XAVIAT 10 mg TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Viatris South Africa (Pty) Ltd

Dosage:

10,0 mg

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS RIVAROXABAN 10,0 mg

Authorization status:

Registered

Patient Information leaflet

22 December 2023
Page 1 of 11
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
XAVIAT 10 MG FILM-COATED TABLETS
RIVAROXABAN
CONTAINS SUGAR: LACTOSE MONOHYDRATE 20,250 MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE XAVIAT 10 MG
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or
other health care provider.
•
XAVIAT 10 MG has been prescribed for you personally and you should not
share your medicine with other people. It may harm them, even if their
symptoms are the same as yours.
_ _
WHAT IS IN THIS LEAFLET
1.
What XAVIAT 10 MG is and what it is used for
2.
What you need to know before you take XAVIAT 10 MG
3.
How to take XAVIAT 10 MG
4.
Possible side effects
5.
How to store XAVIAT 10 MG
6.
Contents of the pack and other information
22 December 2023
Page 2 of 11
1.
WHAT XAVIAT 10 MG IS AND WHAT IT IS USED FOR
XAVIAT 10 MG contains the active substance rivaroxaban. Rivaroxaban
belongs
to a group of medicines called antithrombotic medicines. It works by
inhibiting blood
clotting Factor Xa.
XAVIAT 10 MG is used to prevent blood clots in your veins after a
major operation
on your legs. For example, this could be an operation on your hip or
knee. Your
doctor has prescribed XAVIAT 10 MG for you because after an operation
you are
at an increased risk of getting blood clots.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XAVIAT 10 MG
DO NOT TAKE XAVIAT 10 MG:
•
if you are hypersensitive (allergic) to rivaroxaban or any of the
other ingredients
of XAVIAT 10 MG (listed in section 6).
•
if you are bleeding excessively.
•
if you have a disease or condition in an organ of the body that
increases the risk
of serious bleeding (e.g. stomach ulcer, injury or bleeding in the
brain, recent
surgery of the brain or eyes).
•
if you are taking medicines to prevent blood clotting (e.g. warfarin,
dabigatran,
apixaban or heparin), except when changing anticoagulant treatment or
while
getting heparin through a venous or arterial line to keep it open,

Summary of Product characteristics

22 December 2023
Page 1 of 27
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1
NAME OF THE MEDICINE
XAVIAT 10 mg Film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains rivaroxaban 10 mg.
Contains sugar: lactose monohydrate 20,250 mg per tablet.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet.
A light pink to pink coloured, film-coated, round, biconvex, beveled
edge tablet,
debossed with RX on one side of the tablet and 2 on the other side.
Dimensions: Diameter 5,4 mm
±
0,5 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
XAVIAT 10 mg film-coated tablets are indicated for the prevention of
venous
thromboembolism (VTE) in patients undergoing major orthopaedic surgery
of the
lower limbs.
22 December 2023
Page 2 of 27
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_RECOMMENDED DOSE AND FREQUENCY OF ADMINISTRATION: _
The recommended dose is one XAVIAT 10 mg tablet once daily for the
prevention
of venous thromboembolism (VTE) in major orthopaedic surgery.
The initial dose should be taken within 6 - 10 hours after surgery
provided that
haemostasis has been established.
If a dose is missed the patient should take XAVIAT 10 mg immediately
and
continue on the following day with the once daily intake as before.
_DURATION OF TREATMENT: _
The duration of treatment depends on the type of major orthopaedic
surgery.
After major hip surgery patients should be treated for 5 weeks.
After major knee surgery patients should be treated for 2 weeks.
SPECIAL PATIENT POPULATIONS
_ELDERLY (ABOVE 65 YEARS), GENDER AND BODY WEIGHT: _
No dose adjustment is required for these patient populations.
_PATIENTS WITH IMPAIRED LIVER FUNCTION _
XAVIAT 10 mg is contraindicated in patients with significant hepatic
disease which
is associated with coagulopathy leading to a clinically relevant
bleeding risk. (see
section 4.3).
No dose adjustment is necessary in patients with other hepatic
diseases.
Limited clinical data in patients with moderate hepatic impairment
in