Dabigatran Etexilate Krka 75 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dabigatran etexilate mesilate

Available from:

KRKA, d.d., Novo mesto

ATC code:

B01AE07

INN (International Name):

Dabigatran etexilate mesilate

Pharmaceutical form:

Capsule, hard

Therapeutic area:

dabigatran etexilate

Authorization status:

Not marketed

Authorization date:

2024-01-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DABIGATRAN ETEXILATE KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Dabigatran Etexilate Krka
3.
How to take Dabigatran Etexilate Krka
4.
Possible side effects
5.
How to store Dabigatran Etexilate Krka
6.
Contents of the pack and other information
1.
WHAT DABIGATRAN ETEXILATE KRKA IS AND WHAT IT IS USED FOR
Dabigatran Etexilate Krka 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 Krka is used in adults to:
-
prevent the formation of blood clots in the veins after knee or hip
replacement surgery.
Dabigatran Etexilate Krka is used in children to:
-
treat blood clots and to prevent blood clots from reoccurring.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DABIGATRAN ETEXILATE KRKA
DO NOT TAKE DABIGATRAN ETEXILATE KRKA
-
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

Summary of Product characteristics

Health Products Regulatory Authority
12 January 2024
CRN00CQZ8
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dabigatran Etexilate Krka 75 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 75 mg dabigatran etexilate (as dabigatran
etexilate mesilate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule (capsule)
Capsule cap is white to almost white, capsule body is white to almost
white with longitudinally imprinted black mark 75.
Capsule content are yellowish white to light yellow pellets. Capsule
size: 2, approximately 18 mm in length.
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 Krka 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 dabigatran etexilate 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 VTE 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
Health Products Regulatory Authority
12 January 202