VAZKEPA

Posology The recommended daily oral dose is 4 capsules taken as two 998 mg capsules twice daily. If a dose is missed, patients should take it as soon as they remember. However, if one daily dose is missed, the next dose should not be doubled.

2). 2). 2). Paediatric population There is no relevant use of icosapent ethyl in children aged <18 years of age in reducing the risk of cardiovascular events in statin-treated patients at high cardiovascular risk with elevated triglycerides and other risk factors for cardiovascular disease.

Method of administration Oral use. Vazkepa should be taken with or following a meal. To ensure the full intended dose is received, patients should be advised to swallow the capsules whole and not to break, crush, dissolve, or chew them.

Tabulated list of adverse reactions Adverse reactions are classified according to frequency and system organ class. 9 years. Frequency categories are defined according to the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

. 9% in subjects receiving placebo. 4% vs. 4). 5%). 5% in subjects receiving placebo. Atrial fibrillation or atrial flutter requiring hospitalisation for 24 hours or more occurred in 3% of subjects treated with icosapent ethyl compared with 2% in subjects receiving placebo.

5% vs. 4). 6% of subjects receiving placebo. 2%). The relative incidence of constipation in this study may have been confounded by a residual laxative effect for placebo, which comprised a subtherapeutic dose of light mineral oil (4 mL).

The following adverse reactions have been identified from global post- marketing use of icosapent ethyl. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish causal relationship to drug exposure: blood triglycerides increased, arthralgia, diarrhoea, abdominal discomfort, and pain in the extremities.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. 8). , 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. 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.

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