Apixaban Combino Pharm 2.5 mg film-coated tablets

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

APIXABAN

Доступна с:

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

код АТС:

B01AF02

ИНН (Международная Имя):

APIXABAN 2.5 mg

Фармацевтическая форма:

FILM-COATED TABLET

состав:

APIXABAN 2.5 mg

Тип рецепта:

POM

Терапевтические области:

ANTITHROMBOTIC AGENTS

Обзор продуктов:

Licence number in the source country: NOT APPLICAPABLE

Статус Авторизация:

Authorised

Дата Авторизация:

2021-03-12

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
APIXABAN COMBINO PHARM 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 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 2.5 mg 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

Характеристики продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Apixaban Combino Pharm 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 film-coated tablet contains 52 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round biconvex approximately 6 mm diameter, 3 mm thickness
film-coated tablets.
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.
2
_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 t