Rivaroxaban Clonmel 2.5 mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
20-11-2023
Summary of Product characteristics
(SPC)
20-11-2023
Active ingredient:
Rivaroxaban
Available from:
Clonmel Healthcare Ltd
ATC code:
B01AF01
INN (International Name):
Rivaroxaban
Dosage:
250 Milligram
Pharmaceutical form:
Film-coated tablet
Therapeutic area:
rivaroxaban
Authorization status:
Not marketed
Authorization date:
2023-01-13
Patient Information leaflet
Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
Rivaroxaban Clonmel 2.5 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
You have been given Rivaroxaban Clonmel 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.
Rivaroxaban Clonmel 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 Clonmel will not be given to you on its own. Your doctor
will also tell you to take
either:
o
acetylsalicylic acid or
o
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.
Rivaroxaban Clonmel reduces the risk in adults of getting blot clots
(atherothrombotic events).
Rivaroxaban Clonmel will not be given to you on its own. Your doctor
will also tell you to take
acetylsalicylic acid.
In some cases, if you get Rivaroxaban Cl
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
20 November 2023
CRN00DV9S
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Clonmel 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 58 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 yellow, round, biconvex film-coated tablets with a diameter of
approximately 6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rivaroxaban Clonmel, co-administered with acetylsalicylic acid (ASA)
alone or with ASA plus clopidogrel or ticlopidine, is
indicated for the prevention of atherothrombotic events in adult
patients after an acute coronary syndrome (ACS) with elevated
cardiac biomarkers (see sections 4.3, 4.4 and 5.1).
Rivaroxaban Clonmel, co-administered with acetylsalicylic acid (ASA),
is indicated for the prevention of atherothrombotic
events in adult patients with coronary artery disease (CAD) or
symptomatic peripheral artery disease (PAD) at high risk of
ischaemic events.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 2.5 mg twice daily.
ACS
Patients taking Rivaroxaban Clonmel 2.5 mg twice daily should also
take a daily dose of 75-100 mg ASA or a daily dose of
75-100 mg ASA in addition to either a daily dose of 75 mg clopidogrel
or a standard daily dose of ticlopidine.
Treatment should be regularly evaluated in the individual patient
weighing the risk for ischaemic events against the bleeding
risks. Extension of treatment beyond 12 months should be done on an
individual patient basis as experience up to 24 months
is limited (see section 5.1).
Treatment with Rivaroxaban Clonmel should be started as soon as
possible after stabilisation of the ACS event (including
revascularisation procedures); at the earliest 24 hours after
admission to hospital and at the time when parenteral
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