PRADAXA 150

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DABIGATRAN ETEXILATE AS MESILATE

Available from:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC code:

B01AE07

Pharmaceutical form:

CAPSULES

Composition:

DABIGATRAN ETEXILATE AS MESILATE 150 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

BOEHRINGER INGELHEIM INTERNATIONAL GMBH, GERMANY

Therapeutic area:

DABIGATRAN ETEXILATE

Therapeutic indications:

Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Authorization date:

2015-02-28

Patient Information leaflet

Pradaxa 150 mg capsules
Updated Patient Information Leaflet
Boehringer Ingelheim
June 2020
Page 1 of 7
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
The dispensing of this medicine requires a physician’s prescription
PRADAXA
®
150 MG CAPSULES
ACTIVE INGREDIENT:
Each capsule of PRADAXA 150 contains: 150 mg dabigatran etexilate (as
mesilate)
Inactive ingredients and allergens: see Section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any further questions, ask your
physician or the pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them, even if it
seems to you that their illness is similar to yours.
Patient information card:
This card contains important safety information which you should know
prior to beginning treatment with
Pradaxa and during the treatment with Pradaxa.
The card contains information intended for both the patient and the
healthcare staff. It provides guidance for
the patients on how to minimize the risk of bleeding resulting from
treatment with any anticoagulant agent.
In addition, the card contains personal details of the patient and
information regarding Pradaxa for the
healthcare staff.
Present this card to any healthcare professional involved in your
treatment.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Pradaxa contains the active ingredient dabigatran etexilate which
belongs to a group of medicines called
anticoagulants.
Pradaxa is intended for adults, to:
•
prevent stroke and systemic embolism in adult patients suffering from
irregular heart beat (atrial fibrillation)
that is not in addition to a heart valve disease.
•
treat thrombosis in the leg veins (deep vein thrombosis (DVT)) and in
the pulmonary blood vessels
(pulmonary embolism (PE)), and prevent recurrent thrombosis in these
blood vessels.
THERAPEUTIC GROUP: Anticoagulants.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE I

Summary of Product characteristics

Pradaxa 150
Prescribing Information
Boehringer Ingelheim
January 2022
Boehringer Ingelheim Israel
Page
1
of
38
1
PRADAXA 150
DABIGATRAN ETEXILATE 150 MG
HardCapsules
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Pradaxa 150
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.
The marketing of Pradaxa is subject to a risk management plan (RMP)
including a “Patient safety
information card”. The “Patient safety information card”,
emphasizes important safety information
that the patient should be aware of before and during treatment.
Please explain to the patient the
need to review the card before starting treatment.
_Please provide patient safety information card (patient card) to each
patient who is prescribed with _
_Pradaxa. Explain to the patient the implications of anticoagulant
treatment including the need for _
_compliance. Please also explain the signs of bleeding and when to
seek medical attention. _
_The patient card will inform physicians and dentists about the
patient‘s anticoagulation treatment _
_and will contain emergency contact information. The patient should be
instructed to carry the _
_patient alert card at all times and present it to every health care
provider_.
Pradaxa 150
Prescribing Information
Boehringer Ingelheim
January 2022
Boehringer Ingelheim Israel
Page
2
of
38
2
3.
PHARMACEUTICAL FORM
Hard capsule.
Capsules with light blue, opaque cap and white, opaque body of size 0
(approx. 22 x 8 mm) 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
).
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 ST