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NIQUITIN STRIPS MINT 2.5MG ORAL FILM

Active substance(s): NICOTINE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
NiQuitin Strips Mint 2.5 mg Oral Film

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible film contains 2.5 mg nicotine
Contains ethanol, no more than 3.9 mg per film
For full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Orodispersible Film
Transparent film approximately 20 mm by 30 mm

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
NiQuitin Strips 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 Strips are indicated in pregnant and lactating women making a quit attempt.
NiQuitin Strips should preferably be used in conjunction with a behavioural support
programme.

4.2

Posology and method of administration
Directions for use:
NiQuitin Strips are suitable for smokers who have their first cigarette of the day more
than 30 minutes after waking up.
Place one film on the tongue. Close the mouth and press the tongue gently to the roof
of the mouth until the nicotine film dissolves (approximately 3 minutes). The film
should not be chewed or swallowed whole.

Users should not eat or drink while a nicotine film is in the mouth.
Behavioural therapy, advice and support will normally improve the success rate.

Adults (18 years and over):
Abrupt cessation of smoking:
Users should make every effort to stop smoking completely during treatment with
NiQuitin Strips.
Recommended treatment schedule:
Step 1
Weeks 1 to 6

Step 2
Weeks 7 to 9

Step 3
Weeks 10 to
12

Initial treatment
period

Step down
treatment period

Step down
treatment
period

1 nicotine film
every 1 to
2 hours

1 nicotine film
every 2 to
4 hours

1 nicotine film
every 4 to
8 hours

During weeks 1 to 6 it is recommended that users take a minimum of 9 films per day.
Users should not exceed 15 films per day.
To help stay smoke free beyond 12 weeks, users may take 1-2 NiQuitin Strips per day
only on occasions when they are strongly tempted to smoke.
Those who have quit smoking but are having difficulty discontinuing using NiQuitin
Strips 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 NiQuitin Strips 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 films a day is variable and depends on the patient’s needs.
Nonetheless it should not exceed 15 films 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 NiQuitin Strips 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 films a day is variable and depends on the patient’s needs.
Nonetheless it should not exceed 15 films per day.
If users are still feeling the need to use NiQuitin Strips 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 NiQuitin Strips every 1-2 hours to control troublesome withdrawal symptoms
including craving. Users should not take more than 15 films per day. Users should be
encouraged to stop smoking completely as soon as possible. If users are still feeling
the need to use NiQuitin Strips 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 (12-17 years) should follow the schedule of treatment for abrupt
cessation of smoking as given above. 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
Strips are not recommended for use in children under 12 years of age.

4.3

4.4

Contraindications


people with hypersensitivity to nicotine or any of the excipients



children under the age of 12 years



non-smokers

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.
Dependent smokers with a recent myocardial infarction, unstable or worsening
angina including Prinzmetal’s angina, severe cardiac arrhythmias, uncontrolled
hypertensions or recent cerebrovascular accident should be encouraged to stop
smoking with nonpharmacological interventions (such as counselling). If this fails,
NiQuitin Strips may be considered but as data on safety in this patient group are
limited, initiation should only be under close medical supervision. If there is a
clinically significant increase in cardiovascular or other effects attributable to
nicotine, the film 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 important for diabetics to monitor their blood
glucose levels more closely than usual while using this product.
Allergic reactions: Susceptibility to angioedema or 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.



Gastrointestinal 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.
Ethanol (alcohol): This medicinal product contains small amounts of ethanol
(alcohol), less than 100 mg per nicotine film.

4.5

Interaction with other medicinal products and other forms of interaction
Adults and paediatric (12-17 years inclusive) population
No clinically relevant interactions between nicotine replacement therapy and
other medicinal products 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
There are no known effects of NiQuitin Strips on the ability to drive and use
machines. However, users of nicotine replacement products should be aware
that smoking cessation can cause behavioural changes

4.8

Undesirable effects
Adults
NiQuitin Strips can cause adverse reactions similar to those associated with nicotine
from tobacco. Many of the observed adverse reactions are consistent with the
pharmacological effects of nicotine, which are dose dependent.
The following undesirable effects detailed in Table 1 and Table 2 are nicotine lozenge
and gum adverse reactions which are considered relevant for the NiQuitin Strips
formulation based upon 2 small clinical studies involving nicotine films.

Table 1
Psychiatric Disorders
insomnia*
Common ≥1/100
to <1/10
Nervous system disorders
headache*, dizziness*
Common ≥1/100
to <1/10
Respiratory, Thoracic and Mediastinal Disorders
pharyngitis, cough*, pharyngolaryngeal pain
Common ≥1/100
to <1/10
Gastrointestinal Disorders
Very common
nausea
≥1/10
Common ≥1/100 vomiting, dyspepsia, abdominal pain upper, diarrhoea,
dry mouth, constipation, hiccups, stomatitis, flatulence,
to<1/10
oral discomfort

• May also be due to withdrawal symptoms following smoking cessation
Post Marketing Data
Table 2 shows adverse reactions which were identified from post-marketing
experience of oral gum and lozenge nicotine products. This is considered relevant for
NiQuitin Strips (which is bioequivalent to these formulations) based on 2 small
clinical studies with the film formulation.

Table 2
Immune System Disorders
Frequency: Unknown

hypersensitivity, angioedema, urticaria,
ulcerative stomatitis, and very rare
anaphylactic reactions

Psychiatric Disorders
Frequency: Unknown
nervousness*
Nervous System Disorders
Frequency: Unknown
tremor
Frequency: Not Known
seizures
Cardiac Disorders
Frequency: Unknown
palpitations, tachycardia
Respiratory, Thoracic and Mediastinal Disorders
Frequency: Unknown
dyspnoea
Gastrointestinal Disorders
Frequency: Unknown

dysphagia, eructation, salivary
hypersecretion
General Disorders and Administration Site Conditions
Frequency: Unknown
asthenia*, fatigue*, malaise*, influenza
type illness*

May also be due to withdrawal symptoms following smoking cessation

Paediatric population (12 - 17 years inclusive)

There are no specific adverse event data for this population. However, the frequency,
type and severity of adverse reactions in adolescents are expected to be the same as
adults, based upon a pharmacokinetic study demonstrating a similar pharmacokinetic
profile in the adolescent age group compared to adults.

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 films 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 films 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: N07BA01
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 nicotine films
replace some of the nicotine provided by tobacco. Clinical studies for the
bioequivalent 2 mg lozenge have shown a reduction in intensity of cravings.

5.2

Pharmacokinetic properties
Nicotine films completely dissolve in the oral cavity, and the entire amount of
nicotine contained in the nicotine film becomes available for buccal absorption or
ingestion (swallowing). The complete dissolution of a nicotine film is typically
achieved in approximately 3 minutes. The peak plasma concentrations of nicotine
achieved after a single dose are approximately 4.13 ng/ml.
As the plasma protein binding of nicotine is low (4.9% - 20%), 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 metabolised 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 metabolised primarily to cotinine
but is also metabolised 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 oxidised 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 mild foetal 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 of nicotine films. Effects on fertility have
not been established.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1), Type A
Triethyl Citrate (E1505)
Peppermint Flavour TAK - 032230
Sucralose (E955)
Sodium Hydrogen Carbonate (E500 ii)
Ethanol

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
2 years

6.4

Special precautions for storage
Do not store above 30 oC. Store in the original package to protect from light and
moisture.

6.5

Nature and contents of container
Each NiQuitin Strips Film is contained in a polyethyleneterephthalate
(PET)/aluminium/polyacrylnitrile (PAN) laminate sachet.
Each pack contains 10, 15, 30 or 60 sachets. 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 02855/0252

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14/09/2011

10

DATE OF REVISION OF THE TEXT
01/12/2015

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