PRADAXA 75 MG HARD CAPSULE

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

DABIGATRAN ETEXILATE MESILATE

Boleh didapati daripada:

BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

DABIGATRAN ETEXILATE MESILATE

Unit dalam pakej:

10Capsule Capsules; 30Capsule Capsules; 60Capsule Capsules

Dikeluarkan oleh:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG

Risalah maklumat

PRADAXA
® HARD CAPSULE
Dabigatran etexilate (75 mg, 110 mg, 150 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What PRADAXA is used for
2.
How PRADAXA works
3.
Before you use PRADAXA
4.
How to use PRADAXA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of PRADAXA
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
1. WHAT PRADAXA IS USED FOR
75 mg/ 110 mg: PRADAXA is used to
prevent the formation of blood clots in
the veins after knee or hip replacement
surgery in adults.
110 mg/ 150 mg: PRADAXA is a
medicine which is used to reduce the risk
of brain or body vessel obstruction by
blood clot formation in adult patients
with an abnormal heart beat (atrial
fibrillation) and additional risk factors.
PRADAXA is a blood thinner medicine
that lowers the risk of blood clot
formation. PRADAXA is used to treat
blood clots in the veins of your legs and
lungs and to prevent blood clots from
reoccurring in the vein of your legs and
lungs.
2. HOW PRADAXA WORKS
PRADAXA is a medicine which contains
the active substance dabigatran etexilate.
It works by blocking a substance in the
body which is involved in blood clot
formation.
3. BEFORE YOU USE PRADAXA
-
_When you must not use it _
•
if you are allergic to dabigatran
etexilate or any of the other
ingredients of this medicine
(listed in section 8).
•
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.
•
if you have an increased
tendency to bleed. This may be
inborn, of unknown cause or
due to other medicines.
•
if you have a severely reduced
liver function or liver disease
which could possibly cause
death.
•
if you are taking oral
ketoconazole or itraconazole,
medicines to treat fungal
infections.
•
if you are taking oral
cyclosporine, a medicine to
prevent organ rejection after
transplantation.
•
if you are taking dronedarone, a
medicine used to trea

Ciri produk

Proposed Package Insert – clean copy
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
Hard capsule for oral use.
75 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose
(HPMC) capsule with white opaque
cap and white opaque body of size 2 filled with yellowish pellets. 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 filled with yellowish
pellets. 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 filled with yellowish
pellets. 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.
Reduction of the risk 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:
Reduction of the risk of stroke and systemic embolism in patients with
non-valvular a