VAZKEPA 998 mg Miękka Kapsułka

Treść ulotki

1. Vazkepa 998 mg soft capsules
   1. What is Vazkepa and what is it 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

Vazkepa 998 mg soft capsules

icosapent ethyl

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 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

1. What is Vazkepa and what is it used for

Vazkepa contains the active substance icosapent ethyl, a highly purified omega-3 fatty acid
obtained from fish oil.
Vazkepa reduces levels of triglycerides (a type of fat) in the blood and is used together with a statin
(which lowers cholesterol in the blood) to prevent cardiovascular events, such as:

• myocardial infarction
• stroke
• death from cardiovascular 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 expose them to a 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, to soy or to 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 irregular heartbeat problems(atrial fibrillation or atrial flutter)
• if you are taking a blood-thinning medicine (that prevents blood from clotting), medicines that inhibit platelets in the blood or if you are at risk of bleeding.

If any of these conditions apply to you, talk to your doctor.
Blood tests
During treatment, your doctor may perform blood tests to make sure there are no
liver problems and to check blood clotting.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, because it has not been studied in these
people.

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 have effects on blood clotting together with Vazkepa,
such as a blood thinner, blood control tests will be performed during treatment.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Use of Vazkepa during pregnancy is not recommended unless your doctor recommends it.
Breastfeeding
Use of Vazkepa is not recommended during breastfeeding, because the effects on the baby are not
known. Your doctor will help you assess the benefits of treatment against the risks to the breastfed
baby.
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, contact him/her before taking
this medicine.
Sorbitol (E420 ii)
This medicine contains 83 mg of sorbitol in each capsule.
Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if
you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot
break down fructose, talk to your doctor before taking this medicine.
Soy lecithin
This medicine contains soy lecithin. If you are allergic to soy or peanuts, do not use this
medicine.

3. How to take Vazkepa

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist. Do not change the dose without consulting your doctor.
How to open the bottle
Press on the screw cap and rotate it counterclockwise.

Dosage to be taken
The recommended dose is two capsules to be taken by mouth, twice a day, with a meal or
after a meal.
Swallow the capsules whole; do notbreak, crush, dissolve or chew the capsules.

Use in the elderly
No dose adjustment is necessary in elderly patients. They can take the usually
recommended dose.

If you take more Vazkepa than you should
If you accidentally take more capsules than prescribed by your doctor, ask for advice from 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
medicine for an entire day, take the next dose directly. Do not take a double
doseto make up for a missed dose. If you have any doubts about the use of this
medicine, ask your doctor or pharmacist.

If you stop taking Vazkepa
Do not stop treatment with this medicine before consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor

• if you have palpitations or an irregular heartbeat. These could be symptoms due to a serious condition called atrial fibrillation. This is a commonside effect (may affect up to 1 in 10 people)
• if you bruise easily or cannot stop bleeding. This is a very commonside effect (may affect more than 1 in 10 people). The risk of bleeding may increase if you are also taking an anticoagulant.

Seek medical adviceif you experience any of the following side effects. These symptoms
may be due to a serious condition called hypersensitivity, which can occur in
any time during treatment. This is a uncommonside effect (may
affect up to 1 in 100):

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

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

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

Uncommonside effects (may affect up to 1 in 100):

• bad taste in the mouth

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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 which is stated on the label of the bottle or on the
blister pack after Exp./EXP. The expiry date refers to the last day of that month.
Store at a temperature 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 in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vazkepa contains

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

Description of Vazkepa and contents of the pack
This pack contains oblong soft gelatin capsules, 25 x 10 mm, with the inscription “IPE” imprinted in
white ink, with a shell of straw-yellow or amber color containing a colorless or
pale yellow liquid.
The 120-capsule bottles are made of white 300-cc high-density polyethylene (HDPE) with a
child-resistant heat-sealed polypropylene closure.
Pack of one or three bottles per carton.
The blister packs contain 4x2 capsules in perforated blisters for unit dose in PVC/PCTFE/Al.

Marketing Authorisation Holder
Amarin Pharmaceuticals Ireland Limited
88 Harcourt Street
Dublin 2, D02DK18
Ireland

Manufacturer
MIAS Pharma Limited
Suite 1, Stafford House, Strand Road
Portmarnock
D13 WC83
Ireland
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Amarin Pharmaceuticals Ireland Limited
Tél/Tel: 0800-75394
[email protected]

Lietuva
Amarin Pharmaceuticals Ireland Limited
Tel: +353(0)16915000
[email protected]

България
Amarin Pharmaceuticals Ireland Limited
Teл.: 008002100595
[email protected]

Luxembourg/Luxemburg
Amarin Pharmaceuticals Ireland Limited
Tél/Tel: +353(0)16915000
[email protected]

Česká republika
Amarin Pharmaceuticals Ireland Limited
Tlf: 800720602
[email protected]

Magyarország
Amarin Pharmaceuticals Ireland Limited
Tel.: 0680080683
[email protected]

Danmark
Amarin Pharmaceuticals Ireland Limited
Tlf: +46 84 4685033

Malta
Amarin Pharmaceuticals Ireland Limited
Tel: +353(0)16915000
[email protected]

Deutschland
Amarin Germany GmbH
Tel: 0800-0008975
[email protected]
[email protected]

Nederland
Amarin Pharmaceuticals Ireland Limited
Tel: 0800-0228734
[email protected]

Eesti
Amarin Pharmaceuticals Ireland Limited
Tel: +353(0)16915000
[email protected]

Norge
Amarin Pharmaceuticals Ireland Limited
Tlf: +46 84 468 5033
[email protected]

Ελλάδα
ΒΙΑΝΕΞ Α.Ε.
Τηλ. +30 210 8009111

Österreich
Amarin Pharmaceuticals Ireland Limited
Tel: 0800-281516
[email protected]

España
Amarin Pharmaceuticals Ireland Limited
Tel: 900806101
[email protected]

Polska
Amarin Pharmaceuticals Ireland Limited
Tel.: 008001125446
[email protected]

France
Amarin Pharmaceuticals Ireland Limited
Tél: 0800-991006
[email protected]

Portugal
Amarin Pharmaceuticals Ireland Limited
Tel: 0800-882989
[email protected]

Hrvatska
Amarin Pharmaceuticals Ireland Limited
Tel: 0800787073
[email protected]

România
Amarin Pharmaceuticals Ireland Limited
Tel: 0800 890426
[email protected]

Ireland
Amarin Pharmaceuticals Ireland Limited
Tel: 1800001144
[email protected]

Slovenija
Amarin Pharmaceuticals Ireland Limited
Tel: 080082095
[email protected]

Ísland
Amarin Pharmaceuticals Ireland Limited
Sími: +46-84-4685033
[email protected]

Slovenská republika
Amarin Pharmaceuticals Ireland Limited
Tel: 0800003352
[email protected]

Italia
Amarin Pharmaceuticals Ireland Limited
Tel: 0800-940560
[email protected]

Suomi/Finland
Amarin Pharmaceuticals Ireland Limited
Puh/Tel: +46 84 4685033
[email protected]

Κύπρος
Amarin Pharmaceuticals Ireland Limited
Τηλ: 80090829
[email protected]

Sverige
Amarin Pharmaceuticals Ireland Limited
Tel: +46 84 4685033
[email protected]

Latvija
Amarin Pharmaceuticals Ireland Limited
Tel: +353(0)16915000
[email protected]

United Kingdom (Northern Ireland)
Amarin Pharmaceuticals Ireland Limited
Tel: 0800-0478673
[email protected]

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