Apixaban Combino Pharm 5 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

APIXABAN

Available from:

Combino Pharma (Malta) Ltd. HF60, Hal Far Industrial Estate, BBG07, Hal Far, Malta

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

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-03-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
APIXABAN COMBINO PHARM 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 Combino Pharm is and what it is used for
2. What you need to know before you take Apixaban Combino Pharm
3. How to take Apixaban Combino Pharm
4. Possible side effects
5. How to store Apixaban Combino Pharm
6. Contents of the pack and other information
1.
WHAT APIXABAN COMBINO PHARM IS AND WHAT IT IS USED FOR
Apixaban Combino Pharm 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 Combino Pharm 5 mg 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE APIXABAN COMBINO PHARM
DO NOT TAKE APIXABAN COMBINO PHARM IF
-
YOU AR

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Apixaban Combino Pharm 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg apixaban.
Excipients with known effect: Each film-coated tablet contains 104 mg
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, oval-shaped, biconvex approximately 10 mm length, 5.4 mm width,
4 mm thickness film-coated
tablets.
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 is 2.