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BOOTS NICASSIST 15 MG INHALATOR

Active substance(s): NICOTINE

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Nicorette 15mg Inhalator / Boots NicAssist 15 mg Inhalator.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicotine 15mg per cartridge.
For a full list of excipients see section 6.1

3

PHARMACEUTICAL FORM
Inhalation cartridge for oromucosal use.
A white to slightly coloured porous plug in a sealed, transparent plastic tube.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Nicorette Inhalator 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 Inhalator 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 Inhalator 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 Inhalator and as soon as they are able, reduce the number of
cartridges used until they have stopped completely.
Smokers aiming to reduce cigarettes should use the Inhalator, 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: 6 cartridges.
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 their Inhalator are recommended to contact their pharmacist or doctor
for advice.
Each cartridge can be used for approximately eight 5-minute sessions, with each
cartridge lasting approximately 40 minutes of intense use. The more the subject is
able to use the inhalator, the easier it will be to achieve maximum reduction of
cigarettes and/or quit smoking completely.
Method of administration
The cartridge is inserted into the mouthpiece according to the instructions.
When a patient draws air into the mouth through the mouthpiece, nicotine is
vaporised and absorbed by the buccal mucosa. Minimal nicotine reaches the lungs.
The amount of nicotine from a puff is less than that from a cigarette. To compensate
for less nicotine delivery from a puff it is necessary to inhale more often than when
smoking a cigarette.
The number of cartridges, frequency, puffing/inhalation time and technique does vary
between individuals.
The actual time that the cartridge is active depends on the intensity of use. After about
40 minutes of intense use the maximal dose is achieved and it is about then that the
nicotine amounts released from the cartridge begin to fall away, such that the
cartridge is rejected by the user.

4.3

Contraindications
Hypersensitivity to any component of the inhalator.

Nicorette Inhalator 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 have 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. If a child swallows, chews or sucks on the
nicotine cartridge (used as well as unused) there is a risk of poisoning in the
child.
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.
Lung Disease: Patients with obstructive lung disease may find use of the Inhalator
difficult. Nicotine Gum, Patch, Nasal Spray or Sublingual tablet may be preferred in
such cases. This product should be used with caution in patients with chronic throat
disease and bronchospastic disease.

Allergic reactions: Susceptibility to angioedema and urticaria.
Potential choking hazard: This product contains some small parts. Any unused
cartridges should remain in the cartridge tray to minimise the risk of
swallowing.

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 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
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 foetus 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
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.

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.
4.7

Effects on ability to drive and use machines
This medicinal 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 dose-dependent. At
recommended doses this product has not been found to cause any serious adverse
effects. Excessive use of Nicorette Inhalator by those who have not been in the habit
of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.
Most of the undesirable effects reported by the patient occur during the first weeks
after starting treatment. About 40% of users experience mild local reactions such as
cough and irritation in the mouth and throat.
Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of
this product.
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
Respiratory, Thoracic and
Mediastinal Disorders

Gastrointestinal Disorders

Skin and Subcutaneous Tissue
Disorders

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

Reported Adverse Event
Hypersensitivitya
Anaphylactic reactiona
Abnormal dreamsc
Headachea#
Burning sensation*
Dizziness
Dysgeusia
Paraesthesiaa
Blurred Vision
Lacrimation increased
Palpitationsa
Tachycardiaa
Reversible atrial fibrillation
Flushinga
Hypertensiona
Cough**Throat irritation
Nasal Congestion
Bronchospasm
Dysphonia
Dyspnoeaa
Sneezing
Throat tightness
Nauseaa
Stomatitis
Hiccupsb
Abdominal pain
Diarrhoea***
Dry mouth
Dyspepsia
Flatulence
Salivary hypersecretion
Vomitinga
Eructation
Glossitis
Oral mucosal blistering and
exfoliation
Paraesthesia oral***
Dysphagia
Hypoaesthesia oral***
Retching
Dry throat
Gastrointestinal discomforta
Lip pain
Hyperhidrosisa
Pruritusa

Musculoskeletal and
Connective Tissue Disorders
General Disorders and
Administration Site
Conditions

Uncommon
Uncommon
Not known
Not known
Uncommon
Not known
Common
Uncommon
Uncommon
Uncommon

Rasha
Urticariaa
Angioedemaa
Erythemaa
Pain in Jawb
Muscle tightnessb
Fatiguea
Astheniaa
Chest discomfort and paina
Malaisea

a Systemic effects; b Tightness of jaw and pain in jaw with nicotine gum formulation
c Identified only for formulations applied during the night
* At the application site
**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.

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 in-take 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: Drug for treatment of addiction.
ATC Code: N07B A01
Nicorette Inhalator facilitates uptake of nicotine through the buccal mucosa into the
venous circulation. The amount taken up alleviates the craving symptoms caused by
the absence of nicotine from smoking.
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
The following information is based on data derived from Nicorette 10mg Inhalator:
Nicotine given i.v. has a volume of the distribution of 2 or 3 l/kg with a half life of 12 hours. Average plasma clearance is about 1-2 l/min mainly in the liver. More than
20 metabolites are known, all less active than nicotine: cotinine, with a half life of 1520 hours and concentrations ten times that of nicotine is the main one.
Plasma binding of nicotine below 5% means significant displacement of drugs or
nicotine is unlikely. Nicotine is excreted in the urine principally as cotinine (15%), 3hydroxycotinine (45%), nicotine (10%).
Most inhaled nicotine is absorbed via the buccal mucosa. Forced rapid inhalation
over 20 minutes, results in a wide range of nicotine doses (1.3-6.2 mg). On average 2
mg of nicotine is released during 20 minutes of intensive use. Uptake is slow and free
of the peaks resultant from cigarette smoking. In normal use, plasma levels of 68ng/ml nicotine are obtained – about one third that from smoking, which is equivalent
to an hourly 2mg nicotine chewing gum.
When used like a cigarette the inhalator on average delivers 1mg in 80 puffs (e.g. 8
puffs per minute for 10 minutes). When used in this way this results in, a degree of
nicotine substitution of about 50% compared to hourly smoking. Peak plasma levels
occur within 15 minutes after the end of inhalation. Forced rapid inhalation for 20
minutes per hour for 12 hours achieved steady state plasma levels of 20-25ng/ml.
Ambient temperature affects volatilisation of nicotine, the biologically available dose
rising by 35% for each 10°C above 20°C. Use below 15°C is not recommended.
Because the pattern of use if decided by the patient up to a limit of 6 cartridges per
day to relieve craving, therapeutic levels of nicotine are individual, dictated by the
level of dependence.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Levomenthol
Porous plug of polyethylene

6.2

Incompatibilities
Not applicable

6.3

Shelf life
36 months.
Once inserted into the mouthpiece the cartridge should be disposed of within 48 hours
even if it has not been used.

6.4

Special precautions for storage
Store below 25°C.
This product works best at room temperature. In cold conditions (below 15°C) the
nicotine evaporates less readily and it will be necessary to inhale more frequently,
whilst in warm conditions (above 30°C) nicotine will evaporate more readily and
inhalation should be less frequent to avoid overdose.

6.5

Nature and contents of container
Polypropylene mouthpiece with acrylonitrile / methacrylate copolymer cartridges
containing polyethylene porous plugs with polyester / aluminium foil seals.
The cartridges are provided in a PVC tray which is sealed with aluminium foil.
Pack sizes:
4 cartridges with 1 inhalator mouthpiece
20 cartridges with 1 inhalator mouthpiece

36 cartridges with 1 inhalator mouthpiece
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
Potential choking hazard: This product contains some small parts. Any unused
cartridges should remain in the cartridge tray to minimise the risk of swallowing.
Because of residual nicotine, used cartridges may be a hazard to children, animals and
fish and so should never be thrown away or left lying around. They should be kept in
the case and disposed of with household rubbish.

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 15513/0358

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
03/06/2011

10

DATE OF REVISION OF THE TEXT
26/06/2016

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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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