NiQuitin Mint 2mg Lozenges

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

This medicine is available without prescription. However, you still need to use NiQuitin Mint 2mg and 4mg Lozenges carefully to get the best results from them.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must talk to a doctor if you do not feel better or if you feel worse after 6 months
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

IN THIS LEAFLET:

1. What NiQuitin Mint 2mg and 4mg Lozenges are and what they are used for
2. What you need to know before you take NiQuitin Mint 2mg and 4mg Lozenges
3. How to take NiQuitin Mint 2mg and 4mg Lozenges
4. Possible side effects
5. How to store NiQuitin Mint 2mg and 4mg Lozenges
6. Contents of the pack and other information

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.

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
• have recently suffered from a heart attack, severe heart rhythm disturbances or a stroke
• have unstable or worsening angina or Prinzmetals angina

Warnings and precautions

Talk to your doctor or 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 high blood pressure
• have occlusive peripheral artery disease - which is a narrowing of the blood vessels outside of your heart
• have serious liver or kidney disease
• have a stomach ulcer
• have inflammation of the oesophagus (oesophagitis), which is the tube leading from the mouth to the stomach
• have an uncontrolled, over active thyroid gland
• 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 been diagnosed as having a tumour of the adrenal glands (phaeochromocytoma)
• have had allergic reactions (see also section 4 “Possible side effects”).

Other important information:

When you stop smoking your metabolism slows down and this may alter the way your body responds to certain medicines.

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.

Children and adolescents

NiQuitin Mint 2mg and 4mg Lozenges is NOT for use in children and adolescents under 12 years of age.

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 and breast-feeding

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 contains aspartame, mannitol and sodium.

Each lozenge contains about 15 mg of sodium and the maximum daily dose of these lozenges (15 lozenges) contains 225 mg sodium. To be taken into consideration if you are on a controlled sodium diet.

Contains aspartame (E951) which is a source of phenylalanine. May be harmful for people with phenylketonuria.

Mannitol (E421): May cause Laxative effects.

Your lozenges are sugar free.

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.

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

Very common may affect more than 1 in 10 people:

• nausea

Common (may affect up to 1 in 10 people)

• insomnia (difficulty sleeping), anxiety, irritability, increased appetite
• headache
• pharyngitis (sore throat)
• vomiting, heartburn, indigestion, hiccup, mouth irritation, mouth ulceration, tongue ulceration, diarrhoea, belching, flatulence (wind)

Possible side effects continues overleaf.

Uncommon may affect up to 1 in 100 people

• gingival bleeding (bleeding gums), nosebleed
• anger, aggravated anxiety, abnormal dreaming, abnormal hunger, mood swings, wakefulness
• lightheaded feeling, 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
• jaw pain
• nocturia (needing to urinate during the night)
• overdose effect, pain, leg pain, build-up of fluid in the legs

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.

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

Marketing Authorisation Holder

Manufacturer(s)