Dabigatran etexilaat CF 75 mg, harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DABIGATRANETEXILAATMESILAAT 86,5 mg/stuk SAMENSTELLING overeenkomend met ; DABIGATRANETEXILAAT 75 mg/stuk

INN (Algemene Internationale Benaming):

DABIGATRANETEXILAATMESILAAT 86,5 mg/stuk SAMENSTELLING overeenkomend met ; DABIGATRANETEXILAAT 75 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 75 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
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 bleeding
•
if you have a disease in an organ of the body that increases the risk
of serious bleeding
(e.g. stomach ulcer, injury or bleeding in the brain, recent surgery
of the brain or eyes)
•
if you have an increased tendency to bleed. This may be hereditary, of
unknown cause or
due to other medicines
•
if you are taking medicines to preve

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Dabigatran etexilaat CF 75 mg, harde capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains dabigatran etexilate mesylate equivalent to
75 mg dabigatran
etexilate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule, hard.
Size “2” (17.50 ± 0.40 mm) capsule with a white opaque cap
imprinted “MD” and white opaque
body imprinted “75” 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.
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.
TABLE 1:
DOSE RECOMMENDATIONS AND DURATION OF THERAPY FOR PRIMARY PREVENTION OF
VENOUS THROMBOEMBOLISM IN ORTHOPAEDIC SURGERY
TREATMENT INITIATION
ON THE DAY OF
SURGERY 1-4 HOURS
AFTER COMPLETED
SURGERY
MAINTENANCE
DOSE STARTING
ON THE FIRST
DAY AFTER
SURGERY
DURATION OF
MAINTENANCE
DOSE
Patients following elective knee
replacement surgery
single capsule of
110 mg dabigatran
etexilate
220 mg
dabigatra