lUNLICENSED USEAll preparations are licensed for children
over 12 years (with the exception ofNicotinell®lozenges
which are licensed for children under 18 years only when
recommended by a doctor).
lCAUTIONS
GENERAL CAUTIONSDiabetes mellitus—blood-glucose
concentration should be monitored closely when initiating
treatment.haemodynamically unstable patients
hospitalised with cerebrovascular accident.
haemodynamically unstable patients hospitalised with
myocardial infarction.haemodynamically unstable
patients hospitalised with severe arrhythmias.
phaeochromocytoma.uncontrolled hyperthyroidism
SPECIFIC CAUTIONS
▶When used by inhalationBronchospastic disease.chronic
throat disease.obstructive lung disease
▶With intranasal useBronchial asthma (may exacerbate)
▶With oral useGastritis (can be aggravated by swallowed
nicotine).gummay also stick to and damage dentures.
oesophagitis (can be aggravated by swallowed nicotine).
peptic ulcers (can be aggravated by swallowed nicotine)
▶With transdermal usePatchesshould not be placed on
broken skin.patients with skin disorders
CAUTIONS, FURTHER INFORMATIONMost warnings for
nicotine replacement therapy also apply to continued
cigarette smoking, but the risk of continued smoking
outweighs any risks of using nicotine preparations.
Specific cautions for individual preparations are usually
related to the local effect of nicotine.
lSIDE-EFFECTS
GENERAL SIDE-EFFECTS
▶Common or very commonDizziness.headache.
hyperhidrosis.nausea.palpitations.skin reactions.
vomiting
▶UncommonFlushing
SPECIFIC SIDE-EFFECTS
▶Common or very common
▶When used by inhalationAsthenia.cough.dry mouth.
flatulence.gastrointestinal discomfort.hiccups.
hypersensitivity.nasal complaints.oral disorders.taste
altered.throat complaints
▶With intranasal useChest discomfort.cough.dyspnoea.
epistaxis.nasal complaints.paraesthesia.throat irritation
▶With oral useAnxiety.appetite abnormal.burping.
diarrhoea.dyspepsia (may be caused by swallowed
nicotine).gastrointestinal disorders.hiccups.increased
risk of infection.mood altered.oral disorders.sleep
disorders
▶With sublingual useAsthenia.cough.dry mouth.flatulence
.gastrointestinal discomfort.hiccups.hypersensitivity.
oral disorders.rhinitis.taste altered.throat complaints
▶Uncommon
▶When used by inhalationAbnormal dreams.arrhythmias.
bronchospasm.burping.chest discomfort.dysphonia.
dyspnoea.hypertension.malaise
▶With intranasal useAbnormal dreams.asthenia.
hypertension.malaise
▶With oral useAnger.asthma exacerbated.cough.
dyspepsia aggravated.dysphagia.haemorrhage.
laryngospasm.nasal complaints.nocturia.numbness.
overdose.pain.palpitations exacerbated.peripheral
oedema.tachycardia.taste altered.throat complaints.
vascular disorders
▶With sublingual useAbnormal dreams.arrhythmias.
bronchospasm.burping.chest discomfort.dysphonia.
dyspnoea.hypertension.malaise.nasal complaints
▶With transdermal useArrhythmias.asthenia.chest
discomfort.dyspnoea.hypertension.malaise.myalgia.
paraesthesia
▶Rare or very rare
▶When used by inhalationDysphagia
▶With intranasal useArrhythmias
▶With oral useCoagulation disorder.platelet disorder
▶With sublingual useDysphagia
▶With transdermal useAbdominal discomfort.angioedema.
pain in extremity
▶Frequency not known
▶When used by inhalationAngioedema.excessive tearing.
vision blurred
▶With intranasal useAbdominal discomfort.angioedema.
excessive tearing.oropharyngeal complaints
▶With sublingual useExcessive tearing.muscle tightness.
vision blurred
SIDE-EFFECTS, FURTHER INFORMATIONSome systemic
effects occur on initiation of therapy, particularly if the
patient is using high-strength preparations; however, the
patient may confuse side-effects of the nicotine-
replacement preparation with nicotine withdrawal
symptoms. Common symptoms of nicotine withdrawal
include malaise, headache, dizziness, sleep disturbance,
coughing, influenza–like symptoms, depression,
irritability, increased appetite, weight gain, restlessness,
anxiety, drowsiness, aphthous ulcers, decreased heart rate,
and impaired concentration.
lPREGNANCYThe use of nicotine replacement therapy in
pregnancy is preferable to the continuation of smoking,
but should be used only if smoking cessation without
nicotine replacement fails. Intermittent therapy is
preferable to patches but avoid liquorice-flavoured
nicotine products. Patches are useful, however, if the
patient is experiencing pregnancy-related nausea and
vomiting. If patches are used, they should be removed
before bed.
lBREAST FEEDINGNicotine is present in milk; however, the
amount to which the infant is exposed is small and less
hazardous than second-hand smoke. Intermittent therapy
is preferred.
lHEPATIC IMPAIRMENTUse with caution in moderate to
severe hepatic impairment.
lRENAL IMPAIRMENTUse with caution in severe renal
impairment.
lDIRECTIONS FOR ADMINISTRATIONAcidic beverages, such
as coffee or fruit juice, may decrease the absorption of
nicotine through the buccal mucosa and should be avoided
for 15 minutes before the use of oral nicotine replacement
therapy.
Administration by transdermal patchPatches should be
applied on waking to dry, non-hairy skin on the hip, trunk,
or upper arm and held in position for 10 – 20 seconds to
ensure adhesion; place next patch on a different area and
avoid using the same site for several days.
Administration by nasal sprayInitially 1 spray should be used
in both nostrils but when withdrawing from therapy, the
dose can be gradually reduced to 1 spray in 1 nostril.
Administration by oral sprayThe oral spray should be
released into the mouth, holding the spray as close to the
mouth as possible and avoiding the lips. The patient
should not inhale while spraying and avoid swallowing for
a few seconds after use. If using the oral spray for thefirst
time, or if unit not used for 2 or more days, prime the unit
before administration.
Administration by sublingual tabletEach tablet should be
placed under the tongue and allowed to dissolve.
Administration by lozengeSlowly allow each lozenge to
dissolve in the mouth; periodically move the lozenge from
one side of the mouth to the other. Lozenges last for
10 – 30 minutes, depending on their size.
Administration by inhalationInsert the cartridge into the
device and draw in air through the mouthpiece; each
session can last for approximately 5 minutes. The amount
of nicotine from 1 puff of the cartridge is less than that
from a cigarette, therefore it is necessary to inhale moreBNFC 2018 – 2019 Nicotine dependence 297
Nervous system4