Rivaroxaban Bluepharma 20 mg film-coated tablets

Nchi: Malta

Lugha: Kiingereza

Chanzo: Malta Medicines Authority

Inapatikana kutoka:

Bluepharma Genéricos - Comércio de Medicamentos S.A. São Martinho do Bispo 3045-016 Coimbra , Portugal

ATC kanuni:

B01AF01

INN (Jina la Kimataifa):

RIVAROXABAN 20 mg

Dawa fomu:

FILM-COATED TABLET

Tungo:

RIVAROXABAN 20 mg

Dawa ya aina:

POM

Eneo la matibabu:

ANTITHROMBOTIC AGENTS

Bidhaa muhtasari:

Licence number in the source country: NOT APPLICAPABLE

Idhini hali ya:

Authorised

Idhini ya tarehe:

2022-04-05

Taarifa za kipeperushi

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIVAROXABAN BLUEPHARMA 15 MG FILM-COATED TABLETS
RIVAROXABAN BLUEPHARMA 20 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 Bluepharma is and what it is used for
2.
What you need to know before you take Rivaroxaban Bluepharma
3.
How to take Rivaroxaban Bluepharma
4.
Possible side effects
5.
How to store Rivaroxaban Bluepharma
6.
Contents of the pack and other information
1.
WHAT RIVAROXABAN BLUEPHARMA IS AND WHAT IT IS USED FOR
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.
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
BLUEPHARMA DO NOT TAKE RIVAROXABAN BLUEPHARMA
-
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

Tabia za bidhaa

PAGE 1 OF 28
1.
NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Bluepharma 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 22.90 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)
Deep red color, biconvex round film coated tablets debossed "20" on
one side; plain on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS _ _
Prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation
with one or more risk factors, such as congestive heart failure,
hypertension, age ≥ 75 years,
diabetes mellitus, prior stroke or transient ischaemic attack.
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 stroke and systemic embolism _
The recommended dose is 20 mg once daily, which is also the
recommended maximum dose.
Therapy with Rivaroxaban Bluepharma should be continued long term
provided the benefit of
prevention of stroke and systemic embolism outweighs the risk of
bleeding (see section 4.4).
If a dose is missed the patient should take Rivaroxaban Bluepharma
immediately and continue on
the following day with the once daily intake as recommended. The dose
should not be doubled
within the same day to make up for a missed dose.
_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.
PAGE 2 OF 28
Short duration of therapy (at least 3 months) should be considered in
patients with DVT or PE
provoked by major transient risk factors (i.e. re