Dabigatran etexilate Clonmel 75 mg hard capsules

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Dabigatran etexilate mesilate

זמין מ:

Clonmel Healthcare Ltd

קוד ATC:

B01AE07

INN (שם בינלאומי):

Dabigatran etexilate mesilate

טופס פרצבטיות:

Capsule, hard

איזור תרפויטי:

dabigatran etexilate

מצב אישור:

Not marketed

תאריך אישור:

2023-11-10

עלון מידע

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DABIGATRAN ETEXILATE CLONMEL 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 Clonmel is and what it is used for
2. What you need to know before you take Dabigatran etexilate Clonmel
3. How to take Dabigatran etexilate Clonmel
4. Possible side effects
5. How to store Dabigatran etexilate Clonmel
6. Contents of the pack and other information
1. WHAT DABIGATRAN ETEXILATE CLONMEL IS AND WHAT IT IS USED FOR
Dabigatran etexilate Clonmel contains the active substance dabigatran
etexilate and belongs
to a group of medicines called anticoagulants. It works by blocking a
substance in the body,
that is involved in blood clot formation.
Dabigatran etexilate Clonmel is used in adults to:

prevent the formation of blood clots in the veins after knee or hip
replacement surgery
Dabigatran etexilate Clonmel 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 CLONMEL
DO NOT TAKE DABIGATRAN ETEXILATE CLONMEL

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)

מאפייני מוצר

Health Products Regulatory Authority
10 November 2023
CRN009XWW
Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dabigatran etexilate Clonmel 75 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains dabigatran etexilate mesylate equivalent to
75 mg dabigatran etexilate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Size "2" (17.50 ± 0.40 mm) capsule with a white opaque cap imprinted
"MD" and white opaque body imprinted "75" with black
ink, containing a blend of white to light yellow coloured pellets and
light yellow coloured granulate.
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 Clonmel 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.
_PRIMARY PREVENTION OF VTE IN ORTHOPAEDIC SURGERY_
The recommended doses of Dabigatran etexilate Clonmel and the duration
of therapy for primary prevention of VTE in
orthopaedic surgery are shown in table 1.
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 elect