Nicotinell Mint 1 mg lozenges

Nicotinell Mint lozenges belong to a group of medicines used to help you stop smoking.

How it is used

What are Nicotinell Mint lozenges and what are they used for?

Nicotinell Mint lozenges contain nicotine, one of the ingredients in tobacco.

This medicine belongs to a group of medicines used to help you stop smoking.

When you suck the lozenge, nicotine is slowly released from the lozenge into your mouth and absorbed into your body through the lining of your mouth.

This medicine is used to help people stop smoking. The nicotine in Nicotinell lozenges relieves nicotine withdrawal symptoms and cravings when you stop smoking or temporarily reduce the number of cigarettes you smoke, and makes it easier to give up smoking. In smokers who are motivated to quit, Nicotinell lozenges help to prevent relapse by relieving withdrawal symptoms and cravings.

Counselling and support usually increase the chances of success.

Nicotinell is for use in smokers aged 18 years and over.

How to use it

What are Nicotinell Mint lozenges and what are they used for?

Nicotinell Mint lozenges belong to a group of medicines used to help you stop smoking. Nicotinell Mint lozenges contain nicotine as the active ingredient.

When you suck the lozenge, nicotine is slowly released from the lozenge into your mouth and absorbed into your body through the lining of your mouth.

This medicine is used to help people stop smoking. The nicotine in Nicotinell lozenges relieves nicotine withdrawal symptoms and cravings when you stop smoking or temporarily reduce the number of cigarettes you smoke, and makes it easier to give up smoking. In smokers who are motivated to quit, Nicotinell lozenges help to prevent relapse by relieving withdrawal symptoms and cravings.

Counselling and support usually increase the chances of success.

Nicotinell Mint lozenges are indicated for smokers aged 18 years and over.

What you need to know before you use it

What you need to know before you use Nicotinell Mint lozenges?

Nicotinell Mint 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 a non-smoker.

Warnings and precautions

Talk to your doctor or pharmacist before using Nicotinell Mint lozenges if you have any of the following conditions:
- any form of heart disease such as a recent heart attack, existing heart rhythm problems, heart failure or chest pain (angina including Prinzmetal’s angina). If you experience worsening of your heart condition while using this medicine, Nicotinell should be reduced or stopped.
- if you have had a stroke (cerebrovascular accident).
- high blood pressure.
- circulation problems.
- diabetes mellitus. You should check your blood sugar levels more often than usual when you start using Nicotinell lozenges. Your insulin or medicine requirements may change.
- overactive thyroid gland (hyperthyroidism).
- tumour of the adrenal gland (phaeochromocytoma).
- kidney or liver disease.
- inflammation of the gullet (oesophagitis), inflammation of the mouth and throat, inflammation of the lining of the stomach (gastritis) or stomach or duodenal ulcer (peptic ulcer).
- a history of epilepsy (fits).

Children and adolescents

Nicotinell must not be used by children and adolescents under 18 years of age without medical advice.

The adult dosage may cause severe poisoning or be fatal in young children. It is therefore very important to keep Nicotinell lozenges out of the reach of children at all times. Nicotinell lozenges must not be used by children under 12 years of age.

Using Nicotinell Mint lozenges with other medicines

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

If you stop smoking and are taking other medicines at the same time, your doctor may need to adjust the dose.
There is no information on interactions between Nicotinell lozenges and other medicines. However, ingredients other than nicotine in cigarettes may also affect the way some medicines work.

Stopping smoking may affect the way some medicines work, for example:

• Theophylline (a medicine used to treat bronchial asthma).
• Tacrine (a medicine used to treat Alzheimer’s disease).
• Olanzapine and clozapine (used to treat schizophrenia).
• Insulin doses (a medicine used to treat diabetes) - may need to be adjusted.

Using Nicotinell Mint lozenges with food and drink

Coffee, acidic drinks or fizzy drinks can reduce the absorption of nicotine through the lining of the mouth and should be avoided for 15 minutes before sucking a lozenge. Do not eat or drink while you have a lozenge in your mouth.
Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

It is very important to stop smoking during pregnancy as it can lead to your baby being born underweight. Smoking can also lead to premature birth or even stillbirth. It is best to give up smoking without using nicotine replacement therapy. If you are unable to do this, Nicotinell lozenges should only be used
if you have sought medical advice.

Breast-feeding

Nicotinell Mint lozenges should be avoided during breast-feeding because nicotine passes into breast milk and may affect your baby. If your doctor has recommended that you use Nicotinell Mint lozenges while you are breast-feeding, you should only use the lozenges after breast-feeding, and not within 2 hours before breast-feeding.

Fertility

Smoking increases the risk of infertility in both women and men. The effects of nicotine on fertility are not known.

Driving and using machines

There is no evidence of any risks when driving or operating machinery when the lozenges are used at the recommended dose, but bear in mind that giving up smoking can cause changes in behaviour.

Nicotinell Mint lozenges contain aspartame, maltitol and sodium

Nicotinell Mint 1 mg lozenges contain 10 mg aspartame (E951) per lozenge. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare inherited disorder in which phenylalanine builds up because the body cannot break it down properly.

Do not take Nicotinell lozenges if you have been told by your doctor that you have an intolerance to some sugars.
Nicotinell Mint 1 mg lozenges contain 0.9 g maltitol (E965). This should be taken into account if you are on a diabetes diet. The calorific value is 2.3 kcal/g maltitol. Maltitol may have a mild laxative effect.

This medicine contains less than 1 mmol sodium (23 mg) per lozenge, that is to say essentially
‘sodium-free’.

How to take the medicine

How to use Nicotinell Mint lozenges?

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

Nicotinell Mint lozenges are available in 2 strengths: 1 and 2 mg.

The lozenges can be used on their own (a) or in combination with a Nicotinell transdermal patch (b).

Adults over 18 years of age

(a) Using Nicotinell lozenges on their own


Nicotinell Mint 1 mg lozenges are recommended for smokers with mild to moderate nicotine dependence.

They are not recommended for smokers with a heavy or very heavy nicotine dependence.
Choose your optimum strength using the following table:



If side effects occur when using the higher strength (2 mg lozenge), this should be replaced with the lower strength (1 mg lozenge).

Dosage for adults over 18 years of age

Suck a lozenge whenever you have a craving for a cigarette. Take 1 lozenge every one to two hours. Normally, 8-12 lozenges per day are sufficient, but if you still have cravings for a cigarette, you may take more lozenges. However, do not take more than 24 lozenges/day of the 1 mg strength (for both smoking cessation and reduction). Do not take more than 1 lozenge per hour.

Nicotinell lozenges should be used primarily to help you stop smoking.

Smoking cessation

To increase your chances of stopping smoking successfully, you should stop smoking completely at the start of using the lozenges and for the whole duration of treatment.

The length of treatment varies from person to person. Treatment should normally continue for at least
3 months. After 3 months, you should gradually reduce the number of lozenges you take. Treatment should be stopped when the dose has been reduced to 1 to 2 lozenges per day. Use of products such as Nicotinell Mint lozenges for longer than 6 months is generally not recommended. However, some ex-smokers may need to use treatment for longer to prevent relapse.

Talk to your doctor if you have been taking the lozenges for more than 9 months.

Counselling can help you to stop smoking.

Smoking reduction with the aim of stopping smoking

Using Nicotinell lozenges between cigarettes should reduce the craving for a cigarette and so prolong the smoke-free period. The aim should be to cut down on the number of cigarettes smoked as much as possible. Cigarettes should be replaced gradually by Nicotinell lozenges. If you have not halved your daily cigarette consumption after 6 weeks, you should seek professional help. As soon as you feel able, you should stop smoking completely. This should be no later than 4 months after starting to use Nicotinell lozenges. You should then gradually reduce the number of lozenges you take, for example by missing out one lozenge every 2-5 days.

If you have not attempted to stop smoking completely within 6 months, you should seek professional help. Regular use of Nicotinell lozenges for longer than 6 months is generally not recommended. However, some ex-smokers may need to use treatment for longer to prevent relapse.

Counselling can help you to stop smoking.

Instructions for use:

Do not swallow the lozenge.

1.	Suck the lozenge until you get a strong taste.
2.	Then place the lozenge between your gum and cheek.
3.When the taste fades, start sucking the lozenge again.
4.Repeat this process until the lozenge has dissolved (about 30 minutes).

Avoid coffee, acidic drinks or fizzy drinks for 15 minutes before sucking a lozenge as they can reduce the absorption of nicotine. Do not eat or drink while you have a lozenge in your mouth.


(b) Using Nicotinell 1 mg lozenges in combination with Nicotinell transdermal patch


Smoking cessation

If you have failed to stop smoking using Nicotinell lozenges on their own, you can use Nicotinell transdermal patches together with Nicotinell 1 mg lozenges.

NOTE: Read the package leaflet for Nicotinell transdermal patch before
use.

To increase your chances of stopping smoking successfully, you should stop smoking completely at the start of and for the whole duration of treatment with the lozenges in combination with Nicotinell transdermal patch.
The use of Nicotinell transdermal patch together with Nicotinell 1 mg lozenges is recommended for smokers with moderate to very heavy dependence, i.e. over 20 cigarettes per day. It is strongly recommended that combination therapy is used in conjunction with counselling and support from a healthcare professional.

Combination therapy should only be used to help you stop smoking.

Combination therapy to start with:
Start treatment with one Nicotinell TTS 30 (21 mg/24 h) transdermal patch in combination with Nicotinell 1 mg lozenges. Take at least 4 lozenges at 1 mg per day. In most cases, 5-6 lozenges are sufficient. Do not take more than
15 lozenges on any one day. Treatment should normally continue for 6-12 weeks. You can then gradually reduce the nicotine dose.

Apply the transdermal patch to a clean, dry, hairless and healthy area of skin on the trunk, upper arm or hip and press firmly with the palm of your hand for 10-20 seconds.

To reduce the risk of local irritation, apply Nicotinell transdermal patches to different areas of skin.

Wash your hands thoroughly after applying the patch to avoid irritation of the eyes from nicotine on your hands if you touch your eyes.

Reducing the nicotine dose after the first 6-12 weeks:
This can be done in two ways.

1st possibility:

Use a lower strength patch, i.e. TTS 20 (14 mg/24 h) patch for 3-6 weeks, followed by TTS 10 (7 mg/24 h) patch for a further 3-6 weeks, together with the starting dose of Nicotinell 1 mg lozenges. Then gradually reduce the number of lozenges. Use of Nicotinell lozenges for longer than 6 months is generally not recommended. However, to prevent relapse, some ex-smokers may need to use treatment for longer, but this should not exceed 9 months.

2nd possibility:

Stop the patch treatment and gradually reduce the number of lozenges. Use of Nicotinell 1 mg lozenges for longer than 6 months is generally not recommended. However, to prevent relapse, some ex-smokers may need to use treatment for longer, but this should not exceed 9 months.

Recommended dosage
If you are still taking the lozenges after 9 months, please talk to your doctor or pharmacist.

If you take more Nicotinell Mint lozenges than you should

Sucking too many lozenges can cause the same symptoms as heavy smoking. Symptoms of nicotine poisoning include weakness, pale skin, sweating, excessive saliva, burning sensation in the throat, nausea, vomiting, diarrhoea, abdominal pain, hearing and vision problems, headache, fast heart rate (tachycardia) or other heart rhythm problems, shortness of breath (dyspnoea), dizziness, tremor and confusion.

In severe overdose, the above symptoms may be followed by collapse, low blood pressure, circulatory collapse, coma, respiratory problems and convulsions.
Stop using the lozenges and contact a doctor immediately for advice and assessment of the risk if you have taken more lozenges than you should or if a child has accidentally taken the medicine.

If poisoning is suspected in a child, a doctor should be consulted immediately. Even small amounts of nicotine can be dangerous and potentially life-threatening in children and may cause severe poisoning symptoms or be fatal.

If you forget to use Nicotinell Mint lozenges

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

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

What are the possible side effects?

How to store Nicotinell Mint lozenges?