IXAROLA 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

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:

30 tablets, 15 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

IXAROLA 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, IXAROLA, 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:

Registered

Authorization date:

2023-02-07

Patient Information leaflet

IXAROLA
®
CMI V2.0
1
IXAROLA
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING IXAROLA?
IXAROLA contains the active ingredient rivaroxaban. IXAROLA reduces
the tendency of blood to form clots and is used to treat
a number of conditions. For more information, see Section 1. Why am I
using IXAROLA? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IXAROLA?
Do not use if you have ever had an allergic reaction to IXAROLA or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
IXAROLA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with IXAROLA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE IXAROLA?
•
Follow all directions given to you by your doctor and other health
professionals carefully including:
•
How many tablets to take each day
•
If you need to take these tablets with food
More instructions can be found in Section 4. How do I use IXAROLA? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IXAROLA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
IXAROLA.
•
Take IXAROLA exactly as your doctor has prescribed.
•
Remember to carry your patient alert card in your wallet with you at
all times.
THINGS YOU
SHOULD NOT DO
•
Do not take IXAROLA to treat any other complaints unless your doctor
tells you to.
•
Do not give your medicine to anyone else, even if they have the same
condition as you.
•
Do not stop taking your medicine or lower the dosage without checking
with your doctor first.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or

Summary of Product characteristics

IXAROLA PI V2.0; CCDS 14, 17
Page 1 of 50
AUSTRALIAN PRODUCT INFORMATION
IXAROLA
®
(RIVAROXABAN)
1.
NAME OF THE MEDICINE
IXAROLA
®
(rivaroxaban)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of IXAROLA
-
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 IXAROLA
-
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.
IXAROLA 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.
IXAROLA 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.
IXAROLA 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.
IXAROLA 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.
IXAROLA PI V2.0; CCDS 14, 17
Page 2 of 50
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IXAROLA 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 str