Prospect: information for the patient

Vazkepa 998 mg soft capsulesi

icosapent ethyl

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect thoroughly before starting to take this medicine, becauseit contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to other people
• even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this prospect. See section 4.

Vazkepa contains the active ingredient icosapent ethyl, a highly purified omega-3 fatty acid obtained from fish oil.

Vazkepa reduces blood triglyceride concentrations (a type of fat) and is used with a statin (which reduces blood cholesterol) to prevent cardiovascular events such as:

• myocardial infarction
• stroke
• death from cardiovascular disease or vascular disease

Vazkepa is used in adults with high blood triglyceride levels, who already have cardiovascular disease or diabetes, and other conditions that increase the risk of experiencing cardiovascular events.

Do not take Vazkepa

• if you areallergic to icosapent ethyl, soy or any other component of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vazkepa:

• if you areallergic to fish or shellfish.
• if you haveliver problems.
• if you havean irregular heartbeat(atrial fibrillation or flutter).
• if you are taking an anticoagulant (that prevents blood from clotting), medications that inhibit platelets in the blood or havea risk of bleeding.

Consult your doctor if any of the above applies to you.

Blood tests

During treatment, your doctor will perform several blood tests to check for liver problems and check your blood clotting.

Children and adolescents

This medication should not be administered to children or young people under 18 years of age because it has not been studied in these individuals.

Other medications and Vazkepa

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

If you are taking other medications at the same time as Vazkepa that affect blood clotting, such as an anticoagulant, blood tests will be performed during treatment.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Vazkepa is not recommended during pregnancy unless your doctor advises you to take it.

Breastfeeding

Vazkepa is not recommended during breastfeeding, as its effect on the newborn is unknown. Your doctor will help you weigh the benefits of treatment against any risk to your breastfeeding baby.

Fertility

Discuss fertility with your doctor during treatment.

Driving and operating machinery

It is unlikely that this medication will affect your ability to drive and use tools or machines.

Vazkepa containsmaltitol, sorbitol and soy lecithin

Maltitol (E965 ii)

If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medication.

Sorbitol (E420 ii)

This medication contains 83 mg of sorbitol in each capsule.

Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, which can cause severe adverse effects, consult your doctor before taking this medication.

Soy lecithin

This medication contains soy lecithin. Do not use this medication in case of allergy to peanuts or soy.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Do not change the dose without consulting your doctor.

How to Open the Bottle

Press the cap down and turn it counterclockwise.

How Much to Take

The recommended dose is two capsules taken orally, twice a day, with or after a meal.

Swallow the capsules whole; do not break, crush, dissolve, or chew them.

Use in Elderly Patients

No dose adjustment is necessary in elderly patients. They can take the recommended dose as usual.

If You Take More Vazkepa Than You Should

If you accidentally take more capsules than prescribed by your doctor, consult your doctor or pharmacist.

If You Forget to Take Vazkepa

If you forget a dose, take it as soon as you remember. However, if you forget to take the medication for an entire day, you only need to take the next scheduled dose. Do not take a double dose to make up for the missed dose. If you have any other questions about the use of this medication, ask your doctor or pharmacist. Do Not Take a Double Dose to compensate for the missed dose. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

If You Interrupt Treatment with Vazkepa

Do not stop taking this medication until you have spoken with your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Consult your doctor

• if you have heart palpitations or an irregular heartbeat. They could be symptoms of a serious condition known as atrial fibrillation. This is a frequent adverse effect (may affect up to 1 in 10 people):
• if you bruise easily or do not stop bleeding. This is a very frequent adverse effect (may affect more than 1 in 10 people). Your risk of bleeding may increase if you are also taking an anticoagulant.

Seek medical helpif you experience any of the following adverse effects. These symptoms may be due to a serious condition calledhypersensitivitythat may occur at any time during treatment. This is a rare adverse effect(may affect up to 1 in 100 people):

• difficulty breathing
• throat constriction or itching
• swelling of the lips
• urticaria (hives on the skin) skin rash and itching
• stomach pain or cramps
• diarrhea
• nausea and vomiting

Other adverse effects that may occur

Adverse effectsfrequent(may affect up to 1 in 10 people):

• swelling of the hands, arms, legs, and feet
• muscle, bone, or joint pain
• gout (painful swelling in the joints due to uric acid accumulation)
• skin rash
• constipation
• belching

Adverse effectrare(may affect up to 1 in 100 people)

• bad taste in the mouth

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly throughthenational notification system included in theAppendixVBy reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label of the bottle or on the box of the blisters after CAD or EXP. The expiration date is the last day of the month indicated.

Store below 30 °C.

Bottle: keep the bottle perfectly closed to protect it from moisture.

Blister: store in the original packaging to protect it from moisture.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and the medication that you no longer need. In this way, you will help to protect the environment.

Composition of Vazkepa

• The active ingredient is icosapent ethyl. Each Vazkepa capsule contains 998 mg of icosapent ethyl.
• The other components are

• all-rac-alpha-tocopherol, gelatin, glycerol, liquid maltitol (E965 ii), liquid sorbitol (non-crystallizing) (E420 ii), purified water, and soy lecithin (see section 2 "Vazkepa contains maltitol, sorbitol, and soy lecithin").
• printing ink: titanium dioxide, propylene glycol, hypromellose.

Appearance of the product and contents of the package

In this package, you will find soft, oblong capsules, 25 x 10 mm, with "IPE" printed in white ink, with a clear yellow to amber-colored coating containing a transparent to pale yellow liquid.

The 120-capsule bottles are white, 300 ml, high-density polyethylene (HDPE) with a polypropylene safety cap sealed by heat induction for child safety. The packaging size is one bottle or three bottles per box.

The blister packs contain 4x2 capsules in perforated single-dose PVC/PCTFE/Al blister packs.

Marketing Authorization Holder

Amarin Pharmaceuticals Ireland Limited

88 Harcourt Street

Dublin 2, D02DK18

Ireland

Responsible for manufacturing

MIAS Pharma Limited

Suite 2, Stafford House, Strand Road

Portmarnock

Co. Dublin

Ireland

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last update date of this leaflet:

Other sources of information

For detailed information about this medication, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.