Document: Nicotinell Spearmint medicated chewing gum ENG PL change

• Nicotinell Spearmint medicated chewing-gum PL
• Nicotinell Spearmint medicated chewing gum ENG PL

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Package leaflet: Information for the user

Nicotinell Spearmint 2 mg medicated chewing-gum

Nicotinell Spearmint 4 mg medicated chewing-gum

nicotine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

This medicine is available without prescription. However, you still need to use Nicotinell Spearmint medicated chewing-gum carefully to get the best results from it.

Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.

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

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

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1What Nicotinell Spearmint chewing-gumis and what it is used for

Nicotinell belongs to a group of medicines which are used to help you stop smoking.

Nicotinell Spearmint chewing-gum contains nicotine. When chewed, nicotine is released slowly and absorbed through the lining of the mouth. This medicinal product is used to relieve nicotine craving and withdrawal symptoms in nicotine dependency. It thereby
- counteracts the relapse in smoking in smokers who are motivated to stop or
- facilitate smoking reduction in smokers who cannot or are reluctant to stop.

2What you need to know before you take Nicotinell Spearmint chewing-gum

Do not take Nicotinell Spearmint

• if you are allergic (hypersensitive) to any of the ingredients of this medicine (listed in section 6).

• if you are a non-smoker.

Warnings and precautions

Talk to your doctor before using Nicotinell Spearmint if you have:

• recently had a heart attack or stroke,

• any heart disease,

• high blood pressure,

• diabetes,

• overactive thyroid glands,

• overactive adrenal glands (pheochromocytoma),

• impaired kidney and/or liver function,

• peptic ulcer

In these conditions it is not sure that it is suitable for you to use Nicotinell Spearmint.

People having problems with the joint of the jawbone and denture wearers may experience difficulty in chewing the gum. If you do, it is recommended that you use a different pharmaceutical form of nicotine replacement therapy.

Do not smoke while taking Nicotinell Spearmint, since you may obtain so high a concentration of nicotine that you will feel bad.

Children and adolescents

The correct dose for adults could seriously poison or be fatal to small children. It is therefore essential that you keep Nicotinell Spearmint out of reach and sight of children at all times.

Other medicines and Nicotinell Spearmint chewing-gum

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

No information is available on interactions between Nicotinell Spearmint chewing-gum and other medicines. However, the action of some drugs may be affected if you stop smoking. This is particularly important if you use drugs containing

• theophyllin (a medicine used for the treatment of bronchial asthma) ,

• tacrine (a medicine used to treat Alzheimer's disease),

• olanzapine and clozapine (for the treatment of schizophrenia).

Nicotinell Spearmint with food and drink

Coffee, acidic and soft drinks may decrease the absorption of nicotine and should be avoided for 15 minutes before chewing a Nicotinell Spearmint chewing-gum.

Pregnancy and breast-feeding

Nicotine may affect your unborn baby. Nicotinell Spearmint should only be usedduring pregnancy after prescription by a doctor.

Nicotine is transferred to breast milk and there is a risk that the breast-fed child will be affected. Nicotinell Spearmint should only be usedduring breast-feeding after prescription by a doctor.

Driving and using machines

There is no evidence of risk associated with driving or operating machinery if Nicotinell Spearmint chewing-gum is taken according to the recommended dose but remember that smoking cessation can cause behavioral changes.

Nicotinell Spearmint chewing-gum contains sorbitol, butylhydroxytoluene and sodium

Because Nicotinell Spearmint chewing-gum contains sorbitol: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Nicotinell Spearmint chewing-gum.

Each piece of chewing-gum contains 0.1 g sorbitol, a source of 0.02 g fructose. Calorific value 1.0 kcal/piece of chewing-gum (Nicotinell Spearmint 2 mg) and 0.9 kcal/piece (Nicotinell Spearmint 4 mg) respectively.

The gum contains butylhydroxytoluene (E321) which may cause local irritation to mucous membranes in the mouth.

Nicotinell Spearmint chewing-gum contains 11 mg of sodium per piece. To be taken into consideration by people on a controlled sodium diet.

3How to use Nicotinell Spearmint chewing-gum

Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor if you are not sure.

The appropriate dose will depend on your nicotine dependence. You should use the 4 mg Nicotinell Spearmint chewing-gum if

• you are a smoker with a strong nicotine dependency,

• you have previously failed to stop smoking with the 2 mg chewing-gum.

Otherwise 2 mg Nicotinell Spearmint chewing-gum should be used.

Select your optimal dosage from the following table:

If an adverse event occurs with the use of the high dose (4 mg), use of the low dose (2 mg) should be considered.

It is important to chew the chewing-gum in a correct way to avoid discomfort (e.g. hiccups and heart burn).

Instructions for use:

Do not swallow the chewing-gum.

Dosage for adults over 18 years:

Chew one piece of gum when you feel the urge to smoke.

At the beginning of the treatment, in general, one piece of chewing-gum should be chewed every one or two hours. Normally 8-12 pieces of chewing-gum per day are sufficient, irrespective of strength. Do not exceed 25 pieces a day of 2 mg chewing-gum or 15 pieces per day of 4 mg chewing-gum.

Smoking cessation:

The treatment duration is individual. Normally, treatment should continue for at least 3 months. After 3 months, you should gradually reduce the number of pieces of gum chewed each day. Treatment should be stopped when you have reduced your use of the gum to 1-2 chewing-gums per day.

It is generally not recommended to use Nicotinell Spearmint chewing-gum for longer than 1 year. However, some ex-smokers may need treatment with the chewing-gum for longer to avoid returning to smoking.

Counselling may improve your chances of giving up smoking.

Smoking reduction:

Nicotinell Spearmint is used between periods of smoking in order to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. If a reduction in the number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought. Aquit attempt should be made as soon as you feel ready, but not later than 6 months after start of treatment. If a quit attempt cannot be made within 9 months after starting treatment, professional advice should be sought.

Counselling may improve your chances of giving up smoking.

Use in children and adolescents

Nicotinell should not be used by people under 18 years of age without recommendation from a doctor.

If you take more Nicotinell Spearmint than you should

Chewing too many chewing-gum pieces can result in the same symptoms as smoking too much. The general symptoms of nicotine overdose include weakness, sweating, increased production of saliva, throat burn, nausea, vomiting, diarrhoea, pain in the abdomen, disturbance of hearing and vision, headache, fast or other disturbance in heart beat, shortness of breath.

If you have taken more of the drug than you should, or if a child has taken the drug by mistake, contact a doctor or hospital for assessment of risk and advice.

If poisoning is suspected in a child, a doctor must be consulted immediately. Even small quantities of nicotine are dangerous in children and may result in severe symptoms or death.

If you forget to use Nicotinell Spearmint

Do not take a double dose to make up for a forgotten dose.

4Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some effects 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.

Stop taking Nicotinell Spearmint and contact immediately a doctor if you get any of the following symptoms of a serious allergic reaction (angioedema or anaphylactic reaction)

Other side effects that may occur:

Common (may affect up to 1 in 10 people)

• dizziness, headache and sleep disturbances

• hiccups, stomach issues, nausea, vomiting, increased saliva production, and inflammation of the mouth mucous. Mouth, throat and jaw muscle ache may also occur, especially as a result of intense chewing. Slower chewing will usually overcome these problems.

Uncommon (may affect up to 1 in 100 people)

• palpitations,

• red skin rash (erythema) and itching of raised bumps of the skin (urticaria).

Rare (may affect up to 1 in 1,000 people)

• disturbances in heart beat rhythm

• Hypersensitivity reaction

Mouth ulcers may be related to quitting smoking and not to your treatment.

The gum can stick to and rarely damage dentures or other dental work.

Reporting of side effects

If you get any side effects, talk to your pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5How to store Nicotinell Spearmint chewing-gum

Keep this medicine out of the sight and reach of children.

Do not use Nicotinell Spearmint after the expiry date which is stated on the label of the package after “EXP”. The expiry date refers to the last day of that month.

Do not store above 25°C.

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.

6Contents of the pack and other information

What Nicotinell Spearmint contains

Nicotinell Spearmint medicated chewing-gum is available in two strengths.

The active substance is nicotine.

Each piece of Nicotinell Spearmint chewing-gum contains 2 mg or 4 mg nicotine (as 10 mg or 20 mg nicotine polacrilin (1:4)).

The other ingredients are:

Gum base (containing butylhydroxytoluene (E321)), xylitol, calcium carbonate (E170), sorbitol (E420), mannitol (E421), sodium carbonate anhydrous, sodium hydrogen carbonate, natural mint flavouring, Novamint spearmint, polacrilin, glycerol, levomenthol, sucralose, gelatine, titanium dioxide (E171), acesulfame potassium (E950), carnauba wax and talc.

Nicotinell Spearmint medicated chewing gum is sugar free.

What Nicotinell Spearmint looks like and contents of the pack

Each piece of coated chewing-gum is off-white in colour and rectangular in shape.

The chewing-gums are packed in blisters containing 12 chewing-gums. The blisters are packed in boxes containing 12, 24, 48, 84, 96 or 204 pieces of chewing-gum.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

<To be completed nationally>

This medicinal product is authorised in the Member States of the EEA under the following names:

DK	Nicotinell Spearmint medicinsk tyggegummi 2 mg and 4 mg
FI	Nicotinell Spearmint 2 mg and 4 mg lääkepurukumi
IE	Nicotinell Spearmint 2mg and 4 mg Medicated Chewing Gum
IS	Nicotinell Spearmint 2 mg and 4 mg lyfjatyggigúmmí
NO	Nicotinell 2 mg and 4 mg medisinsk tyggegummi Spearmint
SE	Nicotinell Spearmint 2 mg and 4 mg
UK	Nicotinell Spearmint 2mg and 4 mg Medicated Chewing Gum.

This leaflet was last revised in 2015-02-27