Dabigatran Etexilate DOC 110 mg hard capsules

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Dostupno od:

Doc Generici srl Via Turati, 40-20121, Milano, Italy

ATC koda:

B01AE07

INN (International ime):

DABIGATRAN ETEXILATE 110 mg

Farmaceutski oblik:

HARD CAPSULE

Sastav:

DABIGATRAN ETEXILATE 110 mg

Tip recepta:

POM

Područje terapije:

ANTITHROMBOTIC AGENTS

Proizvod sažetak:

Licence number in the source country: NOT APPLICAPABLE

Status autorizacije:

Authorised

Datum autorizacije:

2022-08-23

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DABIGATRAN ETEXILATE DOC 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 DOC is and what it is used for
2.
What you need to know before you take Dabigatran Etexilate DOC
3.
How to take Dabigatran Etexilate DOC
4.
Possible side effects
5.
How to store Dabigatran Etexilate DOC
6.
Contents of the pack and other information
1.
WHAT DABIGATRAN ETEXILATE DOC IS AND WHAT IT IS USED FOR
Dabigatran Etexilate DOC 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 DOC 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 DOC 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 DOC
DO NOT TAKE DABIGATRAN ETEXILATE DOC
-
if you are allergic to dabigatran etexilate or any of the other
ingredients of this medicine
(listed in s

Svojstava lijeka

1
1.
NAME OF THE MEDICINAL PRODUCT
Dabigatran Etexilate DOC 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 DOC
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.
_PRIMARY PREVENTION OF VTE IN ORTHOPAEDIC SURGERY _
_ _
The recommended doses of dabigatran etexilate 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
VTE 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