Pradaxa 110mg capsules

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Dabigatran etexilate mesilate

Commercializzato da:

Boehringer Ingelheim Ltd

Codice ATC:

B01AE07

INN (Nome Internazionale):

Dabigatran etexilate mesilate

Dosaggio:

110mg

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: 5012816096127 5012816096073

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 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.
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.

Scheda tecnica

OBJECT 1
PRADAXA 110 MG HARD CAPSULES
Summary of Product Characteristics Updated 01-Feb-2018 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
Pradaxa 110 mg hard capsules
2. Qualitative and quantitative composition
Each hard capsule contains 110 mg of dabigatran etexilate (as
mesilate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
Capsules 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”.
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.
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
4.2 Posology and method of administration
Posology
_PRIMARY PREVENTION OF VENOUS THROMBOEMBOLISM IN ORTHOPAEDIC SURGERY _
The recommended doses 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
impairme