VOKE0.45 MG INHALERicotineWhat you should know about the VokeInhalerPl - PDF document

VOKE0.45 MG INHALERicotineWhat you shoul
VOKE0.45 MG INHALERicotineWhat you should know about the VokeInhalerPlease read this leaflet carefullybefore youstart using this medicine. It provides useful information on how to use it safely. Keep thleaflet, you mightneed it again.If you think you are 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 diseaseif you have a longterm throat disease or difficulty breathingdue to bronchitis, emphysema or asthma. Vokemay 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 glandor have a phaeochromocytoma(a tumour of the adrenal gland that can affect blood pressure) your doctor will have told you this.if you have diabetesmonitor 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 medicinessuch 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 breastfeedingFirstly, you should try to give up smoking without usingnicotine 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 Voketo 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 secondhand smoke they w
harmful than the secondhand smoke they would have inhaled ifyou 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 10mg per charged stick.This medicine contains 54mg propylene glycol (E1520) in each pack, which is equivalent to 2.7mg in each ull charge of the stick.HOW AND WHEN TO USE VOKEMethod of administrationCharging the Vokestick: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 uprightand away from you.Insert the arrowed end of the stick into the base of the packush firmly for fiveseconds to chargeThe first time you charge a Voke stick, you need to repeat this charging stepand 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 Vokestick:Inhale through the filter end of the stick as you would with a cigaretteensuring 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 sprayin 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 th

e pack is cold.Recharging the Voke stick
e pack is cold.Recharging the Voke stick:To recharge the stick follow the relevnt instructions in “Charging the Voke stickThestick can be charged up to twenty times, sometimes more if the stick is only partially emptied between chargesWhen to use VokeFor 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 longterm 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 Vokewhen you are unable to smokeor want to avoid causing harm to others e.g. children, friends or family.DosageAdultsaged overyears: s needed; up to a maximum of 2 full packs per dayThe frequency with which you use Vokeand the length of time it lasts will depend on how many cigarettes you previously smoked and how strong they were.If you use more Vokethan you shouldIf you have used more than therecommended number of packs, you may experience feeling sick (nauseasalivation, 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 VokeDo 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 ingestio

n by a child may result in severe poison
n by a child may result in severe poisoninPOSSIBLE SIDEEFFECTSLike all nicotinecontaining products, Vokecan have sideeffects. 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 Vokebefore you are ready to reduce your nicotine intake.These effects include:irritability or aggressionfeeling lowanxietyrestlessnesspoor concentrationincreased appetite or weight gaiurges to smoke (craving)night time awakening or sleep disturbancelowering of heart rateWhen you stop smoking you may also develop mouth ulcers. The reason why this happens is unknown.Effects of too much nicotineYou may get thefollowing effects ifyou are not used to inhaling tobacco smokefeeling faintfeeling sick (nausea)headacheSideeffects for the InhalerIf 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 sideeffects:may affect more than 1 in 10 peopleheadachecoughthroat irritation(feeling sick) nauseasore and inflamed mouthhiccupsCommon sideeffects:may affect up to 1 in 10 peopleallergic reactions (hypersensitivity)burning sensation in the mouthdizzinesstaste disturbance or loss of tastetingling or numbness of the hands and feetblocked nosstomach pain or d

iscomfortdiarrhoeadry mouthindigestionex
iscomfortdiarrhoeadry mouthindigestionexcessive gas or windincreased salivationsickness (vomiting)tiredness (fatigue)Uncommon sideeffects:may affect up to 1 in 100 peopleabnormal dreamchest palpitationsfast heart rate/beatsudden reddening of the face and/or neckhigh blood pressuresudden constriction of the small airways of the lung that can cause wheezing and shortness of breathloss or damage to voiceshortness of breathsneezingthroat tightnessburping (belching)swollen, red, sore tonguemouth ulcers or blistersnumbness or tingling of the mouthhives (urticaria)excessive sweatingitchingrashunusual weaknesschest discomfort and paingeneral feeling of discomfort or being unwell or out of sorts (malaise)are sideeffects:may affect up to 1 in 1,000 peopledifficulty in swallowingdecreased feeling or sensitivy, especially in the mouthfeeling of wanting to be sick (vomit)Very rare sideeffects:may affect up to 1 in 10,000 peopleabnormal beating of the heartOthersideeffectscan includeseriousallergic reactionwhich cause difficulty in breathing or dizziness, swelling of the face or throatblurred vision, watery eyesstomach discomfortredness of the skindry throat, lip painIf you get any sideeffects, talk to your doctor, pharmacist or nurse. This includes any possible sideeffects not listed in this leaflet.You can also report sideeffects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcardor search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting sideeffects you can help provide more information on the safety of this medicine.HOW TO CLEAN,STORE AND DISPOSE OF VOKECleaning the Voke stick:Wipe the mouthpiece of the stick gently with a drytissue.Storing Voke:Keep out of the reach and sight of children and a

nimals.Nicotine in high amounts can be v
nimals.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 °C. Store awayfrom heat or direct sunlight.Do not attempt to light the stick.Once opened discard Voke within 7 days and do not use Vokeafter 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.FURTHER INFORMATIONWhat Vokecontains:The active substance is nicotine.The other ingredients are propylene glycol, ethanol, saccharinlevomenthol and HFA134a (a CFCfree propellant)What Vokelooks like and contents of the pack:Vokecontains one cigarettelike inhaler stick and one pressurised aluminium aerosol canister(enclosed within the pack)containing 20 chargesEach charge contains 0.45mg nicotineequivalent to a delivered dose of 0.43mg nicotine, except for the first charge, which delivers less than 0.43mg (range 0.10 0.30mg) due to stick desigVoke is supplied in 1, 2x1 or 5x1 pack sizes.Not all pack sizes may be marketed.Marketing Authorisation Holder: Kind Consumer Ltd79 Clerkenwell RoadLondon EC1R 5AR Manufacturer: Wasdell Packaging Ltd.Units 1and 58 Euroay Industrial EstateBlagroveSwindon, SN5 8YWUnited KingdomThis leaflet was last revised 11/2019.To request a copyof this leaflet in Braille, large print or audio formatcontact Kind Consumeron 0800 046 , orviaemail info@kindconsumer.com. eMC V8.0 15112019