Pradaxa 75mg capsules
Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Foglio illustrativo
(PIL)
13-06-2018
Scheda tecnica
(SPC)
13-06-2018
Principio attivo:
Dabigatran etexilate mesilate
Commercializzato da:
Boehringer Ingelheim Ltd
Codice ATC:
B01AE07
INN (Nome Internazionale):
Dabigatran etexilate mesilate
Dosaggio:
75mg
Forma farmaceutica:
Capsule
Via di somministrazione:
Oral
Classe:
No Controlled Drug Status
Tipo di ricetta:
Valid as a prescribable product
Dettagli prodotto:
BNF: 02080200; GTIN: 5012816096134 5012816096080
Foglio illustrativo
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
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 is used to prevent the formation of blood
clots in the veins after knee or hip replacement
surgery in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PRADAXA
DO NOT TAKE PRADAXA
- 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 increased tendency to bleed. This may
be inborn, of unknown cause or due to other
medicines.
- if you are taking medicines to prevent blood clotting
(e.g. warfarin, rivaroxaban, apixaban or heparin),
except when changing anticoagulant treatment or
while having a venous or arterial line and you get
heparin through this line to keep it open.
- 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
treat abnormal heart beat.
- if you have received an artificial heart valve which
requires permanent blood thinning.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Pradaxa. You may
also need to talk to your doctor during treatment with
Pradaxa if you experience symptoms or if you
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Scheda tecnica
OBJECT 1
PRADAXA 75 MG HARD CAPSULES
Summary of Product Characteristics Updated 01-Feb-2018 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
Pradaxa 75 mg hard capsules
2. Qualitative and quantitative composition
Each hard capsule contains 75 mg of dabigatran etexilate (as
mesilate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
Capsules 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”.
4. Clinical particulars
4.1 Therapeutic indications
Primary prevention of venous thromboembolic events in adult patients
who have undergone elective total
hip replacement surgery or total knee replacement surgery.
4.2 Posology and method of administration
Posology
_PRIMARY PREVENTION OF VENOUS THROMBOEMBOLISM IN ORTHOPAEDIC SURGERY _
The recommended dose of Pradaxa and the duration of therapy for
primary prevention of venous
thromboembolism 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 elective knee
replacement surgery
single capsule of 110 mg
Pradaxa
220 mg Pradaxa
once daily taken
as 2 capsules of
110 mg
10 days
Patients following elective hip
replacement surgery
28-35 days
_DOSE REDUCTION RECOMMENDED _
Patients with moderate renal
impairment (creatinine clearance
(CrCL 30-50 mL/min)
single capsule of 75 mg
Pradaxa
150 mg Pradaxa
once daily taken
as 2 capsules of
75 mg
10 days (knee
replacement surgery)
or 28-35 days (hip
replacement surgery)
Patients who receive concomitant
verapamil*, amiodarone, quinidine
Patients aged 75 or above
*For patients with moderate renal impairment concomitantly treated
with verapamil see Special
populations
For both
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