To facilitate the cessation of smoking in nicotine-dependent smokers. To reduce addictive
behaviour and cigarette consumption by reducing withdrawal symptoms.

Children and adolescents
Nicotinell Mint is intended for adults over 18 years.
For young people under 18 and over 12 years, the product should only be used in cases of
strong nicotine addiction and after consulting a doctor, pharmacist or druggist (see also
"Contraindications").
The product is contraindicated in children under 12 years. There is only limited experience in
this age group.
Adults
The initial dosage should be individualised on the basis of the patient's nicotine dependence. 8–
12 Nicotinell lozenges are usually sufficient to reach the appropriate dosage strength per day.
In highly nicotine-dependent smokers meaning those who smoke their first cigarette within 20
minutes after getting up and more than 20 cigarettes per day, treatment should be started with
Nicotinell Mint 2 mg lozenges. In people who are less dependent, treatment may start with
Nicotinell Mint 1 mg lozenges. No more than 15 lozenges should be consumed per day.
When there is a desire to smoke, one Nicotinell Mint 1 mg or 2 mg lozenge should be sucked
slowly for 30 minutes for optimal effect. Repeated pauses allow time for the released nicotine to
act on the oral mucosa. Patients should avoid drinking immediately before and while sucking on
the lozenges as this greatly reduces the effect of the released nicotine.

Dose reduction
Most smokers need 8-12 lozenges of the proper dosage per day. Up to 15 Nicotinell lozenges
may be sucked if necessary. This dosage may be taken for up to eight weeks. Over the
subsequent two weeks, the aim is to reduce the number of lozenges by half, so that, after a
further two weeks, the number is reduced to zero on the last day of treatment.
The treatment duration is specific to each case, but should last no more than 3 months.
Nicotinell Mint lozenges are intended as a support for a limited-term cessation therapy whose
success largely depends on the motivation and willpower of the smoker. Professional
counselling improves the chances of quitting.
Reduction of cigarette consumption
The number of required lozenges is usually lower than for cessation, with the same maximum
allowable dosage.
The treatment should last no more than 12 months.
The lozenges should only be used between periods of smoking in order to prolong smoke-free
intervals and thus reduce cigarette consumption as much as possible. If a reduction in the
number of cigarettes smoked per day has not been achieved after 6 weeks, medical advice
should be sought.
An attempt should be made to quit completely as soon as the smoker feels ready, but no more
than six months after the start of treatment. If it is still not possible to stop smoking nine months
after the start of treatment, medical advice should be sought.
Unused lozenges should be kept as the desire to smoke can return suddenly.
At the beginning of treatment, hiccups or nausea or irritation of the mouth or throat can occur if
the lozenges are sucked too rapidly. There is the risk of damage to the oral mucosa with longterm
use.

Dependent smokers with a recent (< 4 weeks) myocardial infarction, unstable or worsening
angina including Prinzmetal's angina, severe cardiac arrhythmias, uncontrolled hypertension or
recent cerebrovascular accident should be encouraged to stop smoking with nonpharmacological
support (such as counselling). If this fails, Nicotinell lozenges may be
considered but as data on safety in this patient group are limited, initiation should only be under
close medical supervision.
Patients with stable cardiovascular diseases (such as stable angina pectoris, a longer history of
myocardial infarction, coronary bypass or angioplasty, cerebrovascular insufficiency, cardiac
insufficiency, hypertension, occlusive arterial disease) should only use Nicotinell after consulting
a doctor.
The benefit-risk balance of therapy with Nicotinell lozenges should be carefully weighed in
patients with severe to moderate hepatic insufficiency or severe renal insufficiency.

Caution is advised in patients with peptic ulcer and chronic diseases of the throat.
Nicotine can stimulate the production of adrenaline and should therefore be used with caution in
patients with uncontrolled hyperthyroidism and pheochromocytoma.
Since smoking can lead to insulin resistance, probably due to the effects of nicotine, patients
with diabetes may require lower insulin doses when quitting smoking.
It is important for the patient to be supported with other activities during the treatment, to make
both reduced cigarette consumption and the cessation of smoking easier.
At the beginning of treatment to stop smoking, the patient should be encouraged to stop
smoking completely. If the patient smokes unabated during treatment to stop smoking with
Nicotinell Mint lozenges, there is a risk of side effects due to exposure to higher nicotine levels
than during ordinary smoking.
Nicotinell lozenges contain the sweetener aspartame instead of sugar. Therefore, Nicotinell
lozenges may also be used by diabetics provided that the precautionary measures are taken.

Stopping smoking, with or without partial nicotine replacement, can alter the response to
medicinal products used concomitantly.
Smoking (but not nicotine) is associated with increased CYP1A2 activity. After stopping smoking
there may be reduced clearance of substrates for this enzyme, which can lead to increased
plasma levels of some medicinal products with a narrow therapeutic window, e.g. theophylline,
tacrine, clozapine and ropirinol. The plasma levels of caffeine may also be increased.
The plasma concentrations of other medicinal products metabolised partially by CYP1A2 e.g.
imipramine, olanzapine, clomipramine and fluvoxamine may also increase when stopping
smoking. However, there is no background data and the clinical significance of this effect for
these substances is unknown.
There is little data indicating that the metabolism of flecainide and pentazocine may be induced
by smoking.

Pregnancy
Nicotine can cause a decreased birth weight, increased risk of abortion and increased perinatal
mortality. Nicotine passes to the foetus and affects the breathing movements and circulation.
The effect on the circulation is dose dependent.
Smoking can seriously endanger the health of the foetus or infant and should be interrupted
during pregnancy. Pregnant women who smoke should only use Nicotinell after consulting their
doctor, pharmacist or druggist.
The specific effect of Nicotinell on foetal development is not known. The doctor, pharmacist or
druggist may consider use of this product during pregnancy when the likelihood of a successful
cessation therapy justifies the risk of nicotine exposure, and the patient would smoke otherwise.
Breastfeeding
The use of Nicotinell lozenges during breastfeeding has not been studied. Nicotine is excreted
in breast milk in small quantities that may affect the child even in therapeutic doses. Should

nicotine replacement be required during breastfeeding, the infant must be switched to bottle
feeding.

Because Nicotinell lozenges may cause undesirable effects such as dizziness, headache and
nausea, they may affect the responsiveness, the ability to operate tools or machines and the
ability to drive.

Nicotinell lozenges can in principle cause adverse reactions similar to those of other forms of
administration of nicotine.
Most of the adverse reactions generally occur during the first 3-4 weeks after initiation of
therapy. Causes are either incorrect sucking technique or the local or systemic pharmacological
effects of nicotine, which are dose-dependent. These adverse effects can be reduced by
observing a pause for about 1 minute before continuing sucking and placing the lozenge in the
cheek. Sometimes it takes a few days before the smoker has learned to suck the lozenges
properly.
Some symptoms, such as dizziness, headache and insomnia, may be caused by the withdrawal
symptoms occurring in the context of smoking cessation. Increased aphthous ulcers may
sometimes occur after stopping smoking. The causality is unclear. Continued nicotine
dependency may occur.
Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare
(>1/10,000, <1/1,000); very rare (<1/10,000), including isolated cases.
Central nervous system
Very common (12%): headache.
Common: dizziness.
Heart
Uncommon: palpitations, tachycardia.
Very rare: reversible atrial fibrillation.
Gastrointestinal tract
Very common (28%): gastrointestinal complaints, hiccups, nausea.
Common: vomiting.
Skin and subcutaneous tissue
Uncommon: erythema, urticaria.
General disorders and administration site conditions
Very common (12%): oral or throat inflammation, pain in the masticatory muscles.
Uncommon: paraesthesia.
Rare: allergic reactions (e.g. angioedema).

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

Overdose can occur if several lozenges are sucked simultaneously or in rapid succession, if the
patient has very low nicotine tolerance before treatment or if other forms of nicotine are used at
the same time (e.g. with continued cigarette smoking). The consequences of an overdose
are often minimised by the early appearance of nausea and vomiting, which are known to be
associated with excessive nicotine intake.
In case of overdose, symptoms are similar to those of acute nicotine poisoning. The following
occur: nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, hearing
disorders and marked weakness. In extreme cases, hypotension, weakness, irregular pulse,
dyspnoea, impotence, circulatory collapse and terminal convulsions can follow.
Doses of nicotine that are tolerated by adult smokers can cause severe symptoms of nicotine
poisoning in young children, which can prove fatal.
The minimum lethal dose of nicotine in humans is 40-60 mg.
In severe intoxication, the following measures are recommended: Immediate interruption of any
nicotine intake and selective treatment of the symptoms observed (maintaining a normal body
temperature, artificial respiration in the event of respiratory insufficiency and standard treatment
for hypotension or cardiovascular collapse if necessary). Activated charcoal reduces the
gastrointestinal absorption of nicotine.

ATC code: N07BA01
Mechanism of action
Reduction of withdrawal symptoms in nicotine-dependent smokers.
Pharmacodynamics
Nicotine, the dependence-producing substance in tobacco, is a biologically highly active alkaloid
with sympathomimetic and cholinergic properties. The clinical manifestations of these effects

include an increased heart rate and increased blood pressure, central stimulation and increased
gastrointestinal motility.
Clinical efficacy
Nicotinell lozenges can be used as replacement therapy for smoking cessation and reduction of
cigarette consumption. They reduce withdrawal symptoms that occur in nicotine-dependent
smokers after stopping tobacco-nicotine, and thereby improves the chances of lasting
abstinence. In the first few weeks or months after stopping smoking, "pharmacological" nicotine
replacement reduces withdrawal symptoms and roughly doubles the chances of successfully
becoming a non-smoker.
Harmful effects caused by the tar and carbon monoxide content in tobacco smoke are avoided.
Nicotinell lozenges are an alternative dosage form to the other forms of Nicotinell.

Absorption
When using Nicotinell Mint 1 mg or 2 mg lozenges, nicotine is evenly released into the mouth
and rapidly absorbed by the oral mucosa. A portion passes through the swallowed nicotinecontaining
saliva into the stomach and the intestines, where nicotine is largely inactivated (firstpass
effect, inactive metabolites).
The maximum plasma concentration after a single dose of Nicotinell Mint 1 mg lozenge was
about 3 ng/ml; that after repeated use (steady state) of Nicotinell Mint 1 mg lozenges was on
average 10.4 ng/ml.
The maximum plasma concentration after a single dose of Nicotinell Mint 2 mg lozenge was
about 4.8 ng/ml; that after repeated use (steady state) of Nicotinell Mint 2 mg lozenges was on
average 22.5 ng/ml.
The predominant route of absorption of nicotine from the lozenge passes directly via the oral
mucosa. The systemic availability of swallowed nicotine is lower due to first-pass elimination.
Therefore, the high and rapidly rising nicotine concentrations observed while smoking are rarely
achieved with tobacco replacement treatment. The therapeutic blood concentrations of nicotine,
i.e. the levels, which alleviate withdrawal symptoms are based on the patient's individual
nicotine dependence.
Distribution
The volume of distribution after intravenous administration of nicotine is approximately 2-3 l/kg.
The plasma protein binding of nicotine is less than 5%. Therefore, changes in nicotine binding
from the use of concomitant medicinal products or due to plasma protein alterations caused by
disease are not expected to have significant effect on nicotine kinetics.
Nicotine crosses the blood, brain and placental barrier and is excreted in breast milk.
Metabolism and elimination
The half-life time is approximately 2 hours. Nicotine is metabolised principally in the liver and the
plasma clearance is 1.2 l/min. Nicotine is also metabolised in the lungs and kidneys. More than
20 metabolites of nicotine have been identified, all believed to be less active than the initial
substance. The main metabolite in plasma is cotinine which has a half-life of 15-20 hours and
reaches approximately ten times higher plasma concentrations than nicotine.

Normally about 10% of nicotine is excreted unchanged via the kidneys. However, at high urine
flow rates and acidification of the urine to a pH below 5, up to 30% can be excreted. Only a
small part of cotinine (15% of the dose) is excreted unchanged via the kidneys. Cotinine is
further metabolised to polar water-soluble substances, and can be found especially in
hydroxylated form in the urine (45% of the dose).
There are no differences in the pharmacokinetics between men and women.
Kinetics in special patient groups
In severe renal impairment, the clearance of nicotine and its metabolites is expected to be
reduced.
Nicotine clearance is unaffected in patients with cirrhosis and mild hepatic impairment (Child
score 5), while it is reduced in moderate hepatic impairment (Child score 7). In smoking patients
with renal insufficiency, increased nicotine levels have been observed.
In elderly patients, slightly reduced total clearance of nicotine has been found, though this does
not justify a dose adjustment.

There are no preclinical data on the safety of Nicotinell lozenges. The toxicity of nicotine as a
component of tobacco is however well documented. Typical symptoms of acute poisoning are a
weak and irregular pulse, respiratory distress and generalised convulsions.
Reproductive toxicity studies with nicotine in various animal species showed non-specific growth
retardation of the foetus. In rats, there was evidence of fertility-impairing effects, prolongation of
gestation and behavioural disorders in the offspring. In mice skeletal defects were observed in
the extremities of the offspring at very high doses. Nicotine crosses the placenta and passes
into breast milk.
There is no clear indication of genotoxic or mutagenic properties of nicotine. The demonstrated
carcinogenicity of tobacco smoke is mainly due to substances produced during the burning of
tobacco. None of these substances are found in Nicotinell lozenges.

Excipients: aromatics, aspartame, other excipients per lozenge.

Not applicable.

Do not use after the date indicated on the package with "EXP".
Don’t store above 25°C

pack of 96 lozenges in a blister.

If you want to throw away a Nicotinell Mint 1 mg lozenge, you must eliminate it in a way that
ensures it will not be accessible to children.
Keep this medicine out of the sight and reach of children. Nicotine is a highly active substance.
Even the tolerated dose in adults can result in life-threatening toxic symptoms and death in
children.