Dabahib 150 mg hard capsules

Land: Malta

Taal: Engels

Bron: Medicines Authority

Beschikbaar vanaf:

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

ATC-code:

B01AE07

INN (Algemene Internationale Benaming):

DABIGATRAN ETEXILATE 150 mg

farmaceutische vorm:

HARD CAPSULE

Samenstelling:

DABIGATRAN ETEXILATE 150 mg

Prescription-type:

POM

Therapeutisch gebied:

ANTITHROMBOTIC AGENTS

Product samenvatting:

Licence number in the source country: NOT APPLICAPABLE

Autorisatie-status:

Authorised

Autorisatie datum:

2022-08-19

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DABAHIB 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 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 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 bleeding (e.g., stomach ulcer,
injury or bleeding in the brain, recent surgery of the brain

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
Dabahib 150 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 150 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 cap and white
to off white body hard capsules
size 0.
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
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.
_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 of dabigatran etexilate in the indications SPAF,
DVT and PE are shown in
table 1.
2
TABLE 1:
DOSE RECOMMENDATIONS FOR SPAF, DVT AND PE
DOSE RECOMMENDATION
Prevention of stroke and systemic embolism in
adult patients with NVAF with one or more risk
factors (SPAF)
300 mg dabigatran etexilate taken as one 150 mg
capsule twice daily
Treatment of DVT and PE, and prevention