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NIQUITIN MINIS ORANGE 1.5 MG LOZENGES

Active substance(s): NICOTINE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
NiQuitin Minis Orange 1.5 mg Lozenges

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 1.5 mg nicotine (as nicotine resinate).
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Compressed Lozenge (lozenge)
White to off white oval tablet with convex surfaces; one surface bearing a debossed
logo.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
NiQuitin Minis 1.5 mg Lozenges relieve and/or prevent craving and nicotine
withdrawal symptoms associated with tobacco dependence. They are 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 Minis 1.5 mg Lozenges are indicated in pregnant and lactating women
making a quit attempt.
NiQuitin Minis 1.5 mg Lozenges should preferably be used in conjunction with a
behavioural support programme.

4.2

Posology and method of administration
Directions for use:
The strength of lozenge to be used will depend on the smoking habits of the
individual.

NiQuitin Minis 1.5 mg Lozenges are suitable for smokers who smoke 20 cigarettes or
less a day.

One lozenge should be placed in the mouth and allowed to dissolve.
Periodically, the lozenge should be moved from one side of the mouth to the
other, and repeated, until the lozenge is completely dissolved (approximately
10 minutes). The lozenge should not be chewed or swallowed whole.
Users should not eat or drink while a lozenge is in the mouth.
Behavioural therapy advice and support will normally improve the success
rate.
Adults (18 year and over)
Abrupt cessation of smoking
Users should make every effort to stop smoking completely during treatment with
NiQuitin Minis 1.5 mg Lozenges.
Use the lozenges whenever there is an urge to smoke.

Sufficient lozenges should be used each day, usually 8-12, up to a maximum
of 15.
Continue use for up to six weeks to break the habit of smoking, then gradually
reduce lozenge use. When daily use is 1-2 lozenges, use should be stopped.
To help stay smoke free after treatment, users may take a lozenge in situations
when they are strongly tempted to smoke.
Those who have quit smoking but are having difficulty discontinuing using the
lozenges are recommended to seek additional help and advice from a
healthcare professional.
Gradual cessation of smoking:
For smokers who are unwilling or unable to quit abruptly.
Use a lozenge 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 lozenges a day is variable and depends on the patients needs.
Nonetheless it should not exceed 15 lozenges 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 the 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 lozenge 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 lozenges a day is variable and depends on the patients needs.
Nonetheless it should not exceed 15 lozenges per day.
If users are still feeling the need to use the lozenges 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 lozenge every 1-2 hours to control troublesome withdrawal symptoms
including craving. Users should not take more than 15 lozenges per day. Users
should be encouraged to stop smoking completely as soon as possible. If users
are still feeling the need to use the lozenges 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.
Children and adolescents:
Adolescents (12-17 years) should follow the schedule of treatment for abrupt
cessation of smoking as given above. Where adolescents are not ready or able
to stop smoking abruptly, advice from a healthcare professional should be
sought.
Safety and effectiveness in children who smoke have not been evaluated. NiQuitin
Minis 1.5 mg Lozenges are not recommended for use in children under the age of 12.

4.3

Contraindications
NiQuitin Minis 1.5 mg Lozenges are contraindicated in:



those with hypersensitivity to nicotine or any of the excipients;

children under the age of 12 years and non-smokers.

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 nonpharmacological interventions. If this fails, NiQuitin Minis 1.5 mg Lozenges 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 lozenge 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 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.



Seizures: Potential risks and benefits of nicotine should be carefully evaluated
before use in subjects taking anti-convulsant therapy or with a history of epilepsy
as cases of convulsions have been reported in association with nicotine.

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.

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.

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 relevant.

4.8

Undesirable effects
NRT can cause adverse reactions similar to those associated with nicotine
administered in other ways, including smoking. These may be attributed to the
pharmacological effects of nicotine, some of which are dose dependent. At
recommended doses NiQuitin Minis 1.5 mg Lozenges have not been found to cause
any serious adverse effects. Excessive consumption of NiQuitin Minis 1.5 mg
Lozenges by those who have not been in the habit of inhaling tobacco smoke could
possibly lead to nausea, faintness or headaches.
Certain symptoms which have been reported such as depression, irritability, anxiety,
increased appetite and insomnia may be related to withdrawal symptoms associated

with smoking cessation. Subjects quitting smoking by any means could expect to
suffer from headache, dizziness, sleep disturbance, increased coughing or a cold.
Immune system disorders
Very rare (<1/10000): anaphylactic reactions
Psychiatric disorders
Common (>1/100, <1/10): irritability, anxiety, sleep disorders incl. abnormal
dreams
Uncommon (>1/1000, <1/100): nervousness, depression
Nervous system disorders:
Common (>1/100, <1/10): dizziness, headaches
Not known: seizures

Cardiac Disorders
Uncommon (>1/1000, <1/100): palpitations, heart rate increased
Respiratory, thoracic and mediastinal disorders
Common (>1/100, <1/10): cough, sore throat
Gastrointestinal disorders
Very common (>1/10): nausea, mouth/throat and tongue irritation
Common (>1/100, <1/10): vomiting, diarrhoea, gastro-intestinal discomfort,
flatulence, hiccups, heartburn, dyspepsia
Skin and Subcutaneous Tissue Disorders
Uncommon (>1/1000, <1/100): rash
General Disorders and Administration Site Conditions
Uncommon (>1/1000, <1/100): fatigue, malaise, chest pain

4.9

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 lozenges ingested) 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
Pharmacotherapeutic group: Drugs used in nicotine dependence.
ATC Code: N07B A01
Nicotine is an agonist at nicotine receptors in the peripheral and central nervous
system and has pronounced CNS and cardiovascular effects. When consumed in
tobacco products, it has been shown to be addictive and abstinence is linked to
craving and withdrawal symptoms. These craving and withdrawal symptoms include
urge to smoke, depressed mood, insomnia, irritability, frustration or anger, anxiety,
difficulty in concentrating, restlessness and increased appetite or weight gain.
Cravings and other symptoms of nicotine withdrawal are at their most intense during
the first few weeks of a quit attempt, diminishing thereafter. The lozenges replace
some of the nicotine provided by tobacco and clinical studies measuring intensity of
cravings and other withdrawal symptoms have been shown to alleviate these
symptoms when they are at their most intense.

5.2

Pharmacokinetic properties
NiQuitin Minis 1.5 mg Lozenges dissolve completely in the oral cavity, and
the entire amount of nicotine contained in the lozenge becomes available for
buccal absorption or ingestion (swallowing). The complete dissolution of
NiQuitin Minis 1.5 mg Lozenges is typically achieved in 10 minutes. When
dosed every hour, the steady state mean cmax and cmin concentrations are 18.4
and 15.0 ng/ml respectively.
As the plasma protein binding of nicotine is low (4.9%), the volume of
distribution of nicotine is large (2.5 l/kg). The distribution of nicotine to tissue

is pH dependent, with the highest concentrations of nicotine found in the
brain, stomach, kidney and liver.
Nicotine is extensively metabolized to a number of metabolites, all of which
are less active than the parent compound. The metabolism of nicotine
primarily occurs in the liver, but also in the lung and kidney. Nicotine is
metabolized primarily to cotinine but is also metabolized to nicotine N′-oxide.
Cotinine has a half-life of 15-20 hours and its blood levels are 10 times higher
than nicotine. Cotinine is further oxidized to trans-3′-hydroxycotinine, which
is the most abundant metabolite of nicotine in the urine. Both nicotine and
cotinine undergo glucuronidation.
The elimination half-life of nicotine is approximately 2 hours (range 1 - 4 hours).
Total clearance for nicotine ranges from approximately 62 to 89 l/hr. Non-renal
clearance for nicotine is estimated to be about 75% of total clearance. Nicotine and
its metabolites are excreted almost exclusively in the urine. The renal excretion of
unchanged nicotine is highly dependent on urinary pH, with greater excretion
occurring at acidic pH.

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 postnatal growth retardation and delays and changes
in postnatal CNS development.
Effects were only noted following exposure to nicotine at levels in excess of
those which will result from recommended use NiQuitin Minis 1.5 mg
Lozenges. Effects on fertility have not been established.
Comparison of the systemic exposure necessary to elicit these adverse
responses from preclinical test systems with that associated with the
recommended use NiQuitin Minis 1.5 mg Lozenges indicate that the potential
risk is low and outweighed by the demonstrable benefit of nicotine therapy in
smoking cessation. However, NiQuitin Minis 1.5 mg Lozenges should only
be used by pregnant women on medical advice if other forms of treatment
have failed.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Mannitol (E 421)
Sodium alginate

Xanthan gum
Potassium bicarbonate
Calcium polycarbophil
Sodium carbonate anhydrous
Acesulfame potassium
Orange Flavour 100176
Peppermint Flavour 081662
Magnesium Stearate

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
2 years.

6.4

Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect the product
from moisture.

6.5

Nature and contents of container
Child resistant polypropylene tablet container/cap incorporating a molecular sieve
desiccant (sodium aluminosilicate) and containing 20 lozenges.
Packs may contain 1 or 3 tablet containers.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 02855/0247

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/10/2012

10

DATE OF REVISION OF THE TEXT
08/12/2015

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