RIVAROXABAN 10 mg AUSTELL TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Austell Pharmaceuticals (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS RIVAROXABAN 10,0 mg

Authorization status:

Registered

Patient Information leaflet

_APPLICANT/PHCR: Innovata Pharmaceuticals (Pty) Ltd _
_PRODUCT PROPRIETARY NAME: RIVAR 10, _
_DOSAGE FORM & STRENGTH: Film-coated Tablets, Rivaroxaban 10 mg _
CTD, Module 1
Approved PIL : 29 MARCH 2022
Page
1
of
12
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
PRODUCT NAME, STRENGTH AND PHARMACEUTICAL FORM
RIVAR 10, (FILM COATED TABLETS)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING RIVAR 10
•
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.
•
RIVAR 10 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
1.
WHAT RIVAR 10 IS AND WHAT IT IS USED FOR:
•
RIVAR 10 belong to a group of medicines called antithrombotic
medicines.
It works by blocking a blood clotting factor (Factor Xa) and thus
reduces
the tendency of the blood to clot.
•
RIVAR 10 prevents blood clots in the veins after a hip or knee
replacement operation. Your doctor has prescribed this medicine 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
DO NOT TAKE RIVAR 10
_APPLICANT/PHCR: Innovata Pharmaceuticals (Pty) Ltd _
_PRODUCT PROPRIETARY NAME: RIVAR 10, _
_DOSAGE FORM & STRENGTH: Film-coated Tablets, Rivaroxaban 10 mg _
CTD, Module 1
Approved PIL : 29 MARCH 2022
Page
2
of
12
•
If you are allergic (hypersensitive) to rivaroxaban or to any
ingredients of
RIVAR 10, (listed in section 6)
•
If you have a bleeding disorder that you have inherited or 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
or heparin),
except when changing anticoagulant treatment or while getting heparin
through a venous or arter

Summary of Product characteristics

_APPLICANT/PHCR: Innovata Pharmaceuticals (Pty) Ltd _
_PRODUCT PROPRIETARY NAME: RIVAR 10, _
_DOSAGE FORM & STRENGTH: Film-coated Tablets, Rivaroxaban 10 mg,_
_ _
_ _
_ CTD, Module 1_
Date of PI: 29 MARCH 2022
Page 1 of 27
SCHEDULING STATUS
1.
NAME OF MEDICINE:
RIVAR 10, (FILM COATED TABLETS)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each RIVAR 10 film-coated tablet contains rivaroxaban 10 mg.
Contains sugar (lactose - 21.0 mg per 10 mg tablet)
For the full list of excipients, see SECTION 6.1
3.
PHARMACEUTICAL FORM
Film coated tablets
RIVAR 10 round pink, biconvex film coated tablets, debossed with
“L” on one side
and “10” on other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RIVAR 10 film-coated tablets are indicated for the prevention of
venous
thromboembolism (VTE) in patients undergoing major orthopaedic surgery
of the
lower limbs.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
RECOMMENDED DOSE AND FREQUENCY OF ADMINISTRATION
The recommended dose is one RIVAR 10 tablet once daily for the
prevention of
venous thromboembolism (VTE) in major orthopaedic surgery.
S4
_APPLICANT/PHCR: Innovata Pharmaceuticals (Pty) Ltd _
_PRODUCT PROPRIETARY NAME: RIVAR 10, _
_DOSAGE FORM & STRENGTH: Film-coated Tablets, Rivaroxaban 10 mg,_
_ _
_ _
_ CTD, Module 1_
Date of PI: 29 MARCH 2022
Page 2 of 27
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 RIVAR 10 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 POPULATIONS
Elderly Population
No dose adjustment is required for these patient populations.
Hepatic Impairment
RIVAR 10 is contra-indicated in patients with significant hepatic
disease which is
associated with coagulopathy lea