Xarelto

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Rivaroxaban 2.5mg

Available from:

Bayer New Zealand Limited

Dosage:

2.5 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Rivaroxaban 2.5mg Excipient: Croscarmellose sodium Hypromellose   Iron oxide yellow Lactose monohydrate Macrogol 3350 Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate Titanium dioxide

Prescription type:

Prescription

Therapeutic indications:

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:

Package - Contents - Shelf Life: Blister pack, PP/Al foil in cardboard carton - 60 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2020-04-09

Patient Information leaflet

XARELTO
®
CMI V5.0
1
XARELTO
®
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 XARELTO?
XARELTO contains the active ingredient rivaroxaban. XARELTO 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 XARELTO? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE XARELTO?
Do not use if you have ever had an allergic reaction to XARELTO 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
XARELTO? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with XARELTO 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 XARELTO?
•
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 XARELTO?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING XARELTO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
XARELTO.
•
Take XARELTO exactly as your doctor has prescribed.
•
THINGS YOU
SHOULD NOT DO
•
Do not take XARELTO 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 tools until you
know how XARELTO affects you.
•
If this medicine makes you fee

Summary of Product characteristics

XARELTO DS VX7.0; CCDS 16, 18
Page 1 of 46
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
® (STRENGTH PHARMACEUTICAL FORM)
XARELTO
®
rivaroxaban 2.5 mg film-coated tablets
XARELTO
®
rivaroxaban 10 mg film-coated tablets
XARELTO
®
rivaroxaban 15 mg film-coated tablets
XARELTO
®
rivaroxaban 20 mg film-coated tablets
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
-
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 excipient(s) see section 6.1.
3.
PHARMACEUTICAL FORM
XARELTO 2.5 MG
Film-coated, round biconvex light-yellow immediate release tablets (6
mm diameter, 9 mm
radius of curvature) and weight of 87.5 mg for oral use. BAYER-cross
on one side and "2.5"
and a triangle on the other side.
XARELTO 10 MG
Film-coated, round, biconvex, light red immediate release tablets of 6
mm diameter and 9 mm
radius of curvature and weight of 87.5 mg for oral use. Bayer-cross on
one side and 10 and a
triangle on the other side.
XARELTO 15 MG
Film-coated, round, biconvex, red tablets of 6 mm diameter, 9 mm
radius of curvature and
weight of 87.5 mg for oral use. Bayer-cross on one side and a triangle
and 15 on the other
side.
XARELTO 20 MG
Film-coated, round, biconvex, brown red tablets of 6 mm diameter, 9 mm
radius of curvature
and weight of 87.5 mg for oral use. Bayer-cross on one side and a
triangle and 20 on the other
side.
XARELTO DS VX7.0; CCDS 16, 18
Page 2 of 46
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
XARELTO is indicated for
•
Prevention of venous thromboembolism (VTE) in adult patients
undergoing elective hip
or knee replacement surgery.
•
Prevention of stroke and systemic embolism in adult pat