NUVIGIL 150 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ARMODAFINIL

متاح من:

ABIC MARKETING LTD, ISRAEL

ATC رمز:

N06BA07

الشكل الصيدلاني:

TABLETS

تركيب:

ARMODAFINIL 150 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

المجال العلاجي:

MODAFINIL

الخصائص العلاجية:

Nuvigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).

تاريخ الترخيص:

2016-04-14

نشرة المعلومات

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with
a doctor’s prescription only
NUVIGIL 50 MG
TABLETS
COMPOSITION
Each tablet contains:
armodafinil 50 mg
NUVIGIL 150 MG
TABLETS
COMPOSITION
Each tablet contains:
armodafinil 150 mg
NUVIGIL 250 MG
TABLETS
COMPOSITION
Each tablet contains:
armodafinil 250 mg
For information about inactive and
allergenic ingredients, see section 2 under
the heading “Important information about
some of the ingredients of the medicine”
and section 6 “Further Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet
contains concise information about the
medicine. If you have further questions,
refer to the doctor or pharmacist.
This medicine has been prescribed for the
treatment of your ailment. Do not pass it
on to others. It may harm them, even if it
seems to you that their medical condition
is similar.
THIS MEDICINE IS NOT INTENDED FOR USE
IN CHILDREN OR ADOLESCENTS UNDER 18
YEARS OF AGE.
THE
MEDICINE
MAY
REDUCE
THE
EFFECTIVENESS OF HORMONAL BIRTH
CONTROL METHODS. You must use additional
effective birth control methods. SEE UNDER
THE HEADING “DRUG INTERACTIONS” IN
SECTION 2 OF THIS LEAFLET.
1. WHAT IS THE MEDICINE INTENDED
FOR?
Nuvigil is intended to improve wakefulness
in adults with excessive sleepiness
associated with one of the following
diagnosed sleep disorders:
• Narcolepsy – uncontrollable daytime
sleeping bouts.
• Sleep disorder due to obstructive sleep
apnea )OSA(, in combination with other
treatments. Nuvigil does not take the
place of a CPAP machine or other
treatments prescribed by the doctor. It is
important to continue these treatments
as prescribed by the doctor.
• Sleep disorder due to working in shifts
)shift work disorder – SWD(.
Nuvigil will not cure these sleep disorders.
Nuvigil may relieve the sleepiness caused
by these conditions, but it may not prevent
it entirely. Nuvigil is not intended to take
the place of sufficient s

خصائص المنتج

1
Nuvigil HS 09/2019 Certification
SUMMARY OF PRODUCT CHARACTERISTICS
NUVIGIL 50 MG, 150 MG AND 250 MG
TABLETS
Each tablet contains:
Armodafinil 50 mg, 150 mg or 250 mg
For the list of excipients, see section 16 "Pharmaceutical
particulars".
1. INDICATIONS AND USAGE
NUVIGIL is indicated to improve wakefulness in adult patients with
excessive sleepiness
associated with obstructive sleep apnea (OSA), narcolepsy, or shift
work disorder (SWD).
LIMITATIONS OF USE
In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as
treatment for the
underlying obstruction. If continuous positive airway pressure (CPAP)
is the treatment of
choice for a patient, a maximal effort to treat with CPAP for an
adequate period of time
should be made prior to initiating NUVIGIL for excessive sleepiness.
2. DOSAGE AND ADMINISTRATION
2.1 DOSAGE IN OBSTRUCTIVE SLEEP APNEA (OSA) AND NARCOLEPSY
The recommended dosage of NUVIGIL for patients with OSA or narcolepsy
is 150 mg to 250
mg taken orally once a day as a single dose in the morning.
In patients with OSA, doses up to 250 mg/day, given as a single dose,
have been well
tolerated, but there is no consistent evidence that these doses confer
additional benefit beyond
that of the 150 mg/day dose _[see Clinical Pharmacology (12.3) and
Clinical Studies (14.1, _
_14.2)]_.
2.2 DOSAGE IN SHIFT WORK DISORDER (SWD)
The recommended dosage of NUVIGIL for patients with SWD is 150 mg
taken orally once a
day as a single dose approximately 1 hour prior to the start of their
work shift.
2.3 DOSAGE MODIFICATION IN PATIENTS WITH SEVERE HEPATIC IMPAIRMENT
In patients with severe hepatic impairment, the dosage of NUVIGIL
should be reduced _[see _
_Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]_.
2.4
USE IN GERIATRIC PATIENTS
Consideration should be given to the use of lower doses and close
monitoring in geriatric
patients _[see Use in Specific Populations (8.5)]_.
_ _
3. DOSAGE FORMS AND STRENGTHS

50 mg – round, white to off-white tablet with
on one side and "205" on the othe