AMBIEN CR 6.25 MG

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

ZOLPIDEM TARTRATE

Tillgänglig från:

SANOFI ISRAEL LTD

ATC-kod:

N05CF02

Läkemedelsform:

TABLETS EXTENDED RELEASE

Sammansättning:

ZOLPIDEM TARTRATE 6.25 MG

Administreringssätt:

PER OS

Receptbelagda typ:

Required

Tillverkad av:

SANOFI WINTHROP INDUSTRIE, FRANCE

Terapeutisk grupp:

ZOLPIDEM

Terapiområde:

ZOLPIDEM

Terapeutiska indikationer:

For the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).

Tillstånd datum:

2014-11-30

Bipacksedel

1986 - )تارضحتسم( ةلديصلا ةمظنأ بجومب
كلهتسملل ةرشن
طقف بيبط ةفصو بجومب ءاودلا ق
ّ
وسي
غلم 6.25 رآ .يس نايبمأ
غلم 12.5 رآ .يس نايبمأ
دتمم ريرحت تاذ صارقأ
:اهتيمكو ةلاعفلا ةداملا
غلم 6.25 تارترات ميديپلوز :ىلع غلم 6.25 رآ
.يس نايبمأ نم صرق لك يوتحي
Zolpidem Tartrate 6.25 mg
غلم 12.5 تارترات ميديپلوز :ىلع غلم 12.5 رآ
.يس نايبمأ نم صرق لك يوتحي
Zolpidem Tartrate 12.5 mg ةماه تامولعم" 2 ةرقفلا رظنأ ـ رضحتسملا
يف ةيساسحلا تادلومو ةلاعفلا ريغ
داوملا
."ةيفاضإ تامولعم" 6 ةرقفلاو "ءاودلا
تابكرم ضعب نع
ةزجوم تامولعم ىلع ةرشنلا هذه يوتحت
.ءاودلل كلامعتسإ لبق اهتياهن ىتح نعمتب
ةرشنلا أرقإ
.يلديصلا وأ بيبطلا عجار ،ةيفاضإ ةلئسأ
كيدل ترفوت اذإ .ءاودلا نع
مهتلاح نأ كل ادب ولو ىتح مهرضي دق وهف
.نيرخلآل هيطعت لا .كلجأ نم جلاعلل
ءاودلا اذه فص
ُ
و
.كتلاحل ةهباشم ةيبطلا
؟ءاودلا صصخم ضرغ يلأ )1
ىلع ظافحلا يف ةبوعص وأ/و مونلا ىلإ
دولخلا يف تابوعصب لثمتملا قرلأا جلاعل
صصخم ءاودلا
.مونلا ةيرارمتسإ
.ةئدهملاو ةمونملا داوملا نم :ةيجلاعلا
ةليصفلا
ءاودلا لامعتسإ لبق )2
:اذإ ءاودلا لامعتسإ زوجي لا
ةقايس لثم) مونلا للاخ يعولا نع جراخ
كولس نم رآ .يس نايبمأ لوانت دعب ةرم تاذ
تيساق ●
يذلا تقولا يف ةيسنج تاقلاع ةسرامم وأ
فتاهلا ربع ثدحتلا ،ماعطلا لوانتو
ريضحت ،ةبكرملا
.("ءاودلا لامعتسإب قلعتت ةصاخ تا�

Produktens egenskaper

1
_ _
_ _
_AMBI-SPC-6.25MG-12.5MG-SPC-19.0 _
AMBIEN CR
PRESCRIBING INFORMATION
WARNING: COMPLEX SLEEP BEHAVIORS
COMPLEX SLEEP BEHAVIORS INCLUDING SLEEP-WALKING, SLEEP-DRIVING, AND
ENGAGING IN OTHER
ACTIVITIES WHILE NOT FULLY AWAKE MAY OCCUR FOLLOWING USE OF AMBIEN CR.
SOME OF THESE
EVENTS MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH. DISCONTINUE
AMBIEN CR
IMMEDIATELY IF A PATIENT EXPERIENCES A COMPLEX SLEEP BEHAVIOR _[SEE
CONTRAINDICATIONS (4) _
_AND WARNINGS AND PRECAUTIONS (8.1)]._
1
NAME OF THE MEDICINAL PRODUCT
AMBIEN CR 6.25 mg
AMBIEN CR 12.5 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each extended-release tablet of Ambien CR 6.25 mg contains zolpidem
tartrate 6.25 mg
Each extended-release tablet of Ambien CR 12.5 mg contains zolpidem
tartrate 12.5 mg
Excipients with known effect:
Each Ambien CR 6.25 mg extended-release tablet contains 138.913 mg mg
lactose
monohydrate.
Each Ambien CR 12.5 mg extended-release tablet contains 138.913 mg mg
lactose
monohydrate.
For the full list of excipients,
_see section 14_
.
3
PHARMACEUTICAL FORM
Extended-release tablets.
Ambien CR 6.25 mg extended-release tablets are: pink, round,
bi-convex, engraved ZMR on
one face.
Ambien CR 12.5 mg extended-release tablets are: blue, round,
bi-convex, engraved ZMR on
one face
4 THERAPEUTIC INDICATIONS
Ambien CR (zolpidem tartrate extended-release tablets) is indicated
for the treatment of
insomnia characterized by difficulties with sleep onset and/or sleep
maintenance (as
measured by wake time after sleep onset).
The clinical trials performed in support of efficacy were up to 3
weeks (using
polysomnography measurement up to 2 weeks in both adult and elderly
patients) and 24
weeks (using patient-reported assessment in adult patients only) in
duration
_ [see Clinical _
_Studies (17)]_
.
2
5
DOSAGE AND ADMINISTRATION
5.1
DOSAGE IN ADULTS
Use the lowest effective dose for the patient. The recommended initial
dose is 6.25 mg for
women and either 6.25 or 12.5 mg for men, taken only once per night
immediately before
bedtime with at leas