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NIQUITIN CLEAR 7 MG PATCH

Active substance(s): NICOTINE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
NiQuitin Clear 7 mg Patch

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
NiQuitin Clear is a transdermal delivery system for topical application available in
systems of 7 cm2 containing 36 mg nicotine, equivalent to 5.1 mg/cm2 of nicotine and
delivering 7 mg over 24 hours.

3

PHARMACEUTICAL FORM
Transdermal patch.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
NiQuitin Clear 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.
NiQuitin Clear is indicated in pregnant and lactating women making a quit attempt.
If possible, when stopping smoking, NiQuitin Clear should be used in conjunction
with a behavioural support programme.

4.2

Posology and method of administration
NiQuitin Clear patches should be applied once a day, at the same time each
day and preferably soon after waking, to a non-hairy, clean, dry skin site and
worn continuously for 24 hours. The NiQuitin Clear patch should be applied
promptly on removal from its protective sachet.
Avoid applying to any skin which is broken, red or irritated. After 24 hours
the used patch should be removed and a new patch applied to a fresh skin site.
The patch should not be left on for longer than 24 hours. Skin sites should not
be reused for at least seven days. Only one patch should be worn at a time.

Patches may be removed before going to bed if desired. However use for
24 hours is recommended to optimise the effect against morning cravings.
Concurrent behavioural support is recommended, as such programmes have
been shown to be beneficial for smoking cessation.
Adults (18 years and over)
Abrupt cessation of smoking:
During a quit attempt every effort should be made to stop smoking with
NiQuitin Clear.
NiQuitin Clear therapy should usually begin with NiQuitin Clear 21 mg Patch
and be reduced according to the following dosing schedule:Dose

Duration

Step 1

NiQuitin Clear 21 mg
Patch

First 6 weeks

Step 2

NiQuitin Clear 14 mg
Patch

Next 2 weeks

Step 3

NiQuitin Clear 7 mg
Patch

Last 2 weeks

Light smokers (e.g. those who smoke less than 10 cigarettes per day) are
recommended to start at Step 2 (14 mg) for 6 weeks and decrease the dose to
NiQuitin Clear 7 mg Patch for the final 2 weeks.
Patients on NiQuitin Clear 21 mg Patch who experience excessive side-effects
(please refer to precautions), which do not resolve within a few days, should
change to NiQuitin Clear 14mg Patch. This strength should then be continued
for the remainder of the 6 week course before stepping down to NiQuitin
Clear 7mg Patch for two weeks. If the symptoms persist the patient should be
advised to seek the advice of a healthcare professional.
For optimum results, the 10 week treatment course (8 weeks for light smokers
or patients who have reduced strength as above), should be completed in full.
Treatment with NiQuitin Clear patch may be continued beyond 10 weeks if
you need it to stay cigarette free, however those who have quit smoking but
have difficulty discontinuing using the patches are recommended to seek
additional help and advice from a healthcare professional.
Further courses may be used at a later time, for NiQuitin Clear patch users
who continue or resume smoking.
Gradual Cessation:
For smokers who are unwilling or unable to quit abruptly.

The 21 mg patch can be used daily for 2-4 weeks while the user continues to
smoke as needed. At the end of the 2-4 weeks the user should quit completely
and continue using Step 1 21 mg patch for 6 weeks daily without smoking.
Thereafter following the Step 2 and 3 directions for abrupt cessation above.
Should the patient feel able to quit completely before their designated quit date
they can do so.
Reduction in smoking:
For smokers who wish to cut down with no immediate plans to quit.
A patch can be used while the user continues to smoke as needed. The user
should 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.
If users are still feeling the need to use the patches 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
Apply a patch to control troublesome withdrawal symptoms including craving
during the period when smoking is being avoided. Users should be encouraged
to stop smoking completely as soon as possible.
If users are still feeling the need to use the patches 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 to 17 years) should follow the schedule of treatment for
abrupt cessation of smoking as given above. Where adolescents are not ready
or not able to stop smoking abruptly, advice from a healthcare professional
should be sought.
Safety and effectiveness in children who smoke has not been evaluated.
NiQuitin Clear is not recommended for use in children under 12 years of age.

4.3

Contraindications
NiQuitin Clear is contraindicated in patients with hypersensitivity to the system, the
active substance, or any of the excipients.
NiQuitin Clear patches should not be used by non-smokers, occasional smokers or
children under 12.

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 haemodynamically unstable should be encouraged to stop smoking with
non-pharmacological interventions. If this fails, NiQuitin Clear patches 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 nicotine
patch 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 more closely than usual while using this product.
Allergic reactions: Susceptibility to angioedema and urticaria.
Atopic or eczematous dermatitis (due to localised patch sensitivity): In the
case of severe or persistent local reactions at the site of application (e.g. severe
erythema, pruritus or oedema) or a generalised skin reaction (e.g. urticaria,
hives or generalised skin rashes), users should be instructed to discontinue use
of NiQuitin Clear and contact their physician.
Contact sensitisation: Patients with contact sensitisation should be cautioned
that a serious reaction could occur from exposure to other nicotine-containing
products or smoking.
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.



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. The patches should be folded in half with the
adhesive side innermost and disposed of with care.
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.
Safety on handling: NiQuitin Clear is potentially a dermal irritant and can
cause contact sensitisation. Care should be taken during handling and in
particular contact with the eyes and nose avoided. After handling, wash hands
with water alone as soap may increase nicotine absorption.

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.
Healthcare professionals are reminded that 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 applicable

4.8

Undesirable effects
NRT may cause adverse reactions similar to those associated with nicotine
administered by other means, including smoking. These may be attributable to
the pharmacological effects of nicotine, some of which are dose dependent. At
recommended doses NiQuitin Clear patches have not been found to cause any
serious adverse effects. Excessive use of NiQuitin Clear patches by those who
have not been in the habit of inhaling tobacco smoke could possibly lead to
nausea, faintness or headaches.
Subjects quitting smoking by any means could expect to suffer from asthenia,
headache, dizziness, sleep disturbance, coughing or influenza-like illness.
Certain symptoms which have been reported such as depression, irritability,
nervousness, restlessness, mood lability, anxiety, drowsiness, impaired
concentration and insomnia may be related to withdrawal symptoms
associated with smoking cessation.
The following undesirable effects have been reported in clinical trials or
spontaneously post-marketing.
Immune System Disorders
Uncommon >1/1000; <1/100: hypersensitivity NOS*
Very rare <1/10000: anaphylactic reactions
Psychiatric
Very common >1/10: sleep disorders including abnormal dreams and insomnia
Common >1/100; <1/10: nervousness
Nervous system disorders
Very Common >1/10: headache, dizziness
Common >1/100; <1/10: tremor
Not known: seizures
Cardiac Disorders
Common >1/100; <1/10: palpitations
Uncommon >1/1000; <1/100: tachycardia NOS
Respiratory, Thoracic and Mediastinal Disorders

Common >1/100; <1/10: dyspnoea, pharyngitis, cough
Gastrointestinal Disorders
Very Common >1/10: nausea, vomiting
Common >1/100; <1/10: dyspepsia, abdominal pain upper, diarrhoea NOS,
dry mouth, constipation
Skin and Subcutaneous Tissue Disorders
Common >1/100; <1/10: sweating increased
Very rare >1/100000; <1/10000: dermatitis allergic*, dermatitis contact*,
photosensitivity
Musculoskeletal and Connective Tissue Disorders
Common >1/100; <1/10: arthralgia, myalgia
General Disorders and Administration Site Conditions
Very common >1/10: application site reactions NOS*
Common >1/100; <1/10: chest pain, pain in limb, pain NOS, asthenia, fatigue
Uncommon >1/1000; <1/100: malaise, influenza-like illness
*see below
Application site reactions, including transient rash, itching, burning, tingling,
numbness, swelling, pain and urticaria are the most frequent undesirable
effects of NiQuitin patch. The majority of these topical reactions are minor
and resolve quickly following removal of the patch. Pain or sensation of
heaviness in the limb or area around which the patch is applied (e.g. chest)
may be reported.
Hypersensitivity reactions, including contact dermatitis and allergic dermatitis
have also been reported. In the case of severe or persistent local reactions at
the application site (e.g. severe erythema, pruritus or oedema) or a generalised
skin reaction (e.g. urticaria, hives or generalised skin rashes) users should be
instructed to discontinue use of NiQuitin and contact their physician.
If there is a clinically significant increase in cardiovascular or other effects
attributable to nicotine, the NiQuitin dose should be reduced or discontinued.

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 a nicotine patch 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
Overdose from Topical Exposure
The nicotine patch(es) should be removed immediately in the event of an
overdose or if the patient shows signs of overdosage. The user should seek
medical attention immediately. The skin surface may be flushed with water
and dried. No soap should be used since it may increase nicotine absorption.
Nicotine will continue to be delivered into the bloodstream for several hours
after removal of the system because of a depot of nicotine in the skin.
Overdose from Ingestion
All nicotine intake should stop immediately. The patient should seek medical
attention immediately and 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 classification: N07BA01
(Anti-smoking agents: N07BA, Nicotine 01)
Nicotine, the chief alkaloid in tobacco products and a naturally occurring autonomic
drug, is an agonist at nicotine receptors in the peripheral and central nervous system
and has pronounced CNS and cardiovascular effects. Withdrawal from nicotine in
addicted individuals is characterised by craving, nervousness, restlessness, irritability,
mood lability, anxiety, drowsiness, sleep disturbances, impaired concentration,
increased appetite, minor somatic complaints (headache, myalgia, constipation,
fatigue) and weight gain. Withdrawal symptoms, such as cigarette craving, may be
controlled in some individuals by steady-state plasma levels lower than those for
smoking.
In clinically controlled trials, nicotine withdrawal symptoms were alleviated as well
as craving. The severity of craving was reduced by at least 35% at all times of day
during the first two weeks of abstinence, compared to placebo (p<0.05).

5.2

Pharmacokinetic properties
Absorption
Following transdermal application, the skin rapidly absorbs nicotine released initially
from the patch adhesive. The plasma concentrations of nicotine reach a plateau
within 2-4 hours after initial application of NiQuitin Clear with relatively constant
plasma concentrations persisting for 24 hours or until the patch is removed.
Approximately 68% of the nicotine released from the patch enters systemic
circulation and the remainder of the released nicotine is lost via vaporisation from the
edge of the patch.
With continuous daily application of NiQuitin Clear (worn for 24 hours), dosedependent steady state plasma nicotine concentrations are achieved following the
second NiQuitin Clear application and are maintained throughout the day. These
steady state maximum concentrations are approximately 30% higher than those
following a single application of NiQuitin Clear.
Plasma concentrations of nicotine are proportional to dose for the three dosage forms
of NiQuitin Clear. The mean plasma steady state concentrations of nicotine are
approximately 17 ng/ml for the 21 mg/day patch, 12 ng/ml for the 14 mg /day patch
and 6 ng/ml for the 7 mg/day patch. For comparison, half-hourly smoking of
cigarettes produces average plasma concentrations of approximately 44 ng/ml.
The pronounced early peak in nicotine blood levels seen with inhalation of cigarette
smoke is not observed with NiQuitin Clear.
Distribution
Following removal of NiQuitin Clear, plasma nicotine concentrations decline with an
apparent mean half-life of 3 hours, compared with 2 hours for IV administration due
to continued absorption of nicotine from the skin depot. If NiQuitin Clear is removed
most non-smoking patients will have non-detectable nicotine concentrations in 10 to
12 hours.
A dose of radio-labelled nicotine given intravenously showed a distribution of
radioactivity corresponding to the blood supply with no organ selectively taking up
nicotine. The volume of distribution of nicotine is approximately 2.5 l/kg.
Metabolism
The major elimination organ is the liver and average plasma clearance is about
1.2 l/min; the kidney and the lung also metabolise nicotine. More than 20 metabolites
of nicotine have been identified, all of which are believed to be pharmacologically
inactive. The principal metabolites are cotinine and trans-3-hydroxycotinine. Steady
state plasma cotinine concentrations exceed nicotine by 10-fold. The half-life of
nicotine ranges from 1 to 2 hours and cotinine’s between 15 and 20 hours.
Excretion
Both nicotine and its metabolites are excreted through the kidneys and about 10% of
nicotine is excreted unchanged in the urine. As much as 30% may be excreted in the
urine with maximum flow rates and extreme urine acidification (pH≤5).
There were no differences in nicotine kinetics between men and women using
nicotine patches. Obese men using nicotine patch had significantly lower AUC and
Cmax values compared with normal weight men. Linear regression of AUC vs total
body weight showed the expected inverse relationship (AUC decreases as weight
increases). Nicotine kinetics were similar for all sites of application on the upper
body and upper outer arm.

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 of NiQuitin Clear. 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 of NiQuitin
Clear indicate that the potential risk is low and outweighed by the demonstrable
benefit of nicotine therapy in smoking cessation. However, NiQuitin Clear 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
Drug Reservoir:
Occlusive Backing:
Rate
Controlling Membrane:
Contact Adhesive and
Protective Layer:
Printing Ink:

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
36 months.

Ethylene Vinyl Acetate Copolymer
Polyethylene Terephthalate/ Ethylene vinyl
acetate
Polyethylene Film
Polyisobutylene Adhesive Laminate
White ink

6.4

Special precautions for storage
Store below 30° C.

6.5

Nature and contents of container
7 or 14 patches in a carton. Each patch is rectangular and is comprised of clear
backing and a protective liner which is removed prior to use. Each patch is contained
in a laminate sachet.

6.6

Special precautions for disposal
Not applicable.

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 02855/0253

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23/06/2000 / 04/03/2009

10

DATE OF REVISION OF THE TEXT
08/12/2015

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