NIQUITIN 4 MG LOZENGES - patient leaflet, side effects, dosage

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 Lozenges carefully to get the best results from them.

• 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).

In this leaflet:

• 1. What NiQuitin Lozenges do

2. Check before you use NiQuitin Lozenges

3. How to use NiQuitin Lozenges

• 4. Possible side-effects

5. How to store NiQuitin Lozenges

• 6. Further information

1. What NiQuitin Lozenges do

NiQuitin Lozenges are used to help people stop smoking. They work 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 cigarettes smoke, such as tar, carbon dioxide and other toxins, are more harmful to your health. NRT products like NiQuitin Lozenges do no have the 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 feelings ill or irritable) that smokes have when they try to give up.

NiQuitin Lozenges can be used to help you:

• Stop smoking straightaway (a quit attempt).
• Cut down on smoking, perhaps before you go on to stop completely (reducing to quit orjust reducing)

In addition, NiQuitin Lozenges may be used when you:

• Do not wish to smoke or are unable to smoke, for example in confined areas (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 Lozenges 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 Lozenges can help you stop. Any risks of 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.

• Call the NHS Free Smoking Helpline on 0800 022 4332, or visit [ or the Irish National Smokers Quitline on 1850 201 203].
• Or visit http:// for information about a free online support plan.

2. check before you use niquitin lozenges 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 aged under 12. The level of nicotine in NRT is not suitable for children under 12. Children are more susceptible to the effects of nicotine, and it could cause severe toxicity, which can be fatal.

Take special care with NiQuitin Lozenges

• 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 ma need to be adjusted.
• If you have serious liver or kidney problems, because you may be more likely to get sideeffects
• 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 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 not get worst you should talk to your doctor. Y9ou might want to use a non-oral form of NRT instead, such as patches.
• If you have had allergic reactions that involve welling of the lips, face and throat (angioedema) or itchy skin rash (uticaria). Using NRT can sometimes trigger this type of reaction.
• If you are on a low sodium diet. Each lozenge contains about 15 mg sodium and the maximum daily dose (15 lozenges) contains 225 mg sodium. The maximum daily dose may be harmful if you are on a low sodium diet.
• If you have phenylketonuria. The lozenges contains aspartame, a source of phenylalanine which may be harmful to you if you suffer from phenylketonuria.
• Before using if you have ever experienced seizures (fits).
• If you have any concerns about becoming dependent or think you have become dependent on this product.

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.

Pregnancy and breast-feeding

If you are pregnant or planning to become pregnant

Smoking when you are pregnant is harmful to the baby. The risks include poor growth before birth, damage to the baby’s lungs, premature birth and stillbirth. 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 without using NRT. If that’s too difficult, using NRT is safer for you and your baby than continuing to smoke. The nicotine in 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 is 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 them, 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 without using NRT. But if you do need to use NRT, the nicotine that gets into breast milk if less dangerous to your baby than breathing in secondhand 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 will not be absorbing nicotine into your body all the time.
• Try to breast-feed just before your 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 lozengesinstructions for use of niquitin lozenges depends on whether you are:

• Stopping smoking straightaway.
• Cutting down on smoking before you stop.
• Cutting down 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 straight away, talk to a healthcare professional for advice.

In all cases:

• NiQuitin 4mg Lozenges are for smokers who smoke within 30 minutes of waking
• NiQuitin 2mg Lozenges are for smokers who smoke more than 30 minutes of waking.
• 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 20 to 30 minutes.
• Do not chew the lozenge or swallow it whole
• Do not use more than 15 lozenges a day

NiQuitin Lozenges are 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 with your quit attempt. It may help to talk to a healthcare professional if you are find your quit attempt difficult.

• Start by using at least 9 lozenges a day (maximum 15). Suck a lozenges whenever you feel the urge to smoke.
• 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 1 – 2 lozenges, a day, try to stop using themaltogether.

To increase your chances of success, complete the step down programme in full and follow a stop smoking behaviour 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 Lozenges to help you cut down on smoking first.

When you feel an urge to smoke, have a lozenge instead of a cigarette to help you manage your cravings. Cut down the number of cigarettes you smoke per day by 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 smoke completely, follow the instructions above, under ‘Stopping smoking straightaway’. If you have not felt ale to make a quit attempt within 6 months of starting to use NRT, you may find it helpful to talk 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 complete in future.

When you feel an urge to smoke, have a lozenge instead of 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 Lozenges can help you manage your cravings so that you can resist cigarettes in situations where smoking is inappropriate, for example:

• Where your second-hand smoke may damager 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 the urge to smoke, have a lozenges instead of a cigarette to help you manage your cravings. Continue t use on lozenges 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 a cigarettes. You can use NiQuitin Lozenges 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 smoking using NRT completely, talk to a healthcare professional.

If you use more NiQuitin Lozenges than you should

If a child has used or eaten any of the lozenges, contact your doctor or hospital emergency department immediately.

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

If you take too many lozenges, you may start to feel sick, dizzy and unwell. Stop using the lozenges 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 take, but not everybody gets them. At the recommended doses, NiQuitin Lozenges have not been found to cause any serious side-effects.

Stopping smoking itself can cause some symptoms such as dizziness, headache, sleep disturbance, cough and cold-like symptoms, depression, irritability, anxiety and night-time awakening.

Other side-effects may include

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

• Feeling/being sick, hiccups, burping, wind, feeling bloated, diarrhoea, constipation.
• Difficulty swallowing, dry mouth/throat/lips, sore throat, mouth irritation, ulcers in/around mouth
• Indigestion, heartburn, bad breath, increase in saliva, shortness of breath.
• Bad dreams, restlessness, lack of energy, alertness, migraine.
• Tight chest, chest pain, stomach pains, changes in appetite, taste changes.
• Rash, itchy skin, hot flushes, feeling unwell.
• Seizures (fits), stop taking this medicine if you experience seizures.

Tell a healthcare professional if you get any of these.

If you do get any side-effects, even those not mentioned in this leaflet, tell a healthcare professional.

5. how to store niquitin lozenges 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 lozenges in the carton, in their lister pack, until you are ready to use one.
• Do not store above 25oC.
• 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 lozenge contains 2 mg or 4 mg (in the form of a resin complex called nicotine resinate). The other ingredients are mannitol (E 421), sodium alginate, xanthan gum, potassium bicarbonate, calcium polycarbophil, sodium carbonate, aspartame (E 951), magnesium stearate and mint flavour.

What NiQuitin Lozenges look like and the contents of the pack

White, round lozenges with convex surfaces.

The 2mg lozenges has “NL2” on one side. The 4 mg lozenge has “NL4” on one side. Pack contains 36 or 72 lozenges.

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 Lozenges is FAMAR A.V.E. ANTHOUSSA PLANT, Anthoussa Avenue 7, Anthoussa Attiki, 15349, Greece.

NiQuitin is a registered trademark of ELAN PHARMA INTERNATIONAL LTD.

Omega Pharma.

This leaflet was last revised in May 2021.