Enkia 20 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC code:

B01AF01

INN (International Name):

RIVAROXABAN 20 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

RIVAROXABAN 20 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2023-03-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ENKIA 15 MG FILM-COATED TABLETS
ENKIA 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 Enkia is and what it is used for
2.
What you need to know before you take Enkia
3.
How to take Enkia
4.
Possible side effects
5.
How to store Enkia
6.
Contents of the pack and other information
1.
WHAT ENKIA IS AND WHAT IT IS USED FOR
Enkia contains the active substance rivaroxaban.
Enkia 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.
Enkia is used in children and adolescents below 18 years and with a
body weight of 30 kg or more to:
-
treat blood clots and prevent re-occurrence of blood clots in the
veins or in the blood vessels of the
lungs, following initial treatment of at least 5 days with injectable
medicines used to treat blood
clots.
Rivaroxaban 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 ENKIA
DO NOT TAKE ENKIA
-
if you are allergic to rivaroxaban or any of the other ingredients of
this medicine (l

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Enkia 15 mg film-coated tablets
Enkia 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 15 mg film-coated tablet contains 15 mg rivaroxaban.
Each 20 mg film-coated tablet contains 20 mg rivaroxaban.
Excipients with known effect: lactose.
Each 15 mg film-coated tablet contains 27.84 mg lactose (as
monohydrate).
Each 20 mg film-coated tablet contains 37.12 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Enkia 15 mg film-coated tablets appear as light-brown, round, biconvex
film-coated tablets with a
diameter of 6 mm, debossed with “E” on one side and plain on the
other side.
Enkia 20 mg film-coated tablets appear as dark red, round, biconvex
film-coated tablets with a diameter
of 7 mm, plain on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
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).
Paediatric population
_Enkia 15 mg film-coated tablets _
Treatment of venous thromboembolism (VTE) and prevention of VTE
recurrence in children and
adolescents aged less than 18 years and weighing from 30 kg to 50 kg
after at least 5 days of initial
parenteral anticoagulation treatment.
_Enkia 20 mg film-coated tablets _
Treatment of venous thromboembolism (VTE) and prevention of VTE
recurrence in children and
adolescents aged less than 18 years and weighing more than 50 kg after
at least 5 days of initial parenteral
anticoagulation treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
2
Posology
_Prevention of stroke and systemic embolism in adults _
The rec