Apixaban Denk 5 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

APIXABAN 5 mg/stuk

Beschikbaar vanaf:

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

INN (Algemene Internationale Benaming):

APIXABAN 5 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (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 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] 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 [INVENTED NAME]
DO NOT TAKE [INVENTED NAME]
IF
-
YOU ARE ALLERGIC
to apixaban or any of the other ingredients of this medicin

Productkenmerken

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