NICORETTE

NICORETTE freshmint 4 mg compressed lozenges

Important notes (mandatory information)

Nicorette freshmint 4 mg lozenges, compressed. Active ingredient: Nicotine. Areas of application: for the relief of withdrawal symptoms and reduction of cravings for nicotine.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicorette freshmint 4 mg lozenges, compressed for use in adults
Active ingredient: Nicotine

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• You are advised to talk to a doctor or pharmacist if you are still having difficulty quitting smoking without the support of Nicorette lozenges after 9 months.

This package leaflet contains

1. WHAT ARE NICORETTE LOZENGES AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING NICORETTE LOZENGES?
3. HOW ARE NICORETTE LOZENGES TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD NICORETTE LOZENGES BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE NICORETTE LOZENGES AND WHAT ARE THEY USED FOR?

This medicine is used to relieve withdrawal symptoms and reduce cravings for nicotine. Both can occur when you try to quit smoking altogether or initially try to reduce the number of cigarettes you smoke. The treatment is intended for adult smokers aged 18 and over. Nicorette 4 mg lozenges are suitable for smokers with a strong tobacco dependence, e.g. smokers who smoke their first cigarette within 30 minutes of waking up or smoke more than 20 cigarettes a day. This medicine can help you quit smoking immediately or smoke less before quitting altogether. If you think you can quit smoking right away, you should do so. However, if you think that is too big a step, you may want to first reduce the number of cigarettes you smoke before quitting altogether. For more details, see section 3 "How are Nicorette lozenges to be used?". Nicorette lozenges relieve nicotine withdrawal symptoms including cravings, i.e. the discomfort that occurs when you stop smoking. When your body suddenly no longer receives nicotine from tobacco, you may experience unpleasant sensations known as withdrawal symptoms. These include irritability, anger, depressed mood, anxiety, restlessness, difficulty concentrating, increased appetite or weight gain, cravings, waking up at night or sleep disturbances. The nicotine in Nicorette lozenges can help relieve or completely prevent these unpleasant sensations and cravings. To increase your chances of quitting smoking, you should also seek advice and support.

2. WHAT SHOULD YOU CONSIDER BEFORE USING NICORETTE LOZENGES?

Nicorette lozenges must not be used:

• if you are allergic to nicotine or any of the other ingredients of this medicine listed in section 6.
• if you are under 12 years old.
• if you have never smoked.

Warnings and precautions

Please talk to your doctor if you have any of the following conditions. You may still be able to use Nicorette lozenges, but you should talk to your doctor first:

• if you have recently had a heart attack or stroke.
• if you have chest pain (unstable angina pectoris) or angina at rest.
• if you have a heart condition that affects your heart rate or heart rhythm (arrhythmia).
• if you have high blood pressure that is not adequately controlled by medication.
• if you have ever had allergic reactions with swelling of the lips, face and throat (angioedema) or itchy rash (urticaria). Using nicotine replacement therapy can sometimes trigger such reactions.
• if you have severe or moderate liver disease.
• if you have severe kidney disease.
• if you have diabetes.
• if your thyroid gland is overactive.
• if you have a tumor of the adrenal glands (pheochromocytoma).
• if you have a stomach or duodenal ulcer.
• if you have inflammation of the esophagus (esophagitis).

This medicine must not be used by non-smokers.

Children

Nicotine doses that are tolerated by adult smokers can cause severe poisoning in children, which can be fatal. Therefore, Nicorette lozenges must be kept out of the reach of children at all times.

Using Nicorette lozenges with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any other medicines. This is especially important if you are taking medicines that contain any of the following active ingredients: theophylline for the treatment of asthma, tacrine for Alzheimer's disease, clozapine for schizophrenia, ropinirole for the treatment of Parkinson's disease.

Using Nicorette lozenges with food and drink

You must not eat or drink while using the lozenges.

Pregnancy and breast-feeding

It is very important to stop smoking during pregnancy, as smoking can lead to low growth of your baby. It can also lead to premature birth or stillbirth. It is best if you can stop smoking without using nicotine-containing medicines. If you cannot do this, you should only use Nicorette lozenges after consulting the healthcare professional who is monitoring your pregnancy, with your family doctor or with a doctor at a center that specializes in supporting people who want to quit smoking. Nicorette lozenges should be avoided during breast-feeding, as nicotine passes into breast milk and can affect your child. If your doctor has recommended that you use Nicorette lozenges, you should use the lozenge immediately after breast-feeding and not in the last two hours before breast-feeding. Smoking increases the risk of infertility in women and men. It is not known what effect nicotine has on fertility.

Driving and using machines

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

3. HOW ARE NICORETTE LOZENGES TO BE USED?

Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The instructions for using Nicorette lozenges depend on whether you:

• quit smoking immediately.
• quit smoking gradually.

Adults aged 18 and over

Quitting smoking with immediate cessation

The aim is to quit smoking immediately and use the lozenge to reduce cravings. Start by using 8 to 12 lozenges per day. Whenever you feel the urge to smoke, you should put a lozenge in your mouth and let it dissolve. Use the lozenges in this way for up to 6 weeks and then gradually reduce the number of lozenges you use per day. Once you only need 1 or 2 lozenges per day, you should stop using them altogether. You may still occasionally feel a strong craving for a cigarette. If this happens, you can use a lozenge again.

Reducing smoking followed by cessation

The aim is to gradually replace some of your cigarettes with a lozenge. Once you have succeeded in doing this, you can then give up your cigarettes altogether with the help of the lozenges. Finally, you will also stop using the lozenges. If you feel a strong craving to smoke, use a Nicorette lozenge instead of a cigarette to satisfy your craving. Reduce the number of cigarettes you smoke per day as much as possible. If you have not been able to reduce the number of cigarettes you smoke per day after 6 weeks, talk to your doctor or pharmacist. As soon as you feel able to do so, you should stop smoking altogether. Follow the instructions above for immediate cessation. Do this as soon as possible. If your attempt to quit smoking completely has not been successful within 6 months of starting to use this medicine, talk to your doctor or pharmacist. Do not exceed the stated dose. Follow the instructions carefully and do not use more than 15 lozenges in one day (24 hours).

Children and adolescents

Adolescents aged 12 to 17

Nicorette lozenges may only be used on a doctor's prescription.

Children under 12 years of age

Children under 12 years of age must not use this medicine.

This medicine is intended for use in the oral cavity. It is placed in the mouth, where it dissolves and releases nicotine, which is absorbed by the body through the oral mucosa. Place a lozenge in your mouth and move it from one side of the oral cavity to the other from time to time until it has completely dissolved. This usually takes less than 20 minutes. You must not chew or swallow the lozenge whole. You should not eat or drink while you have a lozenge in your mouth. Do not use more than 15 lozenges per day. If you feel that you need to use the medicine for more than 9 months in total, you should ask a doctor or pharmacist for advice.

If you are tempted to start smoking again

Talk to your doctor or pharmacist if you:

• are concerned that you might start smoking again.
• have difficulty stopping using the lozenges altogether.

If you do start smoking again, they can advise you on how to achieve the best results with further use of nicotine replacement therapy.

If you use more Nicorette lozenges than you should

Nicotine overdose can occur if you smoke and use Nicorette lozenges at the same time. If a child has used Nicorette lozenges or if you have used more Nicorette lozenges than you should, contact your doctor immediately or go to the nearest hospital. Nicotine doses that are tolerated by adult smokers can cause severe poisoning in children, which can be fatal. Signs of overdose include feeling sick (nausea), vomiting, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, hearing disturbances and severe weakness. At high doses, this can be followed by a drop in blood pressure, weak and irregular pulse, difficulty breathing, extreme tiredness, circulatory collapse and generalized seizures.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Effects associated with smoking cessation (nicotine withdrawal)

Some of the side effects you may experience when you stop smoking may be withdrawal symptoms due to the decrease in nicotine intake. These side effects include:

• Irritability, aggression, impatience or frustration
• Anxiety, restlessness or difficulty concentrating
• Waking up at night or sleep disturbances
• Increased appetite or weight gain
• Depressed mood
• Strong cravings
• Slow heart rate
• Bleeding gums or mouth ulcers
• Dizziness or light-headedness
• Cough, sore throat, blocked or runny nose
• Constipation

If you notice any of the following serious side effects, you must stop using Nicorette lozenges and see a doctor immediately, as they may be signs of a severe allergy

(Not known: frequency cannot be estimated from the available data):

• Hives (a skin condition characterized by itchy, raised or red patches)
• Swelling of the face, tongue or throat
• Difficulty breathing
• Difficulty swallowing

Most side effects occur in the early stages of use. In the first few days of treatment, there may be irritation in the mouth and throat, but this subsides in most users with continued use.

Other possible side effects

Very common (may affect more than 1 in 10 people):

• Cough
• Headache
• Hiccups
• Nausea (feeling sick)
• Irritation of the throat, mouth or tongue

Common (may affect up to 1 in 10 people):

• Local effects such as burning, inflammation of the oral mucosa, taste disturbances
• Feeling cold, feeling hot, tingling of the skin
• Dry mouth or increased salivation
• Digestive problems
• Pain or discomfort in the abdomen
• Vomiting, flatulence, diarrhea
• Heartburn
• Exhaustion
• Hypersensitivity (allergy)

Uncommon (may affect up to 1 in 100 people):

• Effects on the nose such as congestion and sneezing
• Wheezing (bronchospasm), shortness of breath (dyspnea), tightness in the throat
• Skin redness or excessive sweating
• Oral effects such as tingling in the mouth, inflammation of the tongue, mouth ulcers, peeling of the oral mucosa or voice disturbance, pain in the mouth and throat, belching
• Palpitations, rapid heartbeat, high blood pressure
• Hives and/or itching or skin redness
• Abnormal dreams
• Chest discomfort and pain
• Weakness, malaise

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

• Difficulty swallowing, reduced pain sensitivity in the mouth
• rapid and irregular heartbeat that can be treated with appropriate medicines
• Gagging

Not known (frequency cannot be estimated from the available data):

• Blurred vision, increased tear production,
• dry throat, gastrointestinal discomfort, sore lips

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD NICORETTE LOZENGES BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the container and the outer carton. The expiry date refers to the last day of the month. Tablet container: Store in the original container to protect the contents from moisture. Blister pack: This medicinal product does not require any special storage conditions. Do not use the container for other purposes, as it may contain tablet dust residues, which can form a fine film on objects in the container. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Nicorette lozenges contain

The active substance is nicotine (as nicotine resinate). Each lozenge contains 4 mg of nicotine. The other ingredients are: Tablet core: mannitol (Ph. Eur.), xanthan gum, peppermint flavor (contains gum arabic, peppermint, menthol and eucalyptus flavor), sodium carbonate, sucralose (E955), acesulfame potassium (E950), magnesium stearate (Ph. Eur.) [vegetable]. Film coating: hypromellose (E464), peppermint flavor (contains peppermint, menthol and eucalyptus flavor), titanium dioxide (E171), sucralose (E955), hypromellose, microcrystalline cellulose, muscovite, coated with titanium dioxide (E171), acesulfame potassium (E950), polysorbate 80 (E433). Nicorette lozenges are sugar-free.

What Nicorette lozenges look like and contents of the pack

Oval, white to off-white lozenge with the imprint "n" on one side and "4" on the other side.

Pack sizes

Each tablet container contains 20 lo