Nicotinell Patch is a nicotine replacement therapy (NRT)
which reduces:
• some of the unpleasant withdrawal effects that frequently
occur when giving up smoking such as feeling
ill or irritable.
• your desire to smoke by providing some of the nicotine
previously inhaled from cigarettes and therefore helps
your willpower to resist cigarettes.
If you need advice before starting to use nicotine
patches, talk to your doctor, nurse, pharmacist or a
trained counsellor. A support program will increase your
chances of quitting smoking.
Nicotinell Patches are for application to the skin. When
applied to the skin, nicotine passes from the patch,
through the skin and into your body.
Users should stop smoking completely during treatment
with Nicotinell
There are 3 steps:
1. Nicotinell TTS 30 (Step 1) patches contain 52.5mg of
nicotine and deliver on average 21mg of nicotine over
24 hours in a patch size of 30 cm².
2.Nicotinell TTS 20 (Step 2) patches contain 35mg of
nicotine and deliver on average 14mg of nicotine over
24 hours in a patch size of 20 cm².
3.Nicotinell TTS 10 (Step 3) patches contain 17.5mg of
nicotine and deliver on average 7mg of nicotine over
24 hoursin a patch size of 10 cm².

DO NOT use the patches if you:
• are allergic to nicotine or to any of the other ingredients
in the patches (see Section 6)
• are a non-smoker or occasional smoker
• have a skin disease that might be aggravated by the
patches
• Nicotinell should not be used by smokers under
12 years of age, except on the advice of the doctor.
Take special care with Nicotinell Patches Before
using the patches, tell your doctor, nurse or pharmacist
if you:
• If you are pregnant or breast-feeding
have heart disease (including heart attack, worsening
chest pain, disorders of heart rate and/ or rhythm),
uncontrolled high blood pressure or stroke for which
you are in hospital. Patient should be encouraged to
stop smoking with non-pharmacological interventions
(such as counseling). If this fails, Nicotinell may be
considered and should only be under close medical
supervision. have serious liver or kidney problems
• have ever had a stomach ulcer
• are diabetic (see “Taking other medicines”)
• have an overactive thyroid gland
• have a tumor of the adrenal gland
(phaeochromocytoma)
• are taking any other medicines (see next section)
In the event of a severe or persistent skin reaction, discontinue
treatment and use another pharmaceutical form.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription.
The effect of some medicines can be altered when you
stop smoking.
• If you are already taking regular medication you
should tell your doctor, nurse or pharmacist.
• Diabetics should monitor their blood sugar levels more
often than usual when starting to use a patch because
insulin/medication requirements may alter.
Pregnancy
Smoking during pregnancy is associated with risks such
as poor growth of the baby before birth, premature birth
or still birth. Stopping smoking is the single most effective
way to improve both your health and that of your
baby. The earlier smoking stops, the better.
Ideally, stopping smoking during pregnancy should be
done without nicotine replacement therapy.
However, if you have tried and this is not possible,
nicotine replacement therapy may be used because the
risk to the developing baby is less than that expected
from continued smoking.
The decision to use nicotine replacement therapy should
be made as early in the pregnancy as possible with the
aim of discontinuing use after 2–3 months. Patches may
be preferred if you have nausea or sickness.

They should be removed before going to bed at night.
Ask your doctor for advice before taking any medicine.
Breast-feeding
It is better to use nicotine replacement therapy products
that can be taken intermittently (use of oral forms should
be preferred compared with patches). Try to breast-feed
at a time just before you take the product to ensure that
the baby gets the smallest amount of nicotine possible.
If you need to use nicotine replacement therapy to help
you give up smoking, the amount of nicotine that the
baby may receive is considerably smaller and less harmful
than the secondhand smoke they would otherwise be
breathing in.
Driving and using machines
These patches are unlikely to affect your ability to drive
or operate machinery When used following the recommended
dose.
Nicotinell Patches contain Aluminum
Remove the patch before a medical scan or cardiac
procedure to regulate your heart rate as aluminum is
present in one of the layers of the patch.

Always use the patches exactly as your doctor, nurse or
pharmacist has told you and always read the leaflet. Ask
your doctor, nurse or pharmacist if you are not sure.
The Nicotinell patch program involves up to 3 steps.
There are three patch sizes consisting of three different
strengths: 7, 14 and 21 mg/24 hours.
The correct dose for you depends on the number
of cigarettes you smoke per day. The size of your
patch may need to change during your treatment. This
is because your dependence on nicotine will change,
and therefore the dose of nicotine in your patch may be
too low or too high for you. Do NOT cut the patches to
reduce the dose.
• If you smoke 20 or more cigarettes a day,
start with:
Step 1. Nicotinell TTS 30 (21mg/24 hours) patches for
3–4 weeks, followed by,
Step 2. Nicotinell TTS 20 (14mg/24 hours) for
3–4 weeks, followed by,
Step 3. Nicotinell TTS 10 (7mg/24 hours) for
3–4 weeks.
*decision for shifting to a lower patch strength is
depending on how well withdrawal symptoms are being
controlled.
• If you smoke less than 20 cigarettes a day,
start with:
Step 2. Nicotinell TTS 20 (14mg/24 hours) for
3–4 weeks, followed by,
Step 3. Nicotinell TTS 10 (7mg/24 hours) for
3–4 weeks... if necessary, use Step 3 again.
Step 3*. Nicotinell TTS 10 may be used for up to a
further 3–4 weeks.
* Treatment discontinuation can be performed at step
3 in the event of satisfactory results
Do not start the program at Step 3.
The strength of the transdermal patch is to be adapted
to individual response: increase strength if abstinence
from smoking is not complete or if withdrawal symptoms
are observed, decrease in the event of suspected
overdose.

The treatment duration is about 3 months but may vary
as a function of individual response.
This medicinal product should not be used for more than
6 months unless otherwise directed by a physician.
If you have any questions about this ask a doctor, nurse
or pharmacist.
Apply one patch every day. It is important to keep the
patch on day and night especially if you need help to
overcome the early morning craving for a cigarette. If
you are pregnant, the patches should be removed before
going to bed.
The Nicotinell TTS patch program therapy can provide
sufficient nicotine when used as single therapy. However,
smokers who smoke 10 or more cigarettes per
day, or people who experience breakthrough cravings,
or those who have failed to stop smoking using single
therapy may benefit from using additional nicotine
replacement products. Nicotinell 2mg or 4mg medicated
gum can be used to relieve your breakthrough cravings
to smoke.
When using Nicotinell gums together with Nicotinell
patches, do NOT use more than 15 x 2mg gums or
10 x 4mg gums per day. You should try to use as few
pieces of gum as possible each day.
You might feel a sudden craving to smoke long after you
have given up smoking and stopped using the Nicotinell
TTS patch program. Remember! you can use nicotine
replacement therapy again if you feel a sudden craving
to smoke again.

Applying your patches
1. Allow yourself time to put the patch on.
2.Decide where you will put the patch. It is important
to choose a hairless area of skin to make sure that
it sticks properly e.g. the front or side of the chest,
the back or the upper arm. Avoid skin which is red or
irritated.
3. If the patch does not stick successfully you may try it
on any other body site (such as the outer thighs or top
of the buttocks) or clean the area with surgical spirit
and let it dry naturally before re-applying the patch.
Avoid areas where the skin creases (such as over a
joint) or folds when you move.
4.Make sure that the skin is completely clean and dry.
After a hot bath or shower you may continue to sweat
even after toweling. Wait until the skin is completely
dry before sticking the patch on. Never powder or oil
your skin before putting on a patch as it may not stick
properly.
During use
Provided that you have applied the patch correctly, you
can bathe, shower or swim with little risk of the patch
coming off.
If the patch does fall off, throw it away carefully and
apply a new patch to a different area of skin.
During handling avoid contact with the eyes and nose
and wash your hands after application.
Keep out of reach of children.

Changing your patch
1. Apply a new patch at roughly the same time each day
(preferably in the morning).
2. Leave it in place for 24 hours, unless you are pregnant.
If you are pregnant you should remove the patch before
going to bed.

3.When you take off the old patch, fold it in half with the
sticky side inwards and throw it away carefully.
Even used patches will contain some active medication
which could be harmful to children, so make very sure that
your patches are always kept well away from children.
4. Always place your new patch on a different area of
skin.

• Cut open the sachet
along the dotted line (a)
taking care not to damage
the patch inside.
• Take out the yellowish
patch. Carefully remove
the small section of the
silver-coloured backing
(b).

• Remove the larger
section of silver-colored
backing (c). Throw
away the silver-colored
backing. Avoid touching
the sticky surface of the
patch with your fingers,
as far as possible.

• Place the sticky side of
the patch on the chosen
site (d)

• Press firmly with the palm of your hand for at least
20 seconds (e). It may help to time this with a watch.
This is important because the adhesive is pressure
sensitive and will not be effective unless pressure is
applied for the required time.
• Run your finger around the edge of the patch to make
sure that the edge is firmly stuck down (f). Do not fiddle
with the patch during the day.
• If you find the patches are not sticking well, it may
help to clean the area where you want to apply the
patch with a little surgical spirit. Allow this to dry naturally
before applying the patch.

Duration of use
• The Nicotinell Patch program usually lasts for
3 months. However, if you have not stopped smoking
at the end of the 3 month treatment period, further
treatments can be used. This medicinal product
should not be used for more than 6 months unless
otherwise directed by a physician.
Children
Adolescents aged 12–18 years of age should only use
Nicotinell Patch for 12 weeks. If longer is required,
advice should be sought from a doctor, nurse or
pharmacist.
If you use more Nicotinell Patches than you should
Never use more than one patch at a time. An overdose
of nicotine can be dangerous.
General symptoms of nicotine poisoning may include:
weakness, perspiration, salivation, nausea, vomiting,
diarrhea, abdominal pain, hearing and visual disturbances,
headache, tachycardia and cardiac arrhythmia,
dyspnea, prostration, circulatory collapse, coma and
terminal convulsions.
If a child under 12 has used, chewed or swallowed
this medicine, contact a doctor or your nearest hospital
Accident and Emergency department immediately.
Take this leaflet and the pack with you.
Nicotine inhalation or ingestion by a child may result in
severe poisoning.

In the event of an accidental overdose, remove the
patch and wash the skin with water but do NOT use
soap. The skin will continue to deliver nicotine into
the blood stream for several hours after the patch is
removed. Then contact your doctor, pharmacist or nearest
hospital casualty department immediately.
If you forget to use Nicotinell Patches
If you forget to change your patch at the usual time,
change it as soon as you remember. Then go on as
before. Do not use 2 patches to make up for a missed
dose.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

Like all medicines, Nicotinell Patches can cause
side effects, although not everybody gets them.
STOP using the patches and seek medical help
immediately if you have any of the following allergic
reactions:
• difficulty breathing or swallowing, swelling of the
face, lips, tongue or throat.
• severe itching of the skin, with a red rash or
raised lumps.
Some side effects are very common (may affect
more than 1 in 10 people)
• application site reactions such as itching, redness,
oedema (becoming swollen) and burning
sensation where the patch is placed
In the event of a severe skin reaction which will not
go away, you should stop treatment and consult
your doctor or pharmacist to find another form of
nicotine replacement therapy.
These effects are usually caused by not changing
the site of application each day. Changing the site
each day will allow any irritation to disappear naturally
and cause you very little discomfort.
Some side effects are common (may affect between
1 and 10 in every 100 people)
• agitation, anxiety, nervousness, difficulty
sleeping, abnormal dreams
• headache, dizziness or disorder in muscle
condition
• cough
• nausea, abdominal pain or indigestion
• muscle discomfort or arthritis

These effects are often mild and will wear off naturally
and rapidly once you have removed the patch
Some side effects are uncommon (may affect
between 1 and 10 in every 1000 people)
• disturbance in attention, sleepiness, mood changes,
irritability, depressed mood or confusional state

• tingling or numbness, changes in taste or blurred
vision
• palpitations (feeling of heartbeats)
• high blood pressure or hot flushes
• chest infections
• vomiting, constipation, diarrhea, flatulence or dry
mouth
• excessive sweating
• joint pain, muscle cramp or back pain
• feeling of weakness, pain or discomfort
Some side effects are rare (may affect between
1 and 10 in every 10,000 people)
• tremor
• chest pain, shortness of breath or irregular heart
beat
• skin discoloration or inflammation of blood vessels
often with skin rash
Mouth ulcers may be related to stopping smoking
and not to your treatment.
These patches are NOT suitable for non-smokers or
occasional smokers. They may develop signs of nicotine
overdose including headache, sickness, stomach pains,
sweating, increased heart rate, dizziness, disturbed
hearing or vision, weakness and diarrhea. If this happens,
remove the patch at once and contact your doctor
or nearest hospital casualty department immediately.

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

• Keep out of the reach and sight of children.
• Do not use Nicotinell Patches after the expiry date
which is stated on the sachet and on the carton.
• Do not store above 30°C.
• Protect from Heat and Light.
• Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to dispose
of medicines no longer required.
• These measures will help to protect the environment.