This medicine is available without prescription to help you stop smoking. However, you still need to use it 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
• You must talk to a doctor if you do not feel better or if you feel worse

• If you are allergic to any of the ingredients in this medicine (see “What is in this medicine”)
• If you are a child under 12 years of age

• If you are in hospital because of heart disease (e.g. heart attack, problems with your heart rate or rhythm, stroke, angina or high blood pressure) – try to give up smoking first without using NRT. However, once you are out of hospital, if you still need help to stop smoking, you can use this medicine. For other heart conditions that do not require you to be in hospital, using NRT is better than continuing to smoke
• If you have diabetes – monitor your blood sugar levels more often when you start using this medicine. You may find that you need to adjust the amount of insulin you use, or the amount of tablets you take (ask your doctor or diabetes nurse about this)
• If you have an ulcer in your stomach or upper intestine or problems such as pain or swelling of the stomach or oesophagus (the passage between your mouth and stomach)
• If your liver or kidneys do not work properly
• If you have asthma or other lung problems
• If you have an overactive thyroid gland
• If you have high blood pressure due to a tumour near your kidney (your doctor may have told you that you have a condition called phaeochromocytoma)
• If you are taking other medicines regularly prescribed by your doctor (see “If you take other medicines”)
• If you have ever experienced seizures (fits)
• If you are pregnant or breastfeeding (see “Other important information”)

If you are pregnant: You should try to stop smoking without using NRT.

However, if you still need help to stop smoking, you can use this product as the risk to your baby is far less than if you continue to smoke. You should talk to your pharmacist, nurse or doctor for more advice.

NRT products that are used intermittently, such as this one, may be preferable to nicotine patches. However, if you feel sick or are sick (morning sickness) the patches may be better for you. If you do use nicotine patches they should be taken off before bedtime.

If you are breastfeeding: You should try to stop smoking without using NRT.

However, if you still need help to stop smoking, you should use NRT products that are used intermittently, not patches. You should talk to your pharmacist, nurse or doctor for more advice.

Breastfeeding your baby just before you use the nasal spray makes sure that your baby gets the smallest amount of nicotine possible.

The amount of nicotine that your baby may receive when you are using the nasal spray or other NRT products is much smaller and less harmful than the second-hand smoke they would inhale if you smoked.

Tobacco smoke causes breathing and other health problems in babies and children. If your husband, partner or other family members smoke too, try to get them to give up with you.

Driving and using machines: The nasal spray may irritate your nose and may make you sneeze or make your eyes water when you first start using the spray. Do not drive or use machines until you are sure you are not affected.

Nicotine products and children: Nicotine can be very dangerous to children. The amount of nicotine tolerated by adults and adolescents can make children very ill, and can sometimes be fatal. Do not leave your nasal spray where children may get hold of it.

Some of the ingredients can cause problems: Methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216) in this medicine may cause allergic reactions (possibly delayed) and exceptionally, bronchospasm.

Before you use this medicine, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Theophylline, clozapine, ropinirole – your doctor may want to monitor the amount of medicine that you take

When you stop smoking or cut down, your metabolism slows down. This can mean that some medicines may stay in your body longer than usual.

If you take any medicine on a regular basis, tell your doctor that you intend to stop smoking and follow his or her advice about these other medicines.

Read all of the following information carefully before starting to use the nasal spray:

• Follow the instructions in the table. The table shows how many sprays you should be using and when and how you should use the nasal spray. It also shows you the maximum amount of time you should be using nicotine replacement therapy (NRT) for
• Follow the ‘How to use the nasal spray’ instructions to make sure that you use the nasal spray correctly to release the nicotine
• For information on how to stop smoking using the nasal spray, see ‘How to stop smoking’ Use the nasal spray when you feel the urge to smoke. The number of sprays you use each day will depend on how many cigarettes you smoked and how strong they were.
• You can use one spray in each nostril up to twice in an hour but you may find you need to use less than this
• Each spray delivers 500 micrograms of nicotine in 50 microlitres of solution. Each bottle contains enough solution to deliver approximately 200 sprays

The nasal spray may irritate your nose and may make you sneeze or make your eyes water when you first start using the spray.

Take care to avoid the eyes when you are using the spray. If the eyes are sprayed, rinse thoroughly with water.

Adults and children of 12 years and over:

Adults and children of 12 years and over: One spray in each nostril as required to relieve cravings.

Don’t use more than twice an hour.

Don’t use more than 64 sprays per day. This is equivalent to using 2 sprays in each nostril every hour for 16 hours.

Children and adolescents of 12 to 17 years should not use for longer than 12 weeks without asking for help and advice from a pharmacist, nurse or doctor.

Adults of 18 years and over should not use for longer than 9 months in total without asking for help and advice from a pharmacist, nurse or doctor.

How to use the nasal spray

Read all of the following instructions carefully before starting to use the nasal spray.

You need to hold the bottle and use the spray correctly to ensure that nicotine is delivered correctly.

1. Remove the protective dust cap by squeezing the 2 side clips and pulling the cap off.

<Pictogram of how to remove cap>

2. A new spray, or one which has not been used for 2-3 days, may not work the first time and must be “primed” (priming reduces the number of sprays you may get from a bottle).

<Pictogram of how to prime the spray>

• Point the spray away from you and any other adults, children or pets that are near you
• Put your forefinger and middle finger on the collar either side of the nozzle and your thumb underneath the bottle
• Keeping your thumb still, press down firmly and quickly with your fingers to pump the spray until a fine spray appears (up to 7-8 strokes)
• Never try to unblock or enlarge the tiny spray hole with a pin or other sharp object because this may damage the spray mechanism

3. Hold the spray as described for priming the spray.

4. Insert the tip of the spray into one nostril pointing the tip towards the back of your nose NOT straight up your nose. Press down with your fingers firmly and quickly. Then insert the tip of the spray into your other nostril and repeat the process if required.

<pictogram of correct use of the spray in the nose>

5. After using the spray wipe the spray nozzle with a clean tissue and then replace the protective cap. Store the spray out of the sight and reach of children and animals and protect from light.

Because smoking is an addiction you may find it difficult to give up. From time to time you may still have strong urges to smoke but if you follow these recommendations, you have a good chance of quitting.

If you find it hard to stop using the nasal spray, you are worried that you will start smoking again without it or you find it difficult to reduce the number of sprays you are using, talk to your pharmacist, nurse or doctor.

Remember the nasal spray is not intended as a substitute for smoking, it is an aid to giving up.

The idea is to stop smoking immediately and use the nasal spray to relieve the cravings to smoke. After achieving this you then stop using the spray. You should aim to stop using the nasal spray within 12 weeks (3 months).

Adults of 18 years and over

See the following diagram, which shows the basic step by step process.

The times given below are the longest amount of time they should take, and you should try to achieve your move to the next step in the shortest time possible.

Make sure you read the instructions for each step in the information which follows.

Step 1 – Preparation

Step 2 – 8 weeks (2 months)

Step 3 – 2 weeks

Step 4 – 2 weeks

Step 1: Set a date to quit and stop smoking cigarettes.

Step 2: Use the nasal spray for up to 8 weeks (2 months) to relieve your cravings. See the table to see how many sprays you should be using and when and how you should use the nasal spray.

Step 3: Start reducing the number of sprays you use each day over 2 weeks. At the end of the two weeks you should aim to have halved the number of sprays that you use each day.

Step 4: Cut the number of sprays to none at all over the next two weeks.

You may find that using one spray in just one nostril may help you to begin to reduce the number of sprays you need to use in steps 3 and 4.

You should not use Boots NicAssist 10 mg/ml Nasal Spray continuously for more than 3 months.

You might feel a sudden craving to smoke long after you have given up smoking and stopped using Boots NicAssist 10 mg/ml Nasal Spray. Remember you can use nicotine replacement therapy again if this should happen.

If you need to use this product for more than 9 months in total, you should ask your pharmacist, nurse or doctor for advice.

Children and adolescents of 12 to 17 years

Children and adolescents can follow the same method as adults, however they should not use NRT for longer than 12 weeks without asking for help and advice from a pharmacist, nurse or doctor.

If you use too many sprays: You may get the following symptoms – nausea, vomiting, increased salivation, pain in your stomach, diarrhoea, sweating, headache, dizziness, hearing disturbance, weakness.

If this happens contact a doctor or hospital casualty department straight away. Take the medicine and this leaflet with you.

If a child under 12 accidentally uses or swallows some of this medicine, take them to casualty immediately. Take the medicine and this leaflet with you. Nicotine ingestion by a child may cause severe poisoning.

• You develop a fast, slow or irregular heart beat
• You have an allergic reaction to the nasal spray such as rash, itching or swelling of the tongue, mouth or throat (go straight to casualty if severe)
• You experience seizures (fits)

Effects related to stopping smoking (nicotine withdrawal)

You may experience unwanted effects because by stopping smoking you have reduced the amount of nicotine you are taking. You may also experience these effects if you use too few sprays before you are ready to reduce your nicotine intake.

These effects include:

• Irritability or aggression, feeling low, anxiety, restlessness
• Poor concentration, urges to smoke (craving), night time awakening or sleep disturbance
• Increased appetite or weight gain
• Lowering of heart rate
• Dizziness, lightheadedness, blurry vision, nausea
• Cough
• Constipation
• Bleeding gums
• Mouth ulcers
• Swelling of the nasal passages and back of the throat

You may also get these effects if you are not used to inhaling tobacco when you smoke. You may be able to relieve these effects by using the sprays less often.

These effects include:

• Feeling faint. feeling sick (nausea), headache

During the first 2 days of using the nasal spray, many people may get irritation of the nose such as sneezing, runny nose, watering eyes or a cough. If you continue to use the spray these effects and how often you may get them will reduce.

Very common side effects: (more than 1 in every 10 people are affected)

• Runny nose

Common side effects: (less than 1 in every 10 people are affected)

• Headache, dizziness, pins and needles
• Palpitations
• Cough, throat irritation, shortness of breath, nose bleeds
• Feeling sick, being sick
• Itching, skin rash, excess sweating
• Chest pains

Uncommon side effects: (less than 1 in every 100 people are affected)

• Abnormal dreams
• Allergic reactions
• Flushing, high blood pressure
• Feeling tired or unwell

Very rare side effects: (less than 1 in 10,000 people are affected)

• Abnormal beating of the heart

Side effects with an unknown frequency:

• Severe allergic reaction, swelling or redness of the skin, hives
• Watery eyes, nose discomfort, sneezing, discomfort and pain in the mouth and throat
• Stomach discomfort
• Changes in heart rhythm (you may notice a fast heart rate or beat)
• Feeling weak

When you stop smoking you may also develop mouth ulcers. The reason why this happens is unknown.

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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.