Vazkepa 998 mg soft capsules

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

Talk to your doctor or pharmacist before taking Vazkepa:

• If you are allergic to fish or to shellfish.
• If you have problems with your liver.
• If you have problems with irregular heartbeat (atrial fibrillation or flutter).
• If you take an anticoagulant medicine (which prevents blood from clotting), medicines that inhibit platelets in the blood or are at risk of bleeding.

If any of the above applies to you, talk to your doctor.

Blood tests

During your treatment your doctor may carry out blood tests to check for any problems with your liver and to check how your blood is clotting.

Do not give this medicine to children and young people below 18 years of age because it has not been studied in these people.

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

If you are taking other medicines at the same time as Vazkepa that affect how your blood clots, such as an anticoagulant medicine, you will have blood tests during treatment.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breast-feeding

Vazkepa is not recommended for use while breast-feeding as the effect on your baby is not known. Your doctor will help you to weigh up the benefit of treatment against any risk to your breast-feeding baby.

Fertility

Talk with your doctor about fertility during treatment.

This medicine is unlikely to affect your ability to drive or use tools or machines.

Maltitol (E965 ii)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Sorbitol (E420 ii)

This medicine contains 83 mg sorbitol in each capsule.

Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take this medicine.

Soya lecithin

This medicine contains soya lecithin. If you are allergic to soya or peanut, do not use this medicine.

There is no need to change the dose in elderly patients. They can take the usual recommended dose.

If you accidentally take more capsules than your doctor has prescribed, contact your doctor or pharmacist for advice.

If you miss a dose, take it as soon as you remember. However if you missed taking the medicine for a whole day, just take your next scheduled dose. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

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

Get medical help if you get any of the following side effects. These symptoms could be due to a serious condition known as hypersensitivity which can happen at any time during treatment. This is an uncommon side effect (may affect up to 1 in 100 people)

• difficulty breathing
• tightening or scratching of the throat
• swelling of the lips
• hives (raised bumps on the skin)
• rash and an itchy skin
• stomach pain or cramps
• diarrhoea
• nausea and vomiting

Other side effects that may occur

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

• swelling of your hands, arms, legs and feet
• pain in muscles, bones or joints
• gout (painful swelling in the joints because of a build up of uric acid)
• rash
• constipation
• burping

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

• bad taste in the mouth

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme - Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is icosapent ethyl. Each Vazkepa capsule contains 998 mg of icosapent ethyl.
• The other ingredients are
  • all-rac-alpha-tocopherol, gelatin, glycerol, liquid maltitol (E965 ii), liquid sorbitol (non-crystallising) (E420 ii), purified water and soya lecithin (see section 2 “Vazkepa contains maltitol, sorbitol and soya lecithin”).
  • printing ink: titanium dioxide, propylene glycol, hypromellose.

In this pack you will find oblong soft capsules, 25 x 10 mm, printed with “IPE” in white ink, with a light yellow to amber shell containing a colourless to pale yellow liquid.

The bottles containing 120 capsules are white 300-cc, high density polyethylene (HDPE) with a child-resistant polypropylene heat induction sealed closure.

Pack size of one bottle or three bottles per carton.

The blister packs contain 4x2 capsules in PVC/PCTFE/Al perforated unit dose blisters.