PROVIGIL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MODAFINIL

Available from:

ABIC MARKETING LTD, ISRAEL

ATC code:

N06BA07

Pharmaceutical form:

CAPLETS

Composition:

MODAFINIL 100 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TEVA PHARMA B.V., THE NETHERLANDS

Therapeutic area:

MODAFINIL

Therapeutic indications:

To improve wakefulness in patients with excessive sleepiness associated with narcolepsy (with or without cataplexy), obstructive sleep apnea/hypopnea syndrome ( OSAHS ) and shift work sleep disorder (SWDS).

Authorization date:

2019-03-18

Patient Information leaflet

ترشتسإ اذإ لاإ ليجيڤورپ لوانت دعوم
رييغت زوجي لا ●
دق مونلا دعوم نم
ً
ادج
ً
ابيرق ليجيڤورپ لوانت نإ .كبيبط
.مونلا يف ةبوعص ببسي
غضملا/رطشلا/قحسلا
طخ دوجو مدعل )ةلوسبك لكشب ةبح( ةلوسبحلا
رطش زوجي لا
.ةلوسبحلا غضم /قحس صوصخب تامولعم رفوتت
لا .رطشلل
.اهب ىصوملا ةيئاودلا ةعرجلا زواجت زوجي
لا
.ةنس 18 رمع نود لافطأ ىدل جلاعلل صصخم
ريغ ءاودلا اذه
لفط علب اذإ وأ ربكأ ةيئاود ةعرج أطخلاب
تلوانت اذإ
ئراوطلا ةفرغل وأ بيبطلا ىلإ
ً
لااح هجوت ،ءاودلا نم أطخلاب
.كعم ءاودلا ةبلع رضحأو ،ىفشتسملا يف
:لمشت دق ليجيڤورپ نم ةيئاودلا ةعرجلا
طرف ضارعأ
.مونلا يف لكاشم ●
)لملمت( ةحار ةلق ●
.كابترإ
●
.ناهوتب روعشلا
●
.لاعفنإب روعشلا
●
.)نايذه( ةيقيقح ريغ ءايشأب روعشلا وأ
،ةيؤر ،عامس ●
.لاهسإو نايثغ ●
.ءيطب وأ عيرس ضبن ●
.ردصلا يف ملأ
●
.مدلا طغض عافترإ
●
زوجي لاف بولطملا تقولا يف ءاودلا اذه
لوانت تيسن اذإ
ةيلاتلا ةيئاودلا ةعرجلا لوانت .ةفعاضم
ةيئاود ةعرج لوانت
ىلع ةبظاوملا بجي .بيبطلا رشتسإو
يدايتعلإا دعوملا يف
.بيبطلا ةيصوت بسح جلاعلا عباط صيخشت بجي
!
ةمتعلا
يف ةيودلأا
لوانت زوجي لا لوانتت ةرم لك يف ةيئاودلا ةعرجلا نم دكأتلاو ءاودلا . كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض
.
ءاود اهيف ،ءاودلا لامعتسإ لوح ةيفاضإ ةلئسأ كيدل
ترفوت اذإ
.يلديصلا وأ بيبطلا ر

Summary of Product characteristics

Provigil HS 09/2019 Certification
SUMMARY OF PRODUCT CHARACTERISTICS
PROVIGIL
®
CAPLETS
Each caplet contains:
Modafinil 100 mg
1
INDICATIONS AND USAGE
PROVIGIL is indicated to improve wakefulness in patients with
excessive sleepiness
associated with narcolepsy (with or without cataplexy), obstructive
sleep apnea/hypopnea
syndrome (OSAHS) and shift work sleep disorder (SWSD).
Limitations of Use
In OSA, PROVIGIL 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 and during treatment with PROVIGIL
for excessive
sleepiness.
Provigil HS 09/2019 Certification
2
DOSAGE AND ADMINISTRATION
Treatment should be initiated by or under the supervision of a
physician with appropriate
knowledge of indicated disorders.
A diagnosis of narcolepsy should be made according to the
International Classification of
Sleep Disorders (ICSD2) guideline.
Patient monitoring and clinical assessment of the need for treatment
should be performed
on a periodic basis.
Posology
The recommended starting daily dose is 200 mg. The total daily dose
may be taken as a
single dose in the morning or as two doses, one in the morning and one
at noon, according
to physician assessment of the patient and the patient's response.
Doses of up to 400mg in one or two divided doses can be used in
patients with insufficient
response to the initial 200mg modafinil dose.
Long-term use
Physicians prescribing modafinil for an extended time should
periodically re-evaluate the
long-term use for the individual patients as the long-term efficacy of
modafinil has not
been evaluated (> 9 weeks).
Patients with renal impairment
There is inadequate information to determine safety and efficacy of
dosing in patients with
renal impairment.
Patients with hepatic impairment
The dose of modafinil should be reduced by half in patients with
severe hepatic
i