REZALTO 10 mg TABLET

Country: Afrika Selatan

Bahasa: Inggeris

Sumber: South African Health Products Regulatory Authority (SAHPRA)

Boleh didapati daripada:

Austell Pharmaceuticals (Pty) Ltd

Dos:

See ingredients

Borang farmaseutikal:

TABLET

Komposisi:

EACH TABLET CONTAINS RIVAROXABAN 10,0 mg

Status kebenaran:

Registered

Risalah maklumat

2020.12.14 (v1.00) Page 1 of 11
PATIENT INFORMATION LEAFLET FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS: S4
REZALTO 10 MG FILM-COATED TABLETS
RIVAROXABAN
CONTAINS SUGAR: LACTOSE MONOHYDRATE 95,6 MG/TABLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING REZALTO _ _
•
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.
•
REZALTO 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 REZALTO is and what it is used for
2. What you need to know before you take REZALTO
3. How to take REZALTO
4. Possible side effects
5. How to store REZALTO
6. Contents of the pack and other information
1. WHAT REZALTO IS AND WHAT IT IS USED FOR
REZALTO belongs to a group of medicines called antithrombotic
medicines.
It works by blocking a blood clotting factor (factor Xa) and thus
reducing the
tendency of the blood to form clots.
2020.12.14 (v1.00) Page 2 of 11
REZALTO contains the active substance rivaroxaban and is used in
adults to
-
prevent blood clots in the veins (deep vein thrombosis) in patients
undergoing an operation of the lower
limbs, because after an operation you are at an increased risk of
getting blood clots.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REZALTO
DO NOT TAKE REZALTO
-
if you are hypersensitive (allergic) to rivaroxaban or any of the
other ingredients of this REZALTO (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,
-
if you have

Ciri produk

2020.12.14 (v1.00) Page 1 of 2
PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
REZALTO 10 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg rivaroxaban.
Each film-coated tablet contains 95,6 mg lactose monohydrate.
FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round, biconvex film-coated tablets, engraved with “10” on
one side, plain on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
REZALTO 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 recommend dose is one REZALTO once daily for the prevention of
various thromboembolism (VTE) in
major orthopaedic surgery.
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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 REZALTO 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 (ABOVE 65 YEARS). GENDER AND BODY WEIGHT
No dose adjustment is required for these patient populations.
PAEDIATRIC POPULATION
CHILDREN (UP TO 18 YEARS OF AGE)
The safety and efficacy of REZALTO has not been established in
children. No clinical data is available for
children.
PATIENTS WITH IMPAIRED LIVER FUNCTION
REZALTO is contra-indicated in patients with significant hepatic
disease which is associated with coagulopathy
leading to clinically relevant bleeding risk (see section 4.3).
No dose adjustment is necessary in patients with other hepatic
dise