Epadel S900

Epadel S900 Special Precautions

icosapent ethyl


Catalent Japan




Full Prescribing Info
Special Precautions
Careful Administration: (EPADEL S900 should be administered with care in the following patients.)
Patients having menstruation.
Patients with a bleeding tendency.
Patients scheduled to undergo a surgery.
[first 3 patients, bleeding may be aggravated.]
Patients being treated with anticoagulants or drugs that inhibit platelet aggregation (see Interactions).
Important Precautions: When using EPADEL S900 for hyperlipidemia, sufficient attention should be paid to the following points: The use of EPADEL S900 should be considered after performing sufficient tests to confirm hyperlipidemia.
Diet therapy, which is the basis of the treatment of hyperlipidemia, should be used before EPADEL S900. Moreover, exercise therapy or reduction of risk factors for ischemic heart disease such as hypertension and smoking should be sufficiently considered.
Blood lipid level should be measured regularly during the administration and if there is no response to the administration, the administration should be discontinued.
Precautions concerning Use: In oral administration: Because EPADEL S900 is not absorbed well when taken on an empty stomach, patients should be instructed to take it immediately after meals.
Patients should be instructed to take EPADEL S900 without chewing.
Other Precautions: Cerebral haemorrhage was reported in a patient with poorly controlled hypertension using other antiplatelet drugs concomitantly.
Effects on ability to drive and use machine: Effects on ability to drive and use machines have not been studied.
Use in Children: Safety in low birth weight infants, neonates, infants and children has not been established (there is no clinical experience).
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