Nicotinell Support Mint 2mg Medicated Chewing Gum
PATIENT LEAFLET: INFORMATION FOR THE USER
Nicotinell Support Mint 2mg & 4mg Medicated Chewing Gum Nicotine
Regular Strength
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 Nicotinell Support Mint Medicated Chewing Gum carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your doctor, nurse or pharmacist if you need more information or advice.
• If any of the side effects gets serious, or if you notice any side effect not listed on this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Nicotinell Support Mint Medicated Chewing Gum is and what it is used for
2. Before you take Nicotinell Support Mint Medicated Chewing Gum
3. How to take Nicotinell Support Mint Medicated Chewing Gum
4. Possible side effects
5. How to store Nicotinell Support Mint Medicated Chewing Gum
6. Further information
1. What Nicotinell Support Mint Medicated Chewing Gum is and what it is used for
Nicotinell Support Mint Medicated Chewing Gum is a nicotine replacement therapy (NRT) which is used to help you to stop smoking. It is available in two strengths (2mg and 4mg).
The chewing gum contains nicotine, which is one of the substances in tobacco. When chewed, nicotine is release slowly and absorbed through the lining of the mouth. Pharmacy Stop Smoking aid Chewing Gum does not contain the other harmful substances found in tobacco smoke such as tar and carbon monoxide.
Nicotinell 2mg and 4mg Gum can be used to help you:
• Stop smoking completely
• Cut down the amount you smoke - perhaps before you go on to stop completely In addition, they may be used when you:
• Do not wish to smoke. For example in confined spaces (in the car; in the house) or where others (such as children) could be harmed by tobacco smoke
• Are unable to smoke
• Develop cravings once you have stopped smoking
Reducing the number of cigarettes smoked can increase the chances that you will move on to quit completely.
Nicotinell 2mg Gum is for smokers smoking less than 20 cigarettes per day. It can also be used by smokers smoking between 20 and 30 cigarettes per day, and by those who have previously failed to stop smoking with the aid of nicotine replacement therapy.
Smokers of more than 20 cigarettes per day, who are reducing their smoking prior to quit attempt, should use the lower strength Nicotinell 2mg Gum once they have successfully reduced the number of cigarettes smoked per day.
If you smoke more than 30 cigarettes per day then you should use Nicotinell Support Mint Medicated 4mg Medicated Chewing Gum.
Nicotinell 2mg and 4mg Gum can also be used to relieve breakthrough cravings of smokers attempting to quit by following a patch programme.
You might feel a sudden craving to smoke long after you have given up smoking and stopped using Nicotinell Chewing Gums. Remember you can use any nicotine replacement therapy again if this should happen.
If you need advice before starting to use Nicotinell Chewing Gum, talk to your doctor, nurse, pharmacist or trained counsellor.
To help quit smoking you should also try to use a behavioural support programme to increase your chances of success. Talk to your doctor, nurse, pharmacist, or a trained counsellor about this.
2. Before you take Nicotinell Chewing Gum Do NOT take Nicotinell Chewing Gum if you are
• Allergic (hypersensitive) to nicotine or any of the other ingredients of the chewing gum
• A non-smoker or occasional smoker
• Under 12 years of age, except on the advice of a doctor
Take special care with Nicotinell Chewing Gum
Please speak with your doctor, nurse or pharmacist before taking the chewing gum if you:
• Have heart disease, (e.g. heart attack, worsening chest pain, disorders of the heart rate and/or rhythm)
• Have uncontrolled high blood pressure
• Have recently had a stroke
• Have serious liver or kidney disease
• Have or had a stomach ulcer
• Have persistent indigestion
• Have a severe sore throat or inflammation of the mouth
• Are diabetic (see next section)
• Have an overactive thyroid gland
• Have a tumour of the adrenal glands (pheochromocytoma)
• Are fructose intolerant
• Are on a low-sodium diet
• Are taking any other medicines (see next section)
• Are pregnant or breast-feeding (see Pregnancy/Breast-feeding section)
People have problems with the jawbones and some denture wearers may experience difficulty in chewing the gum. If you do, it is recommended that you use a different form of nicotine replacement therapy, such as a patch or a lozenge. Ask your doctor or pharmacist for advice.
Using nicotine replacement therapy is better than continuing to smoke.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The effect of some medicines can be altered when you stop smoking.
• If you are already taking regular medication you should tell your doctor, nurse or pharmacist.
• Diabetics should monitor their blood sugar levels more often than usual when taking chewing gum before your insulin/medication requirements may alter.
Taking Nicotinell Chewing Gum with food and drink
Coffee, juices, acidic and fizzy drinks may reduce the absorption of nicotine and should not be taken for 15 minutes before chewing the gum.
Pregnancy
Smoking during pregnancy is associated with risks such as poor growth of the baby before birth, premature birth or still birth. Stopping smoking is the single most effective way to improve both your health and that of your baby. The earlier smoking stops the better.
Ideally, stopping smoking during pregnancy should be done without nicotine replacement therapy. However if you have tried and this is not possible, nicotine replacement therapy may be used because the risk to the developing baby is less than that expected from continued smoking.
The decision to use nicotine replacement therapy should be make as early on in the pregnancy as possible with the aim of discontinuing use after 2-3 months.
Ask your doctor for advice before taking any medicine.
Breast-feeding
It is better to use nicotine replacement therapy products that can be taken intermittently (not patches). Try to breast-feed at a time just before you take the product to ensure that the baby gets the smallest amount of nicotine possible.
If you need to use nicotine replacement therapy to help you give up smoking, the amount of nicotine that the baby may receive is considerable smaller and less harmful than the second-hand smoke they would otherwise be breathing in.
Driving and using machines
The chewing gum is unlikely to affect your ability to drive or operate machinery.
Important information about some of the ingredients of Nicotinell Support Mint Medicated Medicated Chewing Gum
These chewing gums contain some ingredients of which you may need to be aware of:
• Sorbitol: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Each piece of mint flavour gum contains 0.2 g, a source of 0.04 g fructose.
• Sodium: each piece of mint flavour gum contains 11.5 mg per piece. To be taken into consideration by those on a controlled sodium diet.
• Butylhydroxytoluene (E321): an ingredient of the gum base which may cause local irritation to the lining of the mouth.
For other ingredients see section 6.
3. How to take Nicotinell Chewing Gum
Chew one piece of hum when you feel the urge to smoke. It is important to chew the gum correctly, not like ordinary chewing gum. Follow the instructions below and do NOT swallow the gum:
Chewing technique:
1. Chew one piece of gum slowly until the taste becomes strong
2. Rest between your gum and cheek.
3. Chew again when taste has faded.
4. Repeat this chewing routine for about 30 minutes.
Most people use 8- 12 pieces of 2 mg gum a day.
Do not use more than 1 piece of gum at a time or more than 25 pieces of 2 mg gum a day or more than 15 pieces of 4 mg gum a day.
Remember not to drink certain drinks 15 minutes before chewing the gum (see section 2).
The gum can stick to and very rarely damage dentures or other dental work. You may prefer to use a patch or lozenge.
After 3 months, you should gradually reduce the number of pieces of gum chewed each day. You should stop suing the gum when you are only taking 1-2 pieces of gum per day.
For the relief of breakthrough cravings:
If you are attempting to quit smoking using a patch programme, you can use these gums to relieve any breakthrough cravings you may experience. Chew one piece of gum if you feel the need to smoke. Counselling may improve your chances of giving up smoking.
Children and adolescents (12-18 years) should only use the gum for 12 weeks. If longer is required then talk to your doctor, nurse or pharmacist.
Children under 12 years should not use the gum unless advised by a doctor.
If you take more Nicotinell Chewing Gum than you should
If you accidentally take too many, or if a child has eaten any, contact your doctor or nearest hospital casualty department immediately, take the pack of leaflet with you if possible. Nicotine ingestion by a child may result in severe poisoning.
The general symptoms of nicotine overdose include:
• Weakness, sweating, increased production of saliva, throat burn, headache, sickness, diarrhoea stomach pains, disturbed hearing and vision, disturbance in heartbeat, shortness of breath and circulatory problems
If you forget to use Nicotinell Chewing Gum
Only chew the gum when you need to. Do NOT use more than 1 piece of gum at a time or more than 25 pieces of 2 mg gum a day or more than 15 pieces of 4mg gum a day.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Nicotinell Chewing Gum can cause side effects, although not everybody gets them. STOP using the gum and seek medical help immediately if you have any of the following which may be signs of an allergic reaction:
• Difficulty breathing or swallowing, swelling of the mouth, face, lips, tongue or throat.
• Severe itching of the skin, with a red rash or raised lumps.
Some side effect you may notice in the first few days are dizziness, headache and sleep disturbances. These may be withdrawal symptoms in connection with smoking cessation and may be caused by insufficient administration of nicotine.
Common side effects (occur in 1 to 10 users in 100)
• Dizziness and headache
• Hiccups, stomach trouble such as nausea, flatulence, vomiting, heartburn, increased saliva production, irritation of the mouth and throat and jaw muscle ache may also occur, especially as a result of intense chewing. Check that you are following the correct chewing technique if you experience these effects.
Uncommon side effects (occur in 1 to 10 users in 1,000)
• Palpitations
• Red skin rash (erythema) and itching of raised bumps of the skin (urticaria)
Rare side effects (occur in 1 to 10 users in 10,000)
• Disturbances in heart beat rhythm and allergic reaction
Mouth ulcers may be related to quitting smoking and not to your treatment.
The chewing gum can stick to and very rarely damage denture or other dental work.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. This include any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Nicotinell Chewing Gum
Keep out of the reach and sign of children.
Do not use Nicotinell Chewing Gum after the expiry date which is sated on the blister pack and box after "EXP". The expiry date refers to the last day of that month.
Do not store above 25°C.
To dispose of used gum, wrap in paper before putting into a waste bun. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to product the environment.
6. Further information
What Nicotinell Chewing Gum contains
The active substance is nicotine.
Each piece of Nicotinell Chewing Gum contains 2 mg of nicotine in a resin complex (as 10 mg nicotine polacrilin).
Each piece of Nicotinell Chewing Gum contains 4 mg of nicotine in a resin complex (as 20 mg nicotine polacrilin).
The other ingredients are
• Gum base, calcium carbonate (E170), sorbitol (E420), sodium carbonate anhydrous, sodium hydrogen carbonate (E500), glycerol (E422), levomenthol, butylhydroxytoluene (E321), saccharin, sacchari sodium (E954), acesulfame potassium (E950), xylitol (E967), mannitol (E421), gelatin, titanium dioxide (E171), carnauba wax (E903), talc (E553b), water.
See section 2 for further ingredient information.
Nicotinell gum is sugar-free.
What Nicotinell Chewing Gum looks like and content of the pack
Each piece of chewing gum is off-white in colour and rectangular in shape.
Nicotinell Support Mint 2mg and 4 mg gums are packed in blisters inside boxes containing 96 pieces of gum.
Marketing Authorisation Holder
Novartis Consumer Health, Camberley, GU15 3YL, UK
Manufacturer
FAMAR S.A., 48th km Athens-Lamia, 19011, Avlona, Greece
Help/advice
You can also find additional information and support @ www.smokefree.nhs.uk or by calling the NHS helpline on 0800 022 4322.
This leaflet was last approved December 2013.