TRANDATE TABLETS 100 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LABETALOL HYDROCHLORIDE

Available from:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC code:

C07AG01

Pharmaceutical form:

TABLETS

Composition:

LABETALOL HYDROCHLORIDE 100 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ASPEN BAD OLDESLOE GMBH, GERMANY

Therapeutic group:

LABETALOL

Therapeutic area:

LABETALOL

Therapeutic indications:

Treatment of all grades of hypertension (mild, moderate and severe) when oral antihypertensive therapy is desirable.

Authorization date:

2021-11-30

Patient Information leaflet

ةيبناجلا ضارعلأا )4
.نيلمعتسملا ضعب دنع ةيبناج
ً
اضارعأ ببسي دق تدنارت لامعتسإ نإ ،ءاود
لكب امك
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم .ةيبناجلا
ضارعلأا ةمئاق نم شهدنت لا
ً
ادج ةردان( ةيلاتلا ضارعلأا ىدحإ ترهظ
اذإ بيبطلل
ً
لااح هجوتلا بجي
:)10
٬
000 نيب نم دحاو لمعتسم نم لقأ ىدل رهظتو
حفط ،ةنوخس ،لصافملا يف ملاآ :لثم ضارعأ
ىلإ يدؤت ةيزاهج ةيرارمحإ ةبئذ ●
قاهرإو يدلج
ةرابع ةلاحلا هذه( ةيلوبلا ةناثملا
ءلاتمإ نم مغرلاب لوبتلا ىلع ةماتلا
ةردقلا مدع ●
)ةئراط ةيبط ةلاح نع
خافتنإ لمشت يتلا ضارعأ ىلإ يدؤت نأ
نكمي يتلا )ةيسسحت ةمذو( ةيئاعو ةمذو
●
سفنتلا يف تابوعص ىلإ يدؤت دق يتلا
،ناسللا يفو هجولا يف ،نيتفشلا يف
ةيفاضإ ةيبناج ضارعأ نم رثكأ ىدل رهظت ـ )very common(
ً
ادج ةعئاش ةيبناج ضارعأ
:ةرشع نم دحاو لمعتسم
.ضرملاب ةقلاع اهل سيل دادضأ ● نيلمعتسم 1-10 ىدل رهظت ـ )common( ةعئاش
ةيبناج ضارعأ
:100 نيب نم
بلقلا روصق ●
دعب ةميلس حبصتل ميقلا هذه دوعت ةداع
.دبكلا فئاظو صوحفل ةعفترم ميق ●
ءاودلاب جلاعلا نع فقوتلا
نأ نكميو ةتقؤم نوكت ةداع يتلا ،سأرلا
ةورف يف زخوب روعشو عادص ،راود ●
جلاعلا نم ىلولأا عيباسلأا للاخ رهظت
ةيؤرلا شوشت ●
لوبتلا يف تابوعص ●
يغبني امم عرسأ لكشب ضوهنلا دنع مدلا
طغض يف ضافخنإ ءارج راود
●
postural( فوقولا ىلإ سولجلا نم وأ سولجلا
ىلإ ءاقلتسلإ�

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Trandate tablets 100 mg
Trandate tablets 200 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains 100 mg or 200 mg respectively of labetalol
hydrochloride.
Excipient with known effect:
100 mg: Each film-coated tablet contains 14.6 mg anhydrous lactose,
1.15 microgram sodium
benzoate and 17.2 microgram sunset yellow (E110).
200mg: Each film-coated tablet contains 29.3 mg anhydrous lactose, 2.3
microgram sodium benzoate
and 34.4 microgram sunset yellow (E110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
_100 mg: _
Orange, round, biconvex, engraved TT01 on one face.
_200 mg: _
Orange, round, biconvex, engraved TT02 on one face.
4.
CLINICAL
PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of all grades of hypertension (mild, moderate and severe)
when oral antihypertensive
therapy is desirable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
POPULATIONS
• ADULTS:
Mild, moderate or severe hypertension - Treatment should be initiated
with 100 mg twice daily. If
required, the dose can be increased by 100 mg twice daily at an
interval of 2-14 days. Many patients
achieve blood pressure control with a dose of 200 mg twice daily; up
to 800 mg daily can be given as
two divided doses. In case of severe refractory hypertension, daily
doses of up to 2400 mg have been
given as three or four divided doses.
The dose administered to patients hospitalised with severe
hypertension can be increased on a daily
basis.
Page 2 of 12
Further blood pressure lowering effects should be expected if
labetalol tablets are administered
concomitantly with other blood pressure lowering drugs such as
diuretics, methyldopa etc. When
patients switch from drugs such as these, labetalol tablets should be
introduced with a dosage of
100mg twice daily and the previous therapy should be phased out
gradually. Abrupt withdrawal of
clonidine or beta-blocking agents is undesirable.
For long-term control of hypertensi