XARELTO 10 TABLET

Land: Sydafrika

Språk: engelska

Källa: South African Health Products Regulatory Authority (SAHPRA)

Tillgänglig från:

Bayer (Pty) Ltd û Isando

Dos:

See ingredients

Läkemedelsform:

TABLET

Sammansättning:

EACH TABLET CONTAINS RIVAROXABAN 10,0 mg

Bemyndigande status:

Registered

Tillstånd datum:

2012-03-01

Bipacksedel

Approved XARELTO 10 PIL
Bayer (Pty) Ltd
Approval Date: 12 May 2022
CCPI15/27.08.2020/SA02/09.2020
Page
1
of
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PATIENT INFORMATION LEAFLET
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK
OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HAEMATOMA
A. PREMATURE DISCONTINUATION OF XARELTO INCREASE 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.
_ _
B. SPINAL/EPIDURAL HAEMATOMA:
EPIDURAL OR SPINAL HEMATOMAS HAVE OCCURRED IN PATIENTS TREATED WITH
XARELTO WHO ARE RECEIVING
NEURAXIAL ANAESTHESIA OR UNDERGOING SPINAL PUNCTURE. THESE HAEMATOMAS
MAY RESULT IN LONG-TERM
OR PERMANENT PARALYSIS.
CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS FOR SPINAL PROCEDURES.
FACTORS THAT CAN INCREASE THE RISK OF DEVELOPING EPIDURAL OR SPINAL
HAEMATOMAS IN THESE PATIENTS
INCLUDE:
• USE OF INDWELLING EPIDURAL CATHETERS
• CONCOMITANT USE OF OTHER DRUGS THAT AFFECT HAEMOSTASIS, SUCH AS
NONSTEROIDAL ANTI-INFLAMMATORY
DRUGS (NSAIDS), PLATELET INHIBITORS, OTHER ANTICOAGULANTS
• HISTORY OF TRAUMATIC OR REPEATED EPIDURAL OR SPINAL PUNCTURES
• HISTORY OF SPINAL DEFORMITY OR SPINAL SURGERY
• OPTIMAL TIMING BETWEEN THE ADMINISTRATION OF XARELTO AND NEURAXIAL
PROCEDURES IS NOT KNOWN
MONITOR PATIENTS FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGICAL
IMPAIRMENT. IF NEUROLOGICAL
COMPROMISE IS NOTED, URGENT TREATMENT IS NECESSARY.
CONSIDER THE BENEFITS AND RISKS BEFORE NEURAXIAL INTERVENTION IN
PATIENTS ANTICOAGULATED OR TO BE
ANTICOAGULATED FOR THROMBOPROPHYLAXIS.
SCHEDULING STATUS:
S4
XARELTO 10
Film-coated tablets
RIVAROXABAN
CONTAINS SUGAR (LACTOSE)
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist, nurse

Produktens egenskaper

XARELTO 10 Product Information
Applicant: Bayer (Pty) Ltd
Approved date: 12 May 2022
CCDS16/0.12.2020/SA04/05.2021
Page 1 of 30
SCHEDULING STATUS:
S4
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK
OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HAEMATOMA
A. PREMATURE DISCONTINUATION OF XARELTO INCREASE 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),
SPECIAL WARNINGS AND PRECAUTIONS _
_(4.4.), AND CLINICAL STUDIES (5.1 & 5.2)_].
_ _
B. SPINAL/EPIDURAL HAEMATOMA:
EPIDURAL OR SPINAL HEMATOMAS HAVE OCCURRED IN PATIENTS TREATED WITH
XARELTO WHO ARE RECEIVING
NEURAXIAL ANAESTHESIA OR UNDERGOING SPINAL PUNCTURE. THESE HAEMATOMAS
MAY RESULT IN LONG-TERM
OR PERMANENT PARALYSIS.
CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS FOR SPINAL PROCEDURES.
FACTORS THAT CAN INCREASE THE RISK OF DEVELOPING EPIDURAL OR SPINAL
HAEMATOMAS IN THESE PATIENTS
INCLUDE:
• USE OF INDWELLING EPIDURAL CATHETERS
• CONCOMITANT USE OF OTHER DRUGS THAT AFFECT HAEMOSTASIS, SUCH AS
NONSTEROIDAL ANTI-INFLAMMATORY
DRUGS (NSAIDS), PLATELET INHIBITORS, OTHER ANTICOAGULANTS
• HISTORY OF TRAUMATIC OR REPEATED EPIDURAL OR SPINAL PUNCTURES
• HISTORY OF SPINAL DEFORMITY OR SPINAL SURGERY
• OPTIMAL TIMING BETWEEN THE ADMINISTRATION OF XARELTO AND NEURAXIAL
PROCEDURES IS NOT KNOWN
_[SEE WARNINGS AND PRECAUTIONS (4.4) AND UNDESIRABLE EFFECTS (4.8)]. _
MONITOR PATIENTS FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGICAL
IMPAIRMENT. IF NEUROLOGICAL
COMPROMISE IS NOTED, URGENT TREATMENT IS NECESSARY _[SEE SPECIAL
WARNINGS AND PRECAUTIONS (4.4)]_.
CONSIDER THE BENEFITS AND RISKS BEFORE NEURAXIAL INTERVENTION IN
PATIENTS ANTICOAGULATED OR TO BE
ANTICOAGULATED FOR THROMBOPROPHYLAXIS _(SEE SPECIAL WARNINGS AND
PRECAUTIONS (4.4)_