NiQuitin Mint 2 mg and 4mg Lozenges – patient leaflet, side effects, dosage

1. What NiQuitin Mint 2mg and 4mg

Lozenges are and what they are used for

1. 2. What you need to know before you take NiQuitin Mint 2mg and 4mg Lozenges
2. 3. How to take NiQuitin Mint 2mg and 4mg Lozenges
3. 4. Possible side effects
4. 5. How to store NiQuitin Mint 2mg and

4mg Lozenges

1. 6. Contents of the pack and other information
2. 1.

   What NiQuitin Mint 2mg and

   4mg Lozenges are and what they are used for

NiQuitin Mint 2mg and 4mg Lozenges are

used to help people stop smoking. This type of

treatment is called Nicotine Replacement

Therapy (NRT).

NiQuitin Mint 2mg and 4mg Lozenges can

reduce your urge to smoke by providing some

of the nicotine previously inhaled from

cigarettes and helps you resist cigarettes.

NiQuitin Mint 2mg and 4mg Lozenges do not

have the health dangers of tobacco because

they do not contain the tar or carbon

monoxide of cigarette smoke.

This medicine contains:

• nicotine resin which when sucked, nicotine is released slowly from the resin and absorbed through the lining of the mouth. This nicotine relieves some of the cravings and unpleasant withdrawal symptoms, such as feeling ill or irritable, that smokers frequently feel when they try to give up.

If possible, when giving up smoking these lozenges should be used with a stop smoking behavioural support programme. For further information talk to your healthcare professional.

2. What you need to know before you take NiQuitin Mint 2mg and 4mg Lozenges

Do not take this medicine if you:

• are allergic to nicotine or any of the other ingredients (listed in section 6)
• are a non-smoker
• are under 12 years of age.
• suffer from phenylketonuria, a rare inherited metabolic disorder
• are allergic to soya or peanut, because this product contains soya oil

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using NiQuitin Mint 2mg and 4mg Lozenges if you:

• have heart or circulation problems including heart failure or stable angina (episodes of chest discomfort that are usually predictable)
• have a recent myocardial infarction, unstable or worsening angina pectoris including Prinzmetal angina or a recent cardiovascular accident. You are encouraged to stop smoking without any nicotine replacement therapy (NRT) unless your doctor tells you to use them.
• have high blood pressure
• have occlusive peripheral artery disease - which is a narrowing of the blood vessels outside of your heart

• have moderate to serious liver or kidney problems because you may be more likely to get side effects • have a stomach ulcer or inflammation of

  the oesophagus (oesophagitis), which is the

  tube leading from the mouth to the stomach,

  NRT can make symptoms worse

  • have an uncontrolled, over active thyroid

gland or phaeochromocytoma (a tumour

of the adrenal gland that can affect blood

pressure). Nicotine may make symptoms worse

• are diabetic, as diabetic patients need to

monitor blood sugar levels more closely as

nicotine from smoking or from taking these

lozenges may vary them more than usual

• have had allergic reactions (see also section

4 “Possible side effects”).

• are taking anti-epileptic drugs or have a history

of epilepsy (fits) as cases of convulsions have

been reported in association with nicotine

• have any concerns about becoming dependent

or think you have become dependent on this

product

Other important information:

When you stop smoking your metabolism slows

down and this may alter the way your body

responds to certain medicines.

Children and adolescents

NiQuitin Mint 2mg and 4mg Lozenges are NOT for

use in children and adolescents under 12 years of

age. Other medicines and NiQuitin Mint 2mg and

4mg Lozenges

Please tell your doctor or pharmacist if you are

taking or have recently taken any other medicines,

including medicines obtained without a

prescription.

NiQuitin Mint 2mg and 4mg Lozenges with

food and drink

Do not eat or drink while a lozenge is in the

mouth. Avoid liquids which lower the pH in the

mouth such as coffee, juices and soft drinks, for

up to 15 minutes before the lozenge is used.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you

may be pregnant or are planning to have a baby,

ask your doctor or pharmacist for advice before

taking this medicine.

If you are pregnant or breast-feeding it is best if

you can give up smoking without the use of NRT.

However, if you have tried and this has not worked,

NRT may be recommended by a healthcare

professional to help you stop smoking.

Smoking during pregnancy has risks for the baby.

These include poor growth before birth, premature

birth or stillbirth. Stopping smoking is the best way

to improve both your health and that of your baby.

The earlier you stop smoking the better.

The decision to use NRT should be made as early

on in your pregnancy as possible. Aim to use NRT

for only 2 to 3 months.

lf you are breast-feeding tobacco smoke causes

breathing difficulties and other problems in babies

and children. If you need to use NRT, the amount

of nicotine your baby may get is smaller and less

harmful than breathing in second-hand smoke. It

is better to breastfeed just before you take the

product - this helps your baby to get the smallest

amount of nicotine possible.

Ask your doctor or pharmacist for advice before

taking any medicine.

Driving and using machines

There are no known effects of these lozenges on

your ability to drive or use machines. However,

you should be aware that giving up smoking can

cause behavioural changes that could affect you

in this way.

NiQuitin Mint 2mg and 4mg Lozenges contain

aspartame, mannitol and sodium.

Sodium: This medicinal product contains less than

1 mmol sodium (23mg) per lozenge, that is to say

essentially sodium free.

Aspartame (E591): This medicine contains 6.1mg

aspartame in each lozenge. Aspartame is a

source of phenylalanine. It may be harmful if you

have phenylketonuria (PKU), a rare genetic

disorder in which phenylalanine builds up because

the body cannot remove it properly.

Mannitol (E421): May have a mild laxative effect.

Your lozenges are sugar free.

3. How to take NiQuitin Mint

2mg and 4mg Lozenges

Important: NiQuitin Mint 4mg Lozenges are

suitable for smokers who smoke within 30

minutes of waking. NiQuitin Mint 2mg Lozenges

are suitable for smokers who have their first

cigarette of the day more than 30 minutes after

waking up.

Always use Nicotine Lozenges exactly as

described in this leaflet. Check with your

pharmacist if you are not sure.

The product is for oromucosal use. That means that

the nicotine in the lozenge is released slowly into

the mouth from where it is absorbed into the body.

In all cases you should use NiQuitin Mint

Lozenges by putting one lozenge in your mouth

and from time to time move it from one side of

your mouth to the other, until it is completely

dissolved. This should take around 20-30

minutes.

Do not chew the lozenge or swallow it whole. If

you feel the need to use NiQuitin Mint 2mg

and 4mg Lozenges for longer than 6 months

in total, you should ask a healthcare

professional for advice.

Do not exceed the stated dose. Follow the

instructions carefully and do not use more

than 15 lozenges in one day (24 hours).

Adults (aged 18 years and over):

The recommended treatment schedule is:

During weeks 1-6 it is recommended that you

take at least 9 lozenges per day.

After you have given up you may sometimes feel a

sudden craving for a cigarette. You can use a

lozenge again if this happens.

Adolescents (aged 12-17 years inclusive):

You should only use NiQuitin Mint Lozenges

following advice from a healthcare professional

Children under 12 years of age should not

use NiQuitin Mint Lozenges.

Information: You are more likely to

quit smoking when using this product

with help from your pharmacist,

doctor, a trained counsellor, or a

support programme.

If you use more NiQuitin Mint 2mg and 4mg

Lozenges than you should

If you take more than the recommended number

of lozenges per day, you may suffer a nicotine

overdose and need to get advice from your

doctor. Signs of overdose include headache,

sickness, stomach pains and diarrhoea.

In the event that a child has taken any lozenges or

if an accidental overdose occurs, contact your

doctor or nearest hospital casualty department

immediately as this could be fatal. If possible

show them the pack or this leaflet.

If you forget to take NiQuitin Mint 2mg and

4mg Lozenges

Do not take a double dose to make up for a

forgotten dose.

If you have any further questions on the use of this

product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side

effects although not everybody gets them. They

are similar to those you might get from the

nicotine in cigarettes, and are more likely the more

nicotine you take.

Stopping smoking itself can cause symptoms

such as dizziness, headache, sleep disturbance,

cough and cold-like symptoms, depression,

irritability, anxiety and night-time awakening.

Stop taking the lozenges immediately and

tell a healthcare professional if you get these

symptoms:

Uncommon may affect up to 1 in 100 people:

• tachycardia (heart beating too fast)
• peptic (stomach) ulcer, belching, abdominal

pain, vomiting, loss of appetite,

• dysphagia (difficulty swallowing)

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

• anaphylactic reactions (severe allergic reaction

symptoms which include sudden wheeziness or

tightness of the chest, rash and feeling faint).

Other side effects are listed below- they are based

on the likelihood with which they can occur:

Very common may affect more than 1 in 10

people:

• nausea
• headache, dizziness

Common may affect up to 1 in 10 people:

• insomnia (difficulty sleeping), anxiety, irritability,

increased appetite

• tremor, pharyngitis (sore throat)
• cough, hiccups, dyspnoea (shortness of breath)
• vomiting, heartburn, indigestion, hiccup, mouth

irritation, mouth ulceration, tongue ulceration,

diarrhoea, belching, flatulence (wind), abdominal

pain upper, dry mouth, constipation, oral

discomfort

• asthenia, fatigue, malaise, influenza like illness

Uncommon may affect up to 1 in 100 people

• gingival bleeding (bleeding gums), nosebleed
• anger, aggravated anxiety, abnormal dreaming,

abnormal hunger, mood swings, wakefulness

• localised numbness
• palpitations (feeling your heartbeat)
• vascular disorder, flushing
• laryngismus (throat spasms), aggravated

asthma, lower respiratory tract infection,

coughing, nasal irritation, throat irritation,

nasal congestion

• peptic ulcer, gastroesophageal reflux, hiatus

hernia, oesophagitis (inflammation of the

oesophagus), borborygmus (rumbling

stomach), dry lips, dry throat, tongue

disorder, tooth ache

• parageusia (bad taste in the mouth), metallic

taste, taste perversion

• erythema (skin redness), itching, rash,

localised skin reaction, increased sweating,

urticaria (hives)

• jaw pain
• nocturia (needing to urinate during the night)
• overdose effect, pain, leg pain, build-up of

fluid in the legs

Rare may affect up to 1 in 1,000 people:

• hypersensitivity

Not known frequency cannot be estimated

from the available data:

• fits
• swelling of skin or mucous membrane, face,

tongue and throat causing breathing

difficulties

• taste disturbance/distortion
• tingling mouth
• increased salivation
• a fast and irregular heartbeat (atrial fibrillation)

If you get any side effects, talk to your doctor

or pharmacist. This includes any side effects

not listed in this leaflet.

Reporting of suspected adverse reactions

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any

possible side effects not listed in this leaflet.

You can also report side effects directly via the

Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for

MHRA Yellow Card in the Google Play or

Apple App Store.

By reporting side effects you can help provide

more information on the safety of this

medicine.

5. How to store NiQuitin Mint

2mg and 4mg Lozenges

Keep all medicines out of the sight and

reach of children.

Do not use this medicine after the expiry date

printed on the pack. Do not store above 25°C

and keep in the original carton.

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.

6. Contents of the pack and

other information

What this medicine contains

The active ingredient is nicotine. Each lozenge

contains 2 mg or 4 mg (in the form of a resin

complex called nicotine resinate).

The other ingredients are: mannitol (E421),

magnesium stearate, sodium alginate, xanthan

gum, potassium bicarbonate, sodium

carbonate anhydrous, aspartame (E951) and

peppermint flavour.

What your medicine looks like and

contents of the pack:

Cream / white circular compressed lozenge

with an odour of peppermint.

The 2 mg lozenge is embossed with L344 on

one side. The 4 mg lozenge is embossed with

L873 on one side.

Your lozenges are available in pack sizes of 12,

36, 72, 132, 144 and 204’s. Not all pack sizes

may be marketed.

Marketing Authorisation Holder

Omega Pharma Limited,

Wrafton, Braunton, Devon, EX33 2DL, UK.

Manufacturer(s)

Wrafton Laboratories Limited, Wrafton,

Braunton, Devon, EX33 2DL, United Kingdom

Perrigo Supply Chain International DAC, The

Sharp Building, Hogan Place, Dublin 2, Dublin,

D02 TY74, Ireland

The leaflet was revised in: November 2025