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NIQUITIN 7MG TRANSDERMAL PATCHES

Active substance(s): NICOTINE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
NiQuitin 7 mg transdermal patches

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 7 cm2 transdermal patch contains 36 mg nicotine, equivalent to 5.1 mg/cm2 of
nicotine and delivering 7 mg over 24 hours.
For excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Transdermal patch.
Each patch is rectangular and is comprised of an outer matt pinkish tan-coloured
layer, a middle silver layer and an outer clear layer which is removed prior to use.

4

CLINICAL PARTICULARS

4.1

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

4.2

Posology and method of administration
NiQuitin 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 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
patches.
NiQuitin therapy should usually begin with NiQuitin 21 mg and be reduced according
to the following dosing schedule:Dose

Duration

Step 1 NiQuitin 21 mg

First 6 weeks

Step 2 NiQuitin 14 mg

Next 2 weeks

Step 3 NiQuitin 7 mg

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
7 mg for the final 2 weeks.
Patients on NiQuitin 21 mg who experience excessive side-effects (please refer to
precautions), which do not resolve within a few days, should change to
NiQuitin 14mg. This strength should then be continued for the remainder of the
6 week course before stepping down to NiQuitin 7mg 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 patch may be continued beyond 10 weeks if needed to stay cigarette
free, however, those who have quit smoking but are having difficulty discontinuing
using the patches recommended to seek additional help and advice from a healthcare
professional.
Further courses may be used at a later time, for NiQuitin 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 is
not recommended for use in children under 12 years of age.

4.3

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

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 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 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 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 patches have not been found to cause any
serious adverse effects. Excessive use of NiQuitin 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.
Application site reactions are the most frequent adverse reaction associated with
NiQuitin. NiQuitin can cause other adverse reactions related to the pharmacological
effect of nicotine or withdrawal effects related to smoking.
The following undesirable effects have been reported in clinical trials or
spontaneously post-marketing.
Certain symptoms which have been reported such as depression, irritability,
nervousness, restlessness, mood lability, anxiety, drowsiness, impaired concentration,
insomnia and sleep disturbances may be related to withdrawal symptoms associated
with smoking cessation. Subjects quitting smoking by any means could expect to
suffer from asthenia, headache, dizziness, coughing or influenza-like illness.
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, diarrhea 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 generalized 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: N07B A01
(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, NiQuitin was shown to alleviate nicotine withdrawal
symptoms as well as craving. NiQuitin reduced the severity of cravings 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 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 (worn for 24 hours), dose-dependent
steady state plasma nicotine concentrations are achieved following the second
NiQuitin application and are maintained throughout the day. These steady state
maximum concentrations are approximately 30% higher than those following a single
application of NiQuitin.
Plasma concentrations of nicotine are proportional to dose for the three dosage forms
of NiQuitin. 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.

Distribution
Following removal of NiQuitin, 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 is removed most
non-smoking patients will have non-detectable nicotine concentrations in 10 to 12
hours.
A dose of radiolabelled 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
NiQuitin. Obese men using NiQuitin 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. 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
indicate that the potential risk is low and outweighed by the demonstrable benefit of
nicotine therapy in smoking cessation. However, NiQuitin 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:

Ethylene Vinyl Acetate Copolymer

Occlusive Backing:

Polyethylene/Aluminium/Polyethylene
Terephthalate/ Ethylene vinyl acetate
Polyethylene Film
Polyisobutylene Adhesive Laminate

Rate Controlling Membrane:
Contact Adhesive and
Protective Layer:
Printing Ink:

FGN-7214 NT20 Brown 465 (Ink)

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
3 years

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 contained in a laminate sachet.

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 02855/0254

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/04/2009

10

DATE OF REVISION OF THE TEXT
07/12/2015

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