WAKIX 4.5 MG

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

PITOLISANT AS HYDROCHLORIDE

Inapatikana kutoka:

TRUEMED LTD, ISRAEL

ATC kanuni:

N07XX11

Dawa fomu:

FILM COATED TABLETS

Tungo:

PITOLISANT AS HYDROCHLORIDE 4.45 MG

Njia ya uendeshaji:

PER OS

Dawa ya aina:

Required

Viwandani na:

BIOPROJET PHARMA, FRANCE

Eneo la matibabu:

PITOLISANT

Matibabu dalili:

Wakix is indicated• In adults for the treatment of narcolepsy with or without cataplexy. • To improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP).

Idhini ya tarehe:

2020-03-15

Taarifa za kipeperushi

ءاودلا لوانت نع تفقوت اذإ
ءاقلت نم سكيكاو لوانت نع ئجافم لكشب
فقوتت لا .هلوانتب بيبطلا كدشري املاطل
ءاودلا لوانت ةلصاوم كيلع
.ةيحصلا كتلاح ىلع نسحت أرط ولو ىتح
،بيبطلا ةراشتسإ نودب ءاودلاب جلاعلا
نع فقوتلا زوجي لا .كسفن ةرم لك يف يئاودلا رادقملا نم دكأتلاو
ءاودلا عباط صيخشت بجي !ةمتعلا يف ةيودأ
لوانت زوجي لا
.كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض
.ءاود اهيف لوانتت
.يلديصلا وأ بيبطلا رشتسإ ،ءاودلا اذه
لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت
اذإ
ةيبناجلا ضارعلأا )4
ضارعلأا ةمئاق نم شهدنت لا .نيلمعتسملا
ضعب ىدل ةيبناج
ً
اضارعأ ببسي دق سكيكاو لامعتسإ نإ ،ءاود
لكب امك
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم .ةيبناجلا
:)نيجلاعتم 10 نيب نم دحاو نم رثكأ ىدل
رهظت دق(
ً
ادج ةعئاش ةيبناج ضارعأ
مونلا ءانثأ يدادسنلإا سفنلا عاطقنإ
ةدمجلا ضرم نودب وأ عم يبايتنلإا مونلا
عادص -
:)نيجلاعتم 10 نيب نم دحاو ىتح ىدل رهظت
دق( ةعئاش ةيبناج ضارعأ
مونلا ءانثأ يدادسنلإا سفنلا عاطقنإ
ةدمجلا ضرم نودب وأ عم يبايتنلإا مونلا
قلق ،مونلا يف لكاشم ،مونلا يف تابوعص -
)وغيتريڤ( "راود" ـب روعشلا
-
مدلا طغض عافترإ
-
لاهسإ ،نطبلا يف جاعزنإب روعشلا ،نايثغ
-
ةحارلا مدعو ملأ
-
لكاشم ،بائتكإ ،ةيبصع ،قلق ،مونلا يف
تابوعص
-
مونلا يف
تابارطضإ ،)وغيتريڤ( "راود" ـب روعشلا
،عادص
-
فاجترإ ،نز

Tabia za bidhaa

1
1.
NAME OF THE MEDICINAL PRODUCT
Wakix 4.5 mg
Wakix 18 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Wakix 4.5 mg film-coated tablet
Each tablet contains pitolisant hydrochloride equivalent to 4.45 mg of
pitolisant.
Wakix 18 mg film-coated tablet
Each tablet contains pitolisant hydrochloride equivalent to 17.8 mg of
pitolisant.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Wakix 4.5 mg film-coated tablet
White, round, biconvex film-coated tablet, 3.7 mm diameter, marked
with “5” on one side.
Wakix 18 mg film-coated tablet
White, round, biconvex film-coated tablet, 7.5 mm diameter marked with
“20” on one side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Wakix is indicated

In adults for the treatment of narcolepsy with or without cataplexy.

To improve wakefulness and reduce excessive daytime sleepiness (EDS)
in adult patients
with obstructive sleep apnoea (OSA) whose EDS has not been
satisfactorily treated by, or
who have not tolerated, OSA primary therapy, such as continuous
positive airway pressure
(CPAP).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
NARCOLEPSY WITH OR WITHOUT CATAPLEXY
Treatment should be initiated by a physician experienced in the
treatment of sleep disorders.
Posology
Wakix should be used at the lowest effective dose, depending on
individual patient response and
tolerance, according to an up-titration scheme, without exceeding the
dose of 36 mg/day:
-
Week 1: initial dose of 9 mg (two 4.5 mg tablets) per day.
-
Week 2: the dose may be increased to 18 mg (one 18 mg tablet) per day
or decreased to 4.5 mg
(one 4.5 mg tablet) per day.
-
Week 3: the dose may be increased to 36 mg (two 18 mg tablets) per
day.
At any time the dose can be decreased (down to 4.5 mg per day) or
increased (up to 36 mg per day)
according to the physician assessment and the patient’s response.
The total daily dose should be administered as a single dose in the
morning during breakfast.
2
_Maintenance of efficacy_
As long-term efficacy data are limited