Eliquis 2.5mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Apixaban

Disponível em:

Bristol-Myers Squibb Pharmaceuticals Ltd

Código ATC:

B01AF02

DCI (Denominação Comum Internacional):

Apixaban

Dosagem:

2.5mg

Forma farmacêutica:

Tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 02080200; GTIN: 5012712004097 5012712004103 5012712004110

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELIQUIS 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 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 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 to other organs and prevent normal blood flow
to that organ (also known as a
systemic embolism). A stroke can be life-threate

Características técnicas

OBJECT 1
ELIQUIS 2.5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 13-Jun-2018 | Bristol-Myers
Squibb-Pfizer
1. Name of the medicinal product
Eliquis 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 51.43 mg lactose (see section
4.4).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet)
Yellow, round tablets debossed with 893 on one side and 2½ 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 fibrillation (NVAF) _
The recommended dose of apixaban is 5 mg tak