Dabigatran etexilate STADA Arzneimittel AG 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

Authorization status:

Authorised

Authorization date:

2024-02-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DABIGATRAN ETEXILATE STADA ARZNEIMITTEL AG 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 Arzneimittel AG is and what it is used
for
2.
What you need to know before you take Dabigatran etexilate STADA
Arzneimittel AG
3.
How to take Dabigatran etexilate STADA Arzneimittel AG
4.
Possible side effects
5.
How to store Dabigatran etexilate STADA Arzneimittel AG
6.
Contents of the pack and other information
1.
WHAT DABIGATRAN ETEXILATE STADA ARZNEIMITTEL AG IS AND WHAT IT IS USED
FOR
Dabigatran etexilate STADA Arzneimittel AG 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 Arzneimittel AG 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 Arzneimittel AG 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 ARZNEIMITTEL AG
DO NOT TAKE DABIGATRAN ETEXILATE STADA ARZNEIMITTEL AG

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Dabigatran etexilate STADA Arzneimittel AG 150 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 172.95 mg of dabigatran etexilate (as
mesilate) equivalent to 150 mg of
dabigatran etexilate.
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 (approx. 21.7 mm).
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 STADA Arzneimittel AG 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 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
DO