SAINSBURYS HEALTHCARE 4 MG NICOTINE LOZENGES, MORRISONS NICOTINE 4 MG LOZENGES, ASDA NICOTINE REPLACE 4 MG LOZENGES, WILKO NICOTINE 4 MG LOZENGES, GALPHARM NICOTINE REPLACE 4 MG LOZENGES, NICOTINE 4 MG LOZENGES, ESSENTIAL WAITROSE NICOTINE REPLACEMENT 4 - patient leaflet, side effects, dosage

3. how to take this medicine

Adults and young people aged 12 years and over

Instructions for use of these lozenges depend on whether you are:

• stopping smoking straightaway
• cutting down on smoking before you stop
• cutting down with no immediate plans to stop going without cigarettes for a short time or if you are having cravings after you have stopped smoking.

If you are under 18 years old and not ready to stop smoking straightaway, talk to a healthcare professional for advice.

Important: These lozenges are suitable for smokers who have their first cigarette of the day within 30 minutes of waking up.

How to take your lozenges:

• 1 lozenge should be placed in the side of the mouth and allowed to dissolve
• At intervals, the lozenge should be moved from one side of the mouth to the other; the action should be repeated for 20 to 30 minutes until the lozenge is completely dissolved
• The lozenge should not be chewed or swallowed whole
• Users should not eat or drink while a lozenge is in the mouth as this may reduce the absorption of nicotine
• Do not use more than one lozenge at a time and do not use more than 15 lozenges per day.

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Stopping smoking straightaway Adults and young people aged 12 years and over:

It is important to make every effort to stop smoking completely. But if you do sometimes smoke a cigarette while using NRT, don't be discouraged -just keep going with your quit attempt. It may help to talk to a healthcare professional if you are finding your quit attempt difficult.

Use the lozenges according to the 3-step programme below, which is designed to gradually reduce the number of lozenges you use.

To help you stay smoke free over the next 12 weeks, take a lozenge in situations when you are strongly tempted to smoke. During this initial treatment period (weeks 1 to 6) use at least 9 lozenges a day.

If you find it difficult to give up these lozenges or if you are worried that you may start smoking again then speak to your doctor or pharmacist.

It is important you complete the step down programme in full. This is because urges to smoke and withdrawal symptoms can occur for weeks after stopping smoking. If you resume smoking you may want to talk to your doctor or pharmacist about how to get the best results from your lozenges.

You are more likely to quit smoking when using this product with help from your pharmacist, doctor, a trained counsellor, or a support programme.

Cutting down on smoking before you stop

Adults aged 18 years and over:

You may find it easier to quit completely later if you use these lozenges to help you cut down on smoking first.

When you feel a strong urge to smoke, have a lozenge instead of a cigarette to help you manage your cravings. Cut down the number of cigarettes you smoke per day by 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 a healthcare professional.

AssooiTas yduTeel ready tostop smbkirig-completely, follow the instructions above, under ‘Stopping smoking straightaway'. If you have not felt able to make a quit attempt within 6 months of starting to use NRT, you may find it helpful to talk to a healthcare professional.

Cutting down with no immediate plans to stop

Adults aged 18 years and over: It is always best to stop smoking completely, but using NRT to cut down is less harmful than continuing to smoke heavily. Cutting down the number of cigarettes you smoke each day will make it easier to quit completely in the future.

When you feel an urge to smoke, have a lozenge instead of a cigarette to help you manage your cravings. Cut down the number of cigarettes you smoke per day by as many as possible.

It is best to stop smoking completely as soon as you feel able to. Follow the instructions above, under ‘Stopping smoking straightaway'.

Going without cigarettes for a short time

Adults aged 18 years and over:

• This product can help you manage your cravings so that you can resist cigarettes in situations where smoking is inappropriate, for example: where your second-hand smoke may damage other people, such as children
• where smoking is not allowed, such as on a flight or in a hospital
• when smoking should be avoided, such as before surgery.

When you feel an urge to smoke, have a lozenge instead of a cigarette to help manage your cravings. Continue to use one lozenge every 1 –2 hours (maximum 15 a day) during the period when you are avoiding smoking.

It is best to stop smoking completely as soon as you feel able to. Follow the instructions above, under ‘Stopping smoking straightaway'.

Once you have stopped smoking

After you have stopped smoking, you may sometimes feel a craving for a cigarette. You can use this product again to help you relieve these cravings – using NRT is always better than smoking again.

If you are worried that you may start smoking again, talk to a healthcare professional. They can advise you on how to get the best results from further courses of NRT.

If you are finding it difficult to stop using NRT completely, talk to a healthcare professional.

• 4. What should you do if you take too many lozenges?

If you take more than the recommended number of lozenges per day, you may suffer a nicotine overdose and need to get advice from your doctor. Signs of overdose include headache, sickness, stomach pains and diarrhoea. In the event that a child has taken any lozenges or if an accidental overdose occurs, contact your doctor or nearest hospital casualty department immediately as this could be fatal. If possible show them the pack or this leaflet.

5. possible side effects

Sometimes there can be some side effects from giving up smoking or using the lozenges. This medicine may cause allergic reaction, which involves swelling of the face, lips and throat (angioedema) or itchy skin rash (urticaria). If this happens to you contact your doctor immediately.

Common side effects are:

• coughing, sore throat, mouth irritation or difficulty swallowing, dry mouth/throat/lips, ulcers in/around mouth
• sleep disturbances, including insomnia, anxiety, irritability, dizziness, headache
• feeling sick (nausea), being sick (vomiting), diarrhoea, constipation, hiccups, belching, wind, feeling bloated
• increased appetite, heartburn and indigestion.

None of the above side-effects are serious, and often wear off after a few days' treatment.

Occasionally an increased heart rate may be experienced. If this happens stop using the lozenges and tell your doctor.

Uncommon side effects are:

• nightmares, abnormal dreaming, poor quality sleep, tiredness, lack of energy, feeling unwell, restlessness, alertness
• breathing problems, shortness of breath, asthma or worsening asthma, chest pain, tight chest
• throat irritation, taste disturbance, mouth numbness or burning, bleeding gums, bad breath, toothache, jaw pain, thirst
• migraine, mood swings and anger
• rash, itchy skin, skin irritation, hot flushes
• stomach pains, stomach ulcer, hiatus hernia, changes in appetite, taste changes, increased saliva
• irregular heartbeat (palpitations)
• sneezing, nasal congestion, catarrh, nasal discomfort, nose bleed
• ihcfeasecTsweafing, sehsoryTJisturbance ~ urgency to pass water at night
• painful and swollen legs.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:. By reporting side effects you can help provide more information on the safety of this medicine.

6. how to store your medicine

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date printed on the pack.

Do not store above 25°C and keep in the original carton.

• 7. What is in this medicine?

Your cream / white circular compressed lozenge is embossed with L873 on one side and has an odour of peppermint.

The active ingredient is nicotine 4 mg in the form of a resin complex (nicotine resinate 26.66 mg).

The other ingredients are: mannitol (E421), magnesium stearate, sodium alginate, xanthan gum, potassium bicarbonate, sodium carbonate anhydrous, aspartame (E951) and peppermint flavour.

Your lozenges are available in pack sizes of 12, 36, 72 and 144's, although not all pack sizes may be marketed.

• 8. Who makes this medicine?