Nicabate Cq Mini 4 Mg Compressed Lozenges
PACKAGE LEAFLET : INFORMATION FOR THE USER
Nicotine Mini 4 mg Lozenges Nicotine
Please read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Nicotine Minis carefully to get the best results from them.
• Keep this leaflet. You may need to read it again.
• Ask a healthcare professional e.g. doctor, nurse, smoking cessation adviser or pharmacist if you need more information or advice.
• 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.
• Throughout this leaflet Nicotine Mini 4 mg Lozenges are referred to as Nicotine Minis. In this leaflet:
1. What Nicotine Minis are and what they are used for
2. Before you take Nicotine Minis
3. How to use Nicotine Minis
4. Possible side effects
5. How to store Nicotine Minis
6. Further information
What Nicotine Minis are and what they are used for
Nicotine Minis are used to help people stop smoking. This type of treatment is called Nicotine Replacement Therapy or NRT.
This pack contains 4 mg Nicotine Minis which are for smokers who smoke more than 20 cigarettes a day.
They can help you give up smoking straightaway. They can also help you cut down smoking before stopping completely. If you think you can stop smoking straightaway, then you should because this is usually best. However, if you feel this is too big a step, then you may wish to try cutting down the amount of cigarettes you smoke as a first step before stopping completely. See Section 3 “How to use Nicotine Minis” for further details.
It is the nicotine in cigarettes that can make you physically addicted to them.
• Nicotine Minis help you to give up smoking by replacing some of the nicotine you get from cigarettes.
• This nicotine relieves some of the unpleasant symptoms that smokers may have when they try to give up. These include feeling ill or irritable.
• The nicotine can also relieve your cravings for a cigarette and help you to resist the urge to smoke.
Nicotine Minis do not have the health dangers of tobacco. This is because they do not contain the tar, carbon monoxide or other toxins in cigarette smoke. 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 continuing to smoke. It also an easier habit to break.
Your chances of stopping smoking will be improved if you take part in a support programme. These “stop smoking programmes” are known as behavioural support. For information on stop smoking programmes please talk to a healthcare professional.
2._Before you take Nicotine Minis
Do not use Nicotine Minis if:
• you are allergic (hypersensitive) to nicotine or any of the other ingredients in the lozenge (See Section 6: Further information)
• you are a non-smoker or under the age of 12 years.
There are no health benefits to smoking. It is always better to give up smoking. Using Nicotine Replacement Therapy (NRT), like Nicotine Minis, can help. In general, any possible side effects associated with NRT are far outweighed by the well known dangers of continuing to smoke.
Take special care with Nicotine Minis:
• 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 you should try to quit smoking 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 Nicotine Minis. Your insulin or medicine requirements may change.
• 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 children under 12 years as the levels of nicotine in Nicotine Replacement Therapy (NRT) are not suitable for children under 12. The effects of nicotine affect children more than adults. It could cause severe poisoning in children which can cause death.
• Do not interchange between Nicotine Minis and nicotine gums during any attempt to quit smoking.
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 or breastfeeding below for more information.)
Get help and advice from a healthcare professional if you have:
• If you have heart or circulation problems including heart failure, stable angina, high blood pressure or occlusive peripheral artery disease
• Serious liver or kidney problems because you may be more likely to get side effects.
• 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.
• 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 patches.
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
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.
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 do 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
Stopping smoking can result in difficulties concentrating and increased irritability.
3. How to use Nicotine Minis
The instructions about how to use Nicotine Minis depend on whether you are:
(a) stopping smoking straightaway
(b) cutting down before stopping
Always use Nicotine Minis exactly as stated in this package leaflet. You should check with your healthcare professional if you are not sure.
This product is for oromucosal use. That means that the nicotine in the tablets is released slowly into the mouth from where it is absorbed into the body.
In all cases you should use Nicotine Minis by putting one lozenge in your mouth and from time to time move it from one side of your mouth to the other, until it is 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. If you feel the need to use Nicotine Minis for longer than 9 months in total, you should ask a healthcare professional for advice.
(a) Stopping smoking straightaway Adults (18 years and over)
• Start by using 8 to 12 lozenges a day. Suck a lozenge whenever you have an 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 only 1 or 2 lozenges a day, stop using them altogether.
After you have given up you may sometimes feel a sudden craving for a cigarette. You can use a lozenge again if this happens.
(b) Cutting down before stopping smoking Adults (18 years and over)
When you feel a strong urge to smoke, use a Nicotine Mini 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 able, you should give up cigarettes completely. Follow the instructions for stopping smoking straightaway given above. Do this as soon as possible. If your attempt to stop smoking completely has not been successful within 6 months of starting the use of Nicotine Minis, speak to a healthcare professional.
Young people (12-17 years inclusive)
You should only use Nicotine Minis following advice from a healthcare professional.
Do not exceed the stated dose. Follow the instructions carefully and do not use more than 15 lozenges in one day (24 hours).
Children under 12 years of age should not use Nicotine Minis.
If you are tempted to start smoking again
If you are:
• worried that you may start smoking again
• finding it difficult to stop using the lozenges completely talk to a healthcare professional.
If you do start to smoke again, they can advise you on how to get the best results from further courses of Nicotine Replacement Therapy (NRT).
If you take more Nicotine Minis than you should
If you use too many Nicotine 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. If the lozenges are used by children or non-smokers 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.
Possible Side Effects
Like all medicines Nicotine Minis can cause side effects, some more common than others, although it is possible you may not get any side effects at all. At the recommended doses Nicotine Minis 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. Symptoms such as depression, irritability, anxiety, restlessness, increased appetite and insomnia may also be related to withdrawal symptoms associated with giving up smoking.
Other Side effects are listed below - they are group based on the likelihood with which they can occur:
Very common (affects more than 1 in 10 people)
• The lozenges may cause your mouth or tongue to be slightly sore or irritated. You may also feel sick.
Common (affects between 1 in 10 and 1 in 100 people)
• Sore throat
• Being sick
• Stomach discomfort
• Diarrhoea
• Indigestion/heartburn
• Flatulence
• Hiccups
Less common side effects (affects between 1 in 100 and 1 in 1000 people)
• Nervousness
• Depression
• Palpitations (feeling your heart beat)
• Increased heart beat
• Chest pain
• Rash
• Tiredness and generally feeling unwell
Very rare (affects less than 1 in 10,000 people)
• Severe allergic reaction symptoms of which include sudden wheeziness or tightness of the chest, rash and feeling faint
•
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.
5. How to store Nicotine Minis
• Keep out of the reach and sight of children.
• Do not use the lozenges after the expiry date stated on the container and outer packaging.
The expiry date refers to the last day of the month.
• Do not store above 30°C.
• Store in the original container in order to protect from moisture.
• Do not use the container for anything else due to possible fine coating of tablet dust in the container.
• Dispose of the container responsibly. 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
What Nicotine Minis contain
The active substance is nicotine 4 mg (in the form of a resin complex called nicotine resinate). The other ingredients are mannitol (E421), sodium alginate, xanthan gum, potassium bicarbonate, calcium polycarbophil, sodium carbonate anhydrous, acesulfame potassium, flavours, magnesium stearate.
Nicotine Minis are sugar free.
What Nicotine Minis look like and contents of the pack
White to off-white oval compressed lozenges (lozenges) with convex surfaces.
The 4 mg lozenge has an “F” on one side.
Each container contains 20 lozenges. Packs may contain one or three containers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
To be completed nationally.
The manufacturer of Nicotine Minis is GlaxoSmithKline Dungarvan Limited Knockbrack Dungarvan, Co. Waterford, Ireland
Nicotine is a registered trademark of the GlaxoSmithKline group of companies.
This medicinal product is authorised in the Member States of the EEA under the following names:
This information to be included at the end of the procedure once all MS names have been agreed. This leaflet was last approved in {09/2009}.