Vazkepa 998 mg soft capsules

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Vazkepa 998 mg soft capsules i

icosapent ethyl

This medicinal product is subject to additional monitoring, which will allow for rapid identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Vazkepa is and what it is used for
2. What you need to know before taking Vazkepa
3. How to take Vazkepa
4. Possible side effects
5. How to store Vazkepa
6. Contents of the pack and other information

1. What Vazkepa is and what it is used for

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

Vazkepa reduces concentrations of triglycerides (a type of fat) in the blood and is used in combination with a statin (a cholesterol-lowering medication) to help prevent cardiovascular events such as:

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

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

2. What you need to know before starting to take Vazkepa

Do not take Vazkepa

• if you are allergic to icosapent ethyl, soy, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Vazkepa:

• If you are allergic to fish or shellfish.
• If you have liver problems.
• If you have an irregular heartbeat (atrial fibrillation or flutter).
• If you are taking an anticoagulant (a medicine that prevents blood from clotting), platelet inhibitors, or if you have a risk of bleeding.

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

Blood tests

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

Children and adolescents

This medicine should not be given to children or young people under 18 years of age, as it has not been studied in these populations.

Other medicines and Vazkepa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are taking other medicines at the same time as Vazkepa that affect blood clotting, such as anticoagulants, you will require blood tests during treatment.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

Breastfeeding

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

Fertility

Talk to your doctor about fertility during treatment.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or operate tools or machinery.

Vazkepa contains maltitol, sorbitol, and soy lecithin

Maltitol (E965 ii)

If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

Sorbitol (E420 ii)

This medicine contains 83 mg of sorbitol per capsule.

Sorbitol is a source of fructose. If your doctor has diagnosed you with intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot break down fructose, potentially leading to serious adverse effects, consult your doctor before taking this medicine.

Soy lecithin

This medicine contains soy lecithin. Do not use this medicine if you are allergic to peanuts or soy.

3. How to take Vazkepa

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Do not change the dose without consulting your doctor.

How to open the bottle

Press the screw cap downwards and turn it counterclockwise.

How much to take

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

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

Use in elderly patients

It is not necessary to adjust the dose in elderly patients. They may take the recommended dose routinely.

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 miss a dose, take it as soon as you remember. However, if you forget to take the medicine for an entire day, simply take the next scheduled dose. Do not take a double dose to make up for the missed dose. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

If you stop taking Vazkepa

Do not interrupt treatment with this medicine without first talking to your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Consult your doctor

• if you have palpitations or an irregular heartbeat. These could be symptoms of a serious condition known as atrial fibrillation. This is a common adverse effect (may affect up to 1 in 10 people):
• if you bruise easily or have prolonged bleeding. This is a very common 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 help if you experience any of the following adverse effects. These symptoms may be due to a serious condition called hypersensitivity, which can occur at any time during treatment. This is an uncommon adverse effect (may affect up to 1 in 100 people):

• difficulty breathing
• tightness or itching in the throat
• swelling of the lips
• hives (skin rash), skin rash, and itching
• stomach pain or cramps
• diarrhoea
• nausea and vomiting

Other possible adverse effects

Common adverse effects (may affect up to 1 in 10 people):

• swelling of the hands, arms, legs, and feet
• pain in the muscles, bones, or joints
• gout (painful swelling in the joints due to accumulation of uric acid)
• skin rash
• constipation
• burping

Uncommon adverse effect (may affect up to 1 in 100 people):

• unpleasant taste in the mouth

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vazkepa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label of the bottle or on the blister pack box after CAD or EXP. The expiry date refers to the last day of the month indicated.

Store below 30 °C.

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

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vazkepa

• The active substance 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 non-crystallising sorbitol (E420 ii), purified water and soya lecithin (see section 2, "Vazkepa contains maltitol, sorbitol and soya lecithin").

• printing ink: titanium dioxide, propylene glycol, hypromellose.

Nature and contents of the container

This pack contains oblong soft capsules, 25 x 10 mm, printed with "IPE" in white ink, with a shell ranging in colour from light yellow to amber, containing a clear to pale yellow liquid.

Bottles containing 120 capsules are white, 300 ml, made of high-density polyethylene (HDPE), with a child-resistant polypropylene closure sealed by heat induction. Pack sizes: one bottle or three bottles per carton.

Blister packs contain 4x2 capsules in single-dose perforated PVC/PCTFE/Al blisters.

Marketing Authorisation Holder

Amarin Pharmaceuticals Ireland Limited
88 Harcourt Street
Dublin 2, D02DK18
Ireland

Manufacturer

MIAS Pharma Limited
Suite 2, Stafford House, Strand Road
Portmarnock
Co. Dublin
Ireland

For more information about this medicinal product, you may contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.