Apixaban Denk 2,5 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

APIXABAN 2,5 mg/stuk

Beschikbaar vanaf:

Denk Pharma GmbH & Co. KG Prinzregentenstrasse 79 81675 MÜNCHEN (DUITSLAND)

INN (Algemene Internationale Benaming):

APIXABAN 2,5 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2021-03-12

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
APIXABAN DENK 2,5 MG FILMOMHULDE TABLETTEN
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 [Invented Name] is and what it is used for
2. What you need to know before you take [Invented Name]
3. How to take [Invented Name]
4. Possible side effects
5. How to store [Invented Name]
6. Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented Name] 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.
[Invented Name] 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 or to other organs and prevent normal blood
flow to tha

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Apixaban Denk 2,5 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg apixaban.
Excipient 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 twice daily in
p