APIXABAN TEVA 5 MG
Country: Israel
Language: English
Source: Ministry of Health
Patient Information leaflet
(PIL)
10-10-2023
Public Assessment Report
(PAR)
07-03-2023
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Active ingredient:
APIXABAN
Available from:
TEVA ISRAEL LTD
ATC code:
B01AF02
Pharmaceutical form:
FILM COATED TABLETS
Composition:
APIXABAN 5 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
Therapeutic area:
APIXABAN
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 ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), in adults.
Authorization date:
2020-06-28
Patient Information leaflet
APIXABAN TEVA
PATIENT SAFETY
INFORMATION CARD
APIXABAN 2.5 MG, 5 MG
REPORTING OF SUSPECTED ADVERSE
REACTIONS
For further information, see the consumer leaflet
approved by the Ministry of Health
Side effects can be reported to the Ministry of Health
using the online form. for side effect reporting that is
found in the Ministry of Health homepage:
WWW.HEALTH.GOV.IL
or via the link:
HTTPS://SIDEEFFECTS.HEALTH.GOV.IL
or through the registration holder Teva Israel Ltd via:
SAFETY.ISRAEL@TEVA.CO.IL
MORE INFORMATION
Teva Israel Ltd. P.O.B 3190 124 Dvora HaNevi'a St. Tel
Aviv, Israel Phone: 1-800-805-005
This card was approved in accordance with the
instructions of the Ministry of Health in February 2023
API-PAT-ENG-01
CONCOMITANT MEDICATIONS
Medication
Dose
CASES WHICH REQUIRE SEEKING IMMEDIATE MEDICAL
ATTENTION:
Bleeding, which may be life threatening. An allergic
reaction, including rash, edema, swelling of the face,
lips, mouth, tongue and/or throat, and breathing
difficulty (rare).
SIDE EFFECTS:
SIDE EFFECTS MAY OCCUR WHEN TAKING ANTICOAGULANTS.
YOU SHOULD BE AWARE OF THEM AND SEEK MEDICAL
TREATMENT IF NECESSARY. FOR A FULL LIST OF SIDE EFFECTS,
SEE THE CONSUMER LEAFLET. THE MOST COMMON SIDE
EFFECT IS BLEEDING.
EXPRESSIONS OF HEMORRHAGING MAY
INCLUDE, AMONG OTHERS
•
Gastro-intestinal bleeding, which may be expressed
by blood in stools or black/dark stools, pain (such as
abdominal pain) and swelling
•
Blood in urine (red or pink urine), blood in urine
discovered in a urine test
•
Bleeding eyes, nose or gums
•
Bloody cough and bloody vomit (vomiting of blood
or a granular coffee-like substance)
•
Secretion of blood or fluids from cuts and wounds,
cuts that bleed for a long time
•
Unusual bleeding or bleeding that fails to stop
spontaneously
•
Headache, dizziness, anemia expressed in fatigue
and pallor, nausea
RISK FACTORS OF INCREASED BLEEDING
MAY BE:
A liver disease which causes a coagulation disorder and
risk of bleeding.
An injury or medical condition with an increased
risk of bleeding, such as an act
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