ELIQUIS apixaban 2.5 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

apixaban, Quantity: 2.5 mg

Available from:

Bristol-Myers Squibb Australia Pty Ltd

INN (International Name):

Apixaban

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose; sodium lauryl sulfate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide yellow

Administration route:

Oral

Units in package:

10 tablets, 60 tablets, 30 tablets, 14 tablets, 20 tablets, 100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ELIQUIS is indicated for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or total knee replacement surgery.,ELIQUIS is indicated for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.,ELIQUIS is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adult patients.,ELIQUIS is indicated for the prevention of recurrent DVT and PE in adult patients.

Product summary:

Visual Identification: Yellow, round, biconvex film-coated tablet with "893" debossed on one side and "2 1/2" on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2011-07-21

Patient Information leaflet

ELIQUIS
®
(ELLE-E-KUIS)
_apixaban_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Eliquis.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Eliquis against
the benefits it is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ELIQUIS IS USED
FOR
_WHAT ELIQUIS DOES_
This medicine is used to:
•
prevent blood clots in your veins
after a hip or knee replacement
surgery.
After an operation you are at an
increased risk of getting blood
clots.
•
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.
•
prevent stroke and blood clots in
a condition called atrial
fibrillation, which is a type of
abnormal heart rhythm.
With atrial fibrillation, part of the
heart does not beat the way it
should. This can lead to blood
clots forming and increase your
risk of having a stroke.
_HOW ELIQUIS WORKS_
The active substance in Eliquis is
apixaban. It belongs to a group of
medicines called antithrombotic
agents.
It works by inhibiting a blood clot
forming substance called Factor Xa.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
_USE IN CHILDREN_
There is not enough information to
recommend the use of this medicine
in children and adolescents under the
age of 18 years.
BEFORE YOU TAKE
ELIQUIS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ELIQUIS IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing apixaban

Summary of Product characteristics

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AUSTRALIAN PI – ELIQUIS
® (APIXABAN)
1 NAME OF THE MEDICINE
Apixaban
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg film-coated tablet contains 2.5 mg apixaban.
Each 5 mg film-coated tablet contains 5 mg apixaban.
List of excipients with known effect:
Lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
ELIQUIS containing 2.5 mg apixaban for oral administration is
available as yellow round,
biconvex, film-coated tablets debossed with “893” on one side and
“2½” on the other side.
ELIQUIS containing 5 mg apixaban for oral administration is available
as pink oval-shaped,
biconvex, film-coated tablets debossed with “894” on one side and
“5” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ELIQUIS is indicated for the prevention of venous thromboembolic
events (VTE) in adult
patients who have undergone elective total hip or total knee
replacement surgery.
ELIQUIS is indicated for the prevention of stroke and systemic
embolism in adult patients
with non-valvular atrial fibrillation and at least one additional risk
factor for stroke.
ELIQUIS is indicated for the treatment of deep vein thrombosis (DVT)
and pulmonary
embolism (PE) in adult patients.
ELIQUIS is indicated for the prevention of recurrent DVT and PE in
adult patients.
4.2 DOSE AND METHOD OF ADMINISTRATION
ELIQUIS can be taken with or without food.
MISSED DOSE
If a dose of ELIQUIS is not taken at the scheduled time, the dose
should be taken as soon as
possible on the same day and twice daily administration should be
resumed. The dose should
not be doubled to make up for the missed dose.
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PREVENTION OF VTE: ELECTIVE TOTAL HIP OR TOTAL KNEE REPLACEMENT
SURGERY
The recommended dose of ELIQUIS is 2.5 mg taken twice daily. The
initial dose should be
taken 12 to 24 hours after surgery.
In patients undergoing hip replacement surgery, the recommended
d