Xarelto Film-Coated Tablet 20 mg

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

Rivaroxaban (micronized)

Commercializzato da:

BAYER (SOUTH EAST ASIA) PTE LTD

Codice ATC:

B01AF01

Dosaggio:

20.00 mg

Forma farmaceutica:

TABLET, FILM COATED

Composizione:

Rivaroxaban (micronized) 20.00 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

Prescription Only

Prodotto da:

Bayer AG

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2012-03-13

Foglio illustrativo

 
1. 
NAME OF THE MEDICINAL PRODUCT 

Xarelto 15 mg film-coated tablets 
Xarelto 20 mg film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

XARELTO 15 MG 
1 film-coated tablet contains 15 mg rivaroxaban. 

XARELTO 20 MG 
1 film-coated tablet contains 20 mg rivaroxaban. 

For a full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Film-coated tablet (tablet).  

XARELTO 15 MG 
Red, round biconvex tablets marked with the BAYER-cross on one side and “15” and a triangle 
on the other side.  

XARELTO 20 MG 
Brown-red,  round  biconvex  tablets  marked  with  the  BAYER-cross  on  one  side  and  “20”  and  a 
triangle on the other side.  

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Xarelto is indicated for prevention of stroke and systemic embolism in patients with non-valvular 
atrial fibrillation. 
There are limited data on the relative effectiveness of Xarelto and warfarin in reducing the risk of 
stroke and systemic embolism when warfarin therapy is well-controlled (see section 5.1) . 

Xarelto is indicated for the treatment of Deep Vein Thrombosis (DVT) and pulmonary embolism 
(PE),  and  for  the  prevention  of  recurrent  DVT,  PE  in  adults.  (See  section  4.4  for 
haemodynamically unstable PE patients.) 

4.2

POSOLOGY AND METHOD OF ADMINISTRATION 

_Posology _
Prevention of stroke and systemic embolism  
The recommended dose is 20 mg once daily, which is also the recommended maximum dose.  

If a dose is missed the patient should take Xarelto immediately and continue on the following day 
with the once daily intake as recommended. The dose should not be doubled within the same day 
to make up for a missed dose.  

Scheda tecnica

Xarelto 15mg&20mg_CCDS 17_Dec 2022
1.
NAME OF THE MEDICINAL PRODUCT
Xarelto 15 mg film-coated tablets
Xarelto 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
XARELTO 15 MG
1 film-coated tablet contains 15 mg rivaroxaban.
XARELTO 20 MG
1 film-coated tablet contains 20 mg rivaroxaban.
For a full list of excipients, see section ‘List of excipients’.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
XARELTO 15 MG
Red, round biconvex tablets marked with the BAYER-cross on one side
and “15” and a triangle
on the other side.
XARELTO 20 MG
Brown-red, round biconvex tablets marked with the BAYER-cross on one
side and “20” and a
triangle on the other side.
4.
CLINICAL PARTICULARS
4.1
INDICATIONS
_Adults _
Xarelto is indicated for prevention of stroke and systemic embolism in
patients with non-valvular
atrial fibrillation.
There are limited data on the relative effectiveness of Xarelto and
warfarin in reducing the risk of
stroke
and
systemic
embolism
when
warfarin
therapy
is
well-controlled
(see
section
‘Pharmacodynamic properties’) .
Xarelto is indicated for the treatment of Deep Vein Thrombosis (DVT)
and pulmonary embolism
(PE), and for the prevention of recurrent DVT, PE in adults. (See
section ‘Special warnings and
precautions for use’ for haemodynamically unstable PE patients.)
_Paediatric population _
Xarelto 15 mg
Treatment of venous thromboembolism (VTE) and prevention of VTE
recurrence in children and
adolescents aged less than 18 years and weighing from 30kg to 50 kg
after at least 5 days of
initial parenteral anticoagulation treatment.
Xarelto 15mg&20mg_CCDS 17_Dec 2022
Xarelto 20 mg
Treatment of venous thromboembolism (VTE) and prevention of VTE
recurrence in children and
adolescents aged less than 18 years and weighing more than 50 kg after
at least 5 days of initial
parenteral anticoagulation treatment.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
_POSOLOGY _
_ _
Prevention of stroke and systemic embolism in adults
The recommended dose is 20 mg once daily, which is also t