Voke 0.45 Mg Inhaler
page 2 - 85mm I page 3 - 77mm I page 4 - 77mm I page 5 - 77mm I page 6 - 77mm I page 7 - 76mm I page 8 - 76mm
VOKE® 045MG INHALER NICOTINE
What you should know about the Voke® Inhaler
Please read this leaflet carefully before you start using this medicine. t 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 or 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
5. 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.
3y using this Nicotine Replacement Therapy, you and those around you will not be exposed to the serious health risk associated with smoking.
:or the full health benefits you should use Voke to help you stop smoking :ompletely. 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. :hildren, friends or family.
When you use Voke, nicotine is released and passes into your body, just like a cigarette but without the harmful hemicals in the smoke. You can use Voke as you would a cigarette and inhale as much as desired.
:or 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 n place of cigarettes.
2. BEFORE USING VOKE 3 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:
i if you are pregnant or breast-feeding
- 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 breast-feeding".
if you are in hospital because of heart disease (including heart attack, disorders of heart rate or rhythm, 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, duodena 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.
i 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.
i 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.
A If you are pregnant or breast-feeding:
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.
i If breast-feeding, 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 harmfu than the second-hand smoke they would have inhaled if you smoked. Tobacco smoke produces breathing and other problems in babies and children
A Voke contains ethanol (alcohol)
'This medicinal product contains small amounts of ethanol (alcohol), less than 10mg per charged 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.
Insert the arrowed end of the stick into the base of the pack and push firmly for five seconds to charge.
Click open the side door and remove the Voke stick.
Hold the pack upright and away from you.
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 I 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 nave stopped using them completely. However, it is safer to remain on Voke long-term than to re-start 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. | ||
|
A 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 eaflet and the pack with you. A If a child under 12 uses Voke Do not be alarmed, but contact a doctor or your nearest hospital Accident and Emergency department mmediately. Take this leaflet and the oack with you. Nicotine inhalation or ngestion 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. | ||
|
f 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 oecause by stopping smoking you have reduced the amount of nicotine you are taking. You may also experience these effects if you underuse Voke before you are ready to reduce your nicotine intake. These effects include: i irritability or aggression ■ feeling low | ||
|
■ poor concentration ■ anxiety | ||
|
■ lowering of heart rate ■ restlessness | ||
|
■ urges to smoke (craving) | ||
|
■ increased appetite or weight gain | ||
|
■ night time awakening or sleep disturbance | ||
|
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 sick (nausea) ■ feeling faint | ||
|
■ headache | ||
|
Side-effects for the Inhaler 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) ■ nasal congestion ■ dizziness | ||
|
■stomach discomfort ■ hiccups | ||
|
■feeling sick (nausea) ■ vomiting (sickness) | ||
|
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 | ||
|
If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not isted in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/ | ||
|
yellowcard. 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 (enclosec within the pack) containing 20 charges. Each charge contains 0.45mg nicotine equivalent 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 design. Voke is supplied in 1, 2x1 or 5x1 pack sizes. Not all pack sizes may be marketed. |
Marketing Authorisation Holder: Nicovations Limited
Globe House, 1 Water Street .ondon, WC2R 3LA
Manufacturer:
3espak Europe Ltd, Bergen Way, Kings Lynn, PE30 2JJ.
This leaflet was last revised 02/2015.
To request a copy of this leaflet in Braille, large print or audio format, contact Nicovations on 0800 210 0110, or via email at info@nicovations.com
o
m
3
3
i-
TEM NUMBER (ZINC CODE):
DESCRIPTON:
REPRODUCTION CREATED:
PI
OLDED SIZE(LEAFLET): FLAT (UNFOLDED) SIZE
ORIGINATOR:
.OLOUR TARGETS IN PRINT SEQUENCE:
100% 50%
-I PMS Cool Grey 9 C
Red PMS 186 C
Process Black
.PPROVED / DATE:
This document may not be copied, given to third parties or otherwise improperly used. Earlier document are no longer valid
8mm
|
• |
• • • • | |
|
• |
• | |
|
• • |
• | |
|
• |
• • |
• • |
|
• • |
• |
• • |
|
• |
• • • |
• |
|
• • • |
• |
• |
4mm 30mm 4mm
• • • • • • •••* '••••' * • • • • •........
66mm
11mm
• • • • • * • •
• • • *
Braille Reads:
VOKE
#0.45
MG
OK
Voke can help with cravings when you stop smoking or cut down or replace the number of cigarettes you smoke. This is a safer alternative for you and those around you. You should aim to stop smoking and this may help your motivation to quit. Voke is for adult^ver 18 years of age. #
Contents: 1 stick and 1 aressurifed canistaraHtaining 20 charges, each*containing ).45mg nicotine, equivalent to a delivered dose of 0.43mg nicotine, eitapt for Phie first charge (which delivers less [seejeafletfor detaijj). Also contains propylene glycol, ethanol, le^enthll, Itcmrin and®H<FA1l4a (a CFCfree propellant). Storage: Keep out of the sight and reach of children. Store below 25°C. Once opened discard after 7 days. Pressurised can. Do not puncture, break or burn even when empty. Do not expose to temperatures higher than 50°C. Store away from heat -or direct sunlight.
Maximum daily dose 2 parks. _
TUCK—
open and remove the stick. Hold the pack upright
I Insert Uthe r arrowed LJ end of the stick into the base of the
packand pushfirmly for five secondsto CHARGE. Charge new sticks twice Draw gently through the filter end and INHALE
READ TH LEAFLET
POSITION OF THE 2D PHARMA CODE