Apixaban 2.5 mg film-coated tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Apixaban

Saatavilla:

Norton Waterford

ATC-koodi:

B01AF02

INN (Kansainvälinen yleisnimi):

Apixaban

Annos:

2.5 milligram(s)

Lääkemuoto:

Film-coated tablet

Terapeuttinen alue:

apixaban

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2021-02-19

Pakkausseloste

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
APIXABAN 2.5MG 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 is and what it is used for
2.
What you need to know before you take Apixaban
3.
How to take Apixaban
4.
Possible side effects
5.
How to store Apixaban
6.
Contents of the pack and other information
1.
WHAT APIXABAN IS AND WHAT IT IS USED FOR
Apixaban 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 is used in adults:
•
to prevent blood clots (deep vein thrombosis [DVT]) from forming after
hip or knee replacement
operations. After an operation to the hip or knee you may be at a
higher risk of developing blood
clots in your leg veins. This can cause the legs to swell, with or
without pain. If a blood clot
travels from your leg to your lungs, it can block blood flow causing
breathlessness, with or
without chest pain. This condition (pulmonary embolism) can be
life-threatening and requires
immediate medical attention.
•
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 em

Valmisteyhteenveto

Health Products Regulatory Authority
05 December 2022
CRN00D647
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Apixaban 2.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg apixaban.
Excipients with known effect
Each 2.5 mg film-coated tablet contains 51mg lactose (see section
4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Light yellow, film coated, round tablet, debossed with "TV" on one
side and with "G1" on the other side of the tablet.
Dimension: 5.9 – 6.5mm diameter. 3.0 – 3.6mm thickness.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of venous thromboembolic events (VTE) in adult patients who
have undergone elective hip or knee replacement
surgery.
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 VTE (VTEp): elective hip or knee replacement surgery _
The recommended dose of apixaban 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 the risks of
post-surgical
bleeding in deciding on the time of administration within this time
window.
_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.
_Prevention of stroke and systemic embolism in patients with
non-valv