XARELTO rivaroxaban 10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rivaroxaban, Quantity: 10 mg

Available from:

Bayer Australia Ltd

INN (International Name):

Rivaroxaban

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; sodium lauryl sulfate; croscarmellose sodium; hypromellose; lactose monohydrate; iron oxide red; titanium dioxide; macrogol 3350; magnesium stearate

Administration route:

Oral

Units in package:

15 tablets, 100 tablets, 3 tablets (physician sample pack), 10 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

XARELTO is indicated for: ? Prevention of venous thromboembolism (VTE) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks) ? Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke ? Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the prevention of recurrent DVT and PE,XARELTO, in combination with aspirin, is indicated for ? the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD).

Product summary:

Visual Identification: Light red, round, biconvex, film-coated tablets marked with the BAYER-cross on one side and 10 and a triangle on the other; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-11-24

Patient Information leaflet

XARELTO
CMI XV2.0
1
XARELTO
®
(ZA·REL·TOE)
_rivaroxaban _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
XARELTO. It does not contain
all the available information. It
does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
XARELTO against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT XARELTO IS
USED FOR
The active substance is
rivaroxaban. It belongs to a
group of medicines called
_anticoagulants_
. It works by
inhibiting the blood clotting
protein called Factor Xa, thus
reducing the tendency of blood to
form clots.
XARELTO has been prescribed
to you for one of the following
uses:
-
Prevention of blood clots in
your veins after a hip or knee
replacement operation
because after an operation
you are at an increased risk
of getting blood clots
-
Prevention of blood clots in
your brain (stroke) and/or
other blood vessels in your
body if you have a form of
irregular heart rhythm called
non-valvular atrial
fibrillation
-
Treatment of blood clots in
the veins of your legs (deep
vein thrombosis, DVT) and
clots in your lung
(pulmonary embolism, PE)
and to prevent blood clots
from re-occurring in your
legs and/or lungs.
XARELTO 2.5 mg tablets twice
daily along with aspirin 100 mg
once daily, has been prescribed
to you for:
-
prevention of major heart
related events (stroke, heart
attack and death from heart
related conditions) if you
have poor blood flow in the
blood vessels of your heart
(coronary artery disease or
CAD) and/or arms and legs
(peripheral artery disease or
PAD).
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
XARELTO for another reason.
XARELTO is a prescription
medicine. It should only be used
in adults under medical
supe

Summary of Product characteristics

XARELTO PI XV3.0; CCDS 16
Page 1 of 50
AUSTRALIAN PRODUCT INFORMATION
XARELTO
®
(RIVAROXABAN)
1.
NAME OF THE MEDICINE
XARELTO
®
(rivaroxaban)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of XARELTO
-
2.5 mg contains 2.5 mg of rivaroxaban
-
10 mg contains 10 mg of rivaroxaban
-
15 mg contains 15 mg of rivaroxaban
-
20 mg contains 20 mg of rivaroxaban
_Excipient with known effect _
Each film-coated tablet of XARELTO
-
2.5 mg contains 35.70 mg lactose (as monohydrate)
-
10 mg contains 27.90 mg lactose (as monohydrate)
-
15 mg contains 25.40 mg lactose (as monohydrate)
-
20 mg contains 22.90 mg lactose (as monohydrate)
See Information about excipients
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Film-coated (immediate release) tablet.
XARELTO 2.5 mg – 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.
XARELTO 10 mg – 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.
XARELTO 15 mg – Red, round biconvex tablets (6 mm diameter, 9 mm
radius of curvature)
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 (6 mm diameter, 9
mm radius of
curvature) marked with the BAYER-cross on one side and “20” and a
triangle on the other side.
XARELTO PI XV3.0; CCDS 16
Page 2 of 50
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
XARELTO is indicated for:
•
Prevention of venous thromboembolism (VTE) in adult patients who have
undergone
major orthopaedic surgery of the lower limbs (elective total hip
replacement, treatment
for up to 5 weeks; elective total knee replacement, treatment for up
to 2 weeks)
•
Prevention of stroke and systemic embolism in patients with
non-valvular atrial
fibrillation and at least one additional risk factor for stroke
�