Boots NicAssist 2 mg Microtab

This medicine is available without prescription to help you stop smoking and 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
• Important - these microtabs are sublingual tablets and must be dissolved under the tongue, do not chew or swallow them.

The benefits of stopping smoking tobacco far outweigh any potential risk from using nicotine from NRT. It is the toxins in cigarette smoke such as tar, lead, cyanide and ammonia that cause smoking related disease and death, not the nicotine.

• You may think that smoking tobacco/vaping helps relieve feelings of anxiety and stress, but it does not deal with the cause of the stress. In addition, the feeling of relaxation after smoking/vaping is temporary, with withdrawal symptoms and cravings soon returning.
  NRT can help relieve nicotine withdrawal symptoms such as irritability, low mood, anxiety, restlessness and cravings when used in place of cigarettes/e-cigarettes.
• NRT may benefit smokers and vapers who want to quit, by helping to control weight gain that may be experienced when trying to stop smoking/vaping.

Use of NRT is safer than smoking tobacco but as soon as you are ready, you should aim to stop smoking/vaping completely.

The effects of vaping on your body are not established.

• If you are allergic to any of the ingredients 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/vaping first without using NRT. You can use this medicine to help you stop smoking/vaping once you are out of hospital. 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 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 microtabs but are finding this difficult

If you are pregnant: You should try to stop smoking/vaping without using medicines. If you still need help you can use this product. The risk to your baby whilst using this product is far less than if you continue to smoke. Talk to your pharmacist 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 medicines. If you can’t manage this you are best to use an NRT product that is used intermittently (not patches). You should talk to your doctor, nurse or pharmacist for advice.

Breastfeed your baby just before you use the microtabs to make sure that your baby gets the smallest amount of nicotine possible.

If you need to use this product, the amount of nicotine that your baby may receive 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.

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 microtabs where children may get hold of them.

Information about some of the ingredients in this medicine: This medicine contains 84.65 mg of cyclodextrin(s) in each sublingual tablet.

This medicine contains less than 1 mmol sodium (23 mg) in each sublingual tablet, that is to say essentially ‘sodium – free’.

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 cut down or stop smoking and follow his or her advice about these other medicines.

The microtabs must be dissolved slowly under the tongue (about 30 minutes). This will release the nicotine, which you absorb through the lining of your mouth. Do not chew or swallow them.

Follow the instructions in the table. The table shows you how many microtabs to use, when to use them, how to use them, and the maximum amount of time you should be using them for.

Read this information carefully and then go to “How to stop smoking/vaping – your choice”. This section will help you decide which method to use.

The number of microtabs you use each day will depend on how many cigarettes/e-cigarettes you smoked/vaped and how strong they were. See the table below to find out how many microtabs you should use.

If you smoke 20 cigarettes or less per day or you are a light to moderate vaper (e.g. vape infrequently or use low strength e-liquid), you should use one microtab every hour, although you may want to increase to two microtabs every hour if one is not relieving your cravings. If you smoke more than 20 cigarettes per day or you are a heavy vaper (e.g. vape frequently or use high strength e-liquid) you should use two microtabs every hour. You must not use more than 40 microtabs a day.

Adults and Children of 12 years and over

If you smoke 20 cigarettes or fewer or light to moderate vapers (e.g. vape infrequently or use low strength e-liquid) per day: Use one microtab every hour.

If you smoke more than 20 cigarettes or heavy vapers (e.g. vape frequently or use high strength e-liquid) per day: Use two microtabs every hour.

Most people use between 8 to 24 microtabs per day.

Don’t use more than 40 microtabs per day.

Do not use more than the amount recommended.

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

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

Children under 12 years: Do not give this medicine to children under 12 years of age.

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 microtabs 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 NRT 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 microtabs, you are worried that you will start smoking/vaping again without them or you find it difficult to reduce the number of microtabs you are using, talk to your doctor, pharmacist or nurse.

Stopping immediately

The idea is to stop smoking/vaping immediately and use the microtabs to relieve the cravings to smoke/vape. After achieving this you then stop using the microtabs.

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 time given in step 2 is the longest amount of time 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 – 12 weeks (3 months)

Step 3 – Gradually reduce usage

Step 1: Set a date to quit and stop smoking/vaping cigarettes/e-cigarettes.

Step 2: Use 1 or 2 microtabs every hour to relieve your cravings. See the dosage table to decide how many microtabs are suitable for you to use.

Use the microtabs for up to 12 weeks (3 months) to relieve your cravings to smoke/vape.

Step 3: Start reducing the number of microtabs you use each day. Once you reach only one or two microtabs each day you should try to stop completely.

If you need to use the microtabs for longer than a total of 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 Boots NicAssist Microtabs. Remember you can use NRT again if this should happen.

Children of 12 to 17 years

See the following diagram, which shows the basic step by step process. The time given in steps 2 and 3 are the longest time possible it should take, and you should try to achieve your move to the next step in the shortest amount of time. The total amount of time taken to stop smoking/vaping should not exceed 12 weeks.

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

Step 1 – Preparation

Step 2 – 8 weeks (2 months)

Step 3 – 4 weeks (1 month)

Step 1: Set a date to quit and stop smoking/vaping cigarettes/e-cigarettes.

Step 2: Use 1 or 2 microtabs every hour to relieve your cravings. See the dosage table to decide how many microtabs are suitable for you to use.

Use the microtabs for up to 8 weeks (2 months) to relieve your cravings to smoke/vape.

Step 3: Start reducing the number of microtabs you use each day over the next 4 week period. Once you reach only one or two microtabs each day you should try to stop completely.

You should make sure that you do this within 4 weeks.

If you need to use the microtabs for longer than the 12 weeks (3 months), ask your doctor, pharmacist or nurse for advice.

Stopping gradually

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

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 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 – Gradually reduce usage

Step 1: Work out how many cigarettes/e-cigarettes you smoke/vape 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 1 or 2 microtabs every hour to relieve your cravings. See the dosage table to decide how many microtabs are suitable for you to use.

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 by six months from the beginning of treatment.

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

Step 4: Start reducing the use of the microtabs. You should try to use fewer microtabs each day. When you are using only one or two microtabs 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 microtabs. Remember you can use NRT again if this should happen.

Children of 12 to 17 years

Children should follow the guide to stopping immediately. The recommended duration of NRT in children is 12 weeks maximum. The only time children should stop gradually is if they are having a problem stopping immediately.

Talk to your doctor, pharmacist or nurse before attempting to stop gradually.

If you use too many microtabs: You may get the following symptoms – nausea (feeling sick), vomiting, increased salivation, pain in your stomach, diarrhoea, sweating, headache, dizziness, hearing disturbance or weakness. If this happens contact a doctor or hospital casualty department straight away. Take the medicine and this leaflet with you.

If an adult accidentally swallows a single microtab it is unlikely to have an adverse effect. You may feel sick or be sick.

If a child under 12 accidentally uses, swallows, sucks or chews 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 microtab such as rash, itching or swelling of the tongue, mouth or throat (go straight to casualty if severe)
• You experience seizures (fits)

(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 microtabs 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 microtabs less often.

These effects include:

• Feeling faint, feeling sick (nausea), headache

Side effects of the microtab

Very common side effects:

(more than 1 in every 10 people are affected)

• Headache
• Throat irritation
• Hiccups, feeling sick

Common side effects:

(less than 1 in every 10 people are affected)

• Allergic reactions
• Inflammation of the nose such as a runny, itchy, blocked nose
• Burning sensation in the mouth, dizziness, taste changes, pins and needles
• Cough
• Sore mouth or throat
• Palpitations
• Stomach pain, heartburn, diarrhoea, wind
• Dry mouth, being sick, increase in saliva, inflammation of the mouth
• Feeling tired

Uncommon side effects:

(less than 1 in every 100 people are affected)

• Abnormal dreams
• Changes in heart rhythm (you may notice a fast heart rate or beat)
• Flushing, high blood pressure
• Throat tightness, difficulty breathing, shortness of breath
• Hoarseness of the voice, sneezing, nasal congestion
• Belching, inflammation of the tongue, mouth ulcers, tingling mouth
• Itching, skin rash, hives, excess sweating
• Jaw pain
• Generally feeling unwell or weak, chest pains

Rare side effects:

(less than 1 in every 1,000 people are affected)

• Swelling of the mouth, lips, throat and tongue, swelling and itching of the skin (allergic reaction)
• Difficulty swallowing, retching, mouth feeling numb

Very rare side-effects:

(less than 1 in 10,000 people are affected)

• Abnormal beating of the heart

Side effects with unknown frequency:

• Severe allergic reaction, redness of the skin
• Blurred vision, watery eyes
• Dry throat, stomach discomfort, lip pain
• Tightness of the jaw

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.