What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 39589/0003.


Voke 0.45 mg Inhaler

PATIENT INFORMATION LEAFLET

VOKE 0.45 MG INHALER

nicotine

What you should know about the Voke Inhaler

Please read this leaflet carefully before you start using this medicine. It provides useful information on how to use it safely. Keep the leaflet, you might need it again. If you think you are having side effects, have any questions or are not sure about anything, please ask your doctor, nurse, pharmacist.

In this leaflet:

1. What Voke is and what it is used for
2. Before using Voke
3. How and when to use Voke
4. Possible side effects
5. How to clean, store and dispose of Voke
6. Further information

1 WHAT VOKE IS AND WHAT IT IS USED FOR

Voke is a nicotine inhalation device that is used in a similar way to smoking and substitutes the nicotine that you normally get from cigarettes. Voke is an alternative to 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.

By using this Nicotine Replacement Therapy, you and those around you will not be exposed to the serious health risk associated with smoking.

For the full health benefits you should use Voke to help you stop smoking completely. If you’re not ready to do this, it can also help you cut down. Alternatively you can use Voke when you are unable to smoke or want to avoid causing harm to others e.g. children, friends or family.

When you use Voke, nicotine is released and passes into your body, just like a cigarette but without the harmful chemicals in the smoke. You can use Voke as you would a cigarette and inhale as much as desired.

For the best effect, ensure that you use your Voke correctly. See “How and when to use Voke”.

The benefits of stopping smoking far outweigh any potential risk from using nicotine from Voke. There are no circumstances in which it is safer to smoke than to use Voke.

Since the product replaces nicotine from smoking, it can help relieve nicotine withdrawal symptoms such as irritability, low mood, anxiety, restlessness and cravings when used in place of cigarettes.

2 BEFORE USING VOKE

Do not use Voke:

  • if you have an allergy to nicotine or any of the other ingredients (see section 6).
  • if you are under 18 years of age.

Any risks associated with Voke are less than those of continued smoking. However, talk to your doctor, nurse or pharmacist:

  • if you are pregnant or breastfeeding you may be able to use Voke to help you give up smoking; but you should try to give up without it. See “If you are pregnant or breastfeeding”.
  • if you are in hospital because of heart disease (including heart attack, disorders of heart rate or rhythm, angina, high blood pressure or stroke). In other heart conditions not requiring you to be in hospital,using Voke is better than continuing to smoke.
  • if you have a stomach ulcer, duodenal ulcer, inflammation of the stomach or inflammation of the oesophagus (passage between the mouth and stomach).
  • if you have liver or kidney disease.
  • if you have a long term throat disease or difficulty breathing due to bronchitis, emphysema or asthma. Voke may not be suitable for you to use and you may be advised to use a different type of nicotine product.
  • if you have an overactive thyroid gland or have a phaeochromocytoma (a tumour of the adrenal gland that can affect blood pressure). Your doctor will have told you this.
  • if you have diabetes monitor your blood sugar levels more often when starting to use Voke as you may find your insulin or medication requirements alter.
  • if you are taking any other medicines such as theophylline, clozapine or ropinirole. Stopping smoking or cutting down may require the dose of these medicines to be adjusted.

If you are pregnant or breastfeeding:

  • Firstly, you should try to give up smoking without using a nicotine product. Stopping completely is by far the best option. The earlier and quicker you do this the better it is for you and your baby.
  • Secondly, if you can’t manage this, you can use Voke as a safer alternative to smoking. However, you should talk to your doctor, nurse or pharmacist for advice.
  • If breastfeeding, try to do so before using Voke to ensure the baby gets the smallest amount of nicotine possible. If you do need to use Voke, the amount of nicotine that the baby may receive is considerably smaller and less harmful than the second hand smoke they would have inhaled if you smoked. Tobacco smoke produces breathing and other problems in babies and children.

Voke contains ethanol (alcohol).

This medicinal product contains small amounts of ethanol (alcohol), less than 10 milligrams per charged stick. This medicine contains 54 milligrams propylene glycol (E1520) in each pack, which is equivalent to 2.7 milligrams in each full charge of the stick.

3 HOW AND WHEN TO USE VOKE

Method of administration

Charging the Voke stick:

  • Tear away the strip on the pack and remove the cellophane outer wrap completely.
  • Peel away the foil strip at the bottom of the pack.
  • Click open the side door and remove the Voke stick.
  • Hold the pack upright and away from you.
  • Insert the arrowed end of the stick into the base of the pack and push firmly for five seconds to charge.
  • The first time you charge a Voke stick, you need to repeat this charging step and shake well before use.
  • If you have not used Voke for more than two days, repeat this charging step.
  • You should only fill the stick before you intend to use it.

If spray comes into contact with skin or eyes, rinse gently with water.

Using the Voke stick:

  • Inhale through the filter end of the stick as you would with a cigarette ensuring you don’t cover the air inlet holes at the filter end of the stick.
  • On average each charge apart from the first one provides a comparable number of puffs to a conventional cigarette.
  • The stick is empty when you no longer feel the flavoured spray in your mouth.
  • Put the Voke stick back in the pack when not in use.
  • On normal use, you are unlikely to see any vapour. Whether you see it or not, the vapour is harmless to you and to those around you.
  • As with most inhaled medications, the therapeutic effect of this medication may decrease when the pack is cold.

Recharging the Voke stick:

  • To recharge the stick follow the relevant instructions in “Charging the Voke stick”.
  • The stick can be charged up to twenty times, sometimes more if the stick is only partially emptied between charges.

When to use Voke

For the full health benefits you should use Voke to help you stop smoking completely. When ready, which may be after many months, you should aim to reduce the number of packs until you have stopped using them completely. However, it is safer to remain on Voke long term than to restart smoking.

If you’re not ready to stop smoking completely, Voke can also help you cut down. You should replace as many cigarettes as possible with Voke as reducing the number of cigarettes may also help you to become more motivated to stop smoking.

Alternatively you can use Voke when you are unable to smoke or want to avoid causing harm to others e.g. children, friends or family.

Dosage

Adults aged over 18 years: as needed; up to a maximum of 2 full packs per day.

The frequency with which you use Voke and the length of time it lasts will depend on how many cigarettes you previously smoked and how strong they were.

If you use more Voke than you should

If you have used more than the recommended number of packs, you may experience feeling sick (nausea), salivation, pain in your abdomen, diarrhoea, sweating, headache, dizziness, hearing disturbance or weakness. If you get any of these effects, contact a doctor or your nearest hospital Accident and Emergency department. Take this leaflet and the pack with you.

If a child under 12 uses Voke

Do not be alarmed, but contact a doctor or your nearest hospital Accident and Emergency department immediately. Take this leaflet and the pack with you. Nicotine inhalation or ingestion by a child may result in severe poisoning.

4 POSSIBLE SIDE EFFECTS

Like all nicotine containing products, Voke can have side effects. As many of the effects are due to nicotine, they can also occur when nicotine is obtained by smoking.

If you notice a fast, slow, or irregular heartbeat, stop using the medicine, do not smoke and see your doctor as soon as possible.

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 under use Voke before you are ready to reduce your nicotine intake.

These effects include:

  • irritability or aggression
  • feeling low
  • anxiety
  • restlessness
  • poor concentration
  • increased appetite or weight gain
  • urges to smoke (craving)
  • night time awakening or sleep disturbance
  • lowering of heart rate

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

Effects of too much nicotine

You may get the following effects if you are not used to inhaling tobacco smoke:

  • feeling faint
  • feeling sick (nausea)
  • headache

Side effects for the Inhaler

If you notice any of the following allergic reactions (swelling of the mouth, lips, throat and tongue, itching of the skin, swelling of the skin, ulceration and inflammation of the lining of the mouth) stop using Voke and contact a doctor immediately.

Very common side effects:

(may affect more than 1 in 10 people)

  • headache
  • cough
  • throat irritation
  • (feeling sick) nausea
  • sore and inflamed mouth
  • hiccups

Common side effects:

(may affect up to 1 in 10 people)

  • allergic reactions (hypersensitivity)
  • burning sensation in the mouth
  • dizziness
  • taste disturbance or loss of taste
  • tingling or numbness of the hands and feet
  • blocked nose
  • stomach pain or discomfort
  • diarrhoea
  • dry mouth
  • indigestion
  • excessive gas or wind
  • increased salivation
  • sickness (vomiting)
  • tiredness (fatigue)

Uncommon side effects:

(may affect up to 1 in 100 people)

  • abnormal dreams
  • chest palpitations, fast heart rate/beat
  • sudden reddening of the face and/or neck
  • high blood pressure
  • sudden constriction of the small airways of the lung that can cause wheezing and shortness of breath
  • loss or damage to voice
  • shortness of breath
  • sneezing
  • throat tightness
  • burping (belching)
  • swollen, red, sore tongue
  • mouth ulcers or blisters
  • numbness or tingling of the mouth
  • hives (urticaria)
  • excessive sweating
  • itching
  • rash
  • unusual weakness
  • chest discomfort and pain
  • general feeling of discomfort or being unwell or out of sorts (malaise)

Rare side effects:

(may affect up to 1 in 1,000 people)

  • difficulty in swallowing
  • decreased feeling or sensitivy, especially in the mouth
  • feeling of wanting to be sick (vomit)

Very rare side effects:

(may affect up to 1 in 10,000 people)

  • abnormal beating of the heart

Other side effects can include:

  • serious allergic reactions which cause difficulty in breathing or dizziness, swelling of the face or throat
  • blurred vision, watery eyes
  • stomach discomfort
  • redness of the skin
  • dry throat, lip pain

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.

5 HOW TO CLEAN, STORE AND DISPOSE OF VOKE

Cleaning the Voke stick:

Wipe the mouthpiece of the stick gently with a dry tissue.

Storing Voke:

Keep out of the reach and sight of children and animals. Nicotine in high amounts can be very dangerous and sometimes fatal if used or swallowed by small children.

Pressurised container. Do not expose to temperatures higher than 50°C. Do not puncture, break or burn even when empty. Store below 25°C. Store away from heat or direct sunlight. Do not attempt to light the stick.

Once opened discard Voke within 7 days and do not use Voke after the ‘EXP’ date shown on the carton.

Disposal:

Because of residual nicotine and the potential choking hazard, used packs and sticks may be a hazard to children, animals and fish and so should never be left lying around. The stick should be kept in the pack and disposed of with household rubbish or at an appropriate recycling facility.

6 FURTHER INFORMATION

What Voke contains:

The active substance is nicotine.

The other ingredients are propylene glycol, ethanol, saccharin, levomenthol and HFA134a (a CFC free propellant).

What Voke looks like and contents of the pack:

Voke contains one cigarette like inhaler stick and one pressurised aluminium aerosol canister (enclosed within the pack) containing 20 charges. Each charge contains 0.45 milligrams nicotine equivalent to a delivered dose of 0.43 milligrams nicotine, except for the first charge, which delivers less than 0.43 milligrams (range 0.10 to 0.30 milligrams) due to stick design.

Voke is supplied in 1, 2 or 5 packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Kind Consumer Ltd.
79 Clerkenwell Road
London
EC1R 5AR

Manufacturer:

Wasdell Packaging Ltd.
Units 1 to 3 and 5 to 8 Euroway Industrial Estate
Blagrove
Swindon
SN5 8YW
United Kingdom

This leaflet was last revised November 2019.

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