Rivaroxaban Clonmel 15 mg film-coated tablets Rivaroxaban Clonmel 20 mg film-coated tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Rivaroxaban; Rivaroxaban

Dostupno od:

Clonmel Healthcare Ltd

ATC koda:

B01AF01

INN (International ime):

Rivaroxaban; Rivaroxaban

Farmaceutski oblik:

Film-coated tablet

Područje terapije:

rivaroxaban

Status autorizacije:

Not marketed

Datum autorizacije:

2023-01-13

Uputa o lijeku

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
Rivaroxaban Clonmel 15 mg film-coated tablets
Rivaroxaban Clonmel 20 mg film-coated tablets
TREATMENT INITIATION PACK
Not for use in children
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
Rivaroxaban Clonmel contains the active substance rivaroxaban and is
used in adults to
•
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 Clonmel 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 CLONMEL
DO NOT TAKE RIVAROXABAN CLONMEL
•
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 in the brain, recent surgery
of the brain or eyes)
•
i

Svojstava lijeka

Health Products Regulatory Authority
20 November 2023
CRN00DV9S
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rivaroxaban Clonmel 15 mg film-coated tablets Rivaroxaban Clonmel 20
mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg rivaroxaban.
Each film-coated tablet contains 20 mg rivaroxaban.
Excipient with known effect
Each 15 mg film-coated tablet contains 43 mg lactose (as monohydrate),
see section 4.4.
Each 20 mg film-coated tablet contains 57 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)
15 mg film-coated tablets:
Red, round, biconvex film-coated tablets, with a diameter of
approximately 6 mm.
20 mg film-coated tablets:
Brown red, round, biconvex film-coated tablets, with a diameter of
approximately 7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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
_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 with DVT or PE provoked by major transient risk
factors (i.e. recent major surgery or trauma). Longer duration of
therapy should be considered in patients with provoked DVT or
PE not related to major transient risk factors, unprovoked DVT or PE,
or a history of recurrent DVT or PE.
When extended prevention of recurrent DVT and PE is indicated
(following completion of at least 6 months therapy for DVT or
PE), the recommended dose is 10 mg once daily. In patients in whom the
risk of recurre