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VOKE 0.45 MG INHALER

Active substance(s): NICOTINE

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VOKE® 0.45MG INHALER
NICOTINE

page 9 - 76mm

page 2 - 85mm

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 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
6. Further information

1. WHAT VOKE IS AND WHAT IT
IS USED FOR

page 12 - 77 mm

page 5 - 77mm

Offset
TBC
26.02.2015
TBC

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 underuse Voke before you
are ready to reduce your nicotine intake.
These effects include:
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
listed 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.

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.
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 0.45mg
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.

MASTER CONTROL REF:

FOLDED SIZE(LEAFLET):

F L AT ( U N F O L D E D ) S I Z E :

DWG 0026

38 x 85 mm

38 x 545 mm

F L AT S I Z E ( B A S E L A B E L :

38 x 88 mm

TBC
TBC
PMS Cool Grey 9 C

Marketing Authorisation Holder:
Nicovations Limited
Globe House, 1 Water Street
London, WC2R 3LA
Manufacturer:
Bespak Europe Ltd, Bergen Way,
Kings Lynn, PE30 2JJ.
This leaflet was last revised 02/2015.

Red PMS 186 C

Process Black

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
TBC

(xx g/sm)

Braille Position Guide

8mm

66mm

Braille Reads:

VOKE
#0.45
MG
11mm

4mm

30mm

CLICK

Front cover - 85mm

page 8 - 76mm

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 adults over 18
years of age.
Contents: 1 stick and 1
pressurised canister containing
20 charges, each containing
0.45mg nicotine, equivalent
to a delivered dose of 0.43mg
nicotine, except for the first
charge which delivers less
(see leaflet for details). Also
contains propylene glycol,
ethanol, levomenthol, saccharin
and HFA134a (a CFC-free
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 packs.

PROFILE:

TBC

6. FURTHER INFORMATION

page 14 - 77 mm

page 7 - 76mm

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.

90004.11 VOKE 0.45mg PIL UK.ai

Front cover - 85mm

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.

mock up PIL Voke 0.45mg UK

5. HOW TO CLEAN, STORE AND
DISPOSE OF VOKE

page 13 - 77 mm

page 6 - 77mm

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.
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 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 10mg per charged stick.

UK/VOKE/15/0009

Base label

page 4 - 77mm

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 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, 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.

ITEM NUMBER (ZINC CODE):

4. POSSIBLE SIDE-EFFECTS

page 11 - 77 mm

2. BEFORE USING VOKE

page 10 - 76mm

page 3 - 77mm

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.

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 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.
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.

open and
remove the
stick. Hold
the pack
upright.

Insert
the
arrowed
end of
the stick
into the
base of the
pack and
push firmly
for five
seconds to

CHARGE.

Charge new
sticks twice.
Draw gently
through
the filter
end and

INHALE

READ THE
LEAFLET

POSITION OF THE 2D PHARMA CODE

4mm

TBC

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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