Dabigatran etexilate Clonmel 110 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dabigatran etexilate mesilate

Available from:

Clonmel Healthcare Ltd

ATC code:

B01AE07

INN (International Name):

Dabigatran etexilate mesilate

Pharmaceutical form:

Capsule, hard

Therapeutic area:

dabigatran etexilate

Authorization status:

Not marketed

Authorization date:

2023-11-10

Patient Information leaflet

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DABIGATRAN ETEXILATE CLONMEL 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 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

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 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 et

Summary of Product characteristics

Health Products Regulatory Authority
10 November 2023
CRN009XWW
Page 1 of 34
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dabigatran etexilate Clonmel 110 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains dabigatran etexilate mesylate equivalent to
110 mg dabigatran etexilate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Size "1" (19.40 ± 0.40 mm) capsule having white opaque cap imprinted
"MD" and white opaque body imprinted "110" 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.
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 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 durati