Dabigatran etexilaat CF 110 mg, harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DABIGATRANETEXILAATMESILAAT 126,8 mg/stuk SAMENSTELLING overeenkomend met ; DABIGATRANETEXILAAT 110 mg/stuk

INN (Algemene Internationale Benaming):

DABIGATRANETEXILAATMESILAAT 126,8 mg/stuk SAMENSTELLING overeenkomend met ; DABIGATRANETEXILAAT 110 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2023-11-14

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DABIGATRAN ETEXILAAT CF 110 MG, HARDE CAPSULES
dabigatran etexilate
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 or pharmacist.
•
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
contains the active substance dabigatran etexilate and
belongs to a group of
medicines called anticoagulants. It works by blocking a substance in
the body, that is involved
in blood clot formation.
is used in adults to:
•
prevent the formation of blood clots in the veins after knee or hip
replacement surgery
•
prevent blood clots in the brain (stroke) and other blood vessels in
the body if you have a
form of irregular heart rhythm called nonvalvular atrial fibrillation
and at least one additional
risk factor
•
treat blood clots in the veins of your legs and lungs and to prevent
blood clots from re-
occurring in the vein of your legs and lungs
is used in children to:
•
treat blood clots and to prevent blood clots from reoccurring
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE
•
if you are allergic to dabigatran etexilate or any of the other
ingredients of this medicine
(listed in section 6)
•
if you have severely reduced kidney function
•
if you are currently ble

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Dabigatran etexilaat CF 110 mg, harde capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains dabigatran etexilate mesylate equivalent to
110 mg dabigatran
etexilate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule, hard.
Size “1” (19.40 ± 0.40 mm) capsule having white opaque cap
imprinted “MD” and white opaque
body imprinted “110” with black ink, containing a blend of white
to light yellow coloured pellets
and light yellow coloured granulate.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primary prevention of venous thromboembolic events (VTE) in adult
patients who have
undergone elective total hip replacement surgery or total 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 ischemic attack (TIA);
age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes
mellitus; hypertension.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of
recurrent DVT and PE in adults
Treatment of VTE and prevention of recurrent VTE in paediatric
patients from birth to less than
18 years of age.
For age appropriate dose forms, see section 4.2.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
capsules can be used in adults and paediatric patients
aged 8 years or older
who are able to swallow the capsules whole. There are other age
appropriate dose forms for
the treatment of children below 8 years.
When changing between the formulations, the prescribed dose may need
to be altered. The
dose stated in the relevant dosing table of a formulation should be
prescribed based on the
weight and age of the child.
_PRIMARY PREVENTION OF VTE IN ORTHOPAEDIC SURGERY _
The recommended doses of and the duration of therapy
for primary
prevention of VTE in orthopaedic surgery are shown in table 1.
TA