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BOOTS NICASSIST FRUIT FRESH 4 MG GUM

Active substance(s): NICOTINE RESINATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Nicorette Freshfruit 4 mg Gum
Nicorette Fruitfusion 4mg Gum
Boots NicAssist Fruit Fresh 4 mg Gum

2

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

3

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

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
This product 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.
This product 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
This product 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 than 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.

This product 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 this product, 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 this product are recommended to contact their
pharmacist or doctor for advice.
For those using the 4mg gum, switching to the 2mg 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.
This product 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 this
product presents a lesser hazard than continuing to smoke. However dependent
smokers currently hospitalised as a result of myocardial infarction, unstable or
worsening angina including Prinzmetal’s angina, severe dysrhythmia or CVA
and who are considered to be haemodynamically unstable and/or who suffer
with uncontrolled hypertension should be encouraged to stop smoking with
non-pharmacological interventions. If this fails, this product 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: This product 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, this product 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: This product 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 this product. 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

Fertility, Pregnancy and lactation
Fertility
In females tobacco smoking delays time to conception, decreases in-vitro
fertilization success rates, and significantly increases the risk of infertility.
In males tobacco smoking reduces sperm production, increases oxidative
stress, and DNA damage. Spermatozoa from smokers have reduced fertilizing
capacity.
The specific contribution of nicotine to these effects in humans is unknown.
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 this product
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
This product has no or negligible influence on the ability to drive and use machines.

4.8

Undesirable effects
Effects of Smoking Cessation
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.
Adverse Drug Reactions
This product may cause adverse reactions similar to those associated with
nicotine given by other means, including smoking, and these are mainly dosedependent. At recommended doses this product 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 this product 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.
The adverse reactions observed in patients treated with oral nicotine
formulations during clinical trials and post-marketing experience are listed
below by system organ class (SOC). Frequencies are defined in accordance
with current guidance, as: 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), Not known - cannot be estimated from the available data.
System Organ Class
Immune System Disorders
Psychiatric disorders
Nervous System Disorders

Eye Disorders
Cardiac Disorders

Vascular Disorders

Reported Adverse Event
a
Hypersensitivity
Anaphylactic reactiona
Abnormal dreams*
a#
Headache
Burning sensationc
Dizziness
Dysgeusia
a
Paraesthesia
Blurred Vision
Lacrimation increased
a
Palpitations
Tachycardiaa
Reversible atrial fibrillation
a
Flushing
Hypertensiona

Incidence
Common
Not known
Uncommon
Very Common
Common
Common
Common
Common
Not known
Not known
Uncommon
Uncommon
Very Rare
Uncommon
Uncommon

Respiratory, Thoracic and
Mediastinal Disorders

Gastrointestinal Disorders

Skin and Subcutaneous
Tissue Disorders

Musculoskeletal and
Connective Tissue Disorders
General Disorders and
Administration Site
Conditions

a

Cough**
Sore mouth or throat
Throat irritation
Bronchospasm
Dysphonia
a
Dyspnoea
Nasal Congestion
Sneezing
Throat tightness
a
Nausea
Hiccups
Abdominal pain
Diarrhoea***
Dry mouth
Flatulence
Salivary hypersecretion
Stomatitis
a
Vomiting
Dyspepsia
Eructation
Glossitis
Oral mucosal blistering and
exfoliation
Paraesthesia oral***
Dysphagia
Hypoaesthesia oral***
Retching
Dry throat
a
Gastrointestinal discomfort
Lip pain
a
Urticaria
a
Hyperhidrosis
a
Pruritus
a
Rash
Erythemaa
Pain in Jawb
Muscle tightnessb
a
Fatigue
Astheniaa
Chest discomfort and paina
a
Malaise
Allergic reactions including
angioedema

Very Common
Very Common
Very Common
Uncommon
Uncommon
Uncommon
Uncommon
Uncommon
Uncommon
Very Common
Very Common
Common
Common
Common
Common
Common
Common
Common
Common
Uncommon
Uncommon
Uncommon
Uncommon
Rare
Rare
Rare
Not known
Not known
Not known
Uncommon
Uncommon
Uncommon
Uncommon
Not known
Uncommon
Not known
Common
Uncommon
Uncommon
Uncommon
Rare

Systemic effects; b Tightness of jaw and pain in jaw with nicotine gum formulation
At the application site
*
Identified only for formulations applied during the night
**
Higher frequency observed in clinical studies with inhaler formulation.
***Reported the same or less frequently than placebo
#
Although the frequency in the active group is less than that of the placebo group, the
frequency in the specific formulation in which the PT was identified as a systemic
ADR was greater in the active group than the placebo group.
c

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
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 this product 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.
Increased appetite is a recognised symptom of nicotine withdrawal and postcessation 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
Acesulfame Potassium
Levomenthol
Magnesium oxide, light
Quinoline yellow Al-Lake (E104)
Talc
Sub-coating
Tuttifrutti QL84441
Hypromellose
Sucralose
Polysorbate 80
Purified water
Coating
Xylitol
Acacia
Titanium dioxide (E171)
Tuttifrutti QL84441
Quinoline yellow Al-lake (E104)
Carnauba wax
Purified Water

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
Blister: 3 Years
Box: 3 Years. Shelf life after opening 3 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, 105 and 210 pieces.
Blister packed strips each containing 6 pieces supplied in packs of 12 pieces.
Blister packed strips each containing 10 pieces supplied in packs of 10 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
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 15513/0137

9

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

10

DATE OF REVISION OF THE TEXT
18/05/2016

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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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