Eliquis 5mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Apixaban

Saatavilla:

Bristol-Myers Squibb Pharmaceuticals Ltd

ATC-koodi:

B01AF02

INN (Kansainvälinen yleisnimi):

Apixaban

Annos:

5mg

Lääkemuoto:

Tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: ; GTIN: 5012712004233 5012712004318

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELIQUIS 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 Eliquis is and what it is used for
2.
What you need to know before you take Eliquis
3.
How to take Eliquis
4.
Possible side effects
5.
How to store Eliquis
6.
Contents of the pack and other information
1.
WHAT ELIQUIS IS AND WHAT IT IS USED FOR
Eliquis 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.
Eliquis 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 ELIQUIS
DO NOT TAKE ELIQUIS IF:
-
YOU ARE ALLERGIC
to apixaban or any of the other ingredients of this medicine (listed
in section 6)
-
you are
BLEEDING EXCESSIVELY
-
you have a
DISEASE IN AN ORG

Valmisteyhteenveto

OBJECT 1
ELIQUIS 5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 13-Jun-2018 | Bristol-Myers
Squibb-Pfizer
1. Name of the medicinal product
Eliquis 5 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 5 mg apixaban.
Excipients with known effect
Each 5 mg film-coated tablet contains 102.86 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 tablets debossed with 894 on one side and 5 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.,
recent surgery, trauma, immobilisation).
The reco