XARELTO FILM-COATED TABLETS 10MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

RIVAROXABAN MICRONIZED

Available from:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (International Name):

RIVAROXABAN MICRONIZED

Units in package:

5Tablet Tablets; 100Tablet Tablets; 30Tablet Tablets; 10Tablet Tablets; 28 Tablets

Manufactured by:

BAYER AG

Summary of Product characteristics

Date of text revision : Jun 2023
Reference : CCDS14+17
XARELTO
®
Film-coated Tablet 1.
NAME OF THE MEDICINAL PRODUCT
Xarelto 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg rivaroxaban
Excipient with known effect:
Each film-coated tablet contains 27.90 mg lactose monohydrate, see
section 4.4.
For the full list of excipients, see section 6.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Light red, round biconvex tablets (6 mm diameter, 9 mm radius of
curvature) marked with the BAYER-cross on one side and
"10" and a triangle on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention of venous thromboembolism (VTE) in adult patients
undergoing elective hip or knee replacement surgery.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of recurrent DVT and PE
in adults. (See section 4.4 for haemodynamically unstable PE
patients.)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of VTE in patients undergoing elective hip or knee
replacement surgery_
The recommended dose is 10 mg rivaroxaban taken orally once daily. The
initial dose should be taken 6 to 10 hours after
surgery, provided that haemostasis has been established.
The duration of treatment depends on the individual risk of the
patient for venous thromboembolism which is determined by
the type of orthopaedic surgery.
•
For patients undergoing major hip surgery, a treatment duration of 5
weeks is recommended.
•
For patients undergoing major knee surgery, a treatment duration of 2
weeks is recommended.
If a dose is missed the patient should take Xarelto immediately and
then continue the following day with once daily intake as
before.
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE _
The recommended dose for the initial treatment of acute DVT or PE is
15 mg twice daily for the first three weeks followed by
20 mg once daily for the continued treatment and prevention of
recurrent DVT and PE.
Short dur