NIQUITINMINT 2 mg Lozenge

Зміст інструкції

1. Niquitinmint 2 mg lozenges
   1. What is Niquitinmint and what is it used for
   2. What you need to know before using Niquitinmint
   3. How to use Niquitinmint
   4. Possible side effects
   5. How to store Niquitinmint
   6. Contents of the pack and other information

Niquitinmint 2 mg lozenges

nicotine

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your healthcare professional, such as a doctor, a smoking cessation support centre or a pharmacist.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Niquitinmint is and what it is used for
• 2. What you need to know before using Niquitinmint
• 3. How to use Niquitinmint
• 4. Possible side effects
• 5. How to store Niquitinmint
• 6. Contents of the pack and other information

1. What is Niquitinmint and what is it used for

Niquitinmint is used to help people stop smoking. This type of treatment is defined as
Nicotine Replacement Therapy or NRT.
Niquitinmint 2 mg is indicated for smokers of 20 cigarettes or less per day.
Niquitinmint can help you stop smoking abruptly or gradually. If you think you can stop
smoking abruptly, you should act accordingly as this is the best approach. However, if you think
this is too big a step, you should reduce the number of cigarettes as a first step and then
stop smoking completely. See section 3 “ How to use Niquitinmint” for more details.
It is the nicotine in cigarettes that can make you physically dependent on them.

• Niquitinmint helps you stop smoking by replacing some of the nicotine you normally absorb from cigarettes.
• Nicotine relieves some of the unpleasant symptoms that smokers may experience when trying to quit, including feeling unwell or irritability.
• Nicotine can also relieve cravings and help you resist the urge to smoke.

Niquitinmintdoes not carry the health risks associated with tobacco, as it does not contain tar, carbon monoxide
or other toxins present in cigarette smoke. Some people fear, after quitting smoking,
that they may instead become addicted to nicotine tablets. This is very rare, and if it
occurs, it would still be less harmful than continuing to smoke. It is also a habit that is easier to
break.
If you participate in a support program, you will increase your chances of quitting smoking. These
“smoking cessation programs” are known as behavioral support. For information on
smoking cessation programs, consult your doctor or pharmacist.
Smoking has no health benefits. It is always better to quit smoking. The use of Nicotine Replacement
Therapy (NRT), for example with Niquitinmint, can help you. In general, any possible side effect
associated with NRT is far less than the well-known risks associated with smoking.

2. What you need to know before using Niquitinmint

Do not use Niquitinmint:

• if you are allergic (hypersensitive) to nicotine or any of the other ingredients of this medicine (listed in section 6).
• if you are a non-smoker
• if you are under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using NiquitinmintIf you have recently had a
heart attack or stroke, or if you suffer from serious heart rhythm problems, unstable or worsening angina (chest
pain) or angina at rest ,you should try to quit smoking without the aid of NRT unless this is
recommended by your doctor.

• If you suffer from diabetes when you start using Niquitinmint, you should check your blood sugar levels more frequently than usual. It may be necessary to adjust the amount of insulin or medications.
• If you have a history of epilepsy (convulsions).
• If you have had allergic reactions with swelling of the lips, face and throat (angioedema) or itchy skin rash (urticaria). NRT use can sometimes trigger this type of reaction.

Do not alternate Niquitinmint with nicotine gum during a quit attempt.
If you are pregnant or breastfeeding, it is best to quit smoking without using NRT. However, it is better to quit
smoking using NRT than to continue smoking (see the section on pregnancy and breastfeeding for more
information).

Ask for advice and help from your doctor in the following cases:

• If you have heart or circulation or blood pressure problems, including heart failure, stable angina, hypertension or peripheral occlusive arterial disease.
• If you suffer from severe or moderate liver disorders or severe kidney disorders as you may be more easily exposed to side effects.
• If you suffer from uncontrolled hyperthyroidism or pheochromocytoma(a tumor of the adrenal gland that can affect blood pressure) - your doctor will have already discussed this with you - as nicotine can worsen the symptoms.
• If you suffer from gastric or duodenal ulcer or inflammation of the esophagus(the passage between the mouth and the stomach), because taking nicotine can exacerbate the symptoms. It can also cause mouth ulcers. If the symptoms worsen, see your doctor. A non-oral form of NRT, such as patches, may be preferable.
• If you have had convulsions (fits).
• If you have any doubts about becoming addicted or if you think you have become addicted to this product.

Children and adolescents
This medicine should not be used by children under 12 years of age as it can cause serious
poisoning or be fatal to children. It is therefore essential to always keep Niquitinmint out of the sight and reach of children.

Other medicines and Niquitinmint
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Stopping smoking may change the effects of other medicines you are taking. If you have any
doubts about using this medicine, ask your doctor or pharmacist.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Smoking during pregnancycarries risks for the baby, such as poor growth before birth,
premature birth and stillbirth. Quitting smoking is the best thing you can do for your health and that of your
baby. The sooner you quit smoking, the better.
Ideally, if you are pregnant, you should quit smoking without using NRT. However, if you have tried and the
attempt has failed, NRT may be recommended by your doctor as an aid to quitting smoking as
it is better for the developing fetus than smoking cigarettes. The decision to use NRT should
be made as early as possible during pregnancy and the method involving gradual cessation of
smoking is not recommended. You should aim to use it for only 2-3 months. Remember that the
most important thing is to quit smoking.
Products such as lozenges may be preferable to nicotine patches, as lozenges do not
deliver nicotine continuously. However, patches may be preferable if you suffer from nausea or
vomiting.

Driving and using machines
There are no known effects of Niquitinmint on the ability to drive or operate machines. However, you
should be aware that quitting smoking can cause behavioral disturbances that may affect
the ability to drive or operate machines.

Niquitinmint contains:
Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per lozenge, that is to say essentially
‘sodium-free’.
Mannitol: may have a mild laxative effect

3. How to use Niquitinmint

Instructions on how to use Niquitinmint are different depending on whether you intend to:
a) stop smoking abruptly
b) stop smoking gradually
During any attempt to quit smoking with Niquitinmint, it is important to make every effort to
quit completely.
doctor or pharmacist.
Oral mucosal medicine. This means that the nicotine present in the lozenges is released
slowly in the mouth from which it is then absorbed into the body.
In any case, the lozenge must be kept in the mouth, moving it from side to side from time to time
of the mouth, until complete dissolution is achieved (about 10 minutes). The lozenge should not be chewed or
swallowed whole. Do not take more than 15 lozenges per day. If you feel the need to use Niquitinmint for more
than 9 months in total, ask your doctor or pharmacist for advice.

a) Abrupt smoking cessation
Adults (18 years and over)

• Start by taking 8 to 12 lozenges per day. Take a lozenge whenever you feel the urge to smoke.
• Use the lozenges in this way for up to 6 weeks, then gradually reduce the number of lozenges you consume daily.
• When you get to the point of consuming only 1 or 2 lozenges per day, stop completely. To help you stay smoke-free after treatment, you can take a lozenge whenever you feel a strong urge to smoke.

Weeks 1 to 6:
Start by taking initially 1 lozenge every 1-2 hours; at least 8 lozenges per day.

Weeks 7 to 9
Gradually reduce the number of lozenges to 1 every 2-4 hours.

Weeks 10 to 12
Gradually reduce the number of lozenges to 1 every 4-8 hours
Do not take more than 15 lozenges per day. To help you stay smoke-free after treatment, in the
12 weeks following, you can take 1-2 lozenges per day only on occasions when you feel the need
a strong urge to smoke.

b) Gradual smoking cessation
Adults (18 years and over)
When you feel a strong urge to smoke, take a Niquitinmint lozenge instead of smoking a
cigarette to manage your cravings. Reduce the number of cigarettes consumed per day as much as possible. If after 6 weeks you have not been able to reduce the number of cigarettes daily, consult your doctor
or pharmacist.
As soon as you feel able, you should give up cigarettes completely. You should follow the
instructions above for abrupt smoking cessation. This should be done as soon as possible. If you fail
to start attempting to quit smoking completely within 6 months of starting therapy with
Niquitinmint, consult your doctor or pharmacist.
This gradual smoking cessation method is not recommended during pregnancy (see the section on
pregnancy and breastfeeding for more information).

Use in adolescents
Adolescents (12 to 17 years inclusive)
Use Niquitinmint only on the advice of a doctor.

Do not exceed the indicated doses. Follow the instructions carefully and do not take more than 15 lozenges per day
(24 hours).
Children under the age of 12should not use Niquitinmint.

Ask your doctor or pharmacist if:

• you are worried about starting to smoke again
• you find it difficult to stop taking the lozenges completely

If you start smoking again, they will be able to advise you on how to get the best results with further cycles
of treatment with Nicotine Replacement Therapy (NRT).

If you take more Niquitinmint than indicated
If you take too many Niquitinmint lozenges, you may start to feel nauseous, dizzy and unwell. Stop using
the lozenges and seek immediate medical attention or go to the emergency room of a hospital. If possible, show
The lozenges are not indicated for children under 12 years of age and for non-smokers. If the lozenges are taken
by children or non-smokers, they may induce symptoms of nicotine overdose. These include headache,
unwell, stomach pains and diarrhea. If a child has sucked or eaten one or more lozenges, seek medical attention immediately and go to the emergency room of the nearest hospital. If possible, show the box
If you have any further questions about this product, ask your doctor or pharmacist.
If symptoms persist, consult your doctor.

4. Possible side effects

Like all medicines, Niquitinmint can cause side effects, although not everybody gets them.
At the recommended doses Niquitinmint has not caused serious side effects.
Stop using this medicine and consult your doctor immediately if you have the following symptoms:

• Allergic reactions, tremor, angioedema (swelling of the skin or mucous membranes, face, tongue and throat causing difficulty breathing), dyspnea (shortness of breath).

Stopping smoking itselfcan lead to some symptoms such as dizziness, headache, sleep disturbances, cough
and symptoms similar to those of a cold.
Symptoms such as depression, irritability, anxiety, restlessness, increased appetite and insomnia may be
associated with withdrawal symptoms resulting from smoking cessation.

Other side effectsare listed below, grouped according to how likely they are to occur.
Very common (may affect more than 1 in 10 people)

• nausea.

Common (may affect up to 1 in 10 people)

• Sore throat
• Dry mouth
• Pain or irritation and ulceration of the mouth or tongue
• Vomiting
• Stomach discomfort
• Diarrhoea
• Constipation
• Digestive difficulties / heartburn
• Belching
• Flatulence
• Hiccups
• Pharyngitis
• Increased appetite
• Difficulty sleeping, abnormal dreams
• Anxiety
• Irritability
• Restlessness
• Headache
• Dizziness
• Cough

Uncommon (may affect up to 1 in 100 people)

• Nervousness
• Depression
• Sleep disorders
• Nocturia (frequent urination at night)
• Mood swings
• Appetite disorders
• Altered taste (dysgeusia)
• Palpitations (feeling of heartbeats)
• Increased heart rate
• Chest pain
• Skin rash
• Pain, leg pain
• Swollen legs
• Vascular disease
• Itching or rash, swelling of the skin or mucous membranes, redness of the skin, increased sweating
• Tightness of the throat
• Worsening of asthma
• Irritation of the nose and throat
• Nasal congestion
• Respiratory infections
• Nosebleeds
• Dry lips, dry throat
• Toothache and jaw pain
• Oral paraesthesia (numbness or tingling of the mouth)
• Bleeding gums
• Indigestion
• Dysphagia (difficulty swallowing)
• Stomach ulcer
• Hiatal hernia
• Acid reflux
• Gastric and esophageal irritation
• Abnormal gastrointestinal noises
• Overdose symptoms

Very rare (may affect up to 1 in 10,000 people)

• Symptoms of a severe allergic reaction including sudden shortness of breath or tightness of the chest, rash and feeling of fainting.

Not known (frequency cannot be estimated from available data)

• Convulsions (seizures)
• Increased salivation
• Fatigue and general feeling of illness
• Flu-like illness (flu-like symptoms)
• Hypersensitivity
• Angioedema (swelling of the skin or mucous membranes, face, tongue and throat causing difficulty breathing)
• Tremor
• Dyspnea (shortness of breath)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Niquitinmint

Keep this medicine out of the sight and reach of children.
Do not use the tablets after the expiry date which is stated on the container and the outer packaging. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25ºC.
Store in the original container to protect the medicine from moisture.
Do not use the packaging for other purposes, as a thin layer of dust from the tablets may remain in the
container.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that you no
longer use. This will help protect the environment.

6. Contents of the pack and other information

What Niquitinmint contains
The active substanceis nicotine. Each lozenge contains 2 mg of nicotine (in the form of a complex resin known as
nicotine resin complex).

The excipientsare mannitol (E421), sodium alginate (E401), xanthan gum (E415), potassium bicarbonate
(E501), calcium polycarbophil, anhydrous sodium carbonate (E500), potassium acesulfame (E950), mint flavour,
magnesium stearate (E470b), sucralose.

Description of the appearance of Niquitinmint and contents of the pack
Lozenges, oval from white to off-white with convex surfaces.
The lozenge has the inscription “NIQ2” imprinted on one side.
Each container contains 20 lozenges. Packs may contain 1, 3 or 5 containers.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
PERRIGO ITALIA S.r.l.
Viale Dell’Arte25 – 00144 Rome, Italy

Manufacturer responsible for batch release
Omega Pharma International NV
Venecoweg 26
Nazareth
9810
Belgium
Perrigo Supply Chain
International DAC
The Sharp Building
Hogan Place,
Dublin 2
Dublin, D02 TY74
Ireland