Dabahib 75 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 75 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

DABIGATRAN ETEXILATE 75 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

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DABAHIB 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 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.
Dabahib is used in children to:
-
treat blood clots and to prevent blood clot 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 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 inborn, of
unknown cause or due to other
medicines.
-
if you are taking medicines to prevent blood clotting (e.g., warfarin,
rivaroxaban, apixaban or heparin),
except when changing anticoagulant treat

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Dabahib 75 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 75 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 white to off white
hard capsule size 2.
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
Dabahib capsules 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 VTEIN 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.
2
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
dabigatran
etexilate once
daily taken as 2
capsules of 110
mg
10 days
Patients following elective
hip replacement surgery
28-35 days
_DOSE REDUCTION RECOMMENDED _
Patients with moderate renal
impairment (creatinine
clearance (CrCL 30-50
mL/min)
single capsule of
75 mg dabigatran
Etexilate
150 mg
dabigatran
etexilate