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E-Voke 15 Mg Electronic Inhaler



e-Voke 15 mg

Electronic Inhaler

(Nicotine 15 mg per cartridge)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

•    Keep this leaflet. You may need to read it again.

•    Askyour pharmacist if you need more information or advice.

If you get any side effects, talkto your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What e-Voke is and what it is used for

2.    What you need to know before you use e-Voke

3.    Howto use e-Voke

4.    Possible side effects

5.    Howto store e-Voke

6.    Contents of the pack and other information

1. What e-Voke is and what it is used for

e-Voke contains nicotine. It belongs to a group of medicines known as nicotine replacement therapy (NRT).

e-Voke is used to relieve and /or prevent withdrawal symptoms and reduce the cravings you get when you try to stop smoking or when you cut down the number of cigarettes you smoke. e-Voke Inhalation Cartridges (called cartridges) are for use only with e-Voke Electronic Inhaler (called inhaler).

Ideally you should always aim to stop smoking. You can use e-Voke to achieve this by using it to completely replace all your cigarettes.

You can also use e-Voke to help you to cut down the number of cigarettes you smoke if you feel unable to stop smoking completely, or you only want to replace some cigarettes.

e-Voke may also help increase your motivation to quit smoking. To help you quit smoking you should also try to use a behavioural support programme to increase your chances of success.

How does e-Voke work?

When you stop smoking or cut down the number of cigarettes you smoke, your body misses the nicotine that you have been getting from cigarettes. You may experience unpleasant feelings and a strong desire to smoke (craving). The nicotine you get from using e-Voke replaces the nicotine you were getting from cigarettes. This relieves the unpleasant withdrawal symptoms. It will also help to stop your craving to smoke.

Benefits you can get from using NRT instead of smoking

You may think that smoking helps relieve feelings of anxiety and stress, but it does not deal with the cause of stress and leads to a number of serious diseases. In addition, the feeling of relaxation after smoking is temporary, with withdrawal symptoms and cravings soon returning.

Nicotine replacement therapy, such as e-Voke, can help relieve nicotine withdrawal symptoms such as irritability, low mood, anxiety, restlessness and cravings when used in place of cigarettes. NRT may benefit smokers who want to quit, by helping to control weight gain that may be experienced when trying to stop smoking.

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

2. What you need to know before you use e-Voke

This medicine can be used by adults only.

Do not use e-Voke:

•    if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6).

•    ifyou are under 18 years of age.

Warnings and precautions

Talkto your doctor, pharmacist or nurse before using e-Voke if any of the following apply to

you:

•    ifyou are in hospital because of heart disease (including heart attack, stroke and problems with your heart rate or rhythm). Ifyou have another heart condition but are not in hospital, using NRT is better than continuing to smoke.

•    ifyou have a stomach ulcer, duodenal ulcer, irritation or inflammation of the stomach or throat.

•    ifyou have liver or kidney problems.

•    ifyou have a long term throat disease or difficulty breathing due to bronchitis, emphysema or asthma. e-Voke may not be suitable for you to use and you may be advised to use a different type of NRT.

e-Voke PIL15 mg v2,02-10-15

Talkto your doctor, pharmacist or nurse before using e-Voke if any of the following apply to you:

•    ifyou have an overactive thyroid gland or have a phaeochromocytoma (a tumour of the adrenal gland that can affect blood pressure).

•    ifyou have diabetes - you will need to monitor your blood sugar levels more often when starting to use e-Voke as nicotine may affect these levels. Askyour doctor or pharmacist about this.

•    Ifyou are pregnant or breast feeding - you may be able to use nicotine replacement therapy (NRT) to help you give up smoking but you should try to give up without it. See 'Pregnancy and breast-feeding'.

•    Ifyou are taking any other medicines prescribed by your doctor on a regular basis

(See 'Other Medicines and e-Voke').

Pregnancy and breast-feeding Ifyou are pregnant:

You should try to give up smoking without NRT. Stopping completely is by far the best option. The earlier and quicker you do this the better it is for you and your baby.

Ifyou can't give up smoking, you can use NRT as a safer alternative to smoking for you and your baby. However you should talkto your doctor, nurse or pharmacist for more advice. Nicotine replacement therapies that are used intermittently may be preferable to nicotine patches. However, patches may be more suitable ifyou have nausea or sickness.

Ifyou are breast-feeding:

You should try to give up smoking without NRT.

Ifyou can't give up smoking you should use NRT products that are taken intermittently (not patches), however you should talkto your doctor, nurse or pharmacist for advice.

Breast-feed your baby just before you use NRT to make sure your baby gets the smallest amount of nicotine possible.

The amount of nicotine that the baby may receive ifyou use NRT is considerably smaller and less harmful than the second-hand smoke they would inhale ifyou smoked.

Other medicines and e-Voke

Tell your doctor or pharmacist ifyou are taking any other medicines, particularly:

•    theophylline (used to treat breathing problems)

•    clozapine (used to treat schizophrenia)

•    ropinirole (used to treat restless legs)

Stopping smoking or cutting down slows your metabolism. Your doctor may need to change the dose of these medicines.

Nicotine products and children

This product contains small cartridges which could cause choking if a child attempts to swallow one. Nicotine can be very dangerous to children and can sometimes be fatal.

If a child accidentally uses, sucks, swallows or chews an e-Voke Inhalation Cartridge take them to your nearest Accident and Emergency department immediately. Take the medicine and this leaflet with you. Nicotine ingestion by a child may cause severe poisoning.

Always keep e-Voke out of reach and sight of children and dispose of carefully (see section 5).

3. How to use e-Voke

Always use this medicine exactly as described in this leaflet. Talk with your doctor, pharmacist or nurse ifyou are not sure.

e-Voke is made up of: e-Voke Electronic Inhaler (inhaler) and Inhalation Cartridges (cartridges).

•    Do not use the cartridges with any other electronic inhaler. There is a risk of serious injury if the cartridges are used in other delivery devices.

Adults aged 18 years and over:

•    10 inhalations is typically the amount you need before your cravings will go away.

•    10 inhalations contain approximately 0.56mg of nicotine, although the actual amount will vary depending on how deeply you inhale. How often you need to use the inhaler depends on how many cigarettes you used to smoke.

•    130 inhalations is about the amount in each cartridge. This depends on the depth and length of your inhalations.

•    5 cartridges per day is the maximum you should use. It is up to you how many inhalations you use and how often you use them.

Ifyou are able to stop smoking you should use e-Voke, when needed, in place of cigarettes. As soon as you can, you should reduce the number of cartridges you use until you have stopped using them completely. You should continue using e-Voke until cravings for nicotine disappear.

Ifyou have quit smoking and want to stop using e-Voke but are finding this difficult you should contact your doctor, pharmacist or nurse for advice. Follow the instructions below to make sure you use your inhaler correctly.

The amount of nicotine that you get from e-Voke is not affected by the surrounding temperature.

Ifyou use more e-Voke than you should

Ifyou have used more than the recommended number of cartridges, you may experience nausea (feeling sick), salivation, pain in your abdomen, diarrhoea, sweating, headache, dizziness, hearing disturbance or weakness.

Ifyou get any of these effects, contact a doctor or your nearest hospital Accident and Emergency department immediately. Take this leaflet and the pack with you.

Ifyou have any further questions on the use of this medicine, askyour doctor, pharmacist or nurse.

FRONT

3. How to use e-Voke (continued)

What is the e-Voke Electronic Inhaler and Inhalation Cartridge?

The e-Voke Electronic Inhaler (inhaler) consists of four parts:


1.    a battery unit

2.    a vaporiser

3.    a protective cap

4.    a USB charger





The e-Voke Inhalation Cartridge (cartridge) is sealed with a foil tab. This contains the nicotine.



Setting up the e-Voke Electronic Inhaler

Follow the instructions below.

1. Screw the battery unit and vaporiser together.



2. Pull the clear protective cap from the vaporiser.


3. Remove 1 cartridge from the pack and pull the foil tab from the cartridge.



4. Attach the cartridge to the vaporiser by pushing them together.


5. Waitfor about 10 minutes the first time you use e-Voke, then follow the instructions for use below.


^wait 10 minutes^


How to Use e-Voke Electronic Inhaler and Inhalation Cartridge

A new cartridge gives less nicotine in the first 10 inhalations.

1.    Switch on your e-Voke by unscrewing and rescrewing the battery unit and the vaporisor.

2.    Inhale on the cartridge for about 3 seconds. Usually, you will need 10 inhalations before your cravings will go away.

3.    If e-Voke is not used for about 4 minutes it will go into sleep mode. To re-activate, unscrew and rescrew the vaporiser from the battery unit.

4.    Once the cartridge is used up you should replace it. You will know when the cartridge is used upas you will see less vapour when you exhale. Do not continue to use the cartridge once it is empty as it may result in harmful chemicals being produced.

5.    Throw the cartridge away after 24 hours even if it has not been used up (see Changing the Cartridge).

6.    Replace the inhaler after 6 weeks from first use. Ifyou still need to use e-Voke after 6 weeks you need to get a new inhaler.

Changing the Cartridge

1.    Remove the used cartridge by pulling it from the vaporiser.

2.    To start using e-Voke again attach a new cartridge by following steps 3 - 5 in Setting up the e-Voke Electronic inhaler.

Ifyou are not going to use e-Voke straight away, cover the vaporisor

with the protective cap and store in the original packaging - see section 5

3.    The cartridges should be disposed of carefully - see section 5.

Recharging the Battery Unit

e-Voke will beep 3 times when the battery unit needs charging. The battery unit should last

about 130 inhalations before it needs recharging.

Recharge only with the supplied USB charger to avoid risk of fire:

1. Unscrew the battery unit from the vaporiser and screw it into the USB charger.



2. Insert the USB charger into an active USB port or a USB plug adaptor.

3. Two beeps from the battery unit and a green light on the    m

USB charger will indicate that it is charging.

4. You will hear two beeps and the light on the USB charger will turn red once fully charged. This should take about 2-3 hours.

5. Remove the USB charger from the port and unscrew the battery unit.




0




6. Screw the battery unit and vaporiser together.


Maintaining e-Voke

e-Voke should be kept clean and dry at all times. The battery unit may be cleaned with a wipe but take care not to get any liquid inside the battery unit. Do not use cleaning agents to clean the vaporiser.

Problem Solving

If there is no vapour coming from e-Voke or it does not appear to be working:

•    Check that the battery unit is charged by charging with the USB charger (see Recharging the Battery Unit)

•    Check that you have a cartridge attached to the inhaler.

•    The cartridge may be empty. Insert a new cartridge onto your Inhaler.

•    Check that the vaporiser is attached to the battery unit. Activate by unscrewing and rescrewing.

•    Ensure e-Voke hasn't entered sleep mode. Activate by unscrewing and rescrewing back together.

If the battery unit is connected to the USB charger but it is not charging:

•    Check that the USB charger is inserted into an appropriate, active, USB port.

•    Check that the battery unit is firmly screwed onto the USB charger.


e-Voke PIL15 mg v2,02-10-15


If e-Voke keeps cutting off during use:

• The inhaler is designed to cut off when being used too frequently to prevent overheating. Allow the device to cool before using again.


4. Possible side effects

Like all medicines, e-Voke can cause side effects, although not everybody gets them. As many of the effects are due to nicotine, they can also occur when you inhale nicotine by smoking.

Effects related to stopping smoking

You may experience unwanted effects when you first stop or cut down the number of cigarettes you smoke, when you reduce the amount of nicotine in your body either by stopping smoking or using e-Voke.

These effects include:

•    irritability or aggression

•    feeling low

•    anxiety

•    restlessness

•    poor concentration

Effects of too much nicotine

It is possible to inhale too much nicotine ifyou use e-Voke too often. You may also get these effects ifyou are not used to inhaling when you smoke tobacco.

These effects include:

•    feeling faint    • feeling sick (nausea)    -headache

Side-effects of e-Voke

•    increased appetite or weight gain

•    urges to smoke (craving)

•    nighttime awakening or sleep disturbance

•    lowering of heart rate


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

•    headache    •    cough    •    irritation    of the mouth or throat

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

•    dizziness    •    stomach discomfort    •    hiccups

•    nasal congestion    •    being sick (vomiting)    •    feeling sick (nausea)

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

•    chest palpitations

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

•    abnormal beating of the heart

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

Reporting of side effects

Ifyou get any side effects, talkto your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.


5. How to store e-Voke

•    Keep e-Voke in a safe place out of the sight and reach of children and animals.

•    Store in the original packaging to protect from light. Do not store above 25 C. Do not store e-Voke in your pocket.

•    Do not use this medicine after the expiry date (EXP) which is stated on the pack. The expiry date refers to the last day of that month. After this date return any unused medicine to your nearest pharmacy for safe disposal.

•    Dispose of any cartridge that has been attached to the vaporiser for over 24 hours, even if it has not been used.

•    The inhaler should be disposed of and replaced after it has been used for 6 weeks.

How to dispose of e-Voke

It is very important that you dispose of e-Voke sensibly and safely as the empty cartridge and inhaler still contains some nicotine. This nicotine may not be available for inhalation but could be harmful to children or pets.

Put used cartridges back in the pack and then dispose of them with your household rubbish.

The inhaler should not be disposed of in your household waste. It must be returned to the pharmacy or place of purchase for disposal.

Do not throw away any medicines via wastewater. Askyour pharmacist howto throw away medicines you no longer use. These measures will help protect the environment.


6. Contents of the pack and other information

What e-Voke Electronic Inhaler contains:

• The active substance is nicotine • The other ingredients are glycerol and water.

What does e-Voke Electronic Inhaler look like and contents of the pack

e-Voke Electronic Inhaler is an electronic inhaler composed of a stainless steel, battery powered vaporiser, which has a clear cap to protect the vaporiser when notin use and a USB battery recharger.

e-Voke Inhalation Cartridges are brown plastic. One end has a small hole and the marking N15. Inside there is a smaller cartridge with a foil tab which sticks out. Each cartridge contains 15 mg nicotine, the active ingredient.

One e-Voke Electronic Inhaler is supplied with 5 e-Voke inhalation cartridges in a blister pack. Replacement cartridge packs contain 5,15 or 20 e-Voke inhalation cartridges.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Nicovations Limited, Globe House, 1 Water Street, London, WC2R 3LA Manufacturer

Nicoventures Trading Ltd, 48 Grafton Street, Manchester, M13 9XX

This leaflet was last revised in October 2015


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