Dabigatran Etexilate Stada 150 mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Available from:

STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Germany

ATC code:

B01AE07

INN (International Name):

DABIGATRAN ETEXILATE 150 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

DABIGATRAN ETEXILATE 150 mg

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-02-17

Patient Information leaflet

1
Package leaflet: Information for the patient
DABIGATRAN ETEXILATE STADA 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 Stada is and what it is used for
2.
What you need to know before you take Dabigatran Etexilate Stada
3.
How to take Dabigatran Etexilate Stada
4.
Possible side effects
5.
How to store Dabigatran Etexilate Stada
6.
Contents of the pack and other information
1.
WHAT DABIGATRAN ETEXILATE STADA IS AND WHAT IT IS USED FOR
Dabigatran Etexilate Stada 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 Stada 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 Stada 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 STADA DO
NOT TAKE
DABIGATRAN ETEXILATE STADA
-
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

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Dabigatran Etexilate Stada 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 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 Stada 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 for
the age and weight 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 Stada 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 Stada taken as one 150
mg capsule twice daily
Treatment of dee