Eliquis 2.5mg film-coated tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Apixaban

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Apixaban

Unit dalam pakej:

3 x 10 tablet Tablets; 2 x 10 tablet Tablets

Dikeluarkan oleh:

PFIZER IRELAND PHARMACEUTICALS

Risalah maklumat

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ELIQUIS
®
FILM COATED TABLETS
Apixaban (2.5 mg, 5 mg)
1
WHAT IS IN THIS LEAFLET
1.
What ELIQUIS is used for
2.
How ELIQUIS works
3.
Before you use ELIQUIS
4.
How to use ELIQUIS
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of ELIQUIS
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT ELIQUIS IS USED FOR
ELIQUIS is used to
- prevent blood clots in veins (venous
thromboembolic events (VTE)) after
a hip or knee replacement surgery.
- prevent stroke and blood clots in
adult patients with a condition called
non-valvular atrial fibrillation, which
is a type of irregular heart rhythm
with one or more risk factors, such
as:

previous stroke condition or
transient ischaemic attack (TIA)
(mini stroke);

age
≥
75 years

high blood pressure
(hypertension)

high blood sugar levels
(diabetes mellitus)

symptomatic heart failure
(NYHA Class
≥
II).
- treat blood clots occurring in deep
veins (Deep Vein Thrombosis
[DVT]) and clots in your lungs
(Pulmonary Embolism [PE]) and
also to prevent these from recurring.
HOW ELIQUIS WORKS
The active substance in Eliquis is
apixaban. It helps to prevent blood clot
formation by inhibiting Factor Xa, which
is an important component of blood
clotting.
BEFORE YOU USE ELIQUIS
-
_When you must not use it_
Do not take ELIQUIS if
- you are allergic to Apixaban or to
any of the other ingredients listed at
the end of this leaflet
- you have an injury to a body organ
or any internal bleeding
- you have liver disease associated
with a bleeding disorder called
coagulopathy and an increased risk
of bleeding
- you have any condition or injury to a
body organ that could lead to
significant bleeding (such as ulcers
in stomach; cancerous growth; recent
brain or spinal injury; recent brain,
spinal or eye surgery; bleeding in the
brain; abnormal, enlarged veins in
the tube that connects the throat and
stomach (esophagus); an abnormal
conne

Ciri produk

Pfizer Confidential
1. NAME OF THE MEDICINAL PRODUCT
Eliquis 2.5 mg film-coated tablets.
Eliquis 5 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2.5 MG
Each film-coated tablet contains 2.5 mg Apixaban.
Excipients with known effect:
Each 2.5 mg film-coated tablet contains 51.4 mg lactose (SEE SECTION
4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR USE).
5 MG
Each film-coated tablet contains 5.0 mg Apixaban.
Excipients with known effect:
Each 5 mg film-coated tablet contains 102.9 mg lactose (SEE SECTION
4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR USE).
For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
2.5 MG
Yellow, round, biconvex film-coated tablets (diameter of 5.95 mm) with
“893” debossed on one
side and “2½” on the other side.
5 MG
Pink, oval shaped, biconvex film-coated tablets (9.73 mm x 5.16 mm)
with “894” debossed on
one side and “5” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
FOR 2.5 MG
Prevention of venous thromboembolic events (VTE) in adult patients who
have undergone
elective hip or knee replacement surgery.
FOR 2.5 MG AND 5 MG
Prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation
(NVAF), with one or more risk factors, such as prior stroke or
transient ischaemic attack (TIA);
age ≥75 years; hypertension; diabetes mellitus; symptomatic heart
failure (NYHA Class ≥II).
Pfizer Confidential
1
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of
recurrent DVT and PE in adults (SEE SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR
USE) for haemodynamically unstable PE patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of VTE _(_VTEp_)_: elective hip or knee replacement
surgery _
The recommended dose of Eliquis is 2.5 mg taken orally twice daily.
The initial dose should
be taken 12 to 24 hours after surgery.
Physicians may consider the potential benefits of earlier
anticoagulation for VTE prophylaxis
as well as