Dabahib 110 mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Available from:

G.L. Pharma GmbH Schlossplatz 1, 8502 Lannach, Austria

ATC code:

B01AE07

INN (International Name):

DABIGATRAN ETEXILATE 110 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

DABIGATRAN ETEXILATE 110 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-08-19

Patient Information leaflet

Page
1
of
12
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DABAHIB 110 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 Dabahib is and what it is used for
2.
What you need to know before you take Dabahib
3.
How to take Dabahib
4.
Possible side effects
5.
How to store Dabahib
6.
Contents of the pack and other information
1.
WHAT DABAHIB IS AND WHAT IT IS USED FOR
Dabahib 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.
Dabahib 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.
Dabahib is used in children to:
- treat blood clots and to prevent blood clots from reoccurring.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DABAHIB
DO NOT TAKE DABAHIB
-
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 b

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Dabahib 110 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 110 mg of dabigatran etexilate (as
mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Off white to pale yellow coloured pellets filled in blue hard capsules
size 1.
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
Dabahib can be used in adults and paediatric patients aged 8 years or
older who are able to swallow
the capsules whole.
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
venous thromboembolism in orthopaedic surgery are shown in table 1.
2
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
Patients following elective knee
replacemen