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Galpharm Nicotine Replace 2mg Gum

Nicotine

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you take this medicine because it contains important information you need to know.

This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your doctor, pharmacist lor nurse if you need more information or advice.

IN THIS LEAFLET:

1.    What Galpharm Nicotine Replace 2mg Gum is and what it is used for?

2.    Before you take Galpharm Nicotine Replace 2mg Gum

3.    How to take Galpharm Nicotine Replace 2mg Gum

4.    Possible side effects

5.    Storing Galpharm Nicotine Replace 2mg Gum

6.    Further information

WHAT GALPHARM NICOTINE REPLACE 2MG GUM IS AND WHAT IT IS USED FOR?

Nicotine 2mg Gum can reduce your urge to smoke by providing some of the nicotine previously inhaled from cigarettes. This type of treatment is called Nicotine Replacement Therapy (NRT).

Nicotine 2mg Gum contains nicotine resin which when chewed, releases nicotine which is absorbed (through the lining of the mouth. This nicotine relieves some of the cravings and unpleasant withdrawal symptoms, such as feeling ill, anxious and irritable,

Ithat smokers frequently feel when they try to give up smoking or cut down the number of cigarettes smoked.

hen you are pregnant or breast-feeding it is best if Nicotine 2mg Gum is used to help you stop smoking. Using NRT is safer for you and your baby than continuing to smoke. See the ‘If you are Pregnant or Breast-feeding' section for more information.

Nicotine 2mg Gum can be used to stop smoking completely by replacing all of your cigarettes. However, it can also be used to help:

•    cut down the number of cigarettes you smoke, for example, if you are unable to stop smoking completely or want to replace certain cigarettes

•    in situations where you do not wish to smoke to avoid harming others, such as children or family

•    in situations where you are unable to smoke, such as at work or on public transport.

If possible, when giving up smoking, this medicated chewing gum should be used with a stop smoking behavioural support programme which will increase your chances of success.

This pack contains medicated chewing gum which is for smokers who smoke less than 20 cigarettes a day.

It is always better to stop smoking completely.

Smoking is harmful and has no health benefits. NRT products like this medicated chewing gum can help you stop smoking.

Any risks or possible side effects from NRT are much less than the proven dangers of continuing to smoke, because the chewing gum does not contain the tar, carbon monoxide or other toxic chemicals in cigarette smoke. Some people worry that, when they have stopped smoking, they may become dependent on NRT instead. This is very rare, and if it were to happen it is still safer than continuing to smoke. It is also an easier habit to break.

BEFORE YOU TAKE GALPHARM NICOTINE REPLACE 2MG GUM

Do not take this medicine if you:

•    are allergic to nicotine or any of the other ingredients

•    are under 12 years of age. The level of nicotine in NRT is not suitable for children under 12. Children are more susceptible to the effects of nicotine, and it

^ could cause severe toxicity, which can be fatal.

Talk to your doctor, pharmacist or nurse before taking this medicine if you:

•    are in hospital because of a heart attack, severe heart rhythm disturbances or a stroke.

If you have other heart conditions which do not require you to be in hospital, using NRT is better than continuing to smoke

•    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

•    have liver or kidney disease

•    have a stomach ulcer, duodenal ulcer or have inflammation of the oesophagus (oesophagitis), which is the tube leading from the mouth to the stomach

•    have an uncontrolled, overactive thyroid gland or have been diagnosed as having a tumour of the adrenal glands (phaeochromocytoma)

•    are diabetic, as diabetic patients need to monitor blood sugar levels more closely as nicotine from smoking or from taking the gum may vary them more than usual

•    are taking other medicines such as theophylline, clozapine or ropinirole. When you stop smoking yourl metabolism slows down and this may alter the way your body responds to certain medicines.

Important information about some of the ingredients in this medicine:

This medicine contains maltitol and sucralose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains butylated hydroxytoluene, which may cause local skin reactions (e.g contact dermatitis), and local irritation to the eyes and mucous membranes.

If you are Pregnant or Breast-feeding

If you are pregnant

•    Smoking when you are pregnant is harmful to your baby. If you are pregnant it is best to give up smoking without using NRT. Stopping smoking completely is the best option, and the earlier you stop smoking the better it is for the health of you and your baby

•    If you can't manage stopping smoking, using NRT is a safer alternative than continuing to smoke. However, you should ask for advice from your doctor, nurse or pharmacist. Nicotine 2mg Gum may be more suitable for use than patches as it can be used intermittently. If you have nausea or sickness, patches may be more suitable, however, if you do use patches take them off before going to bed at night.

If you are breast-feeding

•    If you are breast-feeding it is best if you stop smoking without NRT

•    If you do use NRT while breast-feeding, products that are taken intermittently such as gum are best. However, you should talk to your doctor, pharmacist or nurse for more advice.

Try to breast-feed just before you take the gum, when nicotine levels in your body are at their lowest. That way your baby gets as little nicotine as possible. If you do need to use NRT to help you stop smoking, your baby may receive a smaller amount of nicotine and this is less dangerous than breathing in secondhand smoke.

Tobacco smoke is harmful to babies and children, causing breathing difficulties and other problems.

□ HOW TO TAKE GALPHARM NICOTINE REPLACE 2MG GUM

• The following instructions for use depend on whether you are stopping smoking completely, cutting down the number of cigarettes you smoke per day or if you are going without cigarettes for a short time • The 2 mg chewing gums are suitable for people who smoke 20 or fewer cigarettes per day, or by people who are heavier smokers who are reducing the number and strength of product they are using • The chewing gum may not be suitable for use if you have false teeth, as it could stick to them and more rarely, damage the dentures.

Please turn over ta+i

Adults and young people aged 12 years and over

Number of cigarettes smoked per day

One gum as required to manage cravings

How to chew your chewing gum

This is a special type of gum and is not like ordinary chewing gum. Use it as follows:

• Chew 1 piece of medicated chewing gum for about 30 minutes with regular pauses '• It is important to chew the medicated chewing gum slowly and with regular pauses to allow the nicotine to be taken in through the lining of the mouth, and also so that the nicotine is not released too quickly p After 30 minutes dispose of the chewing gum carefully.

Stopping Smoking Completely

Ilf you are able to stop smoking completely, use a medicated chewing gum in place of cigarettes when needed. As soon as you feel ready, you should reduce (the number of chewing gums you use until you are able to stop taking them completely. It is important to make every effort to stop smoking completely. But if you do sometimes smoke a cigarette while using NRT, don't be discouraged - just keep going with your quit attempt. It may help to talk to a healthcare professional If you are finding your quit attempt difficult.

Cutting down the number of cigarettes smoked per day

if you are unable to stop smoking completely or want (to replace certain cigarettes you should use Nicotine 2mg Gum in place of as many cigarettes as possible. (7ou may find it easier to quit completely later if you use his gum to help you cut down on smoking first.

'ou can also use Nicotine 2mg Gum to help manage our cravings in situations where you can't or do not wish to smoke, for example, at work or on public transport.

If you are worried that you may start smoking again, talk to a healthcare professional. They can advise you on |how to get the best results from further courses of NRT.

|lf you are finding it difficult to stop using NRT ompletely, talk to a healthcare professional.

What should you do if you use too many gums?

If you take more than the recommended number of gums, you may suffer a nicotine overdose and need to pet advice from your doctor. Signs of overdose include headache, sickness, stomach pains and diarrhoea.

If a child has used or swallowed the gums Contact a doctor or your nearest hospital casualty 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.

FI POSSIBLE SIDE EFFECTS

Sometimes there can be some side effects from giving iup smoking or using this chewing gum.

Some symptoms may be withdrawal symptoms bonnected with stopping smoking and reducing the amount of nicotine you are taking. These can be; irritability or aggression, feeling low, anxiety, (restlessness, poor concentration, increased appetite or weight gain, urges to smoke, night-time awakening, leep disturbance and lowering of heart rate.

~At the start ot treatment the chewing gum may causeH a slight throat irritation, it may also cause an increase in salivation. Occasionally, the chewing gum may stick to, and rarely, it may damage dentures.

Other side effects include:

Very common side effects (more than 1 in every 10 people are affected)

•    headache

•    stomach discomfort, hiccups and feeling sick

•    sore mouth or throat

•    jaw-muscle ache

Common side effects (less than 1 in every 10 peoplei are affected)

•    dizziness

•    sickness (vomiting)

Uncommon side effects (less than 1 in every 100 people are affected)

•    irregular heartbeat (palpitations)

•    hives (rashes)

•    redness or itching of the skin

Rare side effects (less than 1 in 1000 people are affected)

•    Allergic reactions (swelling of the face, lips and throat (angioedema) which may cause difficulty in swallowing or breathing).

Very rare side effects (less than 1 in 10,000 people are affected)

•    Abnormal heart beats

If any of the side effects get serious, or if you notice side effects not listed in this leaflet, please tell your doctor or pharmacist.

After stopping smoking you may develop mouth ulcers; it is not known why this happens.

Reporting of side effects

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.aov.uk/vellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

STORING GALPHARM NICOTINE REPLACE 2MG GUM

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date printed on the pack.

Do not store above 25°C and store in the original package. Keep blister in the outer carton to protect from light.

Dispose of this medicine sensibly.

FURTHER INFORMATION

Your medicated chewing gum is a white, rectangular shaped and coated piece of chewing gum.

The active ingredient is nicotine 2mg in the form of a resin complex (nicotine resinate 13.2mg).

The other ingredients are: Gum Base (containing butylated hydroxytoluene [E321]), Calcium Carbonate, Xylitol, Sodium Carbonate Anhydrous, Sodium Hydrogen Carbonate, Acesulfame Potassium, Sucralose, Peppermint, Coolmix, L-Menthol, Talc, Maltitol (E965), Titanium Dioxide, Maltitol liquid and Carnauba wax.

The gums are available in pack sizes of 10, 12, 20, 24, 30, 36, 48, 50, 80, 96 and 108 pieces of chewing gum, although not all pack sizes may be marketed.

The Marketing Authorisation holder is

Wrafton Laboratories Limited, Wrafton, Braunton, Devon, EX33 2DL, UK.

The manufacturer is: Fertin Pharma A/S, Vejle, Denmark.

Text revised: September 2015.

Nicotine side effects can generally occur when taking his chewing gum. These effects include; feeling faint, eeling sick, headache and hiccupping (due to excessive swallowing of nicotine).