Niquitin Strips Mint 2.5mg Oral Film
GSK Drawing No.: L629D018/02 Dimensions: 450 x 120 mm
Factory: LTS
Component: Leaflet
Date: 6th June 2013
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NiQuitin* Strips
Mint 2.5 mg Oral Film
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 Strips 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 Strips Mint 2.5 mg Oral Film is referred to as NiQuitin Strips.
In this leaflet:
1. What NiQuitin Strips does
2. Check before you use NiQuitin Strips
3. Flow to use NiQuitin Strips
4. Possible side-effects
5. How to store NiQuitin Strips
6. Further information
NiQuitin Strips 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). They are for smokers who smoke more than 30 minutes after waking. 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 Strips do not 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 feeling III or Irritable) that smokers have when they try to give up.
NiQuitin Strips 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 or just reducing).
In addition, NiQuitin Strips may be used when you:
• do not wish to smoke or are unable to smoke, for example In confined 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 Strips can be used during pregnancy and breast-feeding (see Pregnancy and breast-feeding 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 Strips 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 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.
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• 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 years. 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 Strips
Get help and advice from a healthcare professional:
• if you have had a recent heart attack or stroke, or you suffer from severe heart rhythm problems, unstable or worsening angina (chest pain) or resting angina or uncontrolled high blood pressure you should try to quit smoking without using any NRT products unless your doctor tells you to use them.
• if you have an 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 ever 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 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 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 get worse you should talk to your doctor. You might want to use a non-oral form of NRT instead, such as patches.
• before using if you have ever experienced seizures (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.
Important information about some of the ingredients
NiQuitin Strips contain small amounts of ethanol (alcohol), less than 100 mg per film.
Pregnancy and breast-feeding
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 if possible to use NRT for only 2-3 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 products such as oral films, 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 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 oral film, gum or lozenges to control your cravings as they happen, rather than patches. With oral film, gum or lozenges, you will not be absorbing nicotine into your body all the time.
• Try to breast-feed just before you take the oral film, gum or lozenge, when the nicotine levels in your body are at their lowest. That way, your baby gets as little nicotine as possible.
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Stopping smoking straightaway
lAdults and young people aged 12 years and over:
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
- finding your quit attempt difficult.
• Start by using at least 9 films a day (maximum 15). Use a film whenever you have an | urge to smoke.
• Use the films like this for up to 6 weeks, then gradually cut down the number of films you use a day.
■ Once you are using only 1-2 films a day, try to stop using them altogether. iTo 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
; Adults aged 18 years and over:
' You may find it easier to quit completely later if you use NiQuitin Strips to help you . cut down on smoking first.
When you feel an urge to smoke, have NiQuitin Strips 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 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 talk to a healthcare professional.
Cutting down with no immediate plans to stop
Adults aged 18 years and over:
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, have NiQuitin Strips 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
Adults aged 18 years and over:
NiQuitin Strips can help you manage your cravings so you can resist cigarettes in situations where smoking 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, have NiQuitin Strips instead of a cigarette to help | you manage your cravings. Continue to use one film 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 sometimes feel a craving for a cigarette.
You can use NiQuitin Strips 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.
If you use more NiQuitin Strips than you should
If a child has used or eaten any of the NiQuitin Strips, contact your doctor or hospital \ emergency department immediately.
If possible show them the NiQuitin Strips packet or this leaflet. Symptoms of nicotine overdose in children include headache, sickness, stomach pain and diarrhoea.
If you take too many NiQuitin Strips, you may start to feel sick, dizzy and unwell.
Stop using the films and contact your doctor or hospital emergency department immediately.
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Adults and young people aged 12 years and over
Instructions for use of NiQuitin Strips depend 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 straightaway, talk to a healthcare professional for advice.
In all cases:
NiQuitin Strips are for smokers who smoke more than 30 minutes after waking.
• you should put one film on your tongue, close your mouth and press your tongue gently to the roof of your mouth until the film dissolves (approximately 3 minutes).
• do not chew the film or swallow it whole.
• do not eat or drink while a film is in your mouth, as this may reduce the absorption of the nicotine.
• do not use more than 15 films a day.
NiQuitin Strips 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.
continued overleaf
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 Strips have not been found to cause any serious side-effects.
Stopping smoking itself can cause symptoms such as dizziness, headache, sleep disturbance, cough and cold-like symptoms, depression, irritability, anxiety/nervousness, weakness, tiredness, feeling unwell and night-time awakening.
Other side-effects may include
Very common (affects more than 1 in 10 people)
• feeling sick
Common (affects between 1 in 10 and 1 in 100 people)
• being sick
• indigestion/heartburn
• stomach discomfort
• diarrhoea
• dry mouth
• constipation
• hiccups
• sore or painful or swollen throat
• flatulence
• mouth discomfort
• slight soreness or irritation of mouth or tongue
• headache
• dizziness
• insomnia
• cough
Very rare (affects less than 1 in 10,000 people)
• serious allergic reaction causing swelling of the face, tongue, or throat which may cause difficulty in swallowing or breathing
Other side-effects which have been reported are:
• an increase in your heart rate or awareness of your heart beat
• difficulty swallowing, belching, increased saliva
• feeling weak, lack of energy, flu-like symptoms, feeling unwell
• allergic reaction including itchy bumpy rashes, mouth irritation and ulcers
• tremor
• nervousness
• shortness of breath
• Seizures (fits), stop taking this medicine if you experience seizures.
It is not known how frequently these effects occur.
If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell a healthcare professional.
Reporting of side-effects
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
• Keep out of the reach and sight of children.
• Do not use this medicine after the "EXP" date shown on the foil sachet and on the carton. The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Store in the original package to protect from light and moisture.
• 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.
What NiQuitin Strips contain
The active substance is nicotine. Each film contains 2.5 mg.
The other ingredients are methacrylic acid - ethyl acrylate copolymer (1:1) type A, triethyl citrate (E 1505), peppermint flavour TAK - 032230, sucralose (E 955), sodium hydrogen carbonate (E 500 ii), ethanol.
What NiQuitin Strips look like and contents of the pack
Transparent films approximately 20 mm by 30 mm. Each pack contains 15 or 60 films. Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is GlaxoSmithKline Consumer Healthcare,
Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.
The manufacturer of NiQuitin Strips is LTS Lohmann Therapie-Systeme AG,
Lohmannstr. 2,56626 Andernach, Germany.
If you have any questions or comments about NiQuitin Strips please FREEPHONE our Information Line on 0500 100 222 or e-mail customer.relations@gsk.com.
GlaxoSmithKline
NIQUITIN is a registered trade mark of the GlaxoSmithKline group of companies.
This leaflet was prepared in February 2014. L629123/02L
6509454 /