Pradaxa 110 mg hard capsules

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DABIGATRAN ETEXILATE MESILATE 126.83 mg EQV DABIGATRAN ETEXILATE

Available from:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

ATC code:

B01AE07

Dosage:

110 mg

Pharmaceutical form:

CAPSULE

Composition:

DABIGATRAN ETEXILATE MESILATE 126.83 mg EQV DABIGATRAN ETEXILATE 110 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Boehringer Ingelheim Pharma GmbH & Co.KG (Ingelheim am Rhein site)

Authorization status:

ACTIVE

Authorization date:

2009-08-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PRADAXA
®
75 MG, HARD CAPSULES
110 MG, HARD CAPSULES
150 MG, HARD CAPSULES
[dabigatran etexilate]
▼This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
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 PRADAXA is and what it is used for
2.
What you need to know before you take PRADAXA
3.
How to take PRADAXA
4.
Possible side effects
5.
How to store PRADAXA
6.
Contents of the pack and other information
7.
Marketing Authorisation Holder and Manufacturer
8.
Product registration number
9.
Date of revision
1. WHAT PRADAXA IS AND WHAT IT IS USED FOR
PRADAXA 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.
PRADAXA 75 mg is used in adults to:
•
prevent the formation of blood clots in the veins after knee or hip
replacement surgery.
PRADAXA 110 mg 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 and to prevent blood clots from re-occurring in the
veins o

Summary of Product characteristics

1
PRADAXA
®
Abcd
1. NAME OF THE MEDICINAL PRODUCT
PRADAXA 75 mg hard capsules
PRADAXA 110 mg hard capsules
PRADAXA 150 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 75 mg or 110 mg or 150 mg of dabigatran
etexilate (as mesilate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
75 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose
(HPMC) capsule with white opaque cap
and white opaque body of size 2. The cap is imprinted with the
Boehringer Ingelheim company symbol, the
body with “R75”. The colour of the imprint is black.
110 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose
(HPMC) capsule with light blue opaque
cap and light blue opaque body of size 1. The cap is imprinted with
the Boehringer Ingelheim company symbol,
the body with “R110”. The colour of the imprint is black.
150 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose
(HPMC) capsule with light blue opaque
cap and white opaque body of size 0. The cap is imprinted with the
Boehringer Ingelheim company symbol,
the body with “R150”. The colour of the imprint is black.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
75mg capsule:
Primary prevention of venous thromboembolic events in adult patients
who have undergone elective total hip
replacement surgery or total knee replacement surgery.
110mg capsule:
Primary prevention of venous thromboembolic events in adult patients
who have undergone elective total hip
replacement surgery or total knee replacement surgery.
Prevention of stroke and systemic embolism in patients with
non-valvular atrial fibrillation.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of recurrent DVT
and PE in adults.
150mg capsule:
Prevention of stroke and systemic embolism in patients with
non-valvular atrial fibrillation.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of recurrent DVT
and PE in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATI