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BOOTS NICASSIST 10 MG/ML NASAL SPRAY

Active substance(s): NICOTINE

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Nicorette Nasal Spray
Boots NicAssist 10 mg/ml Nasal Spray

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicotine 10 mg/ml. Each spray of 50 μl delivers 0.5 mg nicotine.
For excipients see section 6.1

3

PHARMACEUTICAL FORM
Nasal Spray, solution.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Nicorette Nasal Spray is indicated for the relief of nicotine withdrawal symptoms as
an aid to smoking cessation in adults and children over 12 years of age. It is also
indicated in pregnant and lactating women (see section 4.6).
If possible, Nicorette Nasal Spray should be used in conjunction with a behavioural
support programme.

4.2.

Posology and method of administration
The patient should make every effort to stop smoking completely during
treatment with Nicorette Nasal Spray.
Behavioural therapy, advice and support will normally improve the success
rate.

This product must only be used with other NRT products under the advice of a
healthcare professional.
Directions for use
1) Remove the protective cap.
2) Prime Nicorette Nasal Spray by placing the nozzle between first and second
finger with the thumb on the bottom of the bottle. Press several times firmly
and quickly until a fine spray appears (up to 7-8 strokes).
Important: Point the spray safely away when priming it. Do not prime it near
children or pets.
3) Insert the spray tip into one nostril, pointing the top towards the back of the
nose.
Press firmly and quickly. Give a spray into the other nostril.
4) Put on the protective cap
Adults (over 18 years of age)
1. The frequency of use depends on the previous smoking habit of the
individual and the level of their nicotine dependence.
2. On commencing treatment the patient uses the spray to treat craving as
required, subject to a limit of one spray to each nostril twice an hour.
3. A 50 μl dose of solution is sprayed into the nostril when the unit is
activated. This is described as a “spray” and dosage is described using this
term. Each spray delivers 0.5 mg of nicotine, about half of which is
absorbed.
4. The daily limit of use is 32mg of nicotine (64 sprays) which is the
equivalent of two sprays to each nostril every hour for 16 hours.
5. The method of use of the spray should be according to the instructions.
6. The 3 month course should take the following pattern:a. For 8 weeks the patient uses the spray as required, subject to the
maxima described above, to relieve craving.
b. After this period the patient reduces usage until after 4 more weeks
treatment has ended. It is suggested that after 2 weeks into this period
usage will have been reduced by a half and usage be zero by the last
day. Spraying into a single nostril during this period may be helpful in
achieving this.
c. Treatment should be limited to three months. The patient should
understand the aim of decreasing the use of the spray to make a final
break with nicotine at the end of the course, and also accept that for the
first few days of the course nasal irritation may be unpleasant.
Adults who use NRT beyond 9 months are recommended to seek additional
help and advice from a healthcare professional.
Adolescents (12 to 18 years)

The dose and method of use are as for adults however as data are limited in
this age group, the recommended treatment duration is 12 weeks. If longer
treatment is required, advice from a healthcare professional should be sought.

4.3.

Contraindications
Hypersensitivity to any component of the nasal spray.
Nicorette Nasal Spray is contraindicated in children under the age of 12 years.

4.4

Special warnings and precautions for use
Any risks that may be associated with NRT are substantially outweighed by
the well established dangers of continued smoking.
Underlying cardiovascular disease: In stable cardiovascular disease this
product presents a lesser hazard than continuing to smoke. However dependent
smokers currently hospitalised as a result of myocardial infarction, unstable or
worsening angina including Prinzmetal’s angina, severe dysrhythmia or CVA
and who are considered to be haemodynamically unstable and/or who have
uncontrolled hypertension should be encouraged to stop smoking with nonpharmacological interventions. If this fails, this product may be considered,
but as data on safety in this patient group are limited, initiation should only be
under medical supervision.
Diabetes mellitus: Patients with diabetes mellitus should be advised to
monitor their blood sugar levels more closely than usual when NRT is
initiated as catecholamines released by nicotine can affect carbohydrate
metabolism.
GI disease: Swallowed nicotine may exacerbate symptoms in patients
suffering from oesophagitis, gastritis or peptic ulcers and oral NRT
preparations should be used with caution in these conditions. Ulcerative
stomatitis has been reported.
Renal or hepatic impairment: Nicorette Nasal Spray should be used with caution in
patients with moderate to severe hepatic impairment and/or severe renal impairment
as the clearance of nicotine or its metabolites may be decreased with the potential for
increased adverse effects.
Danger in small children: Doses of nicotine tolerated by adult and adolescent
smokers can produce severe toxicity in small children that may be fatal. Products
containing nicotine should not be left where they may be misused, handled or
ingested by children.
Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release
of catecholamines, this product should be used with caution in patients with
uncontrolled hyperthyroidism or phaeochromocytoma.

Transferred dependence: Transferred dependence is rare and is both less
harmful and easier to break than smoking dependence.
Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce
the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP
1A1). When a smoker stops smoking, this may result in slower metabolism
and a consequent rise in blood levels of such drugs. This is of potential clinical
importance for products with a narrow therapeutic window, e.g. theophylline,
clozapine and ropinirole.
Bronchial asthma: A few cases of exacerbation of brochospasm in patients
with bronchial asthma have been reported. Use of the spray in patients with
hyperreactive airways is not recommended.
Excipients: This product contains methyl- and propyl- hydroxybenzoates
(E217 and E218); which may cause allergic reactions (possibly delayed).
The label will state: “May initially cause nasal irritation.”
A clinical study confirms the safe use of this product, by smokers with chronic
rhinitis and sinusitis.
Care should be taken not to spray the eyes whilst administering the spray.
4.5

Interaction with other medicinal products and other forms of interaction
No clinically relevant interactions between nicotine replacement therapy and other
drugs has definitely been established. However nicotine may possibly enhance the
haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and
also increase pain response (angina-pectoris type chest pain) provoked by adenosine
administration.

4.6

Fertility, pregnancy and lactation
Fertility
In females tobacco smoking delays time to conception, decreases in-vitro
fertilization success rates, and significantly increases the risk of infertility.
In males tobacco smoking reduces sperm production, increases oxidative
stress, and DNA damage. Spermatozoa from smokers have reduced fertilizing
capacity.
The specific contribution of nicotine to these effects in humans is unknown
Pregnancy
NRT is not contraindicated in pregnancy. The decision to use NRT should be
made on a risk-benefit assessment as early on in the pregnancy as possible
with the aim of discontinuing use as soon as possible.
Smoking during pregnancy is associated with risks such as intra-uterine
growth retardation, premature birth or stillbirth. Stopping smoking is the

single most effective intervention for improving the health of both pregnant
smoker and her baby. The earlier abstinence is achieved the better.
Ideally smoking cessation during pregnancy should be achieved without NRT.
However for women unable to quit on their own, NRT may be recommended
to assist a quit attempt.
Nicotine passes to the fetus affecting breathing movements and has a dosedependent effect on placental/fetal circulation. However the risk of using NRT
to the fetus is lower than that expected with tobacco smoking, due to lower
maximal plasma nicotine concentration and no additional exposure to
polycyclic hydrocarbons and carbon monoxide.
Intermittent dosing products may be preferable as these usually provide a
lower daily dose of nicotine than patches. However, patches may be preferred
if the woman is suffering from nausea during pregnancy. If patches are used
they should be removed before going to bed.
Lactation
NRT is not contraindicated in lactation. Nicotine from smoking and NRT is
found in breast milk. However the amount of nicotine the infant is exposed to
is relatively small and less hazardous than the second-hand smoke they would
otherwise be exposed to.
Using intermittent dose NRT preparations, compared with patches, may
minimize the amount of nicotine in the breast milk as the time between
administrations of NRT and feeding can be more easily prolonged.
4.7

Effects on ability to drive and use machines
The nasal spray should not be used whilst the user is driving or operating machinery
as sneezing and watering eyes could contribute to accidents.

4.8

Undesirable effects
Effects of Smoking Cessation
Some symptoms may be related to nicotine withdrawal associated with
stopping smoking. These can include; irritability/aggression,
dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased
appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep
disturbance and decreased heart rate.
Increased frequency of aphthous ulcer may occur after abstinence from
smoking. The causality is unclear.
Adverse Drug Reactions

This product may cause adverse reactions similar to those associated with
nicotine given by other means, including smoking, and these are mainly dosedependent. At recommended doses this product has not been found to cause
any serious adverse effects. Excessive use of this product by those who have
not been in the habit of inhaling tobacco smoke could possibly lead to nausea,
faintness or headaches.
During the first 2 days of treatment, nasal irritation as sneezing, running nose,
watering eyes, cough was reported by nearly all (94%) of the patients. Both
the frequency and severity declined with continued use.
Allergic reactions (including symptoms of anaphylaxis) occur rarely during
use of this product.
The adverse reactions observed in patients treated with nicotine nasal spray
formulations during clinical trials and post-marketing experience are listed
below by System Organ Class (SOC). Frequencies are defined in accordance with
current guidance as: Very common (≥1/10); common (≥1/100, <1/10); uncommon
(≥1/1 000, < 1/100); rare (≥1/10 000, <1/1 000); very rare (<1/10 000), .: not know
(cannot be estimated from the available data).
System Organ Class
Immune System Disorders
Psychiatric disorders
Nervous System Disorders

Eye Disorders
Cardiac Disorders

Vascular Disorders
Respiratory, Thoracic and
Mediastinal Disorders

Gastrointestinal Disorders

Skin and Subcutaneous
Tissue Disorders

General Disorders and

Incidence
Uncommon
Not known
Uncommon
Common
Common
Common

Reported Adverse Event
Hypersensitivityac#
Anaphylactic reactionb
Abnormal dreams*
Headachea
Dizziness
Paraesthesiaa

Not known
Common
Very rare
Not known
Uncommon
Uncommon
Very common
Common
Common
Common
Common
Not known
Not known
Not known
Common
Common
Not known
Common
Common
Common
Not known
Not known
Not known
Common

Lacrimation increased
Palpitationsa
Reverse atrial fibrillation
Tachycardiaa
Flushinga
Hypertensiona
Rhinorrhoea
Cough**
Throat irritation
Dyspnoeaa
Epistaxis
Nasal discomfort
Oropharyngeal discomfort and pain
Sneezing
Nauseaa
Vomitinga
Gastrointestinal discomforta
Hyperhidrosisa
Pruritusa
Rasha
Angioedemaa
Erythemaa
Urticariaa
Chest discomfort and paina

Administration Site
Conditions

Uncommon
Uncommon
Not known

Fatigueac
Malaisea
Astheniaa

a

Systemic effects; b Reported the same or less frequently than placebo;
c
Although the frequency is <1% the PT occurred at a frequency ≥1% in
another formulation in which the PT was identified as a systemic ADR
*
Identified only for formulations applied during the night
#
Although the frequency in the active group is less than that of the placebo
group, the frequency in the specific formulation in which the PT was identified
as a systemic ADR was greater in the active group than the placebo group.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9

Overdose
Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been
estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea,
salivation, abdominal pain, diarrhoea, sweating headache, dizziness, disturbed
hearing and marked weakness. In extreme cases, these symptoms may be followed by
hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration,
circulatory collapse and terminal convulsions.
Management of an overdose: All nicotine intake should stop immediately and the
patient should be treated symptomatically. Artificial respiration should be instituted if
necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Drug used in nicotine dependence.
ATC code: N07B A01
Through rapid uptake of nicotine through the nasal membranes Nicorette
Nasal Spray provides early relief of nicotine withdrawal symptoms. Clinical
studies have shown that the nicotine containing products can help people give
up smoking.

5.2

Pharmacokinetic properties
Following administration of one dose Nicorette Nasal Spray approximately 56% of
the nicotine enters the systemic circulation.
The volume of distribution following i.v. administration of nicotine is approximately
(2 to) 3 l/kg and the half-life ranges from 1 to 2 hours. The major eliminating organ
is the liver, and average plasma clearance is about 1.2 l/min; the kidney and lung also
metabolise nicotine. More than 20 metabolites of nicotine have been identified, all of
which are believed to be less active than the parent compound. The primary
metabolite of nicotine in plasma, cotinine, has a half-life of 15 to 20 hours and
concentrations that exceed nicotine by 10-fold.
Plasma protein binding of nicotine is <5%. Therefore, changes in nicotine binding
from use of concomitant drugs or alterations of plasma proteins by disease states
would not be expected to have a significant effect on the nicotine kinetics.
The primary urinary metabolites are cotinine (15% of dose) and trans-3hydroxycotinine (45% of the dose). Usually about 10% of nicotine is excreted
unchanged in the urine. As much as 30% may be excreted in the urine with high
urine flow rates and acidification below pH5.
Plasma levels of nicotine obtained with Nicorette Nasal Spray rise rapidly, reaching a
maximum level – mean – after approximately 10-15 minutes. The mean peak plasma
level of nicotine – after steady –state is achieved – given 1 dose/hour, 2 doses/hour
and 3 doses/hour approximately 10, 19 and 28 ng/ml respectively.
After repeated administration of the Nicorette Nasal Spray the AUC was significantly
higher during the last dosing interval as compared to the first giving an accumulation
ratio of 3.1. No dose-dependency has been shown for the doses 0.5 mg and 1 mg
nicotine.
The therapeutic blood concentrations of nicotine, (i.e. the blood levels which relieve
craving) are individually based on the patient’s nicotine dependence.

5.3

Preclinical safety data
No further information.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Disodium phosphate dodecahydrate
Sodium dihydrogen phosphate dihydrate
Anhydrous citric acid
Sodium chloride
Polysorbate 80
NNS aroma DZ-03226 (B-ionine)
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Disodium edetate
Purified water

6.2

Incompatibilities
None relevant.

6.3

Shelf life
Two years.

6.4

Special precautions for storage
No special temperature conditions. Should be stored protected from light.

6.5.

Nature and contents of container
The solution is filled in a Type III Amber glass container equipped with a
spray pump consisting of a polypropylene nosepiece, a polyoxymethylene
nozzle and a polypropylene protective cap.

Pack size: 10ml. Each bottle provides approximately 200 metered sprays / 100
doses.

6.6.

Special precautions for disposal and handling
Any unused product or waste material should be disposed of in accordance with local
requirements.

7

MARKETING AUTHORISATION HOLDER
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 15513/0180

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01 February 2008

10

DATE OF REVISION OF THE TEXT
26/06/2016

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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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