Apixaban Teva 5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Apixaban

Available from:

Teva B.V.

ATC code:

B01AF02

INN (International Name):

Apixaban

Dosage:

5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

apixaban

Authorization status:

Not marketed

Authorization date:

2021-02-19

Patient Information leaflet

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
APIXABAN TEVA 5 MG FILM-COATED TABLETS
apixaban
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, pharmacist or
nurse.

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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Apixaban Teva is and what it is used for
2.
What you need to know before you take Apixaban Teva
3.
How to take Apixaban Teva
4.
Possible side effects
5.
How to store Apixaban Teva
6.
Contents of the pack and other information
1.
WHAT APIXABAN TEVA IS AND WHAT IT IS USED FOR
Apixaban Teva contains the active substance apixaban and belongs to a
group of medicines called
anticoagulants. This medicine helps to prevent blood clots from
forming by blocking Factor Xa, which
is an important component of blood clotting.
Apixaban Teva is used in adults:

to prevent a blood clot from forming in the heart in patients with an
irregular heart beat (atrial
fibrillation) and at least one additional risk factor. Blood clots may
break off and travel to the
brain and lead to a stroke or to other organs and prevent normal blood
flow to that organ (also
known as a systemic embolism). A stroke can be life-threatening and
requires immediate medical
attention.

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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE APIXABAN TEVA
DO NOT TAKE APIXABAN TEVA IF:

YOU ARE ALLERGIC
to apixaban or any of the other ingredients of this medicine (listed
i

Summary of Product characteristics

Health Products Regulatory Authority
19 February 2021
CRN0093FK
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Apixaban Teva 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg apixaban.
Excipients with known effect
Each 5 mg film-coated tablet contains 102 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Light pink, film coated, modified oval shape tablet, debossed with
"TV" on one side and with "G2" on the other side of the
tablet. Dimension: 9.9 – 10.5 mm length, 5.0 – 5.6 mm width, 4.2
– 4.8mm thickness.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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).
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
_Prevention of stroke and systemic embolism in patients with
non-valvular atrial fibrillation (NVAF)_
The recommended dose of apixaban is 5 mg taken orally twice daily.
_Dose reduction _
The recommended dose of apixaban is 2.5 mg taken orally twice daily in
patients with NVAF and at least two of the following
characteristics: age ≥ 80 years, body weight ≤ 60 kg, or serum
creatinine ≥ 1.5 mg/dL (133 micromole/L).
Therapy should be continued long-term.
_Treatment of DVT, treatment of PE and prevention of recurrent DVT and
PE (VTEt)_
The recommended dose of apixaban for the treatment of acute DVT and
treatment of PE is 10 mg taken orally twice daily for
the first 7 days followed by 5 mg taken orally twice daily. As per
available medical guidelines, short duration of treatment (at
least 3 m