Nicotinell patches relieve and/or prevent cravings 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.
Nicotinell patches are indicated in pregnant and lactating women making a quit attempt.
Nicotinell patches should preferably be used in conjunction with a behavioral support program.

Adults:
For individuals smoking 20 cigarettes or more a day, it is recommended that treatment be started
with Nicotinell TTS 30 (Step 1) once daily, applied to a dry non‐hairy area of the skin on the trunk or
upper arm. Those smoking less than this are recommended to start with Nicotinell TTS 20 (Step 2).
Sizes of 30cm2, 20cm2 and 10cm2 are available to permit gradual withdrawal of nicotine
replacement, using treatment periods of 3‐4 weeks (for each size). The size of patch may be adjusted
according to individual response, maintaining or increasing the dose if abstinence is not achieved or
if withdrawal symptoms are experienced. Total treatment periods of more than 3 months and daily
doses above 30cm2 have not been evaluated. The treatment is designed to be used continuously for
3 months but not beyond. However, if abstinence is not achieved at the end of the 3 month
treatment period, further treatments may be recommended.
The dosage must not be adjusted by cutting a patch.
The patch should be used as soon as it has been removed from the child‐resistant pouch. Following
removal of the metallic backing, the patch should be applied to an area of dry skin with no skin
lesion and little hair (shoulder blade, hip, lateral surface of the arms, etc) and held in position for 10‐
20 seconds with the palm of the hand. Each patch should be removed after 24 hours and disposed of
safely (see “Warnings”). A different site of application should be chosen each day and several days
should be allowed to elapse before a new patch is applied to the same area of skin.
Use for 24 hours optimizes the effect against morning cravings but in pregnant patients, it is
recommended that the patch is removed before going to bed (see section 4.6)
During handling, avoid contact with the eyes and nose and wash your hands after application.
Children and young adults:
The above recommendation can be used for adolescences between 12 and 18 years of age. As data
are limited in this age group, medical advice should be obtained should it be found necessary to use
the patch beyond 12 weeks.
Elderly:
Experience in the use of these patches in smokers over the age of 65 years is limited. Nicotinell TTS
does not appear to pose safety problems in this age group.
Potential for abuse and dependence:
Transdermal nicotine is likely to have a very low abuse potential (see also section 4.4 Transferred
Dependence) because of its slow onset of action, low fluctuations in blood concentrations, inability
to produce high blood concentrations of nicotine, and the infrequent (once daily) use. Moreover,
gradual weaning from the patches is instituted within the treatment schedule, and the risk of
dependence after therapy is minimal. The effects of abrupt withdrawal from Nicotinell TTS are likely
to be similar to those observed with tobacco withdrawal from comparable nicotine concentrations.

Any risks that may be associated with nicotine replacement therapy are substantially outweighed by
the well established dangers of continued smoking.
Precautions:
Users should be informed that if they continue to smoke while using the patches, they may
experience increased adverse effects due to the hazards of smoking, including cardiovascular effects.
Nicotinell TTS should be used with caution on diseased skin (see section 4.2). In the event of a severe
or persistent skin reaction, discontinue treatment and use another pharmaceutical form of nicotine
replacement therapy.
Underlying cardiovascular disease
In stable cardiovascular disease Nicotinell TTS presents a lesser hazard than continuing to smoke.
However dependent smokers currently hospitalized as a result of a recent myocardial infarction,
unstable or worsening angina pectoris including Prinzmetal's angina, severe cardiac arrhythmias,
uncontrolled hypertension, or recent cerebrovascular accident and who are considered to be
haemodynamically unstable should be encouraged to stop smoking with non‐pharmacological
interventions (such as counselling). If this fails, Nicotinell TTS may be considered but as data on
safety in this patient group are limited, initiation should only be under medical supervision.
Diabetes mellitus
Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely
than usual when nicotine replacement therapy is initiated as catecholamines released by nicotine
can affect carbohydrate metabolism.

Allergic reactions
Discontinuation of treatment may be advisable in cases of severe or persistent allergic reactions.
Angioedema and urticaria have been reported. Contact sensitisation was reported in a few patients
using transdermal nicotine in clinical trials. Patients who develop contact sensitisation to nicotine
should be cautioned that a severe reaction could occur from smoking or exposure to other nicotine
containing products.
Renal and or hepatic impairment
Should be used in caution in patients with moderate to severe hepatic impairment and/or severe
impairment as the clearance of nicotine or its metabolites may be decreased with the potential for
increased adverse effects.
Gastro‐Intestinal disease
Nicotinell TTS should be used with caution in patients with peptic ulcers.
Phaeochromocytoma and uncontrolled hyperthyroidism
Nicotinell TTS should be used with caution in patients with uncontrolled hyperthyroidism or
phaeochromocytoma as nicotine causes release of catecholamines.
Transferred dependence
Transferred dependence is rare and is both less harmful and easier to break than smoking
dependence.

Danger in small children
Nicotine is a toxic substance. Doses of nicotine that are tolerated by adult and adolescent smokers
can produce severe toxicity in small children that may be fatal (see section 4.9). Both before and
after use, the patch contains a significant amount of nicotine. Subjects must be cautioned that the
patches must not be handled casually or left where they might be inadvertently misused or
consumed by children. Used patches must be disposed of with care by folding them in half with the
adhesive sides inwards, and ensuring that they do not fall into the hands of children under any
circumstances.
Nicotinell TTS contains aluminium. The patch should therefore be removed prior to undergoing any
MRI (Magnetic Resonance Imaging), defibrillation or cardioversion procedures.
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 slower metabolism and
a consequent rise in blood levels of such drugs.

No information is available on interactions between Nicotinell TTS and other drugs. 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.

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 fetus is lower than that expected with smoking tobacco. Stopping completely is by
far the best option but Nicotinell patches 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 fetus would not normally be exposed to nicotine.
Breast Feeding
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.

There is no evidence of any risks associated with driving or operating machinery when Nicotinell TTS
is used following the recommended dose.

In principle, the Nicotinell TTS can cause adverse reactions similar to those associated with nicotine
administered by other means (including smoking) and these are mainly dose dependent. Since the
maximum plasma concentrations of nicotine that are produced by the patch are lower than those
produced by smoking and fluctuate less, nicotine‐related adverse reactions occurring during
treatment with the patch can be expected to be less marked than during smoking.
Clinical trial experience has shown that skin reactions at the application sites are the most frequent
adverse reactions. This led to the premature discontinuation of Nicotinell transdermal patch in
approximately 6% of clinical trial participants. These reactions include application site burning,
oedema, erythema, irritation, pruritus, rash, urticaria and vesicles. The majority of these reactions
were mild. Most of the skin reactions resolved within 48 hours, but in more severe cases the
erythema and infiltration lasted from 1 to 3 weeks. The time of onset of significant skin reactions
was between 3 and 8 weeks from the start of therapy. In isolated cases the skin reactions extended
beyond the application sites. Isolated cases of urticaria, angioneurotic oedema and dyspnoea were
reported.
Upper respiratory tract infection and cough reported as adverse reactions may be linked to a chronic
bronchitis induced by long term smoking in the past.

Aphthous stomatitis may develop in connection with smoking cessation, but any relation with the
nicotine treatment is unclear.
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as:
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare
(≥1/10,000 to <1/1,000); very rare (<1/10,000), or not known (can not to be estimated from
available data). Within each frequency grouping, adverse reactions are presented in order of
decreasing seriousness.

*Symptoms may be ascribed also to withdrawal symptoms in connection with smoking cessation and
may be due to insufficient replacement of nicotine

To report any side effect(s):

Kingdom of Saudi Arabia

-National Pharmacovigilance centre (NPC)

Fax: +966-11-205-7662

Reporting Hotline: 19999

E-mail: npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa

-Haleon Saudi Arabia - Head Office, Jeddah

Tel:  +966-12-601-5444

Mobile: +966-53-553-3647

Email: mystory.sa@haleon.com   

P.O. Box 48034, Jeddah 21572, Saudi Arabia

For any information about this medicinal product, please contact:

Haleon Saudi Arabia - Head Office, Jeddah

Tel:  +966-12-601-5444

Email:  mystory.sa@haleon.com

P.O. Box 48034, Jeddah 21572, Saudi Arabia

The toxicity of nicotine cannot be directly compared with that of smoking, because tobacco smoke
contains additional toxic substances (e.g. carbon monoxide, and tar).
Chronic smokers can tolerate doses of nicotine that, in a non‐smoker, would be more toxic, because
of the development of tolerance.
The acute lethal dose of nicotine in a non‐tolerant man has been estimated to be 0.5 ‐ 0.75mg per kg
body weight, corresponding in an adult to 40 to 60mg. Even small quantities of nicotine are
dangerous in children, and may result in severe symptoms of poisoning which may prove fatal. If
poisoning is suspected in a child, a doctor must be consulted immediately.
Overdose with Nicotinell TTS may occur when many pieces are applied simultaneously on the skin.
Symptoms
Symptoms of acute nicotine poisoning include nausea, vomiting, salivation, abdominal pain,
diarrhoea, sweating, headache, tachycardia, dizziness, disturbed hearing and vision and marked
weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or
irregular pulse, breathing difficulties, prostration, circulatory collapse, coma and terminal
convulsions.
Management of overdose
If the patient shows signs of overdose, the patch should be removed immediately. The skin surface
may be washed with water and dried (no soap should be used). The skin will continue to deliver
nicotine into the blood stream for several hours after removal of the system, possibly because of a
depot of nicotine in the skin. The patient should then be treated symptomatically. Artificial
respiration with oxygen should be instituted if necessary.

Pharmacotherapeutic group: drugs used in nicotine dependence, ATC code: N07BA01
S(‐)‐nicotine is the most pharmacologically active form of nicotine, the major alkaloid of tobacco. S(‐
)‐nicotine acts primarily on cholinergic receptors of the nicotinic type in the peripheral and central
nervous system. For many effects, low doses of S(‐)‐nicotine have a stimulant action, and high doses
a depressant effect. Intermittent administration of S(‐)‐nicotine affects neurohormonal pathways,
and results in the release of acetylcholine, noradrenaline, dopamine, serotinin, vasopressin, betaendorphin,
growth hormone, cortisol and ACTH. These neuroregulators may be involved in the
reported behavioural and subjective effects of smoking.
Quitting smoking abruptly after prolonged, daily consumption induces a withdrawal syndrome
consisting of at least four of the following symptoms: dysphoria or depressive mood, insomnia,
irritability, feelings of frustration or anger, anxiety, difficulty concentrating, agitation or impatience,
slowed cardiac rhythm, increased appetite and weight gain. The craving for nicotine is considered as
a recognized clinical symptom of the withdrawal syndrome.
Nicotine replacement therapy is an established therapy as an aid to smoking cessation. Nicotinell
TTS provides for a convenient once daily administration by exploiting the fact that S(‐)‐nicotine is
readily absorbed through the skin into the systemic circulation. Placebo‐controlled, double‐blind
studies have shown that nicotine replacement therapy with the patch produces smoking abstinence
rates statistically significantly better than placebo, with or without group support. There was also a
strong trend towards reduction of withdrawal symptoms.
Application of Nicotinell TTS to smokers abstinent overnight resulted in small increases in mean
heart rate and systolic blood pressure and a decrease in stroke volume. The effects were smaller in
magnitude than those produced by cigarette smoking.

Absorption
Nicotine is directly absorbed through the skin and enters the systemic circulation.
Following a single application of the Nicotinell TTS to the skin of healthy abstinent smokers, there is
an initial 1‐2 hours delay followed by a progressive rise in nicotine plasma concentrations, with a
plateau attained at about 8‐10 hours after application.
Following withdrawal of the patch, plasma nicotine levels fall more slowly than would be expected
given the plasma elimination half‐life of nicotine (after intravenous administration: 2 hours).
The probable existence of a cutaneous deposit explains why about 10 % of the nicotine reaching the
blood derives from the skin after patch withdrawal. The absolute bioavailability of the patch,
compared to intravenous nicotine perfusion, is about 77 %.
In the majority of subjects, the area under the plasma concentration curve (0‐24 hours) increases in
proportion to the dose of nicotine delivered by the patch.The patch is designed to deliver
approximately 0.7mg/cm2/24 hours.
Steady state plasma concentrations after repeated daily administration are within the range
observed during moderate cigarette smoking.

Absorption of nicotine over 24 hours varies by a factor of two between different individuals;
however within‐individual variability is small indicating consistent performance of the transdermal
system.
Distribution
S(‐)‐nicotine is distributed widely in the body with a volume of distribution of approximately 180
litres. Nicotine crosses the blood‐brain barrier, placenta, and is detectable in breast milk. The plasma
protein binding of nicotine is negligible (< 5%).
Elimination
Total plasma clearance of nicotine ranges from 0.92 to 2.43 litres/min. It is eliminated mainly via
hepatic metabolism and the main metabolites are cotinine and nicotine 1'‐N‐oxide. The renal
elimination of unchanged nicotine is pH‐dependent and minimal in the event of an alkaline urinary
pH.
Nicotine is excreted in breast milk.

No additional data

Pad
Polyester film
Acrylate esters vinylacetate co‐polymers
Fractionated coconut oil
Methacrylic acid esters co‐polymers
Aluminised polyester backing film
Aluminised and siliconised polyester film release liner

None known.

Do not store above 30°C
Protect from heat and light.

Heat‐seal paper/aluminium/polyamide/polyacrylnitrile pouches (child‐resistant) enclosed in a
cardboard carton.
or
Heat‐sealed paper/ aluminium polyacrylnitrile pouches. Each pouch is enclosed within a childresistant
sachet. Sachets are packed in a cardboard container.
Nicotinell TTS 10, 20 & 30 are available in pack sizes of: 7

Keep all medicines out of the reach of children.