Nicabate Minis Citrus 1.5 Mg Compressed Lozenges
Package leaflet: Information for the user
Nicabate Minis Citrus 1.5 mg Compressed Lozenges
Nicotine
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your healthcare professional told you.
- 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 you get any side effects, talk to your healthcare professional. This includes any possible side effects not listed in this leaflet.
- You must talk to a doctor if you have not been able to stop smoking after 9 months of treatment with Nicabate Minis.
- Throughout this leaflet Nicabate Minis Citrus 1.5 mg Lozenges are referred to as Nicabate Minis. What is in this leaflet:
1. What Nicabate Minis are and what they are used for
2. What you need to know before you use Nicabate Minis
3. How to use Nicabate Minis
4. Possible side effects
5. How to store Nicabate Minis
6. Contents of the pack and other information
1. What Nicabate Minis are and what they are used for
Nicabate Minis are used to help people stop smoking. This type of treatment is called Nicotine Replacement Therapy or NRT. Nicabate Minis 1.5 mg Lozenges are suitable for smokers who smoke 20 cigarettes or less a day.
It is the nicotine in cigarettes that can make you physically addicted to them.
• Nicabate 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.
Nicabate 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 is 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 or pharmacist.
There are no health benefits to smoking. It is always better to give up smoking. Using Nicotine Replacement Therapy (NRT), like Nicabate 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 Nicabate Minis
Do not use Nicabate Minis:
• if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6)
• if you are a non-smoker.
• if you are under the age of 12 years.
Warnings and precautions
Talk to your healthcare professional before using Nicabate 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) high blood pressure which is not being controlled by medicines 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 Nicabate 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.
Do not interchange between Nicabate Minis Lozenges and nicotine gums during any attempt to quit smoking.
Get help and advice from a healthcare professional if you have:
• severe or moderate liver or severe 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 inflammation of the oesophagus (gullet) 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 nicotine patches.
Children (under 12 years)
The correct dose for adults could seriously poison or be fatal to small children. It is therefore essential that you keep Nicabate minis out of sight and reach of children at all times.
Other medicines and Nicabate Minis
Tell your healthcare professional if you are using or have recently used or might use any other medicines. This is especially important if you use other medicines which contain: theophylline (to treat asthma), tacrine (for alzheimer’s disease), clozapine (for schizophrenia), ropinirole (to treat Parkinson’s disease).
Stopping smoking may alter the effect of other medicines you may be taking. If you have any questions or concerns about this talk to your healthcare professional.
Nicabate Minis with food or drink
You should not eat or drink while Nicabate Minis are in your mouth.
Pregnancy, breast-feeding and fertility
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.
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 take the product just after breast-feeding . This helps your baby to get the smallest amount of nicotine possible.
Driving and using machines
There are no known effects of Nicabate Minis on your ability to drive or use machines. However you should be aware that giving up smoking can cause behavioural changes that could affect your ability to drive or use machines.
3. How to use Nicabate Minis
Always use this medicine exactly as described in this leaflet or as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
You should use Nicabate 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 Nicabate Minis for longer than 9 months in total, you should ask a healthcare professional for advice.
This product is for oromucosal use.That means that the nicotine in the lozenge is released slowly into the mouth from where it is absorbed into the body.
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.
Do not exceed the stated dose.
Follow the instructions carefully and do not use more than 15 lozenges in one day (24 hours).
Use in children and adolescents Adolescents (12-17 years inclusive)
You should only use Nicabate Minis following advice from a doctor.
Children under 12 years
Children under 12 years of age must not use Nicabate Minis
If you are worried that you may start smoking again
If you are worried that you may start smoking again or 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 NRT.
If you use more Nicabate Minis than you should
If you use too many Nicabate 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.
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 Nicabate 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 coldlike 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 based on the likelihood with which they can occur.
Very common: may affect 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: may affect up to 1 in 10 people
• Sore throat
• Being sick
• Stomach discomfort
• Diarrhoea
• Indigestion/heartburn
• Flatulence
Hiccups
Uncommon: may affect up to 1 in 100 people
• Nervousness
• Depression
• Palpitations (feeling your heart beat)
• Increased heart beat
• Chest pain
• Rash
• Tiredness and generally feeling unwell 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
If you get any side effects, talk to your healthcare professional. This includes any possible side effects not listed in this leaflet.
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: www.yellowcard.mhra.gov.uk. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Nicabate Minis
• Keep this medicine out of the sight and reach of children.
• Do not use the medicine after the expiry date which is 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 the product from moisture.
• Do not use the container for anything else due to possible fine coating of tablet dust in the container.
• Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information What Nicabate Minis contain:
• The active substance is nicotine. Each lozenge contains 1.5 mg of nicotine (in the form of resin complex called nicotine resinate)
• The other ingredients are mannitol (E421), sodium alginate (E401), sodium carbonate anhydrous, calcium polycarbophil, magnesium stearate (E470b),xanthan gum (E415), acesulfame potassium (E950), potassium hydrogen carbonate (E501 ), Citrus flavour and Peppermint flavour.
What Nicabate Minis look like and contents of the pack:
White to off-white oval compressed lozenges with convex surfaces.
The 1.5 mg lozenge has a “U” on one side.
Each container contains 20 lozenges. Packs may contain one (20 lozenges) or three containers (60 lozenges). Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Consumer Healthcare 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom +442080470171
Manufacturer: GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan Co. Waterford, Ireland.
This leaflet was last approved in December 2014