XARELTO 2.5 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

RIVAROXABAN

Available from:

BAYER ISRAEL LTD

ATC code:

B01AF01

Pharmaceutical form:

FILM COATED TABLETS

Composition:

RIVAROXABAN 2.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

BAYER HEALTHCARE MANUFACTURING S.R.L, ITALY

Therapeutic area:

RIVAROXABAN

Therapeutic indications:

Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel , is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.

Authorization date:

2019-04-30

Patient Information leaflet

ً
اضيأ بيبطلا كيصوي فوس .هتاذ دحب درفنم
ءاودك غلم 2.5 وتليراسك كل ىطع
ُ
ي نل
∙
:ةيلاتلا ةيودلأا ىدحإ لوانتب
وأ نيريپسأ مسإب فرعي يذلا كيليسيلاس
ليتيسأ ضمح -
.ليرچوديپولك عم ةيوس كيليسيلاس ليتيسأ
ضمح -
ةعرجلا( ةيفاضلإا ةيودلأا نم اهلوانت
كيلع بجاولا ةيئاودلا ةعرجلا صوصخب
بيبطلا كدشريس
ةرم كيليسيلاس ليتيسأ ضمح نم غلم 100 ىلإ
غلم 75 نيب يه ةداع اهب ىصوملا ةيئاودلا
كيليسيلاس ليتيسأ ضمح نم غلم 100 ىتح غلم
75 تاذ ةيموي ةيئاود ةعرج وأ مويلا يف
.)ليرچوديپولك نم غلم 75 اهردق ةيموي
ةيئاود ةعرج عم ةيوس
.اهب ىصوملا ةيئاودلا ةعرجلا زواجت زوجي
لا
دعب كلذو نكمي ام عرسأب ةداح ةيجات
ةمزلاتم دعب غلم 2.5 وتليراسك ـب جلاعلا
ءدب بجي
ىفشتسملا لوخد دعب ةعاس 24 نكمي ام ركبأ
،ةداحلا ةيجاتلا ةمزلاتملا رارقتسإ
قيقحت
.ةنقح ةطساوب ىطعي يذلا رثختلا داضمب
جلاعلا فاقيإ هيف متي ةداع يذلا تقولا
يفو
نييارشلا ضرم كيدل صخ
ُ
ش اذإ غلم 2.5 وتليراسك ـب جلاعلا أدبت
ىتم كبيبط كدشريس
.ةيطيحملا نييارشلا ضرم وأ ةيجاتلا
.جلاعلا ةرتف صوصخب كبيبط ررقيس
لوانتل ىرخأ قرط لوح كبيبط عم ثدحت
،لماكلا هلكشب صرقلا علب بعصتست تنك اذإ
.غلم 2.5 وتليراسك
.هلوانت لبق ةرشابم ،حافتلا سورهم وأ
ءاملا عم هطلخو صرقلا قحس ناكملإاب
بوبنأ قيرط نع قوحسملا غلم 2.5 وتليراسك
كئاطعإب كبيبط موقيس ،ةجاحلا تع

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Xarelto 2.5 mg
Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg rivaroxaban.
Excipient with known effect:
Each film-coated tablet contains 35.70 mg lactose monohydrate, see
section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Light yellow, round biconvex tablets (6 mm diameter, 9 mm radius of
curvature) marked with the
BAYER-cross on one side and "2.5" and a triangle on the other side.
PRESCRIBER GUIDE
THIS
PRODUCT
IS
MARKETED
WITH
prescriber
guide
providing
recommendations
for
the
risk
minimization in the use of Xarelto 2.5 mg. Please ensure you are
familiar with this material as it
contains important safety information.
PATIENT SAFETY INFORMATION CARD
The marketing of Xarelto 2.5 mg is subject to a risk management plan
(RMP) including a 'Patient
safety
information
card'.
The
'Patient
safety
information
card',
emphasizes
important
safety
information that the patient should be aware of before and during
treatment. Please explain to the
patient the need to review the card before starting treatment.
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES
THE RISK OF THROMBOTIC EVENTS,
(B) SPINAL/EPIDURAL HEMATOMA
A.
PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF
THROMBOTIC EVENTS
PREMATURE DISCONTINUATION OF ANY ORAL ANTICOAGULANT, INCLUDING
XARELTO, INCREASES
THE RISK OF THROMBOTIC EVENTS. IF ANTICOAGULATION WITH XARELTO IS
DISCONTINUED FOR A
REASON OTHER THAN PATHOLOGICAL BLEEDING OR COMPLETION OF A COURSE OF
THERAPY, CONSIDER
COVERAGE WITH ANOTHER ANTICOAGULANT _ [SEE POSOLOGY AND METHOD OF
ADMINISTRATION (4.2), _
_AND SPECIAL WARNINGS AND PRECAUTIONS FOR USE(4.4)]_.
B.
SPINAL/EPIDURAL HEMATOMA
EPIDURAL OR SPINAL HEMATOMAS HAVE OCCURRED IN PATIENTS TREATED WITH
XARELTO WHO
ARE RECEIVING NEURAXIAL ANESTHESIA OR UNDERGOING SPINAL PUNCTURE.
THESE HEMATOMAS
MAY RESULT IN LONG-TERM OR PERMANENT PARALYSIS. CONSIDER THESE RISKS
WHEN SCHEDULING
PATIENTS F