Nicotine 0.45mg Inhaler

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

NICOTINE

Disponible des:

Kind Consumer Limited 79 Clerkenwell Road, London EC1R 5AR, United Kingdom

Codi ATC:

N07BA01

Designació comuna internacional (DCI):

NICOTINE

formulario farmacéutico:

PRESSURISED INHALATION, SOLUTION

Composición:

NICOTINE 0.45 milligram(s)

tipo de receta:

OTC

Área terapéutica:

OTHER NERVOUS SYSTEM DRUGS

Estat d'Autorització:

Authorised

Data d'autorització:

2019-03-26

Informació per a l'usuari

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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 side-effects, have any questions or are not sure about
anything, please ask your doctor,
nurse, pharmacist.
IN THIS LEAFLET:
1.
What Nicotine Inhaler is and what it is used for
2.
Before using Nicotine Inhaler
3.
How and when to use Nicotine Inhaler
4.
Possible side-effects
5.
How to clean, store and dispose of Nicotine Inhaler
6.
Further information
1
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
INH

Fitxa tècnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nicotine 0.45 mg Inhaler
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pack contains 9 mg nicotine and provides approximately 20 charges
of the stick device. Each
charge contains approximately 0.45 mg nicotine, equivalent to a
delivered dose of 0.43 mg nicotine,
except for the first charge, which delivers less than 0.43 mg (range
0.10 – 0.30 mg) due to stick
design.
Excipient: ethanol (contains less than 10 mg of ethanol per charged
stick).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pressurised inhalation solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicotine 0.45 mg Inhaler relieves and/or prevents craving and nicotine
withdrawal symptoms
associated with tobacco dependence. It is indicated to aid smokers
wishing to quit or reduce prior to
quitting, to assist smokers who are unwilling or unable to smoke, and
as a safer alternative to
smoking for smokers and those around them.
Nicotine 0.45 mg Inhaler is indicated in pregnant and lactating women
making a quit attempt.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nicotine 0.45 mg Inhaler is for oral inhalation use only.
_Posology _
ADULTS OVER 18 YEARS OF AGE:
Nicotine 0.45 mg Inhaler should be used whenever the urge to smoke is
felt or to prevent cravings
in situations where these are likely to occur.
Smokers willing or able to stop smoking immediately should initially
replace all their cigarettes
with the Inhaler and as soon as they are able, reduce the number of
charges used until they have
stopped completely.
Smokers aiming to reduce cigarettes should use the Inhaler, as needed,
between smoking episodes
to prolong smoke-free intervals and with the intention to reduce
smoking as much as possible.
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As soon as they are ready, smokers should aim to quit smoking
completely.
Maximum daily dose: 2 packs
When making a quit attempt, behavioural therapy, advice and support
will normally improve the
success rate. Those who have quit smoking,