Dabigatran Etexilate Stada 110 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 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:

2022-02-17

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DABIGATRAN ETEXILATE STADA 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 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 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.
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

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Dabigatran Etexilate Stada 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
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.
_PRIMARY PREVENTION OF VENOUS THROMBOEMBOLISM IN ORTHOPAEDIC SURGERY _
_ _
The recommended doses of Dabigatran Etexilate Stada 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
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