MODAFINIL SPR modafinil 100 mg tablets blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

modafinil, Quantity: 100 mg

Dostupno od:

Arrotex Pharmaceuticals Pty Ltd

INN (International ime):

Modafinil

Farmaceutski oblik:

Tablet

Sastav:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; methylcellulose

Administracija rute:

Oral

Jedinice u paketu:

30's pack, 60's pack

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Modafinil 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.

Proizvod sažetak:

Visual Identification: White round, biconvex tablets, engraved "MOD" over "100" on one side, "APO" on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Licence status A

Datum autorizacije:

2017-03-20

Uputa o lijeku

APO-MODAFINIL TABLETS
_Contains the active ingredient modafinil_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
This medicine contains the active
ingredient modafinil.
It is used:
•
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 (SWSD), where non-
drug therapies have been
inappropriate or unsuccessful.
•
as an adjunct to continuous
positive airways pressure (CPAP)
in obstructive sleep apnoea/
hypopnoea syndrome (OSAHS)
to improve wakefulness.
It is not known how modafinil works,
but it is known that it acts on the
central nervous system (the brain). It
differs from other stimulant
medicines that promote wakefulness.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
This medicine should not be used in
children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
modafinil
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips

Svojstava lijeka

1
AUSTRALIAN PRODUCT INFORMATION
APO- MODAFINIL (MODAFINIL) TABLETS
1
NAME OF THE MEDICINE
Modafinil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg modafinil, as the active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
White, round, biconvex tablets. Engraved “MOD” over “100” on
one side,”APO” on the other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Modafinil 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
DOSE AND METHOD OF ADMINISTRATION
APO- Modafinil Tablets are intended for oral administration.
DOSAGE
Modafinil should be used only in patients who have had a complete
evaluation of their
excessive sleepiness, and in whom a diagnosis of either narcolepsy,
OSAHS, and/or SWSD
has been made in accordance with ICSD or DSM diagnostic criteria. Such
an evaluation
usually consists of a complete history and physical examination, and
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) (see
section 5.1
PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS).
Treatment with modafinil should be initiated and supervised by
physicians with appropriate
experience in the treatment of sleep disorders who have access to
sleep laboratory diagnostic
facilities.
2
NARCOLEPSY
The dose of modafinil is 200 to 400 mg/day, given as a single dose in
the morning, or as two
divided doses, in the morning and at noon. Tablets should be swallowed
whole.
Doses of 400 mg/day have been well tolerated, but there is no
statistically signific