NIQUITIN FRESH MINT 4 MG MEDICATED CHEWING GUMS - patient leaflet, side effects, dosage

Patient leaflet - NIQUITIN FRESH MINT 4 MG MEDICATED CHEWING GUMS

NiQuitin

Nicotine

Please read right through this leaflet before you start using this medicine. This medicine is available without prescription, but you still need to use NiQuitin Fresh Mint Gum carefully to get the best results from it.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask a healthcare professional (doctor, nurse, smoking cessation advisor or pharmacist).
Throughout this leaflet NiQuitin Fresh Mint 2 mg and 4 mg Medicated Chewing Gums are referred to as NiQuitin Fresh Mint Gum.

In this leaflet:

1. What NiQuitin Fresh Mint Gum does

NiQuitin Fresh Mint Gum is used to help people stop smoking. It works by replacing some of the nicotine you get from cigarettes. This type of treatment is called Nicotine Replacement Therapy (NRT).

The nicotine in cigarettes makes them addictive, but other substances in cigarette smoke, such as tar, carbon dioxide and other toxins, are more harmful to your health. NRT products like NiQuitin Fresh Mint Gum do not have the same health dangers of tobacco.

The nicotine from NRT reduces your cravings for cigarettes and helps you resist the urge to smoke. It also relieves some of the unpleasant symptoms (like feeling ill or irritable) that smokers have when they try to give up.

NiQuitin Fresh Mint Gum can be used to help you:

stop smoking straightaway (a quit attempt)
cut down on smoking, perhaps before you on to stop completely (reducing to quite or just reducing).

In addition, NiQuitin Fresh Mint Gum may be used when you:

do not wish to smoke or are unable to smoke, for example in confines spaces (in the car, in the house), where others (such as children) could be harmed by tobacco smoke or in places where smoking is prohibited (temporary abstinence).
develop cravings once you have stopped smoking.

Reducing the number of cigarettes smoked can increase the chances that you will go on to quit completely.

NiQuitin Fresh Mint Gum can be used during pregnancy and breast-feeding (see Pregnancy and Breastfeeding below).

Some people worry that, when they have stopped smoking, they may become dependent on NRT instead. This is very rare, and if it were to happen it is still safer than continuing to smoke. It is also an easier habit to break.

It is always better to stop smoking completely. Smoking is harmful and has no health benefits. NRT products like NiQuitin Fresh Mint Gum can help you stop. Any risks or possible side-effects of nicotine from NRT are much less than the proven dangers of continuing to smoke.

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:

call the NHS Free Smoking Helpline on 0800 022 4332, or visit [or the Irish National Smokers Quit line on 1850 201 203]
or visit http://or information about a free online support plan.

2. check before you use niquitin fresh mint gum if you have ever had an allergic reaction to nicotine or any of the other ingredients (listed in section 6).

if you are a non-smoker.
if you are under 12 years. The level of nicotine in NRT is not suitable for children under 12. children are more susceptible to the effect s of nicotine, and it could cause sever toxicity, which can be fatal.

Take special care with NiQuitin Fresh Mint Gum

if you are in hospital because you have had a heart attack, severe heart rhythm disturb ancesor a stroke. Try to quit smoking without NRT unless your doctor has told you to use it. Once you are discharged from hospital, you can use NRT as normal.

if you have diabetes. When you start using NRT, you need to monitor your blood sugar levels more often than usual, because your dose of medication for diabetes may need to be adjusted.
if you have serious liver or kidney problems because you may be more likely to get side effects.
if you have uncontrolled overactive thyroid gland or an adrenal gland tumour (phaeochromocytoma) because nicotine may make your symptoms worse.
if you have stomach or duodenal ulcers or inflammation of the oesophagus or gullets (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 non-oral form of NRT instead, such as patches.
if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. NiQuitin Fresh Mint Gum contains sorbitol (E420) and maltitol liquid.
if you are on a low sodium diet. Each piece of gum contains 11.4mg sodium and the maximum daily dose (15 pieces of gum) contains 171mg sodium. The maximum daily dose may be harmful if you are on a low sodium diet.
if you have any concerns about becoming dependent or think you have become dependent on this product.
if you have a history of epilepsy (fits).

If you are taking other medicines

Stopping smoking 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.

Other things you may need to know:

NiQuitin Fresh Mint Gum contains butylhydroxytoluene(E321) which may cause irritation to the mouth or the skin around it.
NiQuitin Fresh Mint Gum is sugar-free.
If you were dentures (false teeth) that are poorly fitting or not clear you may have difficulty chewing the gum. Another NRT product may be more suitable for you, such as patch or lozenge.
Chewing nicotine gum may loosen fillings or dental implants.

Pregnancy and breast-feeding

The risks include poor growth before birth, damage to the baby's lungs, premature birth and still birth. Stopping smoking is the best way to improve your health and the health of your baby, and the earlier you stop smoking the better.

It is best to give up smoking wit out using NRT. If that's too difficult, using NRT is safer for you and your baby than continuing to smoke. The nicotine n NRT is less dangerous than the more harmful substances in cigarette smoke, such as tar and other toxins.

If you have tried to stop smoking without using NRT, and haven't been able to, your healthcare advisor may recommend NRT to help you stop. If you do use NRT during pregnancy:

Start as early in your pregnancy as possible.
Aim if possible, to use NRT for only 2 to 3 months. But remember – the most important thing is not to smoke. It is safer to carry on using NRT than to start smoking again.
If you can use t hem, NRT gum or lozenges are better than patches. That's because you will not be absorbing nicotine into your body all the time. But if you feel sick, you may need to use NRT patches instead.

If you are breast-feeding

Tobacco smoke is harmful to babies and children, causing breathing difficulties and other problems.

If you are breast-feeding, it is best if you stop smoking w t h out using NRT. But if you do need to use NRT, the nicotine that gets into breast milk is less dangerous to your baby than breathing in second-hand smoke. If you do use NRT while breast-feeding:

It is better to use NRT gum or lozenges to control your cravings as they happen, rather than patches. With gum or lozenges, you wiII not be absorbing nicotine into your body all the time.
Try to breast-feed just before you take the gum or lozenge, when the nicotine levels in your body are at their lowest. That way, your baby gets as little nicotine as possible.

3. how to use niquitin fresh mint guminstructions for use of niquitin fresh mint gum depend on whether you are:

stopping smoking straightaway.
cutting down on smoking before you stop.
cutting do n with no immediate plans to stop.
going without cigarettes for a short time or if you have cravings after you have stopped smoking.

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

In all cases:

NiQuitin Fresh Mint 4 mg Medicated Chewing Gums are for smokers who smoke within 30 minutes of waking.
NiQuitin Fresh Min 2 mg Medicated Chewing Gums are for smokers who smoke more than 30 mins after waking.
You should put a piece of gum in your mouth and periodically chew it, as described in the instructions below, for about 30 minutes. Dispose of it carefully.
Do not use more than 15 pieces of gum a day.

NiQuitin Fresh Mint Gum is not suitable for children under 12 years of age or for non-smokers. They may develop signs of nicotine overdose, including headache, sickness, stomach pain and diarrhoea.

Stopping smoking straightaway

It is important to make every effort to stop smoking completely. But if you do sometimes smoke a cigarette while using NRT, don’t be discouraged – just keep going while your quite attempt. It may help to talk to a healthcare professional if you are finding your quit attempt difficult.

Use 8–12 pieces of gum a day. Take a piece of gum whenever you have urge to smoke.
Use the gum like this for up to 3 months in total, then gradually reduce the number of pieces you use a day.
Once you are using only 1–2 pieces of gum a day, try to stop using it altogether.
If you started using the 4mg gum, you can change to the 2mg gum during the reduction stage. To increase your chances of success, complete the step-down programme in full and follow a stop smoking behavioural support programme – see the end of Section 1 for more details.

Cutting down on smoking before you stop

You may find it easier to quit completely later if you use NiQuitin Fresh Mint Gum to help you cut down on smoking first.

When you feel an urge to smoke, chew a piece of gum instead of having a cigarette to help you manage your cravings. Cut down the number of cigarettes your smoke per day as many as possible. If you have not been able to cut down the number of cigarettes you smoke each day after 6 weeks, talk to a healthcare professional.

As soon as you feel ready to stop smoking completely, follow the instructions above, under ‘Stopping smoking 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 take to a healthcare professional.

Cutting down with no immediate plans to stop

It is always best to stop smoking completely but using NRT to cut down is less harmful than continuing to smoke heavily. Cutting down the number of cigarettes you smoke each day will make it easier to quit completely in future.

When you feel an urge to smoke, chew a piece of gum instead of having a cigarette to help you manage your cravings. Cut down the number of cigarettes you smoke per day by as many as possible.

It is best to stop smoking completely as soon as you feel able to. Follow the instructions above, under ‘Stopping smoking straightaway’.

Going without cigarettes for a short time

NiQuitin Fresh Mint Gum can help you manage your cravings so that you can resist cigarettes in situations where smoke is inappropriate, for example:

where your second-hand smoke may damage other people, such as children.
where smoking is not allowed, such as on a flight or in a hospital.
when smoking should be avoided, such as before surgery.

When you feel an urge to smoke, chew a piece of gum instead of having a cigarette to help you manage your cravings. Continue to use one piece of gum every 1 –2 hours (maximum 15 a day) during the period when you are avoiding smoking.

It is best to stop smoking completely as soon as you feel able to. Follow the instructions above, under ‘Stopping smoking straightaway’.

Once you have stopped smoking...

After you have stopped smoking, you may still sometimes feel a craving for cigarette. You can use NiQuitin Fresh Mint Gum again to help you relieve these cravings – using NRT is always better than smoking again.

If you are worried that you may start smoking again, talk to a healthcare professional. They can advise you on how to get the best results from further courses of NRT.

If you are finding it difficult to stop using NRT completely, talk to a healthcare professional.

How to use the gum

The method of chewing nicotine gum is not the same as for ordinary chewing gum. The gum is chewed to release nicotine then rested, so that nicotine can be taken into your system through the lining of the mouth. If the nicotine gum is chewed continuously, the nicotine is release too quickly and swallowed. This may irritate you throat, upset your stomach and give you hiccups.

Chew a piece of gum when you feel the urge to smoke.
Chew slowly until the taste becomes strong (about 1 minute) then stop and rest the gum against your cheek.
When the taste fades chew a few times until the taste gets strong then rest the gum again.
Keep chewing like this for about half an hour.
When the gum has lost its strong taste, you should dispose of it carefully.

If you use more NiQuitin Fresh Mint Gum than you should

If possible, show them the NiQuitin Fresh Mint Gum packet or this leaflet. Symptoms of nicotine overdose in children include headache, sickness, stomach pain and diarrhoea.

If you take too much gum, you may start to feel sick, dizzy and unwell. Stop using this gum and contact your doctor or hospital emergency department immediately.

4. Possible side-effects

Like all medicines, the nicotine in NRT products can have side-effects. They are similar to those you might get from the nicotine in cigarettes, and are more likely the more nicotine you tale, nut not everybody gets them. At the recommended doses NiQuitin Fresh Mint Gum has not been found to cause any serious side-effects.

Stopping smoking itself can cause symptoms such as dizziness, headache, sleep disturbance and more mouth ulcers than usual.

Other side-effects may include:

Troublesome side-effects do not improve,
Not known: seizures (fits).

Stop taking the gum and tell a healthcare professional if you get these.

Allergic reactions e.g. swelling, a rapid irregular heartbeat or palpitations (feeling your heartbeat).
Sore/irritated throat, more saliva than usual, hiccups.
Feeling sick, stomach pains, jaw ache.
Red or itchy skin.

Tell a healthcare professional if you get any of these.

If you wear dentures it is possible that the gum may stick to them or, in rare cases, damage them.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell a healthcare professional.

Reporting of side effects

If you get any side effects, talk to 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: 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 fresh mint gum do not use this medicine after the ‘exp’ date shown on the blister pack and outer packaging. the expiry date refers to the last day of the month.

Keep all pieces of gum in the carton, in their blister pack, until you are ready to use one.
Do not store above 25°C.
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. Further information

The active substance is nicotine. Each medicated chewing gum contains 2mg or 4mg (in the form of a resin complex called nicotine resinate). The other ingredients are chewing gum base, calcium carbonate, butylhydroxytoluene (E321) as an antioxidant, sorbitol (E420), maltitol liquid, glycerol, acesulfame potassium, mint flavour, mannitol (E421), sodium carbonate anhydrous, sodium hydrogen carbonate, talc, xylitol, acacia, titanium dioxide, eucamenthol flavour, menthol flavour, carnauba wax. NiQuitin Fresh Mint 4mg Medicated Chewing Gums also contain colour quinoline yellow(E104).

What NiQuitin Fresh Mint Gum looks like and the contents of the pack

Rectangular, pillow-shaped gum. The 2mg gum is off-white and the 4mg gum is yellow. Packs contain 12, 24, 36, and 96 pieces. In addition, 2 mg gum packs contain 48 pieces. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder is Omega Pharma Ltd, 32 Vauxhall Bridge Road, London, SW1V 2SA, UK. and all enquiries should be sent to this address.

The manufacturer of NiQuitin Fresh Mint Gum is Fertin Pharma A/S, 7100 Vejle, Denmark.

NiQuitin is a registered trade mark of ELAN PHARMA INTERNATIONAL LTD.

This leaflet was last revised in December 2019.