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NIQUITIN FRESH MINT 2 MG MEDICATED CHEWING GUMS

Active substance(s): NICOTINE RESINATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
NiQuitin Fresh Mint 2 mg Medicated Chewing Gums.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each medicated chewing gum contains 2 mg nicotine (equivalent to 10.9 mg
nicotine resinate).
Excipients with known effect:
Sorbitol (E 420) 156.31 mg/piece gum
Maltitol liquid 25 mg/piece gum
Butyhydroxytoluene (E 321) 0.49 mg/piece gum
Sodium 11.4 mg /piece gum.
For full list of excipients see 6.1.

3

PHARMACEUTICAL FORM
Medicated chewing gum.
Off-white rectangular pillow-shaped gum.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
NiQuitin Fresh Mint 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.

NiQuitin Fresh Mint Gum is indicated in pregnant and lactating women
making a quit attempt.
NiQuitin Fresh Mint Gum should preferably be used in conjunction with a
behavioural support programme.

4.2

Posology and method of administration
Directions for use:
NiQuitin Fresh Mint Gum should be chewed slowly according to the
instructions.
NiQuitin Fresh Mint 2 mg Gum is suitable for smokers who have their first
cigarette of the day more than 30 minutes after waking up.
Behavioural therapy, advice and support will normally improve the success
rate.
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.
Adults (18 years and over)
Abrupt cessation of smoking:
Users should make every effort to stop smoking completely during treatment
with NiQuitin Fresh Mint Gum.
NiQuitin Fresh Mint Gum should be chewed as directed whenever there is an
urge to smoke to maintain complete abstinence from smoking.
Sufficient gums should be used each day, 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. Any spare gum should be retained, as craving may suddenly return.
Those who have quit smoking but are having difficulty discontinuing using the
gum are recommended to seek additional help and advice from a healthcare
professional.
For those using the 4 mg gum, the 2 mg gum will be helpful during withdrawal
from treatment.
Gradual cessation of smoking:

For smokers who are unwilling or unable to quit abruptly. Use a piece of gum
whenever there is a strong urge to smoke in order to reduce the number of
cigarettes smoked as far as possible and to refrain from smoking as long as
possible. The number of pieces of gum a day is variable and depends on the
patients needs. Nonetheless it should not exceed 15 pieces per day.
If a reduction in cigarette consumption has not been achieved after 6 weeks of
treatment, a healthcare professional should be consulted.
Reduced tobacco consumption should lead to complete cessation of smoking.
This should be attempted as soon as possible. When the number of cigarettes
has been reduced to a level from which the user feels able to quit completely,
then start on the schedule for “abrupt cessation” as given above.
If an attempt to stop smoking completely has not been started within 6 months
after the beginning of treatment, it is recommended to consult a healthcare
professional.
Reduction in smoking:
For smokers who wish to cut down with no immediate plans to quit.
Use a piece of gum whenever there is a strong urge to smoke in order to
reduce the number of cigarettes smoked as far as possible and to refrain from
smoking as long as possible. Users should be encouraged to stop smoking
completely as soon as possible.
The number of pieces of gum a day is variable and depends on the patients
needs. Nonetheless it should not exceed 15 pieces per day.
If users are still feeling the need to use the gum on a regular basis 6 months
after the start of treatment and have still been unable to undertake a permanent
quit attempt, then it is recommended to seek additional help and advice from a
healthcare professional.
Temporary abstinence:
Use a piece of gum whenever there is a strong urge to smoke to control
troublesome withdrawal symptoms including cravings. Users should not take
more than 15 pieces of gum per day.
Users should be encouraged to stop smoking completely as soon as possible.
If users are still feeling the need to use gum on a regular basis 6 months after
the start of treatment and have still been unable to undertake a permanent quit
attempt, then it is recommended to seek additional help and advice from a
healthcare professional.
Adolescents and children
Adolescents (12 to 17 years) should follow the above usage advice for abrupt
cessation of smoking. Where adolescents are unwilling or unable to quit
smoking abruptly, advice from a healthcare professional should be sought.

Safety and effectiveness in children who smoke has not been evaluated.
NiQuitin Fresh Mint Gum is not recommended for use in children under 12
years of age.

4.3

Contraindications
Hypersensitivity to nicotine or any of the other ingredients in this product.

4.4

Special warnings and precautions for use
The risks associated with the use of NRT are substantially outweighed in
virtually all circumstances by the well established dangers of continued
smoking.
Patients hospitalised for MI, severe dysrhythmia or CVA who are considered
to be haemadynamically unstable should be encouraged to stop smoking with
non-pharmacological interventions. If this fails, NiQuitin Mint Gum may be
considered, but as data on safety in this patient group are limited, initiation
should only be under medical supervision. Once patients are discharged from
hospital they can use NRT as normal. If there is a clinically significant
increase in cardiovascular or other effects attributable to nicotine, the gum
dose should be reduced or discontinued.
Diabetes: Blood glucose levels may be more variable when stopping smoking,
with or without NRT as catecholamines released by nicotine can affect
carbohydrate metabolism, so it is important for diabetics to monitor their blood
glucose levels more closely than usual while using this product.
Allergic reactions: susceptibility to angioedema and urticaria.
A risk-benefit assessment should be made by an appropriate healthcare
professional for patients with the following conditions:


Renal and hepatic impairment: Use 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.



Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution
in patients with uncontrolled hyperthyroidism or phaeochromocytoma as
nicotine causes release of catecholamines.



GI Disease: Swallowing of nicotine may exacerbate symptoms in persons
suffering from active oesophagitis, oral or pharyngeal inflammation,
gastritis, gastric ulcer or peptic ulcer and oral NRT preparations should be

used with caution in these conditions. Ulcerative stomatitis has been
reported.
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. NiQuitin Mint Gum should be disposed of
with care.
Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce
the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1).
When a smoker stops this may result in a slower metabolism and a consequent
rise in blood levels of such drugs.
Transferred dependence: Transferred dependence is rare and is both less
harmful and easier to break than smoking dependence.
Smokers who wear dentures may experience difficulty in chewing NiQuitin
Mint Gum.
Sorbitol and Maltitol liquid content: Patients with rare hereditary problems of
fructose intolerance should not take this medicine.
Sodium content: Each piece of NiQuitin Mint Gum contains 11.4 mg of
sodium. To be taken into consideration by patients on a controlled sodium
diet.

4.5

Interaction with other medicinal products and other forms of interaction
No clinically relevant interactions between nicotine replacement therapy and other
drugs have definitely been established, however nicotine may possibly enhance the
haemodynamic effects of adenosine. Smoking cessation itself may require the
adjustment of some drug therapy.

4.6

Fertility, 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. However, if the mother cannot (or is considered unlikely
to) quit without pharmacological support, NRT may be used as the risk to the
foetus is lower than that expected with smoking tobacco. Stopping completely
is by far the best option but NRT 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 foetus 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
NRT may cause adverse reactions similar to those associated with nicotine
administered by other means, including smoking. These may be attributable to
the pharmacological effects of nicotine, some of which are dose dependent. In
relation to this some reported symptoms, such as dizziness, headache and sleep
disturbances may be related to withdrawal symptoms associated with
abstinence from smoking. Increased frequency of aphthous ulcer may occur
after abstinence from smoking.
NiQuitin Fresh Mint Gum in the recommended dose has not been found to
cause any serious adverse effects. Excessive consumption of NiQuitin Fresh
Mint Gum by those who have not been in the habit of inhaling tobacco smoke
could possibly lead to nausea, faintness or headache (as may be experienced
by such a patient if tobacco smoke is inhaled). Nicotine from the gum may
sometimes cause a slight irritation of the throat at the start of treatment and
may also cause increased salivation. Excessive swallowing of dissolved
nicotine may, at first, cause hiccuping.
Those with a tendency to indigestion may suffer initially from minor degrees
of indigestion or heartburn if the 4 mg nicotine gum is used; slower chewing
and the use of the 2 mg nicotine gum (if necessary more frequently) will
usually overcome this problem.

Common
(>1/100)

CNS:

Dizziness, headache

Gastrointestinal:

Nausea, gastro-intestinal discomfort,
hiccups

Local:

Sore mouth or throat. Jaw-muscle ache.
The gum may stick to, and may in rare
cases, damage dentures.

Circulatory:
Uncommon
(1/100-1/1000) Dermatological:

Rare
(<1/1000)
Very Rare
(<1/10000)

4.9

Palpitation
Erythema, urticaria

Local:

Stomatitis

Cardiovascular

Atrial fibrillation

Other:

Allergic reactions such as angio-oedema
Anaphylactic reactions

Overdose
The minimum lethal dose of nicotine in a non tolerant man has been estimated
to be 40 to 60 mg. Even small quantities of nicotine may be dangerous in
children and may prove fatal. Suspected nicotine poisoning in a child should
be considered a medical emergency and treated immediately.
Symptoms
Signs and symptoms of an overdose from nicotine lozenges would be expected
to be the same as those of acute nicotine poisoning, including pallor, cold
sweat, salivation, nausea, vomiting, abdominal pain, diarrhoea, headache,
dizziness, disturbed hearing and vision, tremor, mental confusion and
weakness. Prostration, hypotension, respiratory failure, rapid or weak or
irregular pulse, circulatory collapse and convulsions (including terminal
convulsions) may ensue with large overdoses.
Management
In the event of an overdose (e.g. too many gum pieces chewed) the user should
seek medical attention immediately. All nicotine intake should cease
immediately and the patient be treated symptomatically. Artificial respiration
with oxygen should be instituted if necessary. Activated charcoal reduces the
gastrointestinal absorption of nicotine.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC code: N07B A01
The pharmacological effects of nicotine are well documented. Those resulting
from chewing NiQuitin Fresh Mint 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.

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
The general toxicity of nicotine is well known and taken into account in the
recommended posology. Nicotine was not mutagenic in appropriate assays.
The results of carcinogenicity assays did not provide any clear evidence of a
tumorigenic effect of nicotine. In studies in pregnant animals, nicotine
showed maternal toxicity, and consequential mild fetal toxicity. Additional
effects included pre-and post natal growth retardation and delays and changes
in post-natal CNS development. Effects were only noted following exposure
to nicotine at levels in excess of those which will result from recommended
use of NiQuitin Fresh Mint Gum. Effects on fertility have not been
established. There are no other pre-clinical data of relevance.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Gum centre:
Chewing gum base
Calcium carbonate

Butylhydroxytoluene (E 321)
Sorbitol (E 420)
Maltitol liquid
Glycerol
Acesulfame potassium
Mint flavour
Mannitol
Sodium carbonate, anhydrous
Sodium hydrogen carbonate
Talc
Coating:
Talc
Xylitol
Acacia
Titanium dioxide
Eucamenthol flavour
Menthol flavour
Carnauba wax

6.2

Incompatibilities
Not applicable

6.3

Shelf life
24 months

6.4

Special precautions for storage
Do not store above 25°C. Store in the original package.

6.5

Nature and contents of container
NiQuitin Fresh Mint 2 mg Medicated Chewing Gums are available in
packages of 12, 24, 36, 48 and 96 gums.
Not all pack sizes may be marketed. Gums are packed 12 to a blister strip in
3 rows of 4 gums. The blister is part-perforated, splitting the blister into
2 sections of 6 gum pieces each.
The Triplex blister pack is a trilaminate of 250 micron polyvinyl chloride

(PVC)/30 micron polyethylene (PE)/90 gsm polyvinylidenechloride (PVdC).
The lidding material is 20 micron hard temper aluminium foil.

6.6

Special precautions for disposal
None

7

MARKETING AUTHORISATION HOLDER
Omega Pharma Ltd.
1st Floor
32 Vauxhall Bridge Road
LONDON, SW1V 2SA
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 02855/0255

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
02/04/2009

10

DATE OF REVISION OF THE TEXT
08/12/2015

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