Dabigatran Etexilate Krka 150 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 150 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 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.
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

Summary of Product characteristics

Health Products Regulatory Authority
12 January 2024
CRN00CQZ8
Page 1 of 33
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dabigatran Etexilate Krka 150 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 150 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 blue, capsule body is white to almost white with
longitudinally imprinted black mark 150. Capsule content are
yellowish white to light yellow pellets. Capsule size: 0 elongated,
approximately 24 mm in length.
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 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 venous thromboembolic events (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.
_PREVENTION OF STROKE AND SYSTEMIC EMBOLISM IN ADULT PATIENTS WITH
NVAF WITH ONE OR MORE RISK FACTORS (SPAF) _
_TREATMENT OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE),
AND PREVENTION OF RECURRENT DVT, AND PE IN _
_ADULTS (DVT/PE)_
The recommended doses