Nicabate Mint 2.5 Mg Orodispersible Film
PACKAGE LEAFLET: INFORMATION FOR THE USER
Nicabate Mint 2.5 mg Orodispersible Film
Nicotine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always
you.
use this medicine exactly as described in this leaflet or as your healthcare professional has told 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 the leaflet.
Throughout this leaflet Nicabate Mint 2.5 mg Orodispersible Films are referred to as Nicabate Films or nicotine films.
What is in this leaflet:
1. What Nicabate Films are and what they are used for
2. What you need to know before you use Nicabate Films
3. How to use Nicabate Films
4. Possible side effects
5. How to store Nicabate Films
6. Contents of the pack and other information
1. What Nicabate Films are and what they are used for
Nicabate Films are used to help people stop smoking. This type of treatment is called Nicotine Replacement Therapy or NRT.
It is the nicotine in cigarettes that can make you physically addicted to them.
Nicabate Films 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 Films 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 Nicabate Films 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. What you need to know before you use Nicabate Films.
Do not use Nicabate Films if:
• you are allergic to nicotine or any of the other ingredients in this medicine listed in section 6)
• 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 Nicabate Films, can help. In general, any possible side effects associated with NRT are far outweighed by the well known dangers of continuing to smoke.
Warning and precautions
Talk to your healthcare professional before using Nicabate Films
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 diabetes you should monitor your blood sugar levels more often than usual when you start using Nicabate Films. 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:A normal dose for adults could cause a severe poisoning in children which can cause death. It is therefore very important to always keep Nicabate Films out of the sight and reach of children
If you are pregnant or breastfeeding 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 and breastfeeding below for more information.)
Get help and advice from a healthcare professional if you have:
• 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.
Children (under 12 years)
Children under12 years of age should not use nicotine films.
Other medicines and Nicabate Films
Please tell your healthcare professional if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Nicabate Films with food and drink
You should not eat or drink while a Nicabate Film is in the mouth.
Pregnancy or breastfeeding
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 Nicabate Films may be preferable to nicotine patches. This is because with Nicabate Films, you do not get the nicotine all the time. However, patches may be preferred if you have nausea or sickness.
If you are breastfeeding 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 need to 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 a Nicabate Film, rather than patches). It is also better to breastfeed just before you use the product. This helps your baby to get the smallest amount of nicotine possible.
Driving and using machines
There are no known effects of Nicabate Films 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.
Nicabate Films contain small amounts of ethanol (alcohol), less than 100 mg per Nicabate Film.
3. How to use Nicabate Films
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.
During any attempt to give up smoking using Nicabate Films it is important that you make every effort to stop smoking completely. However, if you do smoke a cigarette while you are using NRT, you should continue your quit attempt. If you continue to have difficulty stopping smoking talking to your doctor, nurse, smoking cessation advisor or pharmacist may help.
Instructions for opening the sachet are on the outside of the sachet. Do not use if nicotine film is
damaged.
You should use Nicabate Films by putting one film on your tongue, close your mouth and press the tongue gently to the roof of the mouth until the Nicotine Film dissolves (approximately 3 minutes). Do not chew the film or swallow it whole. You should not eat or drink while a Nicabate Film is in your mouth as this may reduce the absorption of the nicotine. Do not use more that 15 Nicabate Films a day. If you feel the need to use Nicabate Films for longer than 9 months in total, you should ask a healthcare professional for advice.
Adults (18 years and over)
The table below shows how many nicotine films to use during the first 12 weeks of treatment.
For the first 6 weeks use at least 9 nicotine films a day • For the first 6 weeks use at least 9 nicotine films a day
|
STEP 1 Weeks 1 to 6 | ||
|
STEP 2 Weeks 7 to 9 | ||
|
STEP 3 Weeks 10 to 12 | ||
|
Initial treatment |
Step down treatment |
Step down treatment |
|
period |
period |
period |
|
1 nicotine film eveiy |
1 nicotine film eveiy |
1 nicotine film eveiy |
|
1 to 2 horn s |
2 to 4 horns |
4 to 8 horns |
• To help you stay smoke free over the next 12 weeks, you can use 1-2 nicotine films per day in situations where you are strongly tempted to smoke.
• Once you are using only 1 -2 nicotine films a day, stop using them altogether.
Use in children and adolescents Adolescents (12-17 years inclusive)
You should only use Nicabate Films following advice from a doctor.
Children under 12 years of age should not use nicotine films.
This product is for oromucosal use. This means that the nicotine in the nicotine films is released slowly into the mouth from where it is absorbed into the body.
Do not exceed the stated dose. Follow the instructions carefully and do not use more than 15 nicotine films in one day (24 hours).
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 nicotine films 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 use more nicotine films than you should
If you use too many nicotine films you may start to feel sick, dizzy and unwell. Stop using the nicotine films and get advice straightaway from a doctor or hospital casualty department. If possible, show them the packet or this leaflet.
The nicotine films are not suitable for children under 12 or non-smokers. If the nicotine films 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 nicotine films, 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.
If you forget to use Nicabate Films
You should carry on using the medicine as recommended.
If you stop using Nicabate Films
If you stop using the medicine before the recommended time you may feel the urge to smoke again.
4. Possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets them.
Stopping smoking itself can cause symptoms such as headache, dizziness, increased coughing or a cold. Symptoms such as weakness, tiredness, feeling unwell, nervousness and insomnia may also be related to giving up smoking.
Other side effects are listed below - they are based on the likelihood with which they can occur:
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 swollen throat flatulences
light soreness or irritation of mouth or tongue
Othe
headache dizziness insomnia cough 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
It is not known how frequently these effects occur. 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
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 website: 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 films
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the sachet and 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Nicabate Films contain
The active substance is nicotine 2.5 mg per orodispersible film.
The other ingredients are Methacrylic Acid - Ethyl Acrylate Copolymer (1:1), Type A, Triethyl Citrate (E1505), Peppermint Flavour TAK - 032230, Sucralose (E955), Sodium Hydrogen Carbonate (E500 ii), Ethanol.
What Nicabate Films look like and contents of the pack
Nicabate Films are transparent films approximately 20 mm by 30 mm.
Each film comes in its own sachet. Each pack contains 10, 15, 30 or 60 sachets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Omega Pharma Ltd, 32 Vauxhall Bridge Road, London, SW1V 2SA, UK
Manufacturer: LTS Lohmann Therapie- Systeme AG, Lohmannstr. 2, D- 56626 Andernach, Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Belgium Czech Republic
NiQuitin Mint 2,5 mg Schmelzfilme NiQuitin mint 2,5 mg, film orodispersible NiQuitin Mint 2,5 mg Orodispergovatel
NiQuitin Mint 2,5 mg smeltefilm NiQuitin Mint 2,5mg Schmelzfilm
film Denmark Germany
This leaflet was last revised in October 2015.