Nicorette Fruitfusion 6mg Gum
BRAND: Nicorette Gum Flat leaflet
DATE: 2013-08-13/MPS-j_
ARTICLE No: 651253_
DESCRIPTION: Nico gum 6mg FF LP MP
REPLACES No: New_
COUNTRY: England/GB_
SIZE: 280x180 mm -- 2 pages
Black 355
PMS
COLORS:
LAF - LABELING APPROVAL FORM
REGISTRATION DEPARTMENT We hereby confirm that we have examined and approved the following:
□ Text EH Spelling □ Inline printing during production
□ Codes □ Name and Address (Licence holder) □ Country specific symbols/text e.g. legal
□ Licence No.: (Market authorisation No.) EH Exp. date:
Country Date / Signature
MARKETING DEPARTMENT We hereby confirm that we have examined and approved the following:
□ Design Date / Signature / Country:_
By signing the attached artwork the market confirm that this document has been checked completely, i.e. the correctness of all aspects (text, dosage values, spelling, font size etc.) is certified. In case of alterations the concerned parts must be marked clearly. The market approval of this document authorizes the plant to .print the content for this proof. The market takes full responsibility for correctness of this print proof.
PDD McNeil, HBG, SWE August 13, 2013 10:39:37
651253
nicorette fruitfusion 6 mg gum Nicotine chewing gum
What you should know about nicorette® fruitfusion 6 mg gum
(6 mg nicotine chewing gum)
Please read this leaflet carefully before you start using this medicine. It provides useful information on how to use it safely. Keep the leaflet, you might need it again.
If you think you are having side-effects, have any questions or are not sure about anything please ask your doctor, nurse or pharmacist.
1 What the medicine is for
NICORETTE® fruitfusion 6 mg gum is a nicotine replacement therapy (NRT) for heavy smokers.
It is used to relieve and/or prevent withdrawal symptoms and reduce the cravings for nicotine that you get when you try to stop smoking, or when cutting down the number of cigarettes you smoke.
NICORETTE® fruitfusion 6 mg gum can also be used when you are pregnant or breast-feeding to help you stop smoking, as the risks to your baby are far less than if you continue to smoke.
For more information, see "If you are pregnant or breast-feeding" section.
Ideally you should always aim to stop smoking.
You can use NICORETTE® fruitfusion 6 mg gum to achieve this by using it to completely replace all your cigarettes.
However NICORETTE® fruitfusion 6 mg gum can also be used in other ways,
■ if you feel unable to stop smoking completely, or wish to replace certain cigarettes and therefore it can help you to cut down the number of cigarettes you smoke,
■ at those times when you can't or do not want to smoke. For example,
- Where you don't want to smoke and avoid harm to others e.g children or family.
- Smoke free areas e.g Pub, work, public transport e.g aeroplanes.
It may also help increase your motivation to quit. When making a quit attempt a behavioural support programme will increase your chances of success. Details of NICORETTE® ActiveStop are at the end of this leaflet.
The initial dosage should be individualised based on your nicotine dependence:
■ If you smoke 20 or fewer cigarettes a day, the
2 mg nicotine gum will help relieve your cravings.
■ If you smoke more than 20 cigarettes a day, the 4 or 6mg nicotine gum may be more appropriate. The 6 mg gum is particularly recommended if you require enhanced craving relief (i.e. greater decrease in craving intensity, faster craving relief and/or longer craving relief) when compared to the 4mg gum.
What does nicorette® fruitfusion 6 mg gum do?
When you stop smoking, or cut down the number of cigarettes you smoke, your body misses the nicotine that you have been absorbing. You may experience unpleasant feelings and a strong desire to smoke (craving). This indicates that you were dependent on nicotine.
When you chew NICORETTE® fruitfusion 6 mg gum, nicotine is released and passes into your body through the lining of your mouth. The nicotine released from the gum is sufficient to relieve the unpleasant withdrawal symptoms. It will also help to stop the craving to smoke, but NICORETTE® fruitfusion 6 mg gum will not give you the "buzz" you get from smoking a cigarette. Benefits you can get from using NRT instead of smoking
For the best effect, make sure you chew NICORETTE® fruitfusion 6mg gum correctly. See "How to chew NICORETTE® fruitfusion 6 mg gum - the NICORETTE® chewing technique".
The benefits of stopping smoking far outweigh any potential risk from using nicotine from NRT.
It is the toxins in cigarette smoke such as tar, lead, cyanide and ammonia that cause smoking related disease and death, not the nicotine.
■ You may think that smoking helps relieve feelings of anxiety and stress, but it does not deal with the cause of the stress and leads to a number of serious diseases. In addition, the feeling of relaxation after smoking is temporary, with withdrawal symptoms and cravings soon returning.
Nicotine replacement therapy can help relieve nicotine withdrawal symptoms such as irritability, low mood, anxiety, restlessness and cravings
when used in place of cigarettes.
■ NRT may benefit smokers who want to quit, by helping to control weight gain that may be experienced when trying to stop smoking.
Use of NRT is safer than smoking tobacco but as soon as you are ready, you should aim to stop smoking completely.
2 Before using this medicine
□ Do not use nicorette® fruitfusion 6 mg gum:
■ If you are a child under 12 years of age.
■ if you have an allergy to nicotine or any of the other ingredients.
ATalk to your doctor, nurse or pharmacist...
■ if you are pregnant or breast-feeding - you may
be able to use nicotine replacement therapy (NRT) to help you give up smoking but you should try to give up without it. See "If you are pregnant or breast-feeding" section.
■ if you are in hospital because of heart disease
(including heart attack, disorders of heart rate or rhythm, or stroke). In other heart conditions not requiring you to be in hospital, using NRT is better than continuing to smoke.
■ if you have a stomach ulcer, duodenal ulcer, inflammation of the stomach or inflammation of the oesophagus (passage between the mouth and stomach).
■ if you have liver or kidney disease.
■ if you have an overactive thyroid gland or have a phaeochromocytoma (a tumour of the adrenal gland that can affect blood pressure) -your doctor will have told you this.
■ if you have diabetes - monitor your blood sugar levels more often when starting to use NICORETTE® fruitfusion 6 mg gum as you may find your insulin or medication requirements alter.
■ if you are taking other medicines such as theophylline, clozapine or ropinirole. Stopping smoking or cutting down may require the dose of these medicines to be adjusted.
V If any of these applies, talk to your doctor, nurse or pharmacist.
A Some of the ingredients can cause problems
■ NICORETTE® fruitfusion 6 mg gum contains butylated hydroxy toluene (E321), an anti-oxidant, which may irritate your mouth.
A If you are pregnant or breast-feeding
If you are pregnant:
1) Firstly, you should try to give up smoking without NRT. Stopping completely is by far the best option. The earlier and quicker you do this the better it is for you and your baby.
2) Secondly, if you can't manage this, you can use NRT as a safer alternative to smoking as the risks to your baby are far less than smoking, however you should talk to your doctor, nurse or pharmacist for advice.
Products that are used intermittently, including NICORETTE® fruitfusion 6 mg gum, may be preferable to nicotine patches. However, patches may be more suitable if you have nausea or sickness. If you do use patches take them off before going to bed at night.
If you are breast-feeding:
1) Firstly, you should try to give up smoking without NRT.
2) Secondly, if you can't manage this you are best
to use NRT products that are taken intermittently (not patches), however you should talk to your doctor, nurse or pharmacist for advice. Breast-feed just before you use NICORETTE® fruitfusion 6 mg gum to ensure that the baby gets the smallest amount of nicotine possible.
If you do need to use NRT to help you quit, the amount of nicotine that the baby may receive is considerably smaller and less harmful than the second-hand smoke they would inhale if you smoked. Tobacco smoke produces breathing and other problems in babies and children.
3 How and when to use this medicine
O When to use nicorette" fruitfusion 6 mg gum
The table below contains the dosage information for NICORETTE® fruitfusion 6 mg gum. This shows the number of gums you should be using, when and how you should take them.
Please read this information carefully and then go to the "Howto stop smoking" section, which will help you decide which method to use to give up smoking.
■ Use the "How to chew NICORETTE® fruitfusion 6 mg gum -the NICORETTE® chewing technique" instructions which follow. The method of chewing is NOT the same as that for ordinary chewing gum. This way of chewing ensures that the nicotine is correctly released from the gum.
■ The number of NICORETTE® fruitfusion 6 mg gums you use each day will depend on how many cigarettes you smoked and how strong they are. See the dosing table to find out the dose you should take.
© Children under 1 2 years
Do not give this product to children under 12 years.
© Adults and Children 1 2 years and over
|
Number of cigarettes you smoke per day |
Dose of Gums |
|
20 cigarettes or fewer |
One 2 mg gum as required to relieve cravings. |
|
More than 20 cigarettes as required to relieve cravings |
One 4 mg gum as required to relieve cravings. |
|
More than 20 cigarettes requiring strong craving relief |
One 6 mg gum as required to provide enhanced craving relief (i.e. decrease in craving intensity, faster craving relief or longer craving relief) when compared to the 4mg gum |
|
■ Use only one piece of gum at a time. ■ Do not use more than 15 gums per day. ■ The frequency with which you use the gums will depend on how many cigarettes you smoked and how strong they were. ■ Children aged between 12 to 18 years, should consult with a doctor, nurse or pharmacist before starting to use this product. | |
© If you smoke more than
20 cigarettes and experience excessive side-effects
When using the highest strength 6 mg gum, if you experience excessive side-effects, discard the gum and increase the period of time taken between
turn over
651253
each gum. If you continue to experience side-effects, you should switch to the 4 mg gum.
O How to chew nicorette® fruitfusion 6 mg gum - the nicorette® Chewing Technique
The method of chewing NICORETTE® fruitfusion 6 mg gum is not the same as for ordinary chewing gum. NICORETTE® fruitfusion 6 mg gum is chewed to release nicotine then rested so that nicotine can be taken in through the lining of the mouth. If NICORETTE® fruitfusion 6 mg gum is chewed continuously, the nicotine is released too quickly and is swallowed. This may irritate your throat, upset your stomach or give you hiccups.
If you have false teeth you may have difficulty chewing the gum as nicorette fruitfusion 6mg gum could stick to them and on rare occasions, damage dentures. If you experience a problem, other types of nicotine replacement therapy such as a skin patch, inhalator or microtab may be more suitable for you.
© The nicorette® chewing technique
1. Chew slowly until taste becomes strong.
2. Rest between gum and cheek.
3. Chew again when the taste has faded.
■ Keep chewing like this for about half an hour. After this time the gum will have lost its strength and you should dispose of it carefully.
© How to stop smoking
If you are able to stop smoking you should use NICORETTE® fruitfusion 6 mg gum, when needed, in place of cigarettes. As soon as you can (this could be after a number of weeks or months) you should reduce the number of gums you use until you have stopped using them completely.
If you are unable to stop smoking or do not feel ready to quit at this time, you should replace as many cigarettes as possible with NICORETTE® fruitfusion 6 mg gum. There are toxins in cigarettes that can cause harm to your body. NICORETTE® fruitfusion 6 mg gum provides a safer alternative to smoking, for both you and those around you. Reducing the number of cigarettes may also help you to become more motivated to stop smoking. As soon as you are ready you should aim to stop smoking completely.
You can also use NICORETTE® fruitfusion 6 mg gum on those occasions when you can't or don't want to smoke e.g. Social situations such as a party, in the pub or when at work.
When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. If you have quit smoking and want to stop using NICORETTE® fruitfusion 6 mg gum but are finding this difficult you should contact your doctor, nurse or pharmacist for advice.
A If you have used too many gums
If you have used more than the recommended dosage you may experience nausea (feeling sick), vomiting, increased salivation, pain in your abdomen, diarrhoea, sweating, headache,
dizziness, hearing disturbance or weakness.
■ If you do get any of these effects contact a doctor or your nearest hospital Accident and Emergency department immediately. Take this leaflet and the pack with you.
A If a child has used or swallowed the gums
Contact a doctor or your nearest hospital Accident and Emergency department immediately if a child under 12 years uses, chews or swallows this medicine. Take this leaflet and the pack with you.
Nicotine ingestion by a child may result in severe poisoning.
4 Possible side-effects
Like all medicines, NICORETTE® fruitfusion 6 mg gum can have side-effects. As many of the effects are due to nicotine, they can also occur when nicotine is obtained by smoking.
Effects related to stopping smoking (nicotine withdrawal)
You may experience unwanted effects because by stopping smoking you have reduced the amount of nicotine you are taking. You may also experience these effects if you under use NICORETTE® fruitfusion 6 mg gum before you are ready to reduce your nicotine intake.
A These effects include:
■ Irritability, frustration or anger
■ feeling low
■ anxiety
■ restlessness or impatience
■ poor concentration
■ increased appetite or weight gain
■ urges to smoke (craving)
■ night time awakening or sleep disturbance
■ lowering of heart rate
■ bleeding gums or mouth ulcers
■ dizziness or light headedness
■ sore throat or cold-like symptoms
■ cough
■ constipation
Effects of too much nicotine
You may also get these effects if you are not used to inhaling tobacco smoke.
These effects include:
■ feeling faint
■ feeling sick (nausea, vomiting)
■ headache
■ hiccuping (due to excessive swallowing of nicotine) Side-effects of nicorette® fruitfusion 6 mg gum
NICORETTE® fruitfusion 6 mg gum can sometimes
cause a slight irritation of the throat at the start of the treatment. It may also cause increased salivation.
Those who suffer from indigestion may suffer from heartburn or indigestion and may benefit from slower chewing and using either the 2 or 4 mg gum.
The gum may occasionally stick to dentures and in rare cases damage them.
If you notice any of the following allergic reactions (swelling of the mouth, lips, throat and tongue, itching of the skin, swelling of skin, ulceration and inflammation of the lining of the mouth) stop taking nicorette fruitfusion gum and contact a doctor immediately.
Very common side-effects:
(more than 1 in every 10 people are affected)
■ headache
■ sore mouth or throat
■ jaw-muscle ache
■ stomach discomfort
■ feeling sick (nausea)
■ hiccups
■ tingling or numbness of the hands and feet Common side-effects:
(less than 1 in every 10 people are affected)
■ dizziness
■ indigestion
■ sickness (vomiting)
■ increased amount of saliva Uncommon side-effects:
(less than 1 in every 100 people are affected)
■ hives (urticaria)
■ redness or itching of the skin
■ chest palpitations Very rare side-effects:
(less than 1 in 10,000 people are affected)
■ abnormal beating of the heart
V If you get any side effects, talk to your doctor, pharmacist or nurse. 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.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5 Storing and disposal
■ Keep NICORETTE® fruitfusion 6 mg gum out of reach and sight of children and animals. Nicotine in high doses can be very dangerous and sometimes fatal if taken by small children.
■ This medicinal product does not require any special temperature storage conditions. Store in original container to protect from light.
■ Do not use the gum after the 'Use before' date on the box.
■ For the gums in loose-filled cardboard boxes, dispose of within 3 months of opening.
■ Dispose of NICORETTE® fruitfusion 6mg gum sensibly.
■ Medicines should not be disposed of via waste water 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’s in this medicine?
The active ingredient in NICORETTE® fruitfusion 6 mg Gum is 6 mg nicotine.
Other ingredients in NICORETTE® fruitfusion 6 mg gum are: Chewing gum base, xylitol (E967), peppermint oil, sodium carbonate (E500), acesulfame potassium (E950), levomenthol, magnesium oxide (E530), Tuttifrutti flavour, hypromellose (E464), sucralose (E955), polysorbate 80 (E433), acacia, titanium dioxide (E171) and carnauba wax (E903). The chewing gum base contains butylated hydroxytoluene (E321), an anti-oxidant.
The gums do not contain sugar (sucrose) or animal products.
What the medicine looks like
NICORETTE® fruitfusion 6 mg gum is a whitish square coated piece of gum.
Pack types and pack sizes:
The gums are blister packed in sheets of 15 and supplied in packs of 105 or 210 pieces.
The gums are loose-fill packed in a box, wrapped in a transparent plastic film, supplied in packs of 100 (4x25) and 200 (8x25) pieces.
Not all pack sizes may be marketed.
Who makes nicorette® fruitfusion 6 mg gum?
The Product Licence holder is McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.
The manufacturer is McNeil AB, Helsingborg, Sweden. The leaflet was prepared in August 2013.© Information about nicorette®
Active Stop
NICORETTE® ActiveStop is a personalised support programme which works with NICORETTE® to support you, with the aim of helping you give up smoking.
All you need is internet access.
Call 0800 244 838 for information
/mm ActiveStop
Supporting you, body & mind