Boots NicAssist 10 mg/ml Nasal Spray

This medicine is available without prescription to help you stop smoking tobacco or vaping. 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, chest pain, 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. The risks of continued vaping are not yet established. 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 have quit smoking/vaping and want to stop using the nasal spray but are finding this difficult.

If you are pregnant: You should try to stop smoking/vaping 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. The effects of vaping on babies and children are not established.

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. The effects of vaping on your body during pregnancy are not established.

If you are breastfeeding: You should try to stop smoking/vaping without using NRT. However, if you still need help to stop smoking/vaping, you should use NRT products that are used intermittently, not patches. You should talk to your pharmacist, nurse or doctor for more advice.

Breastfeed your baby just before you use the nasal spray to make 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. The effects of vaping on your body during breastfeeding are not established.

Tobacco smoke causes breathing and other health problems in babies and children. The effects of vaping on babies and children are not established. If your husband, partner or other family members smoke/vape 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.

The nasal spray contains polysorbate 80 which can cause allergic reactions.

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 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.

Directions for using the spray

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

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).

• 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.

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

Some people may find it easier to set a date to quit and stop smoking/vaping immediately. Others who are unable or not ready to stop smoking/vaping abruptly, may benefit from gradually reducing the number of cigarettes/e-cigarettes they smoke/vape each day until they feel ready to stop completely.

You can also use the nasal spray on those occasions when you can’t or don’t want to smoke/vape e.g. social situations such as a party, in the pub or when at work.

If you are an adult you can follow either one of these options. However children should follow the guide to stopping immediately as the recommended duration of nicotine replacement therapy in children is 12 weeks maximum. The only time children should stop gradually is if they are having a problem stopping immediately and they should talk to their doctor, pharmacist or nurse beforehand.

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

Stopping immediately

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

There is a difference in how you stop depending on whether you are aged between 12 and 17 years or 18 years and over. Make sure you follow the age range applicable to you.

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/vaping cigarettes/e-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.

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 should follow the guide to stopping immediately, however they should not use NRT for longer than 12 weeks.

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

Stopping gradually

The idea is to start gradually replacing some of your cigarettes/e-cigarettes with the nasal spray. After achieving this you then give up cigarettes/e-cigarettes completely while using the spray. Finally you give up using the spray.

Adults 18 years and over

See the following diagram which shows the basic step by step process. The time given for steps 2 and 3 are the longest it 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 – 24 weeks (6 months)

Step 3 – 12 weeks (3 months)

Step 4 – 4 weeks reduce usage

Step 1: Work out how many cigarettes/e-cigarettes you use per day. Set a date to start reducing the number of cigarettes/e-cigarettes you smoke/vape.

Step 2: Start reducing. Over the next few months, reduce the number of cigarettes/e-cigarettes you smoke/vape by using the nasal spray to relieve your cravings. See Dosage section to see how many sprays you are allowed to use and how often you can use the nasal spray.

If after 6 weeks you have not reduced the number of cigarettes/e-cigarettes you smoke/vape, ask your doctor, pharmacist or nurse for advice.

You should aim to stop smoking/vaping completely within six months from the beginning of treatment.

Step 3: Stop smoking/vaping. Cut out all cigarettes/e-cigarettes and continue using the spray for up to 3 months to relieve your cravings to smoke/vape.

Step 4: Start reducing the use of the nasal spray. You should try to use fewer sprays each day. Cut the number to none within 4 weeks or sooner. When you are only using one or two sprays per day you should stop completely.

If you need to use the product for longer than 9 months, ask your doctor, pharmacist or nurse for advice.

You might feel a sudden craving to smoke/vape long after you have given up smoking/vaping and stopped using the nasal spray. Remember you can use nicotine replacement therapy again if this should happen.

Children and adolescents of 12 to 17 years

Children and adolescents should follow the guide to stopping immediately, however they should not use NRT for longer than 12 weeks. The only time children and adolescents should stop gradually is if they are having a problem stopping immediately. Ask for help and advice from a pharmacist, nurse or doctor before attempting to stop gradually.

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/vaping (nicotine withdrawal)

You may experience unwanted effects because by stopping smoking/vaping 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 smoke or vaping. 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.