Patient Information Leaflet

Warning! Keep the leaflet, information on the immediate packaging is in a foreign language.
Omacor
1000 mg, soft capsules
Omega-3 acidorum esteri ethylici 90
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Omacor is and what it is used for
Important information before taking Omacor
How to take Omacor
Possible side effects
How to store Omacor
Contents of the pack and other information

1. What Omacor is and what it is used for

Omacor contains highly purified omega-3 polyunsaturated fatty acids.
Omacor belongs to a group of medicines that lower cholesterol and triglyceride levels. Omacor is used:

in the treatment of certain types of disorders characterized by elevated levels of triglycerides (fats) in the blood, when dietary changes alone have not been sufficient

2. Important information before taking Omacor

When not to take Omacor:

if the patient is allergic to the active ingredient or to any of the other ingredients of Omacor (see section 6: Contents of the pack and other information)

If any of the above apply to the patient, Omacor must not be taken and the patient should
contact a doctor.
Warnings and precautions
Before starting treatment with Omacor, consult a doctor or pharmacist:

if the patient is planning or has recently undergone surgery
if the patient has recently sustained an injury
if the patient has impaired kidney function
if the patient has uncontrolled diabetes
if the patient has impaired liver function. The doctor should monitor the effect of Omacor on liver function by ordering blood tests
if the patient is allergic to fish
if the patient has or has previously had heart disorders
if the patient experiences dizziness, weakness, palpitations or shortness of breath, as these may be symptoms of an irregular and very rapid heartbeat (atrial fibrillation)

Omacor with other medicines
If the patient is taking medications that prevent blood clotting in arteries, such as warfarin, additional blood tests may be required and the dose of anticoagulant medicines may need to be adjusted.
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Omacor with food and drink
The capsules should be taken during meals. This will help prevent gastrointestinal discomfort.
Elderly patients
Caution should be exercised when administering Omacor to patients over 70 years of age.
Children
Omacor must not be used in children.
Pregnancy and breastfeeding
Omacor should not be used during pregnancy or while breastfeeding, unless the doctor decides it is absolutely necessary.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
It is unlikely that Omacor will affect the ability to drive or operate tools or machinery.
Omacor contains soya oil
Omacor contains soya oil. If the patient is allergic to peanuts or soya, Omacor must not be used.

3. How to take Omacor

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
consult your doctor or pharmacist.

Swallow the capsules with water.
The capsules may be taken with meals to avoid gastrointestinal discomfort.
Your doctor will decide how long you should continue taking this medicine.

Dosage for high blood triglyceride levels (high blood fat levels
or hypertriglyceridemia)
The usual dose is two capsules per day, as prescribed by your doctor.
If the effect of the medicine is insufficient, your doctor may increase the dose to four capsules per day.

Accidentally taking more Omacor than prescribed
Accidental overdose should not cause concern, as it usually does not require special treatment. However, you should consult your doctor or pharmacist for advice.

If you forget to take Omacor
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and take the next dose at the usual time. Do not take a double dose (twice the prescribed amount) to make up for a missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The following adverse reactions may occur during treatment with Omacor:
Common adverse reactions (may occur in up to 1 in 10 people):

irregular, rapid heartbeat
gastrointestinal problems such as bloating, pain, constipation, diarrhoea, indigestion (dyspepsia), gas, belching, gastric reflux, nausea and vomiting

Uncommon adverse reactions (may occur in up to 1 in 100 people):

high blood sugar levels
gout
dizziness
taste disturbances
headache
low blood pressure
nosebleeds
blood in the stool
rash

Rare adverse reactions (may occur in up to 1 in 1000 people):

hypersensitivity reactions
itchy rash (urticaria)
liver disorders with possible changes in laboratory test results

Other adverse reactions which occurred in a small number of people, but their exact frequency is unknown:

itching

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Omacor

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Store below 25°C in the original packaging. Do not freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Omacor contains
The active substance in this medicine is omega-3 acid ethyl esters.
Each capsule contains 1000 mg of 90% omega-3 acid ethyl esters, including 460 mg of eicosapentaenoic acid ethyl ester (EPA) and 380 mg of docosahexaenoic acid ethyl ester (DHA) (these substances are known as omega-3 polyunsaturated fatty acids), and as an antioxidant, 4 mg of D-α-tocopherol (mixed with a vegetable oil, e.g. soybean oil).
Capsule shell: gelatin, glycerol, purified water, lecithin (soy), fractionated coconut oil, isopropyl alcohol, anhydrous ethanol.

What Omacor looks like and contents of the pack
Omacor is available as transparent, soft capsules containing a light yellow oil. The pack contains 28 capsules.

For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Romania, country of export:
BASF AS
Lilleakerveien 2B
0283 Oslo
Norway

Manufacturer:
BASF AS
Framnesveien 41
3222 Sandefjord
Norway
Pierre Fabre Médicament Production
Le Payrat
46000 Cahors
France

Parallel importer:
Polypharm S.A.
ul. Barska 33
02-315 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland

Marketing authorisation number in Romania, country of export: 9639/2017/01
Parallel import authorisation number: 421/24