TOPAMAX 50

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

TOPIRAMATE

Beschikbaar vanaf:

J-C HEALTH CARE LTD

ATC-code:

N03AX11

farmaceutische vorm:

FILM COATED TABLETS

Samenstelling:

TOPIRAMATE 50 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

CILAG AG, SWITZERLAND

Therapeutische categorie:

TOPIRAMATE

Therapeutisch gebied:

TOPIRAMATE

therapeutische indicaties:

In adjunctive therapy of adults and children (from 2 years) with partial seizures and generalized tonic-clonic seizures. In adjunctive therapy of seizures with Lennox-Gastaut syndrome in adults and children. Topamax is indicated as monotherapy in patients with newly diagnosed epilepsy in children aged 7 years and above or for conversion to monotherapy in patients with epilepsy. Topamax is indicated in adults for the prevention of migraines. The use of Topamax in the acute treatment of migraine has not been studied.

Autorisatie datum:

2022-09-30

Bijsluiter

Toxic Epidermal( يمسلا يرخنلا ةرشبلا للاحنإو
نوسنوج سنڤيتس ةمزلاتم لثم ،ةريطخ
ةيدلج لعف دودر
●
،دلجلا يف جيهت ،تلاصيوح نودب وأ عم حفط
لكش ىلع رهظت نأ نكمي هذه لعفلا دودر ـ
)Necrolysis
ىلإ يدلجلا حفطلا روطتي دق .ةيلسانتلا
ءاضعلأا لوحو نينيعلا ،فنلأا ،ةرجنحلا
،مفلا ةقطنم يف خافتنإو حورق
لكشت تايعادت هل ثيح )ةيحطسلا ةيطاخملا
ةيشغلأاو ةيجراخلا دلجلا ةقبط رشقت(
قاطنلا عساو يدلج ررض
.ةايحلا ىلع
ً
ارطخ
:)دعب ددحي مل اهعويش ضارعأ( فورعم ريغ
اهعويش ،ةيفاضإ ةيبناج ضارعأ
،نينيعلا عمدت ،ءوضلل ةيساسح ،ملأ
،نيعلا يف رارمحإ لثم ضارعأب قفارتي
يذلا )uveitis( نيعلا يف ةيبنعلا باهتلإ
.ةيؤرلا شوشت وأ ةريغص طاقن ةيؤر
:تمقافت لاح يف بيبطلا غلب ،ةيفاضإ
ةيبناج ضارعأ
ةرشع نم دحاو لمعتسم نم رثكأ ىدل رهظت
ضارعأ ـ VERY COMMON ـ
ً
ادج ةعئاش ةيبناج ضارعأ
ةرجنحلا يف ملأ ،حشر ،فنلأا ناقتحإ
●
مسجلا نم ةفلتخم ءازجأ يف ردخ وأ/و ملأ
،زخو ●
مونلا ىلإ ليملا وأ قاهرإ
●
راود
●
لاهسإ
●
نايثغ
●
نزولا صقانت ●
100 نيب نم نيلمعتسم 1-10 ىدل رهظت ضارعأ ـ
COMMON ـ ةعئاش ةيبناج ضارعأ
)مدلل ضفخنم دادعت( مد رقف ●
)ىرش ،هجولا يف خافتنإ ،ةكح ،رارمحإ
،دلجلا يف حفط لثم( يسسحت لعف در ●
ماعطلل ةيهشلا نادقف وأ ماعطلل ةيهشلا
ضافخنإ
●
يدايتعإ ريغ فرصت ،بضغ ،قلق ،ةيناودع ●
مونلا وأ مونلا ىلإ دولخلا يف ة�

Productkenmerken

Page 1 of 20
Topamax_spc_May2022_ref_EU SmPC Apr2022
1.
NAME OF THE MEDICINAL PRODUCT
Topamax 25 mg film-coated tablets
Topamax 50 mg film-coated tablets
Topamax 100 mg film-coated tablets
Topamax 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 25 mg of
topiramate.
One tablet contains 50 mg of topiramate.
One tablet contains 100 mg of topiramate.
One tablet contains 200 mg of topiramate.
Excipients with known effect: also includes lactose monohydrate:
One 25 mg tablet contains 30.85 mg lactose monohydrate
One 50 mg tablet contains 61.70 mg lactose monohydrate
One 100 mg tablet contains 123.40 mg lactose monohydrate
One 200 mg tablet contains 43.50 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
25 mg: White round film coated tablets, “TOP” on one side,
“25” on the other, with white core side.
50 mg: Light yellow round film coated tablets, “TOP” on one side,
“50” on the other, with white core.
100 mg: Yellow round film coated tablets, “TOP” on one side,
“100” on the other, with white core.
200 mg: Salmon round film coated tablets, “TOP” on one side,
“200” on the other, with white core.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TOPAMAX
®
is indicated as adjunctive therapy for adults
and children aged 2 years and above with partial
onset seizures generalized tonicclonic seizures
.
TOPAMAX
®
is also indicated in adults
and
children as adjunctive therapy
for the treatment of seizures
associated with Lennox-Gastaut syndrome.
TOPAMAX
®
can be prescribed as monotherapy in patients with recently diagnosed
epilepsy in adults and children
aged 7 and above or for conversion to monotherapy in patient with
epilepsy.
TOPAMAX
®
is indicated in adults for the
prevention of migraines. The use
of
TOPAMAX in the
acute
treatment
of migraine has not been studied
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
It is recommended that therapy be initiated at a low dose followed