NiQuitin Minis Citrus 2 mg lozenges – patient leaflet, side effects, dosage

1. What NiQuitin Minis are and what they are used for

NiQuitin Minis are used to help people stop smoking and quit vaping (e-cigarettes/heat-not-burn tobacco/heated tobacco). This type of treatment is called Nicotine Replacement Therapy (NRT).

Nicotine is a highly addictive substance that is present in cigarettes, vapes/e-cigarettes and in heat-not-burn tobacco/heated tobacco products.

In cigarette smoke, there are other substances, such as tar, carbon monoxide and other toxins, which are more harmful to your health. NRT products like NiQuitin Minis do not have the health dangers of tobacco.

Other ways of consuming nicotine e.g. vaping/e-cigarettes/heat-not-burn tobacco/ heated tobacco are difficult to control and can lead to excessive consumption and addiction to nicotine. NRT products like NiQuitin Minis are medicines that contain precise amounts of nicotine and allow you to regulate, reduce and quit nicotine.

• NiQuitin Minis help you to give up smoking or vaping, by replacing some of the nicotine you get from cigarettes, vaping devices/e-cigarettes or heat-not-burn tobacco/heated tobacco.
• This nicotine relieves some of the unpleasant symptoms that smokers or vapers may have when they try to give up. These include feeling ill or irritable.
• The nicotine can also relieve your cravings for cigarettes or vapes/e-cigarettes/ heat-not-burn tobacco/heated tobacco and help you to resist the urge to use them. NiQuitin Minis provide enough nicotine, generally at a lower level than from cigarettes, vaping (e-cigarettes/heat-not-burn tobacco/heated tobacco), to help with cravings and other symptoms of nicotine addiction.

Some people worry that after stopping smoking, they may become dependent on nicotine lozenges instead. This is very rare, and if it did happen, it is less harmful than with continuing to consume high levels of nicotine through smoking. It is also an easier habit to break. The risk of long-term vaping/e-cigarettes/heat-not-burn tobacco/heated tobacco use are not yet established. It is always best to stop smoking or vaping completely. NiQuitin Minis can be used to help you stop straightaway (a quit attempt). However, NiQuitin Minis can also be used to cut down on smoking or vaping, perhaps before you go on to stop completely (reducing to quit or just reducing). In addition, NiQuitin Minis can be used when you:

• do not wish or are unable to smoke or vape, for example in confined spaces (in the car, in the house), where others (such as children) could be harmed by tobacco smoke or vape vapor, or in places where smoking, vaping/e-cigarettes are prohibited (temporary abstinence).
• are already using NiQuitin patches but have difficulty controlling your cravings: you can use NiQuitin Minis in combination with your patches, as it is more effective than using patches alone.
• develop cravings once you have stopped smoking or vaping.

Reducing your nicotine intake can increase the chances that you will go on to quit completely.

NiQuitin Minis may be recommended by a healthcare professional during pregnancy and breastfeeding (see Pregnancy and breast-feeding below).

If you are smoking cigarettes, your chance of stopping smoking will be improved if you also take part in a support programme. These ‘Stop Smoking’ programmes are known as behavioural support. For more information, talk to a healthcare professional or:

• call the NHS Free Smoking Helpline on 0800 022 4332, or visit http://www.smokefree. nhs.uk [or the Irish National Smokers Quitline on 1850 201 203]
• or visit http://www.niquitin.co.uk for information about a free online support plan. It is always better to stop smoking or vaping completely. Cigarettes and other tobacco products are especially harmful, and nicotine has no health benefits. Using Nicotine Replacement Therapy (NRT) like NiQuitin Minis can help. In general, any possible side effects associated with NRT are far outweighed by the well-known dangers of continuing to smoke.

2. What you need to know before you use NiQuitin Minis

Do not use NiQuitin Minis if:

• you are allergic to nicotine, or any of the other ingredients of this medicine (listed in

  Section 6).

  • you are a non-smoker or non-vaper, or an occasional user.

  • you are aged under 12. The level of nicotine in NRT is not suitable for children under

    1. 12. Children are more susceptible to the effects of nicotine, and its could cause severe toxicity, which can be fatal.

Warnings and precautions

Talk to your healthcare professional before using NiQuitin Minis:

• If you have had a recent heart attack or stroke, or you suffer from severe heart rhythm problems, unstable or worsening angina pectoris (chest pain) or resting angina pectoris you should try to quit smoking or vaping. without using any NRT products unless your doctor tells you to use them.
• If you have diabetes, you should monitor your blood sugar levels more often than usual when you start using NiQuitin Minis. Your insulin or medicine requirements may change.
• If you have had allergic reactions that involve swelling of the lips, face, and throat (angioedema) or itchy skin rash (urticaria). Using NRT can sometimes trigger this type of reaction.
• If you have a history of epilepsy (fits).
• If you have serious or moderate liver or kidney problems, because you may be more likely to get side-effects.
• If you have uncontrolled overactive thyroid gland or phaeochromocytoma (a tumour of the adrenal gland that can affect blood pressure) - your doctor will have told you this - because nicotine may make your symptoms worse.
• If you have stomach or duodenal ulcers or an inflamed oesophagus or gullet (the passage between the mouth and stomach) because swallowing nicotine can make your symptoms worse. It may also cause mouth ulcers. If your symptoms do get worse, you should talk to your doctor. You might want to use a non-oral form of NRT instead, such as NiQuitin patches.
• If you have any concerns about becoming dependent or think you have become dependent on this product.

If you are pregnant or breast feeding it is best if you can give up smoking without the use of NRT. However, it is better to stop smoking using NRT than to continue smoking. (See the section on pregnancy and breastfeeding below for more information.)

Children (under 12 years)

The level of nicotine in NRT is not suitable for children under 12. Nicotine affects children more than adults. It could cause severe poisoning in children which can cause death.

Other medicines and NiQuitin Minis

Tell your healthcare professional if you are taking or have recently taken any other medicines. Stopping smoking or vaping may alter the effect of other medicines you may be taking. If you have any questions or concerns about this, talk to a healthcare professional.

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.

Pregnancy

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. Ideally, if you are pregnant, you should stop smoking without using NRT. However, if you have tried and this has not worked, NRT may be recommended by a healthcare professional to help you stop smoking.

This is because it is better for your developing baby than if you carry on smoking. The decision to use NRT should be made as early on as possible in your pregnancy. You should aim to use it for only 2-3 months. Remember, the most important thing is to stop smoking. Products such as lozenges may be preferable to nicotine patches. This is because with lozenges, you do not get the nicotine all the time.

However, patches may be preferred if you have nausea or sickness.

Breast-feeding

If you are breast feeding, tobacco smoke causes breathing difficulties and other problems in babies and children. Ideally you should stop smoking without using NRT. However, if you have tried and this has not worked, NRT may be recommended by a healthcare professional. If you need to use NRT to help you quit, the amount of nicotine your baby may get is small. It is much less harmful than breathing in second-hand smoke. It is best to use NRT products that are taken at certain times of the day (such as gum or lozenge, rather than patches). It is also better to breast feed just before you take the product. This helps your baby to get the smallest amount of nicotine possible.

Driving and using machines

There are no known effects of Nicotine Minis on the ability to drive or use machines. However, you should be aware that giving up smoking or vaping can cause behavioural changes that affect your ability to drive or use machines.

Nicotine Minis contain

Sodium – This medicinal product contains less than 1 mmol sodium (23 mg) per lozenge, that is to say essentially sodium free.

3. How to use NiQuitin Minis

Always use NiQuitin lozenges exactly as described in this leaflet or as your healthcare professional has told you. Check with your healthcare professional if you are not sure. During any attempt to give up smoking or vaping using NiQuitin Minis it is important that you make every effort to stop completely. However, if you do smoke a cigarette or vape (e-cigarettes/heat-not-burn tobacco/heated tobacco) while you are using NRT, you should continue your quit attempt. If you continue to have difficulty stopping smoking or vaping talking to your doctor, nurse, smoking cessation advisor or pharmacist may help.

Adults and young people 12 years and over

Instructions for use of NiQuitin Minis depends on whether you are:

• Stopping smoking or vaping straightaway.
• Cutting down on smoking or vaping before you stop.
• Cutting down with no immediate plans to stop
• Going without cigarettes or vapes (e-cigarettes heat-not-burn tobacco/heated tobacco) for a short time or if you have cravings after you have stopped smoking or vaping.
• Already using NiQuitin patches but have difficulty controlling your cravings: you can use NiQuitin Minis in combination with your patches, as it is more effective than using patches alone.

If you are under 18 years old and not ready to stop smoking or vaping straight away, talk to a healthcare professional for advice.

In all cases:

• NiQuitin Minis Citrus 2 mg Lozenges are for:

  • Smokers who smoke 20 cigarettes or less a day.
  • Vape users who use nicotine liquid strengths below 12 mg/ml (1.2%).

• You should put one lozenge in your mouth and periodically move it from one side of your mouth to the other, until it has completely dissolved. This should take around 10

  minutes.

• Do not chew the lozenge or swallow it whole.

• Do not use more than 15 lozenges a day

  File title: PRG002677_1458_LF31880B_NiQuitin Mini Citrus Lozenges 2mg 60s_Leaflet_UK v4 Item No.: 25K00SXJ2

  OPI No.: LF31880B

  Replacement No.: 25K00SXJ1

  Last edit: 23rd October 2025 Brand: NiQuitin

  Variant: Mini Mint Lozenges 2mg 60s Component: Leaflet

  Market/s United Kingdom Tech. Draw Ref: L178

  Spec. Ref.: ...

  Substrate: White Paper

  EAN Code: …

  Other Code/Spec.: …

  Manufacturing Site: Perrigo Wrafton

  Print process: ...

  No. of Colours: 1

  512 Metal Box Factory,

  30 Great Guildford Street,

  London, SE1 0HS, UK

  +44 (0)20 3982 8471 london@oneagency.co

  LINE SPACING USED:

  8.5pt / 3mm

  Frutiger Roman

  7.9pt

  (1.42mm ‘x’ height)

  80% h-scale / -20 track

  Times New Roman

  9pt (1.42mm ‘x’ height)

NiQuitin Minis are not suitable for children under 12 years of age or for non-smokers or non-vapers or people who only use occasionally. They may develop signs of nicotine overdose, including headache, sickness, stomach pain and diarrhoea.

Stopping smoking or vaping e-cigarettes/heat-not-burn tobacco/heated tobacco straightaway

Adults and young people aged 12 years and over:

• Start by using 8 – 12 lozenges a day. Suck a lozenge whenever you have an urge to smoke or vape.
• Use the lozenges like this for up to 6 weeks, then gradually cut down the number of lozenges you use a day.
• Once you are using only 1 – 2 lozenges a day, try to stop using them altogether.

Gradual cessation: if you are unwilling or unable to quit smoking or vaping e-cigarettes/heat-not-burn/heated tobacco abruptly

Adults aged 18 years and over:

You may find it easier to quit completely later if you use NiQuitin Minis to help you cut down on your smoking or vaping first. When you feel a strong urge to smoke or vape, have a lozenge to help you manage your cravings. Cut down the amount of nicotine you use per day by as much as possible. If you have not been able to cut it down after 6 weeks, talk to a healthcare professional.

As soon as you feel ready to stop smoking or vaping completely, follow the instructions above, under ‘Stopping smoking or vaping e-cigarettes/heat-not-burn tobacco/heated tobacco straightaway’. If you have not felt able to make a quit attempt within 6 months of starting to use NRT, you may find it helpful to talk to a healthcare professional.

Smoking or vaping reduction: cutting down with no immediate plans to stop Adults aged 18 years and over:

It is always best to stop smoking or vaping completely but using NRT to cut down is less harmful than continuing smoking heavily. Cutting down the amount of smoking or vaping each day will make it easier to quit completely in the future. When you feel an urge to smoke or vape, have a lozenge instead to help you manage your cravings. Cut down the amount of cigarettes, vapes, e-cigarettes or heat-not-burn tobacco/heated tobacco you use per day by as many as possible.

The number of lozenges a day is variable and depends on your needs. Nonetheless, it should not exceed 15 lozenges per day. If you are still feeling the need to use the lozenges on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

It is best to stop smoking or vaping completely as soon as you feel able to. Follow the instructions above, under ‘Stopping smoking or vaping e-cigarettes/heat-not-burn tobacco/heated tobacco straightaway’.

Going without cigarettes or vaping e-cigarettes/heat-not-burn tobacco/heated tobacco for a short time

Adults aged 18 years and over:

NiQuitin Minis can help you manage your cravings so that you can resist in situations where smoking or vaping is inappropriate, for example:

• where your second-hand smoke or vapour may damage other people, such as children.
• where smoking or vaping is not allowed, such as on a flight or in a hospital.
• when smoking or vaping should be avoided, such as before surgery. When you feel an urge to smoke or vape, have a lozenge instead to help you manage your cravings. Continue to use one lozenge every 1 – 2 hours during the period when you are avoiding smoking or vaping.

It is best to stop smoking or vaping completely as soon as you feel able to. Follow the instructions above, under ‘Stopping smoking or vaping e-cigarettes/heat-not-burn tobacco/heated tobacco straightaway’.

If you feel the need to use NiQuitin for longer than 6 months in total, you should ask a healthcare professional for advice.

Combination therapy with NiQuitin patches

For smokers or vapers (e-cigarettes/heat-not-burn tobacco/heated tobacco) who have relapsed after NRT, or when lozenges alone are not sufficient to control cravings, or as first line treatment in nicotine users with a high level of dependence. You can combine patches and oral NRT (gum, lozenges, etc.) as the combination gives better effectiveness than using patches alone.

Initial treatment should begin with the determination of the dose of the patch, which depends on your previous nicotine habit in combination with NiQuitin. The recommended daily intake of NiQuitin 2 mg lozenge, when combined with patches, is 5 to 6 pieces. The maximum daily dose is 15 pieces. Only one type of oral NiQuitin product (either compressed lozenge or gum) shall be used in combination with the patches. You should continue to use oral NiQuitin for 2 - 3 months, then begin to reduce use gradually as you experience less nicotine cravings. When daily use is reduced to 1-2 doses, treatment should be stopped.

* Do not use more than 15 pieces of NiQuitin Minis Mint 2 mg lozenges per 24 hours.

** Do not use more than 15 pieces of NiQuitin Minis Mint 2 mg lozenges per 24 hours.

Once you have stopped smoking or vaping…

After you have stopped smoking or vaping, you may still sometimes feel a craving for nicotine. You can use NiQuitin Minis again to help you relieve these cravings - using NRT is always better than smoking again.

Use in children and adolescents

Adolescents (12-17 years inclusive)

You should follow the instruction above for stopping smoking or vaping straightaway, but you should only use the lozenges for 12 weeks in total. If you feel the need to use NiQuitin minis for longer than 12 weeks or if you are not ready to stop smoking or vaping, you should talk to a healthcare professional for advice.

Do not exceed the stated dose.

Children (under 12 years)

Children under 12 years must not use NiQuitin Minis.

Talk to a healthcare professional if you are:

• worried that you may start smoking or vaping again
• finding it difficult to stop using the lozenges completely

If you do start to smoke or vape again, they can advise you on how to get the best results from further courses of NRT.

If you use more NiQuitin Minis than you should

If you use too many NiQuitin Minis you may start to feel sick, dizzy, and unwell. Stop using the lozenges and get advice straightaway from a doctor or hospital casualty department. If possible, show them the packet or this leaflet.

The lozenges are not suitable for children under 12 or non-smokers or non-vapers. If the lozenges are used by children or non-smokers or non-vapers, they may show signs of nicotine overdose. These include headache, sickness, stomach pains and diarrhoea. If a child has used or eaten any of the lozenges, contact your doctor or nearest hospital casualty department straightaway. If possible, show them the packet or this leaflet. If you have any further questions on the use of this product, ask your healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. At the recommended doses NiQuitin Minis have not been found to cause any serious side-effects.

Stop using this medicine and seek medical attention immediately if you have the following symptoms:

• Allergic reactions, tremor, angioedema (swelling of skin or mucous membrane, face, tongue, and throat causing breathing difficulties), dyspnoea (shortness of breath). Stopping smoking or vaping itself can cause some symptoms such as dizziness, headache,

sleep disturbance, cough, and cold-like symptoms. Symptoms such as depression, irritability, anxiety, and insomnia may also be related to withdrawal symptoms associated with giving up smoking or vaping.

Other side-effects are listed below – they are grouped based on the likelihood with which they can occur.

Very common (may affect more than 1 in 10 people)

• feeling sick.

Common (may affect up to 1 in 10 people)

• sore throat, mouth/tongue irritation or ulceration, sleep disturbance, headache, anxiety, irritability, being sick, belching, flatulence, diarrhoea, increased appetite, indigestion, heartburn, dry mouth, constipation, pharyngitis (swelling in the back of the throat), hiccups, coughing, dizziness.

Uncommon side-effects (may affect up to 1 in 100 people)

• an increase in your heart rate or awareness of your heart beat abnormal dreams, mood changes, worsening anxiety, feeling angry, wakefulness, abnormal hunger
• worsening asthma or difficulty breathing, difficulty swallowing, chest infections, nose and throat irritation, nasal congestion dry lips, dry throat, jaw or tooth pain, bleeding gums, taste disturbance/distortion, local numbness stomach rumbling, worsening indigestion, acid regurgitation, gut irritation, stomach ulcer, hiatus hernia
• itching or a rash, redness of the skin, localised skin reaction, increased sweating, skin flushes,
• nosebleed pain, leg pain or swelling frequent urination at night symptoms of overdose.

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

• severe allergic reaction, symptoms of which include sudden wheeziness or tightness of the chest, rash and feeling faint.

Not known (frequency cannot be estimated from the available data)

• seizures (fits), increased salivation, asthenia (lack of energy), fatigue (tiredness), malaise (feeling of general discomfort), influenza like illness (flu like symptoms).
• a fast and irregular heartbeat (atrial fibrillation).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, nurse, or smoking cessation advisor. 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 Minis

Keep out of the sight and reach of children.

• Do not use this medicine after the ‘EXP’ date shown on the container and outer packaging. The expiry date refers to the last day of the month.
• Keep all lozenges in the original container.
• Do not store above 25°C.
• Do not use the container for anything else due to possible fine coating of tablet dust inside.
• Do not throw medicines away 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 NiQuitin Minis contain

The active substance is nicotine 2 mg (in the form of nicotine resinate). The other ingredients are mannitol, sodium alginate, xanthan gum, potassium bicarbonate, calcium polycarbophil, sodium carbonate anhydrous, acesulfame potassium, citrus flavor, sucralose, and magnesium stearate. NiQuitin Minis are sugar free.

What NiQuitin Minis look like and the contents of the pack

White to off-white biconvex oval lozenges. The 2 mg lozenge has “CIT2” on one side. Each container contains 20 lozenges. Packs may contain one, three or five containers in a blister card or five containers in a carton.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder is Omega Pharma Ltd., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom and all enquiries should be sent to this address. The Manufacturer of NiQuitin Minis Citrus Lozenges is Wrafton Laboratories Limited, Exeter Road, Wrafton, Braunton EX33 2DL, UK.

PL 02855/0329

This leaflet was last revised in November 2025

LF31880B 25K00SXJ2

File title: PRG002677_1458_LF31880B_NiQuitin Mini Citrus Lozenges 2mg 60s_Leaflet_UK v4 Item No.: 25K00SXJ2

OPI No.: LF31880B

Replacement No.: 25K00SXJ1

Last edit: 23rd October 2025 Brand: NiQuitin

Variant: Mini Mint Lozenges 2mg 60s Component: Leaflet

Market/s United Kingdom Tech. Draw Ref: L178

Spec. Ref.: ...

Substrate: White Paper

EAN Code: …

Other Code/Spec.: …

Manufacturing Site: Perrigo Wrafton

Print process: ...

No. of Colours: 1

512 Metal Box Factory,

30 Great Guildford Street,

London, SE1 0HS, UK

+44 (0)20 3982 8471 london@oneagency.co

LINE SPACING USED:

8.5pt / 3mm

Frutiger Roman

7.9pt

(1.42mm ‘x’ height)

80% h-scale / -20 track

Times New Roman

9pt (1.42mm ‘x’ height)