Rivaroxaban Clonmel 10 mg film-coated tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Rivaroxaban

Tersedia dari:

Clonmel Healthcare Ltd

Kode ATC:

B01AF01

INN (Nama Internasional):

Rivaroxaban

Bentuk farmasi:

Film-coated tablet

Area terapi:

rivaroxaban

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2023-01-13

Selebaran informasi

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
Rivaroxaban Clonmel 10 mg film-coated tablet
rivaroxaban
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Rivaroxaban Clonmel is and what it is used for
2. What you need to know before you take Rivaroxaban Clonmel
3. How to take Rivaroxaban Clonmel
4. Possible side effects
5. How to store Rivaroxaban Clonmel
6. Contents of the pack and other information
1. WHAT RIVAROXABAN CLONMEL IS AND WHAT IT IS USED FOR
Rivaroxaban Clonmel contains the active substance rivaroxaban and is
used in adults to
•
prevent 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.
•
treat blood clots in the veins of your legs (deep vein thrombosis) and
in the blood vessels of your
lungs (pulmonary embolism), and to prevent blood clots from
re-occurring in the blood vessels of
your legs and/or lungs.
Rivaroxaban Clonmel belongs to a group of medicines called
antithrombotic agents. It works by
blocking a blood clotting factor (factor Xa) and thus reducing the
tendency of the blood to form clots.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIVAROXABAN CLONMEL
DO NOT TAKE RIVAROXABAN CLONMEL
•
if you are allergic to rivaroxaban or any of the other ingredients of
this medicine (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

Karakteristik produk

Health Products Regulatory Authority
20 November 2023
CRN00DV9S
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Clonmel 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 49 mg lactose (as monohydrate), see
section 4.4.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Light pink, round, biconvex film-coated tablets with a diameter of
approximately 6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of venous thromboembolism (VTE) in adult patients
undergoing elective hip or knee replacement surgery.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of recurrent DVT and PE in adults.
(See section 4.4 for haemodynamically unstable PE patients.)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of VTE in adult patients undergoing elective hip or knee
replacement surgery_
The recommended dose is 10 mg Rivaroxaban Clonmel taken orally once
daily. The initial dose should be taken 6 to 10 hours
after surgery, provided that haemostasis has been established.
The duration of treatment depends on the individual risk of the
patient for venous thromboembolism which is determined by
the type of orthopaedic surgery.

For patients undergoing major hip surgery, a treatment duration of 5
weeks is recommended.

For patients undergoing major knee surgery, a treatment duration of 2
weeks is recommended.
If a dose is missed the patient should take Rivaroxaban Clonmel
immediately and then continue the following day with once
daily intake as before.
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE_
The recommended dose for the initial treatment of acute DVT or PE is
15 mg twice daily for the first three weeks followed by
20 mg once daily for the continued treatment and prevention of
recurrent DVT and PE.
Short duration of