RAVELTO 10 TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Innovata Pharmaceuticals

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: RAVELTO 10, _
_DOSAGE FORM & STRENGTH: Film-coated Tablets, Rivaroxaban 10 mg _
CTD, Module 1
Approved PIL : 29 MARCH 2022
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1
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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
PRODUCT NAME, STRENGTH AND PHARMACEUTICAL FORM
RAVELTO 10, (FILM COATED TABLETS)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING RAVELTO 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.
•
RAVELTO 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 RAVELTO 10 IS AND WHAT IT IS USED FOR:
•
RAVELTO 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.
•
RAVELTO 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 RAVELTO 10
_APPLICANT/PHCR: Innovata Pharmaceuticals (Pty) Ltd _
_PRODUCT PROPRIETARY NAME: RAVELTO 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
RAVELTO 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
throu

Summary of Product characteristics

_APPLICANT/PHCR: Innovata Pharmaceuticals (Pty) Ltd _
_PRODUCT PROPRIETARY NAME: RAVELTO 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:
RAVELTO 10, (FILM COATED TABLETS)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each RAVELTO 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
RAVELTO 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
RAVELTO 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 RAVELTO 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: RAVELTO 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 RAVELTO 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
RAVELTO 10 is contra-indicated in patients with significant hepatic
disease which is
associated with