GSL: General Sales List
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
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:
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:
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:
If spray comes into contact with skin or eyes, rinse gently with water.
Using the Voke stick:
Recharging the Voke stick:
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.
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:
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:
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)
Common side effects:
(may affect up to 1 in 10 people)
Uncommon side effects:
(may affect up to 1 in 100 people)
Rare side effects:
(may affect up to 1 in 1,000 people)
Very rare side effects:
(may affect up to 1 in 10,000 people)
Other side effects can include:
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.
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.
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:
This leaflet was last revised November 2019.
eMC V8.0 15112019
79 Clerkenwell Road, London, EC1R 5AR
+44 (0)1271 334 609
0800 046 9980
+44 (0)203 206 4940