ZOLPIMIST zolpidem tartrate 5 mg per actuation oromucosal spray bottle with a non-pressurised metered pump

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

zolpidem tartrate, Quantity: 5 mg/actuation

Beszerezhető a:

Arovella Therapeutics Ltd

Gyógyszerészeti forma:

Spray, solution

Összetétel:

Excipient Ingredients: benzoic acid; citric acid monohydrate; dilute hydrochloric acid; neotame; propylene glycol; purified water; Flavour

Az alkalmazás módja:

Oromucosal

db csomag:

60 metered actuations (7.7 mL solution), 28 meterred actuations (4.5 mL solution)

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

Zolpimist is indicated for the short term treatment of insomnia in adults (see Section 4.2 Dose and method of administration)

Termék összefoglaló:

Visual Identification: Zolpimist is available as a clear, colourless to yellowish, cherry flavoured solution; Container Type: Bottle, with integral pump - manual actuated; Container Material: Glass Type I Coloured; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Engedélyezési státusz:

Registered

Engedély dátuma:

2020-08-03

Betegtájékoztató

ZOLPIMIST®
Version 2.0
1
ZOLPIMIST®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING ZOLPIMIST?
ZOLPIMIST contains the active ingredient zolpidem tartrate. ZOLPIMIST
is used to initiate and maintain sleep in those with
sleeping difficulties, also called insomnia in patients over 18 years
of age. For more information, see Section
1. Why am I using
ZOLPIMIST? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ZOLPIMIST?
Do not use if you have ever had an allergic reaction to ZOLPIMIST or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use ZOLPIMIST?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ZOLPIMIST and affect how it works. A
list of these medicines is in Section 3. What if I am
taking other medicines? in the full CMI.
4.
HOW DO I USE ZOLPIMIST?
•
In adults, the usual dose is two sprays (10 mg). In people over 65
years of age, the dose is one spray (5 mg) before bedtime.
•
Follow the instructions carefully to prime the pump, when using for
the first time, and when taking a dose of ZOLPIMIST.
More instructions can be found in Section 4. How do I use ZOLPIMIST?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ZOLPIMIST?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist, or pharmacist that you visit, that you are
using ZOLPIMIST.
•
If you become pregnant or suspect that you are pregnant while taking
ZOLPIMIST, stop
taking it and tell your doctor or pharmacist immediately.
THINGS YOU SHOULD NOT DO
•
Do not take ZOLPIMIST if you have sleep apnoea, myasthenia gravis,
severe liver
p

Termékjellemzők

Zolpimist (zolpidem tartrate) Oromucosal Spray 5 mg/100 µL
Page 1 of 22
Arovella Therapeutics Ltd
Version 2.0
2022-01-21
AUSTRALIAN PI – ZOLPIMIST (ZOLPIDEM TARTRATE)
OROMUCOSAL SPRAY
WARNING: Zolpidem may be associated with potentially dangerous complex
sleep-
related behaviours which may include sleep walking, sleep driving and
other bizarre
behaviours. Zolpidem is not to be taken with alcohol. Caution is
needed with other CNS
depressant drugs. Limit use to four weeks maximum under close medical
supervision.
1
NAME OF THE MEDICINE
Zolpidem tartrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered actuation (one spray) of Zolpimist delivers 5 mg of
zolpidem tartrate in
100 μL. Two actuations deliver 10 mg of zolpidem tartrate in 200 μL.
Excipient with known effect: benzoates.
3
PHARMACEUTICAL FORM
Zolpimist is an oromucosal spray which is a clear, colourless to
yellowish, cherry flavoured
solution designed to be sprayed directly into the mouth over the
tongue..
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Zolpimist is indicated for the short-term treatment of insomnia in
adults (see Section 4.2
Dose and method of administration).
4.2
Dose and method of administration
Zolpimist acts rapidly and should therefore be taken immediately
before retiring, or in bed,
with at least 7-8 hours remaining before the planned time of
awakening. For faster sleep
onset, as with all zolpidem products, Zolpimist should not be
administered with or
immediately after a meal (see Section 5.2 Pharmacokinetic properties).
Zolpimist should be taken in a single intake and not be
re-administered during the same night.
As with all hypnotics, long term use of zolpidem is not recommended.
Treatment should be
as short as possible and should not exceed four weeks.
For oral use only. Zolpimist is designed to be sprayed directly into
the mouth over the tongue.
Discontinuation of treatment: see Section 4.8 Adverse effects
(Undesirable effects).
Withdrawal Effects: see Section 4.4 Special warnings and precautions
for use.
Zolpimis