Apixaban Pinewood 5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Apixaban

Available from:

Pinewood Laboratories Ltd

ATC code:

B01AF02

INN (International Name):

Apixaban

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

apixaban

Authorization status:

Not marketed

Authorization date:

2023-02-10

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
APIXABAN PINEWOOD 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.
The name of this medicine is Apixaban Pinewood 5 mg film-coated
tablets which will be called
Apixaban Pinewood throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Apixaban Pinewood is and what it is used for
2.
What you need to know before you take Apixaban Pinewood
3.
How to take Apixaban Pinewood
4.
Possible side effects
5.
How to store Apixaban Pinewood
6.
Contents of the pack and other information
1.
WHAT APIXABAN PINEWOOD IS AND WHAT IT IS USED FOR
Apixaban Pinewood 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 Pinewood 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.
WHA

Summary of Product characteristics

Health Products Regulatory Authority
10 February 2023
CRN00CFNM
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Apixaban Pinewood 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg apixaban.
Excipient(s) with known effect
Each 5 mg film-coated tablet contains 101.7 mg lactose (see section
4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pink coloured, oval shaped, biconvex, beveled edge film-coated tablets
having "H5" debossed on one side and plain on the
other side
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.,