Dabigatran Etexilate Viatris 75 mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

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

Authorization status:

Authorised

Authorization date:

2024-01-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DABIGATRAN ETEXILATE VIATRIS 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 Viatris is and what it is used for
2.
What you need to know before you take Dabigatran Etexilate Viatris
3.
How to take Dabigatran Etexilate Viatris
4.
Possible side effects
5.
How to store Dabigatran Etexilate Viatris
6.
Contents of the pack and other information
1.
WHAT DABIGATRAN ETEXILATE VIATRIS IS AND WHAT IT IS USED FOR
Dabigatran Etexilate Viatris 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 Viatris is used in adults to:
-
prevent the formation of blood clots in the veins after knee or hip
replacement surgery
Dabigatran Etexilate Viatris 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 VIATRIS
_ _
DO NOT TAKE DABIGATRAN ETEXILATE VIATRIS
-
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 inc

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dabigatran Etexilate Viatris 75 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains dabigatran etexilate mesilate corresponding to
75mg of dabigatran etexilate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Hard capsule
Size 1 (approximately 19 mm), white opaque cap and white opaque body,
hard hypromellose capsule filled
with light yellow to yellowish pellets, printed with ‘VTRS’ over
‘DC75’ on both cap and body in black ink.
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 Viatris capsules can be used in adults and
paediatric patients aged 8 years or older who
are able to swallow the capsules whole. The dose stated in the
relevant dosing table should be prescribed
based on the weight and age of the child.
There are other age appropriate dose forms of dabigatran etexilate
medicinal products for the treatment of
children younger than 8 years of age. When changing between
formulations, the prescribed dose may need to
be altered.
_PRIMARY PREVENTION OF VTE IN ORTHOPAEDIC SURGERY _
The recommended doses of dabigatran etexilate and the duration of
therapy for primary prevention of
VTE 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 following elective knee
replacement surgery
single capsule of
110 mg dabigatran
etex