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Document: Nicorette Pepparmint compressed lozenge ENG PL change

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• Nicorette Pepparmint compressed lozenge ENG PL

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PACKAGE LEAFLET : INFORMATION FOR THE USER

Nicorette Pepparmint 2 mg compressed lozenges and Nicorette Pepparmint 4 mg compressed lozenges

Nicotine

Please 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 Nicorette Pepparmint carefully to get the best results from it.

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

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

- 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.

- You are recommended to seek professional advice if after 9 months you still have difficulties refraining from smoking, without the help of Nicorette Pepparmint.

In this leaflet:

push the opening button on the side while lifting the lid

This medicine is used to relieve withdrawal symptoms and reduce the cravings for nicotine that you get when you try to stop smoking or when you are cutting down the number of cigarettes you smoke while trying to stop smoking. The treatment is for adult smokers 18 years and above.

Nicorette Pepparmint 2 mg Lozenges are suitable for smokers who have a low nicotine dependency e.g., who either have their first cigaretteof the day more than 30 minutes after waking up or who smoke fewer than 20 cigarettes per day.

Nicorette Pepparmint 4 mg lozenges are suitable for smokers with high nicotine dependency e.g., those smoking their first cigarette of the day within 30 minutes after waking up or those who smoke more than 20 cigarettes per day.

This medicine can help you give up smoking straightaway or to cut down smoking before stopping completely. If you think you can stop smoking straightaway, then you should. However, if you feel this is a too big step, then you may wish to try cutting down the amount of cigarettes you smoke as a first step before stopping completely. See Section 3 “How to use Nicorette Pepparmint” for further details.

Nicorette Pepparmint relieve the nicotine withdrawal symptoms, including cravings, you get whenyou stop smoking. When your body suddenly stops getting nicotine from tobacco, you get hit by different kinds of unpleasant feelings called withdrawal symptoms,such as irritability, feeling angry or low, anxiety, restlessness, poor concentration, increased appetite or weight gain, urges to smoke (craving), night time awakening or sleep disturbance. The nicotine in Nicorette Pepparmint can help prevent or reduce these unpleasant feelings and cravings for smoking.

To improve the chances of helping you to stop smoking, also seek counseling advice and support.

Do not use Nicorette Pepparmint if:

• you are allergic (hypersensitive) to nicotine or any of the other ingredients in the lozenge.

• you are under 12 years of age.

• you have never smoked.

Take special care with Nicorette Pepparmint:

Contact your doctor if you suffer from the following. You may still be able to use Nicorette Pepparmint Lozenges, but need to discuss with your doctor first if you have:

• Recently had a heart attack or stroke

• Chest pain (unstable angina) or resting angina

• A heart condition that affects your heart rate or rhythm (arrhythmia)

• High blood pressure which has not been controlled by medicines

• Heart failure or problems with your circulation

• Ever had allergic reactions that involve swelling of the lips, face and throat (angioedema) or itchy skin rash (urticaria). Using NRT can sometimes trigger this type of reaction

• Severe or moderate liver disease

• Severe kidney disease

• Diabetes

• An overactive thyroid gland

• A tumour of the adrenal gland (phaeochromocytoma)

• Stomach or duodenal ulcer

• Oesophagitis

This medicine should not be used by someone who has never smoked or a child under the age of 12 years.

Nicorette Pepparmint lozenges are sugar-free.

Using other medicines

Some chemicals in tobacco smoke can affect how other drugs are broken down in the body. When a smoker stops smoking, with or without Nicorette Pepparmint, this may result in a slower breakdown and a consequent rise in blood levels of such drugs:

Adjustment of the dose by your doctor may be required when taking the following medicines: Asthma medicine (theophylline, salbutamol), antidepressives (imipramine, clomipramine, fluvoxamine), analgesics (pentazocine, phenacetin), anti-inflammatory medicines (phenylbutazone), treatments for dementia (Alzheimer’s disease) (tacrine), treatments for schizophrenia (olanzapine, clozapine), treatments for irregular or fast heart beats (flecainide), antidiabetics (insulin), treatment for Parkinson`s disease (ropinirole), medicines for heart problems (prazosin, propanolol, isoprenaline) or medicines containing caffein.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Nicorette Pepparmint with food and drink

Do not eat or drink when administering the lozenges. Beverages that make the mouth acidic, such as coffee, juice and soft drinks, may reduce the absorption of nicotine. To reach maximal absorption of nicotine these beverages should be avoided for up to 15 minutes before the lozenge is taken.

Pregnancy and breast-feeding

It is very important to stop smoking during pregnancy because it can result in low birth weight or miscarriage. It is best if you can give up smoking without the use of medicines containing nicotine. If you cannot manage this, Nicorette Pepparmint should only be used after consulting your doctor. However, Nicorette patches may be preferred if you suffer from nausea during pregnancy.

As nicotine passes into breast milk and may affect your child, this medicine should only be used during breast-feeding after consultation with your doctor. If your doctor has recommended you to use Nicorette Pepparmint, the lozenge should be taken just after breast-feeding and not during the two hours before breast-feeding.

Driving and using machines

No effects on the ability to drive cars or use machines have been observed.

People under 18 years of age should not use this medicine, unless prescribed by a doctor. The instructions about how to use Nicorette Pepparmint depend on whether you are:

Always use Nicorette Pepparmint exactly as stated in this package leaflet. You should check with your healthcare professional if you are not sure. Those between 12 and 17 years of age should not use Nicorette Pepparmint, unless recommended by a doctor.

This medicine is for oromucosal use. This medicine is to be placed in the mouth where it is allowed to dissolve and release nicotine for absorption through the lining of the mouth into the body.

In all cases you should use this medicine by putting one lozenge in your mouth and from time to time move it from one side of your mouth to the other, until it is completely dissolved. This should usually take less than 20 minutes. Do not chew the lozenge or swallow it whole. Do not use more than 15 lozenges a day. If you feel the need to use this medicine for longer than 9 months in total, you should ask a doctor for advice.

The idea is to stop smoking immediately and use the lozenge to relieve the cravings to smoke.

Adults (18 years and over)

• Start by using 8 to 12 lozenges a day. Whenever you have an urge to smoke, one lozenge should be placed in the mouth and allowed to dissolve.

• Use the lozenges like this for up to 6 weeks, then gradually cut down the number of lozenges you use a day.

• Once you are using only 1 or 2 lozenges a day, stop using them altogether. After you have given up you may sometimes feel a sudden craving for a cigarette. You can use a lozenge again if this happens.

The idea is to start by gradually replacing some of your cigarettes with the lozenge. After achieving this you then give up cigarettes completely while using the lozenge. Finally, you give up using the lozenge.

Adults (18 years and over)

When you feel a strong urge to smoke, use a Nicorette Pepparmint Lozenge instead of a cigarette to help you manage your cravings. Cut down the number of cigarettes you smoke per day as many as possible. If you have not been able to cut down the number of cigarettes you smoke each day after 6 weeks, talk to your healthcare professional.

As soon as you feel able, you should give up cigarettes completely. Follow the instructions for stopping smoking straightaway given above. Do this as soon as possible. If your attempt to stop smoking completely has not been successful within 6 months of starting the use of this medicine, speak to a healthcare professional.

Do not exceed the stated dose. Follow the instructions carefully and do not use more than 15 lozenges in one day (24 hours).

You should not eat or drink while a lozenge is in the mouth (see Taking Nicorette Pepparmint with food and drink).

Children 12 years and over

Nicorette Pepparmint should only be used following advice from a doctor.

Children under 12 years of age

Do not give this medicine to children under 12 years.

If you are tempted to start smoking again

If you are:

• worried that you may start smoking again

• finding it difficult to stop using the lozenges completely talk to a healthcare professional.

If you do start to smoke again, they can advise you on how to get the best results from further courses of nicotine Replacement Therapy (NRT).

If you take more Nicorette Pepparmint than you should

If you have used too many Nicorette Pepparmint Lozenges you may experience symptoms similar to those resulting from heavy smoking: paleness, cold sweat, nausea, salivation, burning sensation in the throat, vomiting, stomach pain, diarrhoea, headache, dizziness, disturbed hearing and vision, tremor, mental confusion and weakness.

Overdosing of nicotine may occur if you smoke at the same time as you take Nicorette Pepparmint.

At high doses, the symptoms detailed above may be followed by low blood pressure, weak and irregular pulse, difficulty breathing, extreme tiredness, collapse and convulsions.

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.

The lozenges are not suitable for children under 12 or people who have never smoked. If the lozenges are used by children or people who have never smoked they may show signs of nicotine overdose. If a child takes this medicine, contact your doctor or go to the nearest hospital immediately. Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in small children and may prove fatal.

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

Like all medicines Nicorette Pepparmint can cause side effects, some more common than others, although it is possible you may not get any side effects at all.

Stopping smoking itself can cause symptoms such as dizziness, headache, sleep disturbance, cough and cold-like symptoms. The side effects are generally dependent on the dose you take. Symptoms such as depression, irritability, anxiety, restlessness, increased appetite and insomnia may also be related to withdrawal symptoms associated with giving up smoking.

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

• nausea mouth/throat and tongue irritation

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

cough, sore throat dizziness, headache irritability, anxiety, sleep disorders including abnormal dreams vomiting , Diarrhea, Gastro-intestinal discomfort, flatulence, hiccups, heartburn, dyspepsia (indigestion)

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

• nervousness, depression

• palpitation (unusual feeling of your heart beating), increased heart rate,

• skin rash

• fatigue, malaise, chest pain

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

Very rare side effects (affects less than 1 user in 10,000)

If you notice any of the following serious side effects stop taking Nicorette Pepparmint and contact a doctor immediately, as they may be a sign of severe allergy:

• hives (a skin condition characterised by itching raised or red spots)

• swollen face, tongue or throat

• difficulty in breathing

• difficulty in swallowing

Most of the side effects occur during the early phase of use. During the first few days of treatment irritation in the mouth and throat may be experienced, however most users adapt to this with continued use.

• Keep out of the reach and sight of children.

• Do not use the lozenges after the expiry date stated on the container and outer packaging. The expiry date refers to the last day of the month.

• In polypropylene container: Store in the original container in order to protect from moisture.

• In blister: this medicinal product does not require any special storage conditions.

• Do not re-use the container for anything else as there may be tablet dust in the container which may deposit a fine coating on items within.

• Dispose of the container responsibly. 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.

What Nicorette Pepparmint contain

The active substance is nicotine (in the form of nicotine resinate). Each lozenge contains 2 mg or 4 mg nicotine.

The other ingredients are tablet core: mannitol (E421), xanthan gum, Winterfresh RDE4-149 Spray dried (gum arabic (E414), peppermint, menthol and eucalyptol flavourings), sodium carbonate, anhydrous (E500)(i), sucralose (E955), acesulfame potassium (E950), magnesium stearate (E470b)

coating: hypromellose (E464), Winterfresh RDE4-149 (peppermint, menthol and eucalyptol flavourings), titanium dioxide (E171), sucralose (E955), Sepifilm Gloss (hypromellose (E464), microcrystalline cellulose (E460), potassium aluminium silicate (E555), titanium dioxide (E171)), acesulfame potassium (E950), polysorbate 80 (E433)

Nicorette Pepparmint Lozenges are sugar free.

What Nicorette Pepparmint look like and contents of the pack

An oval, white to off-white tablet imprinted with a “n” on one side and “2” or “4” on the other side.

Pack sizes:

Each plastic bottle contains 20 lozenges. Packs may contain one, four or eight bottles.

Each cardboard box contains 2 blister charts of 12 lozenges. With and without a carrying case.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

To be completed nationally.

This medicinal product is authorised in the Member State of the EEA under the following name:

< {Name of the Member State} > < {Name of the medicinal product} >

< {Name of the Member State} > < {Name of the medicinal product} >

This leaflet was last approved in 17 May 2016 SE takes over as RMS