Apixaban Tiefenbacher 2.5 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

APIXABAN

Available from:

ALFRED E. TIEFEMBACHER (GmbH &Co. KG) Van-der-Smissen-Straße 1, 22767 Hamburg, Germany

ATC code:

B01AF02

INN (International Name):

APIXABAN 2.5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

APIXABAN 2.5 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-04-08

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
APIXABAN TIEFENBACHER 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 Tiefenbacher is and what it is used for
2.
What you need to know before you take Apixaban Tiefenbacher
3.
How to take Apixaban Tiefenbacher
4.
Possible side effects
5.
How to store Apixaban Tiefenbacher
6.
Contents of the pack and other information
1.
WHAT APIXABAN TIEFENBACHER IS AND WHAT IT IS USED FOR
Apixaban Tiefenbacher 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 Tiefenbacher 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 t

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Apixaban Tiefenbacher 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 73.50 mg lactose monohydrate,
5 mg croscarmellose sodium
(see section 4.4), 0.092 mg Sunset yellow FCF aluminium lake (E110)
and 0.552 mg Tartrazine
Aluminum lake (E102).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Yellow colored, round, biconvex film-coated tablets debossed with
‘AX’ on one side and ‘2.5’ 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