Dabigatran Etexilate Stada 75 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 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:

2022-02-17

Patient Information leaflet

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

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Dabigatran Etexilate Stada 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
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 AFTER
SURGERY
DURATION OF
MAINTENANCE
DOSE
Patients following elective
knee replacement surgery
single capsule of
110 mg Dabigatran
Etexilate Stada
220
mg
Dabigatran
Etexilate
Stada
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 (Cr