Apixerin 5 mg film-coated tablets

Country: Malta

Language: English

Source: Malta Medicines Authority

Available from:

PharmaPath S.A. 28is Oktovriou 1, Agia Varvara, 123 51, , Greece

ATC code:

B01AF02

INN (International Name):

APIXABAN 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

APIXABAN 5 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Authorised

Authorization date:

2023-08-21

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
APIXERIN 2.5 MG FILM-COATED TABLETS
APIXERIN 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 Apixerin is and what it is used for
2.
What you need to know before you take Apixerin
3.
How to take Apixerin
4.
Possible side effects
5.
How to store Apixerin
6.
Contents of the pack and other information
1.
WHAT APIXERIN IS AND WHAT IT IS USED FOR
Apixerin 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.
_ _
Apixerin is used in adults:
_Apixerin 2.5 mg film-coated tablets:_
-
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 bl

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Apixerin 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of apixaban.
Excipient(s) with known effect
Each 5 mg film-coated tablet contains 104.4 mg lactose (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pink, oval film-coated tablets with dimensions 10.0 mm x 5.2 mm
approximately.
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 months)
should be based on transient risk
factors (e.g., recent surgery, trauma, immobilisation).
2
The recommended dose of apixaban for the prevention of recurrent DVT
and PE