses Nicorette Mint 4mg 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 Mint 4mg 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

Incidence
*

Reported adverse event

Nervous
system
disorders:

Very
common:

Headache

Common
:

Dizziness

Uncomm
on:

Palpitations

Very
rare:

Reversible atrial fibrillation

Very
common:

Gastrointestinal discomfort,
hiccups, nausea

Common
:

Vomiting

Cardiac
disorders:

Gastrointesti
nal disorders:

Skin and
subcutaneous
tissue
disorders:

Uncomm
on:

Erythema, urticaria

General
disorders and
administratio
n site
conditions:

Very
common:

Sore mouth or throat, jaw-muscle
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
The pharmacological effects of nicotine are well documented. Those resulting from
chewing Nicorette Mint 4mg 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 hypernoea; peripheral
vasoconstriction (usually associated with a rise in systolic pressure); suppression of
appetite and stimulation of peristalsis.

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
Polacrilin
Chewing gum base, containing butylated hydroxy toluene (E321)
Xylitol
Peppermint oil
Menthol
Sodium carbonate anhydrous
Quinoline Yellow Al-lake (E104)
Magnesium oxide, light
Talc

6.2

Incompatibilities
None relevant

6.3

Shelf life
30 months

6.4

Special precautions for storage
Do not store above 25oC

6.5

Nature and contents of container
PVC/PVDC/Al Blister packed strips each containing 15 pieces supplied in packs of
15, 30 or 105 pieces. Packs containing a blister strip of 6 pieces (not marketed).

6.6

Special precautions for disposal
See section 4.2

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 15513/0172

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

21/01/2008

10

DATE OF REVISION OF THE TEXT

21/01/2008

Expand view ⇕

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.

Hide
(web2)