Vazkepa

Patient information leaflet

Vazkepa 998 mg soft capsules

icosapent ethyl
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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 levels of triglycerides (a type of fat) in the blood and is used together with a statin
(a medicine that lowers blood cholesterol) to prevent cardiovascular events such as:

• myocardial infarction
• stroke
• cardiovascular death

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

2. What you need to know before taking 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 taking Vazkepa:

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

If any of the conditions listed above apply to you, consult your doctor.
Blood tests
During treatment, your doctor may perform blood tests to make sure you do not have liver problems and to monitor your blood clotting.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as it has not been studied in this population.
Other medicines and Vazkepa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking other medicines that affect blood clotting together with Vazkepa, such as anticoagulants, blood monitoring tests will be performed during treatment.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The use of Vazkepa during pregnancy is not recommended, unless your doctor specifically recommends it.
Breastfeeding
The use of Vazkepa is not recommended during breastfeeding, as its effects on the infant are unknown. Your doctor will help you weigh the benefits of treatment against the potential risks to the breastfed 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 machinery.
Vazkepa contains maltitol, sorbitol and soy lecithin
Maltitol (E965 ii)
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor 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 told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
Soy lecithin
This medicine contains soy lecithin. If you are allergic to soy or peanuts, do not take this medicine.

3. How to take Vazkepa

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist. Do not change the dose without consulting your doctor.

How to open the bottle
Press down on the screw cap and turn it counterclockwise.

Dose to be taken
The recommended dose is two capsules taken orally twice daily, with a meal or shortly after a meal.
Swallow the capsules whole; do not split, crush, dissolve, or chew the capsules.

Use in the elderly
Dose adjustment is not necessary in elderly patients (aged 65 years and older). They may take the usual recommended dose.

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

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 a whole day, take your next dose at the usual time. Do not take a double dose to make up for the missed dose. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

If you stop taking Vazkepa
Do not stop treatment with this medicine unless advised by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Contact your doctor

• if you have palpitations or an irregular heartbeat. These could be symptoms of a serious condition called atrial fibrillation. This is a common side effect (may affect up to 1 in 10 people).
• if you bruise easily or are unable to stop bleeding. This is a very common side effect (may affect more than 1 in 10 people). The risk of bleeding may increase if you are also taking an anticoagulant.

Consult your doctor if you experience any of the following side effects. These symptoms may be due to a serious condition called hypersensitivity, which can occur at any time during treatment. This is an uncommon side effect (may affect up to 1 in 100 people):

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

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

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

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

• bad taste in the mouth

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• pharyngeal swelling (sore throat)

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vazkepa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label or on the blister pack box after Scad./EXP. The expiry date refers to the last day of that month.
Store below 30 °C.
Bottle
Keep the bottle tightly closed to protect the medicine from moisture.
Blister pack
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vazkepa contains

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

Description of the appearance of Vazkepa and package contents
Oblong soft capsules, 25 x 10 mm, imprinted with the letters “IPE” in white ink, with a pale yellow or amber-coloured shell containing a colourless or pale yellow liquid.
Bottles containing 120 capsules are made of white, high-density polyethylene (HDPE), 300-cc, with a heat-sealed polypropylene child-resistant closure.
Pack sizes: one bottle or three bottles per carton.
Blister packs contain 4 x 2 capsules in perforated unit-dose blisters made of PVC/PCTFE/Al.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali 1
20148 Milano
Italy

Manufacturer
MIAS Pharma Limited
Suite 1, Stafford House, Strand Road
Portmarnock
D13 WC83
Ireland

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Recordati BV
Tel: +32 2 461 01 36

България (Bulgaria)
Recordati Bulgaria Ltd.
Tel: +359 2 829 39 37

Česká republika (Czech Republic)
Herbacos Recordati s.r.o.
Tel: +420 466 741 915

Danmark (Denmark)
Recordati AB
Tlf: +46 8 545 80 230

Deutschland (Germany)
Recordati Pharma GmbH
Tel: +49 731 70470

Eesti (Estonia)
Recordati Polska sp. z o.o.
Tel: +48 22 206 84 50

Ελλάδα (Greece)
ΒΙΑΝΕΞ Α.Ε.
Τηλ: +30 210 8009111

España (Spain)
Casen Recordati, S.L.
Tel: +34 91 351 88 00

France
Laboratoires Bouchara-Recordati
Tél: +33 1 45 19 10 00

Hrvatska (Croatia)
Recordati Industria Chimica e Farmaceutica S.p.A.
Tel: +39 02 487871

Ireland
Recordati Ireland Ltd.
Tel: +353 21 4379400

Ísland (Iceland)
Recordati AB
Sími: +46 8 545 80 230

Italia (Italy)
Recordati Industria Chimica e Farmaceutica S.p.A.
Tel: +39 02 487871

Κύπρος (Cyprus)
Recordati Industria Chimica e Farmaceutica S.p.A.
Τηλ: +39 02 487871

Latvija (Latvia)
Recordati Polska sp. z o.o.
Tel: +48 22 206 84 50

Lietuva (Lithuania)
Recordati Polska sp. z o.o.
Tel: +48 22 206 84 50

Luxembourg/Luxemburg
Recordati BV
Tél/Tel: +32 2 461 01 36

Magyarország (Hungary)
Recordati Industria Chimica e Farmaceutica S.p.A.
Tel: +39 02 487871

Malta
Recordati Industria Chimica e Farmaceutica S.p.A.
Tel: +39 02 487871

Nederland (Netherlands)
Recordati BV
Tel: +32 2 461 01 36

Norge (Norway)
Recordati AB
Tlf: +46 8 545 80 230

Österreich (Austria)
Recordati Austria GmbH
Tel: +43 664 128 4879

Polska (Poland)
Recordati Polska sp. z o.o.
Tel: +48 22 206 84 50

Portugal
Jaba Recordati, S.A.
Tel: +351 21 432 95 00

România (Romania)
Recordati România S.R.L.
Tel: +40 21 667 17 41

Slovenija (Slovenia)
Recordati Industria Chimica e Farmaceutica S.p.A.
Tel: +39 02 487871

Slovenská republika (Slovakia)
Herbacos Recordati s.r.o.
Tel: +420 466 741 915

Suomi/Finland
Recordati AB
Puh/Tel: +46 8 545 80 230

Sverige (Sweden)
Recordati AB
Tel: +46 8 545 80 230

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu