NIQUITIN CLEAR 14 MG PATCH

Active substance: NICOTINE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
NiQuitin Clear 14 mg Patch

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
NiQuitin Clear is a transdermal delivery system for topical application available in systems of
15 cm2 containing 78 mg nicotine, equivalent to 5.1 mg/cm2 of nicotine and delivering 14 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 nonpharmacological 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.
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.
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.

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

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
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:

Polyethylene Terephthalate/ Ethylene vinyl acetate

Rate Controlling Membrane:

Polyethylene Film

Contact Adhesive and
Protective Layer:

Polyisobutylene Adhesive Laminate

Printing Ink:

6.2

Ethylene Vinyl Acetate Copolymer

White ink

Incompatibilities
Not applicable.

6.3

Shelf life
24 months

6.4

Special precautions for storage
None stated.

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
Beecham Group PLC
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
T/A GlaxoSmithKline Consumer Healthcare
Brentford
TW8 9GS

8

MARKETING AUTHORISATION NUMBER(S)
PL 00079/0355

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23rd June 2000

10

DATE OF REVISION OF THE TEXT

28/03/2013

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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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