NUVIGIL armodafinil 50 mg tablet bottle

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

armodafinil

Dostupné s:

Teva Pharma Australia Pty Ltd

INN (Mezinárodní Name):

armodafinil

Stav Autorizace:

Registered

Informace pro uživatele

NUVIGIL
®
_Armodafinil_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NUVIGIL tablets.
As this leaflet does not contain all the
available information, it is important
that you talk to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you receiving NUVIGIL
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT NUVIGIL IS USED
FOR
NUVIGIL is used to improve
wakefulness in people with excessive
daytime sleepiness associated with
the medical condition known as
narcolepsy or with Obstructive Sleep
Apnoea/Hypopnoea Syndrome
(OSAHS), or shift work sleep
disorder (SWSD).
In narcolepsy, there is a sudden and
irresistible tendency to fall asleep
during normal waking hours. This
happens at unpredictable times, even
when it is inappropriate or may be
unsafe to do so. NUVIGIL decreases
this unwanted excessive daytime
sleepiness.
With OSAHS, daytime sleepiness
may occur due to an interrupted night
time sleep. NUVIGIL only treats the
symptom of sleepiness and does not
treat the cause of OSAHS. Whilst
taking NUVIGIL you should
continue with treatments intended to
help manage your underlying
medical condition, such as
Continuous Positive Airway
Pressure, unless your doctor tells you
otherwise.
If you have been diagnosed with
moderate to severe chronic Shift
Work Sleep Disorder (SWSD) and
non-drug therapies have been
unsuitable or unsuccessful,
NUVIGIL may be prescribed to keep
you awake during your work shift.
Precisely how NUVIGIL works is
not known, but it is known that it acts
on the central nervous system (the
brain). It differs from other stimulant
medicines that promote wakefulness.
NUVIGIL increases wakefulness.
Your doctor may have prescribed
NUVIGIL for another reason. Ask
your doctor if you have any questions
about why NUVIGIL has been
prescribed for you.
BEFORE YOU

Charakteristika produktu

Teva Pharma Australia Pty Ltd Version 7.0 1
Based on CCSI: 794/02/07/16
AUSTRALIAN PRODUCT INFORMATION – NUVIGIL
® (ARMODAFINIL)
TABLETS
1
NAME OF THE MEDICINE
Armodafinil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NUVIGIL® tablets contain 50, 150 or 250 mg of armodafinil.
NUVIGIL® tablets contain lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The appearance of NUVIGIL® tablets are as follows:
50 mg: Each round, white to off-white tablet is debossed with
on one side and “205” on the
other.
150mg: Each oval, white to off-white tablet is debossed with
on one side and “215” on the
other.
250mg: Each oval, white to off-white tablet is debossed with
on one side and “225” on the
other
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
NUVIGIL® is indicated:

to
improve wakefulness
in
patients
with excessive
daytime
sleepiness
associated
with
narcolepsy;

to treat excessive sleepiness associated with moderate to severe
chronic shift work sleep
disorder where nonpharmacological interventions are unsuccessful or
inappropriate;

as
an
adjunct
to
continuous
positive
airways
pressure
(CPAP)
in
obstructive
sleep
apnoea/hypopnoea syndrome in order to improve wakefulness.
4.2
D
OSE AND METHOD OF ADMINISTRATION
NUVIGIL® (armodafinil) is for oral administration.
NUVIGIL® should be used only in patients who have had a complete
evaluation of their excessive
sleepiness, and in whom a diagnosis of the underlying disorder of
narcolepsy, OSAHS, or SWSD has
been made in accordance with ICSD or DSM diagnostic criteria. Such an
evaluation usually consists
Teva Pharma Australia Pty Ltd Version 7.0 2
Based on CCSI: 794/02/07/16
of a complete history and physical examination, and it may be
supplemented with testing in a
laboratory setting. Some patients may have more than one sleep
disorder contributing to their
excessive sleepiness (e.g., OSAHS and SWSD coincident in the same
patient).
NUVIGIL® may be taken with or without food, however administ