Rivaroxaban Abdi 10 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Abdi Farma GmbH Donnersbergstraße 4 64646 Heppenheim, , Germany

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 10 MG FILM-COATED TABLETS
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 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
Rivaroxaban Abdi 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 Abdi 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 ABDI
DO NOT TAKE RIVAROXABAN ABDI:
- 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 serious
bleeding (e.g. stomach ulcer, injury or bleeding

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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 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 therapy (at least 3 months) should be considered in
patients