Xarelto Film Coated Tablet 2.5mg

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

rivaroxaban micronized

Commercializzato da:

BAYER (SOUTH EAST ASIA) PTE LTD

Codice ATC:

BO1AX06

Dosaggio:

2.5mg

Forma farmaceutica:

TABLET, FILM COATED

Composizione:

rivaroxaban micronized 2.5mg

Via di somministrazione:

ORAL

Tipo di ricetta:

Prescription Only

Prodotto da:

Bayer AG

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2013-12-06

Foglio illustrativo

1.

NAME OF THE MEDICINAL PRODUCT  
Xarelto 2.5 mg film-coated tablets 
2.

QUALITATIVE AND QUANTITATIVE COMPOSITION  
XARELTO 2.5 MG  
1 film-coated tablet contains 2.5 mg rivaroxaban. 
Each 2.5 mg film-coated tablet contains 35.70 mg lactose monohydrate (= 33.92 mg lactose) per 
tablet. 
For a full list of excipient(s) see section ’List of excipients_ _
3.

PHARMACEUTICAL FORM  
XARELTO 2.5 MG  
Film-coated, round, biconvex, light yellow immediate release tablets of 6 mm diameter and 9 mm 
radius of curvature for oral use.  
Bayer-cross on the bottom side and 2.5 and a triangle on the top side.  
4.

CLINICAL PARTICULARS 
4.1

INDICATIONS 
Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or 
ticlopidine, is indicated for the prevention of cardiovascular death in adult patients  after an acute 
coronary syndrome (ACS) with elevated cardiac biomarkers (see sections ‘Contraindications’, 
‘Special warnings and precautions for use’ and ‘Pharmcodynamic properties’)  
4.2

DOSAGE AND METHOD OF ADMINISTRATION  
4.2.1

METHOD OF ADMINISTRATION 
Oral use 
4.2.2

RECOMMENDED USUAL DOSE 
The recommended dose is 2.5 mg twice daily. Patients should also take a daily dose of 75-100 mg 
ASA or a daily dose 75-100 mg ASA in addition to either a daily dose of 75 mg clopidogrel or a 
standard daily dose of ticlopidine. 
4.2.3

DURATION OF TREATMENT 
Treatment should be regularly evaluated in the individual patient weighing the risk for ischaemic 
events against the bleeding risks. Extension of treatment beyond 12 months should be done one an 
individual patient basis as experience up to 24 months is limited (see section ‘Pharmcodynamic 
properties’) 

4.2

Scheda tecnica

Xarelto 2.5mg_CCDS 17_Oct 2022
1.
NAME OF THE MEDICINAL PRODUCT
Xarelto 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
XARELTO 2.5 MG
1 film-coated tablet contains 2.5 mg rivaroxaban.
Each 2.5 mg film-coated tablet contains 35.70 mg lactose monohydrate
(= 33.92 mg lactose)
per tablet.
For a full list of excipient(s) see section ‘List of excipients’.
_ _
3.
PHARMACEUTICAL FORM
XARELTO 2.5 MG
Film-coated, round, biconvex, light yellow immediate release tablets
of 6 mm diameter and
9 mm radius of curvature for oral use.
Bayer-cross on the bottom side and 2.5 and a triangle on the top side.
4.
CLINICAL PARTICULARS
4.1
INDICATIONS
Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with
ASA plus clopidogrel
or ticlopidine, is indicated for the prevention of cardiovascular
death in adult patients after an
acute coronary syndrome (ACS) with elevated cardiac biomarkers (see
sections
‘Contraindications’, ‘Special warnings and precautions for
use’ and ‘Pharmacodynamic
properties’)
XARELTO, in combination with aspirin, is indicated to reduce the risk
of major
cardiovascular events (cardiovascular (CV) death, myocardial
infarction (MI) and stroke) in
adult patients with chronic coronary artery disease (CAD) or
peripheral artery disease (PAD)
at high risk of ischemic events.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
4.2.1
METHOD OF ADMINISTRATION
Oral use
4.2.2
RECOMMENDED USUAL DOSE
ACS
Xarelto 2.5mg_CCDS 17_Oct 2022
The recommended vascular protection regimen is one tablet of 2.5 mg
Xarelto twice daily.
Patients should also take a daily dose of 75-100 mg ASA or a daily
dose 75-100 mg ASA in
addition to either a daily dose of 75 mg clopidogrel or a standard
daily dose of ticlopidine.
CAD or PAD
The recommended vascular protection regimen for patients with CAD or
PAD is one tablet of
2.5 mg Xarelto twice daily in combination with a daily dose of 75-100
mg ASA.
4.2.3
DURATION OF TREATMENT
Treatment should be regularly evaluated in the individual patient
weighing the risk for