Apixaban Mylan 2.5 mg film-coated tablets

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

APIXABAN

Saatavilla:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC-koodi:

B01AF02

INN (Kansainvälinen yleisnimi):

APIXABAN 2.5 mg

Lääkemuoto:

FILM-COATED TABLET

Koostumus:

APIXABAN 2.5 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

ANTITHROMBOTIC AGENTS

Tuoteyhteenveto:

Licence number in the source country: NOT APPLICAPABLE

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2021-06-30

Pakkausseloste

PACKAGE LEAFLET
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Package leaflet: Information for the user
Apixaban Mylan 2.5 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 Mylan is and what it is used for
2.
What you need to know before you take Apixaban Mylan
3.
How to take Apixaban Mylan
4.
Possible side effects
5.
How to store Apixaban Mylan
6.
Contents of the pack and other information
1.
What Apixaban Mylan is and what it is used for
Apixaban Mylan 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 Mylan 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 heartbeat (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 flo

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
2 of 27
1.
NAME OF THE MEDICINAL PRODUCT
Apixaban Mylan 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg of apixaban.
Excipients with known effect
Each 2.5 mg film-coated tablet contains 52 mg of lactose (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Yellow, round (approximately 6 mm diameter), biconvex, film-coated
tablet, debossed with ‘IU1’ on
one side and plain on the other side.
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-valvular atrial fibrillation (NVAF)
The recommended dose of apixaban is 5 mg taken orally twice daily.
3