Rivaroxaban Medichem 10mg film-coated tablets

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

RIVAROXABAN

제공처:

Medichem, S.A. Fructuós Gelabert 6-8, 08970, Sant Joan Despí, (Barcellona), Spain

ATC 코드:

B01AF01

INN (International Name):

RIVAROXABAN 10 mg

약제 형태:

FILM-COATED TABLET

구성:

RIVAROXABAN 10 mg

처방전 유형:

POM

치료 영역:

ANTITHROMBOTIC AGENTS

승인 상태:

Authorised

승인 날짜:

2019-03-13

환자 정보 전단

193
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN MEDICHEM 15 MG FILM-COATED TABLETS
RIVAROXABAN MEDICHEM 20 MG FILM-COATED TABLETS
rivaroxaban
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Medichem is and what it is used for
2.
What you need to know before you take Rivaroxaban Medichem
3.
How to take Rivaroxaban Medichem
4.
Possible side effects
5.
How to store Rivaroxaban Medichem
6.
Contents of the pack and other information
1.
WHAT RIVAROXABAN MEDICHEM IS AND WHAT IT IS USED FOR
Rivaroxaban Medichem contains the active substance rivaroxaban and is
used in adults to:
-
prevent blood clots in brain (stroke) and other blood vessels in your
body if you have a form of
irregular heart rhythm called non-valvular atrial fibrillation.
-
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 Medichem 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 MEDICHEM
DO NOT TAKE RIVAROXABAN MEDICHEM
-
if you are

제품 특성 요약

This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Medichem 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
27.90
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 red, round biconvex, film-coated tablets marked with "I" on one
side.
The specific tablet dimensions are 5.95- 6.05 mm of diameter and 2.70-
2.90 mm of thickness.
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 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 Medichem
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_