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Nicorol Toffee 2 Mg Pastilles

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicorol Toffee 2 & 4 mg Pastilles Nicorol Citrus 2 & 4 mg Pastilles Nicorol Spearmint 2 & 4 mg Pastilles

Nicotine

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Nicorol Pastilles carefully to get the best results from them.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if you cannot refrain from smoking after 6 months’ treatment with Nicorol Pastilles.

•    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.

In this leaflet:

1.    What Nicorol Pastilles are and what they are used for

2.    Before you take Nicorol Pastilles

3.    How to take Nicorol Pastilles

4.    Possible side effects

5.    How to store Nicorol    Pastilles

6.    Further information

1.    WHAT NICOROL PASTILLES ARE AND WHAT THEY ARE USED FOR

Nicorol Pastilles belong to a group of medicines which are used to help you stop smoking.

The nicotine in Nicorol Pastilles relieves withdrawal symptoms (including craving for nicotine) when you stop smoking and counteracts thereby relapse into smoking in smokers who are motivated to stop.

When you suddenly stop providing nicotine in the form of tobacco to your body, you get hit by different kinds of discomfort, called withdrawal symptoms. By means of Nicorol Pastilles you can prevent or at least reduce this discomfort, by continuing to provide a small amount of nicotine to your body during a short period of time.

Advice and support normally improve the success rate.

2.    BEFORE YOU TAKE NICOROL PASTILLES Do not take Nicorol Pastilles

•    if you are allergic (hypersensitive) to nicotine or any of the other ingredients of Nicorol Pastilles (see section 6, Further Information)

•    if you are a non-smoker

Take special care with Nicorol Pastilles

Talk to your doctor before using Nicorol Pastilles if any of the following apply to you:

•    if you have untreated high blood pressure

•    if you have any other cardio- or cerebrovascular disorders, such as

o chest pain due to angina o recent heart attack or stroke o problems with your blood circulation o heart failure

o abnormalities in heart beat rhythm

•    if you have diabetes

•    if you have an overactive thyroid gland (hyperthyroidism)

•    if you have a tumour of the adrenal gland (pheochromocytoma)

•    if you have a stomach ulcer

•    if you have inflammation of the mouth, throat or gullet

•    if you have severe kidney or liver problems

People under 18 years of age should not use Nicorol Pastilles, unless prescribed by a doctor.

The correct dose for adults could seriously poison or even kill small children. It is therefore essential that you keep Nicorol Pastilles out of reach and sight of children at all times.

You should stop smoking completely during treatment with Nicorol Pastilles.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription. This is especially important if you are taking any of the following medicines:

•    caffeine (in some cough and cold medicines)

•    theophylline, and salbutamol (for asthma)

•    imipramine, clomipramine or fluvoxamine (for depression)

•    pentazocine, phenacetin, propoxyphene or phenylbutazone (painkillers)

•    tacrine (for Alzheimer’s disease)

•    olanzapine or clozapine (for schizophrenia)

•    flecainide (for heart rhythm problems)

•    ropirinol (for parkinson’s disease)

•    prazosin and propranolol (for high blood pressure).

•    insulin (for diabetes)

•    furosemide (“water tablets”)

•    isoprenaline (for heart attacks)

•    medicines used to treat stomach ulcers

Taking Nicorol Pastilles with food and drink

Do not eat or drink whilst you have a Nicorol pastille in your mouth.

You should also avoid drinking coffee, fruit juice and other soft drinks for at least 15 minutes before taking a pastille because it may decrease the absorption of nicotine.

Pregnancy and Breast-feeding

It is very important to stop smoking during pregnancy because it can result in poor growth of your baby. It can also lead to premature births and even stillbirths, if you continue smoking during the third trimester. Ideally you should try to give up smoking without the use of medicines containing nicotine. If you cannot manage this, Nicorol Pastilles should only be used after consulting the healthcare professional who is managing your pregnancy, your family doctor, or a doctor in a centre that is specialized in helping people quit smoking.

Nicorol Pastilles should be avoided during breast-feeding as nicotine is found in breast milk and may affect your child. If your doctor has recommended you to use Nicorol Pastilles during breast-feeding, the pastille should be taken just after breast-feeding and not during the two hours before breast-feeding.

Driving and using machines

Nicorol Pastilles should not affect your ability to drive or use machines when used following the recommended dose.

However, stopping smoking can cause changes in your behaviour such as irritability.

Important information about some of the ingredients of Nicorol Pastilles

These pastilles contain sorbitol (an artificial sweetener). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

Each pastille contains 0.5 mmol (11.5mg) sodium. The maximum daily dose of 30 pastilles for the 2 mg strength contains 15 mmol (345 mg) of sodium. To be taken into consideration by patients on a controlled sodium diet.

3. HOW TO TAKE NICOROL PASTILLES

Always take Nicorol Pastilles exactly as stated in this package leaflet. You should check with your doctor or pharmacist if you are not sure.

You should stop smoking completely during the treatment with Nicorol Pastilles.

How many Pastilles should I take?

Start your treatment by taking one pastille every 1-2 hours. In most cases 8-12 pastilles per day is sufficient.

The following table provides an approximate guidance for selecting a proper dosage:

Number of cigarettes / day    Suggested Dosage

around 20 - 30    2 mg

about more than 30 cigarettes    4 mg

The 4 mg pastilles should also be taken if you have previously failed to give up smoking after using Nicorol 2mg pastilles.

If you feel that the Nicorol 2mg pastilles are too strong for you, take advice from your pharmacist for reducing the dosage further.

For Nicorol 2 mg pastilles the maximum dose is 30 pastilles per day.

For Nicorol 4mg pastilles the maximum dose is 15 pastilles per day.

In addition to Nicorol Pastilles, professional counselling may help you quit smoking.

Instructions for proper use:

1.    The pastille should be moistened in the mouth and then moved to either cheek cavity.

The pastille should not be aggressively sucked, chewed or swallowed whole.

2.    At intervals, the pastille should be moved from one side of the mouth to the other until the pastille is completely dissolved (20-30 minutes).

Different types of nicotine replacement products may release different amounts of nicotine at different speeds and may therefore not be directly interchangeable.

For how long should I take Nicorol Pastilles?

How long you take Nicorol Pastilles will vary from person to person. The duration of treatment is individual, but is normally 2 to 3 months and after that you should gradually reduce the number or strength of the pastilles you are taking each day. You should stop using Nicorol Pastilles when your dose has reduced to 1 or 2 pastilles of 4mg or 2mg per day. If you wish to reduce the dose further ask your pharmacist.

It is recommended that you do not use Nicorol Pastilles for more than 6 months. Some exsmokers may need to take the pastilles for longer to avoid returning to smoking. Do not use Nicorol Pastilles for more than 6 months without asking your doctor or pharmacist for advice.

People under 18 years of age should not use Nicorol Pastilles, unless prescribed by a doctor.

If you take more Nicorol Pastilles than you should

Even small amounts of nicotine are poisonous for children. If poisoning is suspected in a child or if you (or someone else) have taken too many Nicorol Pastilles, contact your doctor or hospital casualty department straight away.

If you have taken too many Nicorol Pastilles, you may experience stomach pain, diarrhoea, headache, dizziness, increased saliva, feel or be sick and sweat excessively. In the case of a large overdose you may experince extreme tiredness, a drop in your blood pressure, weak an irregular pulse, difficullty breathing and convulsions.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nicorol Pastilles can cause side effects, although not everybody gets them. Nicorol Pastilles can give the same side effects as nicotine given in another way. The side effects are generally dose-dependent.

Most of the side effects reported by patients generally occur during the first 3-4 weeks. If any of the side effects get troublesome, talk to your doctor or pharmacist.

Very common side effects (affects more than 1 user in 10):

•    bitter taste in the mouth

Common side effects (affects 1 to 10 users in 100):

•    gas formation

•    headache

•    dizziness

•    nausea (feeling sick)

•    hiccups

•    inflammation of the throat

•    dry mouth

•    irritation of the mouth and/or gullet

•    blocked nose

•    cough

Uncommon side effects (affects 1 to 10 users in 1,000):

•    fast or irregular heartbeat

Rare side effects (affects 1 to 10 users in 10,000):

•    reversible heart fibrillation (heart failure)

•    allergic reactions, which can be serious

Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

Aphthous mouth ulcers may occur when trying to quit smoking, but the relationship to the nicotine treatment is not clear.

Some symptoms such as dizziness, headache and sleeping disturbances may be caused by withdrawal symptoms during smoking cessation and can depend on too low supply of nicotine.

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

5.    HOW TO STORE NICOROL PASTILLES Keep out of the reach and sight of children.

Do not use Nicorol Pastilles after the expiry date which is stated on the blister and the carton after <to be completed nationally>: The expiry date refers to the last day of that month.

Do not store above 30C.

Store in the original package in order to protect from moisture.

Medicines should not be disposed of via wastewater 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 Nicorol Pastilles contain

•    The active substance is nicotine. Each pastille contains 2 mg or 4 mg nicotine.

•    The other ingredients are spray-dried acacia, liquid sorbitol (non-crystallising) (E420), xylitol, sodium dihydrogen phosphate dihydrate, tri-sodium phosphate dodecahydrate, sodium hydroxide, talc, maize starch, Capol (contains white beeswax and vegetable oil).

Nicorol Toffee:, toffee flavour, which contains natural flavouring substance, propylene glycol, ethyl alcohol 95%.

Nicorol Citrus: orange oil and lemon oil.

Nicorol Spearmint: spearmint flavour,.which contains anethole, cornmint oil (Mentha arvensis), orange oil, spearmint oil, alpha-terpineol

What Nicorol Pastilles look like and the contents of the pack

Nicorol Pastilles are round and light brown to brown and marked N2 (2 mg) or N4 (4 mg) on one side.

The pastilles are packaged in blisters with 2, 14, 20, 28, 42, 56, 60, 72, 100 Pastilles in each package.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf., Reykjavikurvegur 76-78, IS - 220 Hafnarfjordur, Iceland Manufacturer

Jemedic AB, Lotangsgatan 7, S-803 01, Gavle, Sweden This leaflet was last approved in: 04/2010