Nicorette QuickMist

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Nicotine 13.6 mg/mL ((1 mg per spray))

Available from:

JNTL Consumer Health (New Zealand) Limited

INN (International Name):

Nicotine 13.6 mg/mL ((1 mg per spray))

Dosage:

1 mg/dose

Pharmaceutical form:

Oral spray

Composition:

Active: Nicotine 13.6 mg/mL ((1 mg per spray)) Excipient: Acesulfame potassium Cooler 2 SN046680 Ethanol Glycerol Hydrochloric acid Levomenthol Poloxamer 407 Propylene glycol Purified water Red fruit flavour 911441 Sodium bicarbonate Sucralose Trometamol

Prescription type:

General sale

Manufactured by:

Siegfried Ltd

Therapeutic indications:

Stop smoking aid to relieve nicotine cravings and withdrawal symptoms

Product summary:

Package - Contents - Shelf Life: Spray bottle, plastic, metered, clear PET bottle with crimped spray head - 150 dose units - 24 months from date of manufacture stored at or below 25°C - Spray bottle, plastic, metered, clear PET bottles with crimped spray head (2 x 150 dose units) - 300 dose units - 24 months from date of manufacture stored at or below 25°C - Spray bottle, plastic, metered, clear PET bottles with crimped spray head (3 x 150 dose units) - 450 dose units - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2016-10-10

Summary of Product characteristics

Page 1 of 11
NICORETTE
®
QUICKMIST Datasheet
Date of Preparation: 25 November 2022
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
NICORETTE
®
QUICKMIST (1mg nicotine/spray, mouth spray)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
NICORETTE
®
QUICKMIST contains nicotine as the active ingredient. 0.07 ml contains
1 mg
nicotine, corresponding to 1mg nicotine/spray dose and is available in
2 flavours: freshmint
and cool berry.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Clear to weakly opalescent, colorless to light yellow solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of tobacco dependence by relieving nicotine craving
and withdrawal symptoms
thus:
Facilitating smoking cessation in smokers motivated to quit.
Helping smokers to temporarily abstain from smoking.
Facilitating smoking reduction in smokers unable or unwilling to quit.
4.2 DOSE AND METHOD OF ADMINISTRATION
After priming, the spray nozzle should be pointed as close to the open
mouth as possible. The top
of the dispenser is then pressed releasing one spray into the mouth,
avoiding the lips. The
patient
should not inhale while spraying to avoid getting spray into the
respiratory tract. For
best
results,
do not swallow for a few seconds after spraying. Do not eat or drink
when
administering the mouth spray.
CHILDREN AND ADOLESCENTS
NICORETTE® QUICKMIST SHOULD NOT BE ADMINISTERED TO CHILDREN UNDER 12
YEARS OF AGE.
NICORETTE
®
QUICKMIST should be used in adolescents only under the supervision of
a doctor
or pharmacist.
When
deciding
whether
to
recommend
NRT
an
assessment
should
be
made
on
the
individual’s
nicotine
dependence,
motivation
to
quit and
willingness
to
accept
counselling.
Counselling
is
considered
to
be
vitally
important
in
the
effective
treatment
of
tobacco
dependence in this age group.
Use for up to 6 weeks to break the habit of smoking, and then
gradually reduce mouth spray use
over a 6 week period. When daily use is 2 to 4 sprays, use should be
stopped.
As data are limited in this age g