Special Warning : אזהרת שימוש

4.4    Special warnings and precautions for use

Allergies to fish and/or shellfish

Icosapent ethyl is obtained from the oil of fish. It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to icosapent ethyl. Icosapent ethyl should be used with caution in patients with known hypersensitivity to fish and/or shellfish.

Hepatic impairment

In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) concentrations should be monitored as clinically indicated before the start of treatment and at appropriate intervals during treatment.

Atrial fibrillation or flutter

Icosapent ethyl was associated with an increased risk of atrial fibrillation or flutter requiring hospitalisation in a double-blind placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or flutter (see section 4.8). Patients, particularly those with a relevant medical history, should be monitored for clinical evidence of atrial fibrillation or atrial flutter (e.g., dyspnoea, palpitations, syncope/dizziness, chest discomfort, change in blood pressure, or irregular pulse). Electrocardiographic evaluation should be performed when clinically indicated.

Bleeding

Treatment with icosapent ethyl has been associated with an increased incidence of bleeding. Patients taking icosapent ethyl along with antithrombotic agents, i.e., antiplatelet agents, including acetylsalicylic acid, and/or anticoagulants, may be at increased risk of bleeding and should be monitored periodically (see section 4.8).

Excipients content

Sorbitol (E420 ii)
This medicinal product contains 83 mg of sorbitol in each capsule. The additive effect of concomitantly administered medicinal products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

Patients with hereditary fructose intolerance (HFI) should not take this medicinal product.

Maltitol (E965 ii)
This medicinal product contains 30 mg of maltitol in each capsule.
Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.

Soya lecithin
This medicinal product contains soya lecithin. Patients who are allergic to soya or peanut should not use this medicinal product.

Effects on Driving

4.7    Effects on ability to drive and use machines

On the basis of its pharmacodynamic profile and clinical study adverse reaction data, icosapent ethyl is expected to have no or negligible influence on the ability to drive and use machines.