Rivaroxaban Abdi 10 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Abdi Farma, Unipessoal Lda Quinta da Fonte, Rua dos Malhões, Edifício D. Pedro I 2770-071 Paço de Arcos, Portugal

ATC code:

B01AF01

INN (International Name):

RIVAROXABAN 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

RIVAROXABAN 10 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-03-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN ABDI 2.5 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 Abdi is and what it is used for
2. What you need to know before you take Rivaroxaban Abdi
3. How to take Rivaroxaban Abdi
4. Possible side effects
5. How to store Rivaroxaban Abdi
6. Contents of the pack and other information
1. WHAT RIVAROXABAN ABDI IS AND WHAT IT IS USED FOR
You have been given Rivaroxaban Abdi because
- you have been diagnosed with an acute coronary syndrome (a group of
conditions
that includes heart attack and unstable angina, a severe type of chest
pain) and have
been shown to have had an increase in certain cardiac blood tests.
This medicine reduces the risk in adults of having another heart
attack or reduces the
risk of dying from a disease related to your heart or your blood
vessels.
Rivaroxaban Abdi will not be given to you on its own. Your doctor will
also tell you
to take either:
• acetylsalicylic acid or
•·acetylsalicylic acid plus clopidogrel or ticlopidine.
or
- you have been diagnosed with a high risk of getting a blood clot due
to a coronary
artery disease or peripheral artery disease which causes symptoms.
This medicine reduces the risk in adults of getting blot clots
(athero

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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 Abdi 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 140.0 mg lactose, see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pink, round shaped, biconvex, film-coated tablets (7.8 – 8.4 mm)
debossed “R2” on one side and plain
on the other side.
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 Abdi
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 init