Eliquis

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Apixaban 2.5mg;  ;  

Available from:

Pfizer New Zealand Limited

INN (International Name):

Apixaban 2.5 mg

Dosage:

2.5 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Apixaban 2.5mg     Excipient: Croscarmellose sodium Lactose Magnesium stearate Microcrystalline cellulose Opadry Yellow Sodium laurilsulfate

Units in package:

Blister pack, PVC/PVDC/Al in outer cardboard carton, 10 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Siegfried Evionnaz SA

Therapeutic indications:

Eliquis is indicated for the prevention of venous thromboembolic events in adult patients who have undergone elective total hip or total knee replacement surgery.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al in outer cardboard carton - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al in outer cardboard carton - 14 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al in outer cardboard carton - 20 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al in outer cardboard carton - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al in outer cardboard carton - 60 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al in outer cardboard carton - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2012-09-06

Patient Information leaflet

ELIQUIS®
1
ELIQUIS®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ELIQUIS?
ELIQUIS contains the active ingredient apixaban. ELIQUIS is used to
treat various conditions.
For more information, see Section 1. Why am I using ELIQUIS? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ELIQUIS?
Do not use if you have ever had an allergic reaction to apixaban or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ELIQUIS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ELIQUIS and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ELIQUIS?

Your doctor will tell you how many tablets you need to take each day.

Swallow the tablet(s) whole with a full glass of water.
More instructions can be found in Section 4. How do I use ELIQUIS? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ELIQUIS?
THINGS YOU
SHOULD DO

Remind any doctor, dentist or pharmacist you visit that you are using
apixaban.

ELIQUIS should be temporarily stopped before surgery. Tell your
surgeon, doctor or dentist that you
are using apixaban if you are going to have any surgery or procedure.
Your doctor will tell you when
to stop and restart taking ELIQUIS after your surgery or procedure.

Tell your doctor immediately if you become pregnant while taking this
medicine.
THINGS YOU
SHOULD NOT DO

Do not stop using this medicine suddenly or lower the dosage without
first checking with your
doctor.
DRIVING OR USING
MACHINES

ELIQUIS is not expected to affect your ability to drive a car or
operate machinery; however, use
caution when performing these

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
1. PRODUCT NAME
ELIQUIS
®
2.5 mg and 5 mg film-coated tablets.
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.
Excipients with known effects:
•
Lactose monohydrate
•
Lactose
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
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 with 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 orally twice daily.
The initial dose should
be taken 12 to 24 hours after surgery.
In patients undergoing hip replacement surgery, the recommended
duration of treatment is 32 to
38 days.
In patients undergoing knee replacement surgery, the recommended
duration of treatment is 10 to
14 days.
The dosage of 2.5 mg taken orally twice daily, and the duration
specified for each type of surgery
should not be exceeded.
Anti-platelet agents other than acetylsalicylic acid (AS