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BOOTS NICASSIST 2MG MICROTAB

Active substance(s): NICOTINE BETA-CYCLODEXTRIN COMPLEX

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Nicorette Microtab or Boots NicAssist 2 mg microtab.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicotine ß-cyclodextrin complex 17.4 mg, equivalent to 2 mg nicotine.
For excipients see section 6.1

3

PHARMACEUTICAL FORM
Sublingual tablet.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Nicorette Microtab 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, Nicorette
Microtab may also be used as part of a programme to reduce smoking prior to
stopping completely.
If possible, Nicorette Microtab should be used in conjunction with a
behavioural support programme.

4.2

Posology and method of administration
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 this product .

The initial dose is based on the individual’s nicotine dependence. The tablet is used
sublingually with a recommended dose of one tablet per hour or, for heavy smokers
(smoking more than 20 cigarettes per day), two tablets per hour. Allow the tablet to
dissolve slowly (about 30 minutes).You should not swallow or chew the tablet.
Increasing to two tablets per hour may be considered for patients who fail to stop
smoking with the one tablet-per-hour regimen or for those whose nicotine withdrawal
symptoms remain so strong as to foresee a relapse.
Most smokers require 8 to 12 or 16 to 24 tablets per day, not to exceed 40 tablets.
The duration of treatment is individual, but up to three months of treatment is
recommended. The nicotine dose should then be gradually reduced, by decreasing
the total number of tablets used per day. The treatment should be stopped when the
daily consumption is down to one or two tablets.
Adults who use NRT beyond 9 months 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 this product.
The initial dose is based on the individual’s nicotine dependence. The tablet is used
sublingually with a recommended dose of one tablet per hour or, for heavy smokers
(smoking more than 20 cigarettes per day), two tablets per hour. Increasing to two
tablets per hour may be considered for patients who fail to stop smoking with the one
tablet-per-hour regimen or for those whose nicotine withdrawal symptoms remain so
strong as to foresee a relapse.
Most smokers require 8 to 12 or 16 to 24 tablets per day, not to exceed 40 tablets. Use
for up to 8 weeks to break the habit of smoking, then gradually reduce the dose over a
4 week period. The treatment should be stopped when the daily consumption is down
to one or two tablets. 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 this product 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 this product 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 sublingual tablet.

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.
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.

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
NRT is not contraindicated in pregnancy. The decision to use NRT should be made
on a risk-benefit 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
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 dose-dependent. At
recommended doses this product has not been found to cause any serious adverse
effects. 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.
Most of the undesirable effects associated with Nicorette Microtab occur during the
first 3-4 weeks after starting treatment. Irritation in the mouth and throat may be
experienced, however most subjects adapt to this with ongoing use.

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
Incidence
Infections and infestations Common
Immune System Disorders Common
Not known
Psychiatric disorders
Uncommon
Nervous System
Very Common
Disorders
Common
Common
Common
Common
Eye Disorders
Not known
Not known

Reported Adverse Event
Rhinitis
Hypersensitivitya
Anaphylactic reactiona
Abnormal dreams*
Headachea#
Burning sensationc
Dizziness
Dysgeusia
Paraesthesiaa
Blurred Vision
Lacrimation increased

Cardiac Disorders

Common
Uncommon
Very Rare

Palpitationsa
Tachycardiaa
Reversible atrial fibrillation

Vascular Disorders

Uncommon
Uncommon
Very Common
Very Common
Common
Uncommon
Uncommon
Uncommon
Uncommon
Uncommon
Uncommon
Very Common
Very Common
Common
Common
Common
Common
Common
Common
Common
Common
Uncommon
Uncommon

Flushinga
Hypertensiona
Cough**
Throat irritation
Sore mouth or throat
Bronchospasm
Dysphonia
Dyspnoeaa
Nasal Congestion
Sneezing
Throat tightness
Hiccups
Nauseaa
Abdominal pain
Diarrhoea***
Dry mouth
Dyspesia
Flatulence
Salivary hypersecretion
Stomatitis
Vomitinga
Eructation
Glossitis

Respiratory, Thoracic and
Mediastinal Disorders

Gastrointestinal Disorders

Uncommon

Musculoskeletal and
connective tissue
disorders
Skin and Subcutaneous
Tissue Disorders

General Disorders and
Administration Site
Conditions

Uncommon
Rare
Rare
Rare
Not known
Not known
Not known

Oral mucosal blistering and
exfoliation
Paraesthesia oral***
Dysphagia
Hypoaesthesia oral***
Retching
Dry throat
Gastrointestinal discomforta
Lip pain

Uncommon
Not known

Pain in Jawb
Muscle tightnessb

Uncommon
Uncommon
Uncommon
Uncommon
Not known
Common
Unommon
Uncommon
Uncommon
Rare

Hyperhidrosisa
Pruritusa
Rasha
Urticaria**
Erythemaa
Fatiguea
Astheniaa
Chest discomfort and paina
Malaisea
Allergic reactions including
angioedema

a

Systemic effects; b Tightness of jaw and pain in jaw with nicotine gum
formulation
c
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.
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,
convulsions.

prostration,

circulatory

collapse

and

terminal

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: Drug used in nicotine dependence.
ATC code: N07B A01
The pharmacological effects of nicotine are well documented. Those resulting from
using Nicorette Microtab are comparatively small. The response at any one time
represents a summation of stimulant and depression actions from direct, reflex and
chemical mediator influences on several organs. The principal 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
Most of the absorption of nicotine from Nicorette Microtab occurs directly
through the buccal mucosa. The absolute bioavailability, after sublingual
administration of the tablet, is approximately 50%.
The systemic
bioavailability of orally administered nicotine is lower due to the amount
removed initially by the liver (the first-pass effect). Hence, the high and
rapidly rising nicotine concentrations seen after smoking are rarely produced
by treatment with Nicorette Microtab.
Nicotine from smoking is rapidly absorbed from the lungs into arterial plasma
whereas nicotine from sublingual tablets passes more slowly into the venous
system.
Steady-state trough nicotine plasma concentrations, achieved after ten hourly
doses of one tablet, are in the order of magnitude of 10 ng/mL, which is about
50% of normal smoking levels.
There is a slight deviation from dose-linearity of AUCinf and Cmax when single
doses of one, two and three tablets are given. This deviation may be explained
by a larger fraction of the higher doses being swallowed and subject to firstpass elimination.

The therapeutic blood concentrations of nicotine, i.e. the blood levels which
relieve craving, are based on the individual’s nicotine dependence.

5.3

Preclinical safety data
Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Crospovidone
ß-cyclodextrin
Colloidal anhydrous silica
Magnesium stearate

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
Two (2) years.

6.4

Special precautions for storage
Do not store above 25ºC.

6.5

Nature and contents of container
Aluminium foil/PVC-PVDC circular-shaped blister strips (discs) of fifteen
(15) tablets assembled in cartons, together with a dispenser. The dispenser is
used to remove the tablets from the disc.
Package sizes
30 Tablets (two strips), together with the dispenser.

105 Tablets (seven strips), together with the dispenser.
Or
Al/Al blister strips of 10 sublingual tablets
Package sizes
Cardboard box of 10, 20, 30, 90, 100, 150 or 210 sublingual tablets with a
package insert/booklet.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
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(S)
PL 15513/0178

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/01/2008

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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