Dabigatran Etexilate Accord

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Dabigatran etexilate mesilate

Available from:

Accord Healthcare S.L.U.

ATC code:

B01AE07

INN (International Name):

dabigatran etexilate

Therapeutic group:

Antithrombotic agents

Therapeutic area:

Venous Thromboembolism; Arthroplasty, Replacement

Therapeutic indications:

Prevention of venous thromboembolic events

Authorization status:

Authorised

Authorization date:

2023-05-26

Patient Information leaflet

144
B.
PACKAGE LEAFLET
145
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DABIGATRAN ETEXILATE ACCORD 75 MG HARD 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 Dabigatran etexilate Accord is and what it is used for
2.
What you need to know before you take Dabigatran etexilate Accord
3.
How to take Dabigatran etexilate Accord
4.
Possible side effects
5.
How to store Dabigatran etexilate Accord
6.
Contents of the pack and other information
1.
WHAT DABIGATRAN ETEXILATE ACCORD IS AND WHAT IT IS USED FOR
Dabigatran etexilate Accord contains the active substance dabigatran
etexilate and belongs to a group
of medicines called anticoagulants. It works by blocking a substance
in the body which is involved in
blood clot formation.
Dabigatran etexilate Accord is used in adults to:
-
prevent the formation of blood clots in the veins after knee or hip
replacement surgery.
Dabigatran etexilate Accord is used in children to:
-
treat blood clots and to prevent blood clots from re-occurring.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DABIGATRAN ETEXILATE ACCORD
DO NOT TAKE DABIGATRAN ETEXILATE ACCORD
-
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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Dabigatran etexilate Accord 75 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains dabigatran etexilate mesilate equivalent to
75 mg of dabigatran etexilate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Size “2” (approx. 18 x 6 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
Dabigatran etexilate Accord hard capsules can be used in adults and
paediatric patients aged 8 years or
older who are able to swallow the capsules whole. Other pharmaceutical
forms may be more
appropriate for administration to this population such as coated
granules which can be used in children
aged less than 12 years as soon as the child is able to swallow soft
food. Other pharmaceutical forms
such as powder and solvent for oral solution should only be used in
children aged less than 1 year.
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 dabigatran etexilate and the duration of
therapy for primary prevention of
VTE in orthopaedic surgery are shown in table 1.
3
TABLE 1: DOSE RECOMMENDATIONS AND DURATION OF THERAPY FOR PRIMARY
PREVENTION OF VTE IN
ORTHOPAE