Pradaxa 150mg capsules
Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Foglio illustrativo
(PIL)
19-06-2018
Scheda tecnica
(SPC)
19-06-2018
Principio attivo:
Dabigatran etexilate mesilate
Commercializzato da:
Boehringer Ingelheim Ltd
Codice ATC:
B01AE07
INN (Nome Internazionale):
Dabigatran etexilate mesilate
Dosaggio:
150mg
Forma farmaceutica:
Capsule
Via di somministrazione:
Oral
Classe:
No Controlled Drug Status
Tipo di ricetta:
Valid as a prescribable product
Dettagli prodotto:
BNF: ; GTIN: 5012816096066
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 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.
‑ if you are taking dronedarone, a medicine used to
treat abnorm
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Scheda tecnica
OBJECT 1
PRADAXA 150 MG HARD CAPSULES
Summary of Product Characteristics Updated 01-Feb-2018 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
Pradaxa 150 mg hard capsules
2. Qualitative and quantitative composition
Each hard capsule contains 150 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 white, opaque body of size 0
filled with yellowish pellets. The
cap is imprinted with the Boehringer Ingelheim company symbol, the
body with “R150”.
4. Clinical particulars
4.1 Therapeutic indications
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
_PREVENTION OF STROKE AND SYSTEMIC EMBOLISM IN ADULT PATIENTS WITH
NVAF WITH ONE OR MORE RISK FACTORS _
_(SPAF) _
_TREATMENT OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE),
AND PREVENTION OF RECURRENT _
_DVT, AND PE IN ADULTS (DVT/PE) _
The recommended doses of Pradaxa in the indications SPAF, DVT and PE
are shown in table 1.
TABLE 1: DOSE RECOMMENDATIONS FOR SPAF, DVT AND PE
DOSE RECOMMENDATION
Prevention of stroke and systemic embolism in
adult patients with NVAF with one or more risk
factors (SPAF)
300 mg Pradaxa taken as one 150 mg capsule twice daily
Treatment of deep vein thrombosis (DVT) and
pulmonary embolism (PE), and prevention of
recurrent DVT, and PE in adults (DVT/PE)
300 mg Pradaxa taken as one 150 mg capsule twice daily
following treatment with a parenteral anticoagulant for at
least 5 days
_DOSE REDUCTION RECOMMENDED _
Patients aged ≥80 years
daily dose of 220 mg Pradaxa taken as one 110 mg
capsule twice daily
Patients
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