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NICOTINE 0.45 MG INHALER

Active substance(s): NICOTINE

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CONFIDENTIAL

Module 1.3.1- Nicotine
0.45mg Inhaler Patient
Information Leaflet

Last Edit: 22 Apr 2015

by

NW

Status: Issue 1 Final
Page 1 of 6

NICOTINE 0.45 MG INHALER
nicotine
What you should know about the Nicotine 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 sideeffects, have any questions or are not sure about anything, please ask your doctor, nurse, pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.
1.

What Nicotine Inhaler is and what it is used for
Before using Nicotine Inhaler
How and when to use Nicotine Inhaler
Possible side-effects
How to clean, store and dispose of Nicotine Inhaler
Further information
WHAT NICOTINE INHALER IS AND WHAT IT IS USED FOR

Nicotine Inhaler is a nicotine inhalation device that is used in a similar way to smoking and substitutes
the nicotine that you normally get from cigarettes. Nicotine Inhaler 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 Nicotine Inhaler 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 Nicotine Inhaler
when you are unable to smoke or want to avoid causing harm to others e.g. children, friends or family.
When you use Nicotine Inhaler, nicotine is released and passes into your body, just like a cigarette
but without the harmful chemicals in the smoke. You can use Nicotine Inhaler as you would a
cigarette and inhale as much as desired.
For the best effect, ensure that you use your Nicotine Inhaler correctly – see “How and when to use
Nicotine Inhaler”.
The benefits of stopping smoking far outweigh any potential risk from using nicotine from
Nicotine Inhaler. There are no circumstances in which it is safer to smoke than to use Nicotine
Inhaler.
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 NICOTINE INHALER

Do not use Nicotine Inhaler:

CONFIDENTIAL

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Module 1.3.1- Nicotine
0.45mg Inhaler Patient
Information Leaflet

Last Edit: 22 Apr 2015

by

NW

Status: Issue 1 Final
Page 2 of 6

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 Nicotine Inhaler 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 Nicotine Inhaler 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, or stroke). In other heart conditions not requiring you to be in hospital, using
Nicotine Inhaler 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. Nicotine Inhaler 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
Nicotine Inhaler 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 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 Nicotine Inhaler 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 Nicotine Inhaler to ensure the baby gets the smallest
amount of nicotine possible. If you do need to use Nicotine Inhaler, 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.

Nicotine Inhaler contains ethanol (alcohol).
This medicinal product contains small amounts of ethanol (alcohol), less than 10mg per charged stick.
3.

HOW AND WHEN TO USE NICOTINE INHALER

Method of administration

Charging the Nicotine Inhaler 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 Nicotine Inhaler 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 Nicotine Inhaler stick, you need to repeat this charging step and
shake well before use.
 If you have not used Nicotine Inhaler for more than two days, repeat this charging step.

CONFIDENTIAL

Module 1.3.1- Nicotine
0.45mg Inhaler Patient
Information Leaflet

Last Edit: 22 Apr 2015

by

NW

Status: Issue 1 Final
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 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 Nicotine Inhaler 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 Nicotine Inhaler 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 Nicotine Inhaler stick:
 To recharge the stick follow the relevant instructions in “Charging the Nicotine Inhaler stick”.
 The stick can be charged up to twenty times, sometimes more if the stick is only partially
emptied between charges.
When to use Nicotine Inhaler
For the full health benefits you should use Nicotine Inhaler 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 Nicotine Inhaler longterm than to re-start smoking.
If you’re not ready to stop smoking completely, Nicotine Inhaler can also help you cut down. You
should replace as many cigarettes as possible with Nicotine Inhaler as reducing the number of
cigarettes may also help you to become more motivated to stop smoking.
Alternatively you can use Nicotine Inhaler 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.

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Module 1.3.1- Nicotine
0.45mg Inhaler Patient
Information Leaflet

Last Edit: 22 Apr 2015

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NW

Status: Issue 1 Final
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The frequency with which you use Nicotine Inhaler 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 Nicotine Inhaler 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 Nicotine Inhaler
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, Nicotine Inhaler 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 Nicotine Inhaler
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
Very common side-effects:
(more than 1 in every 10 people are affected)
- headache
- cough
- irritation of the mouth or throat

CONFIDENTIAL

Module 1.3.1- Nicotine
0.45mg Inhaler Patient
Information Leaflet

Last Edit: 22 Apr 2015

by

NW

Status: Issue 1 Final
Page 5 of 6

Common side-effects:
(less than 1 in every 10 people are affected)
- dizziness
- nasal congestion
- 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.
5.

HOW TO CLEAN, STORE AND DISPOSE OF NICOTINE INHALER

Cleaning the Nicotine Inhaler stick:
Wipe the mouthpiece of the stick gently with a dry tissue.
Storing Nicotine Inhaler:
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 Nicotine Inhaler within 7 days and do not use Nicotine Inhaler 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 an appropriate recycling facility.
6.

FURTHER INFORMATION

What Nicotine Inhaler contains:
The active substance is nicotine.
The other ingredients are propylene glycol, ethanol, saccharin, levomenthol and HFA134a (a CFCfree propellant).

CONFIDENTIAL

Module 1.3.1- Nicotine
0.45mg Inhaler Patient
Information Leaflet

Last Edit: 22 Apr 2015

by

NW

Status: Issue 1 Final
Page 6 of 6

What Nicotine Inhaler looks like and contents of the pack:
Nicotine Inhaler 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
0.43 mg (range 0.10 – 0.30 mg) due to stick design.
Nicotine Inhaler 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, London,
WC2R 3LA
Manufacturer: Bespak Europe Ltd, Bergen Way, Kings Lynn, PE30 2JJ.
This leaflet was last revised in 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.
Nicotine Inhaler is a registered trade mark of Nicovations Limited.**
{** text will be included on marketed pack when an appropriate tradename is approved by variation for
‘Nicotine Inhaler’ before placing the product on the market}

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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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