Omacor

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Omacor

1000 mg, soft capsules

Omega-3 acid ethyl esters 90

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Omacor and what is it used for
• 2. Important information before taking Omacor
• 3. How to take Omacor
• 4. Possible side effects
• 5. How to store Omacor
• 6. Contents of the packaging and other information

1. What is Omacor and what is it 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:

• to treat certain types of disorders characterized by elevated triglyceride levels (fats) in the blood, when dietary changes have proven insufficient.

2. Important information before taking Omacor

When not to take Omacor:

If any of the above statements apply to the patient, they should not take the medicine and should consult a doctor.

Warnings and precautions

Before starting to take Omacor, the patient should consult a doctor or pharmacist:

• in case of planned or recent surgery
• in case of recent injury
• in case of kidney dysfunction
• in case of uncontrolled diabetes
• in case of liver dysfunction. The doctor should monitor the effect of Omacor on liver function by ordering blood tests

Omacor and other medicines

In case of taking medicines that prevent blood clots in arteries, such as warfarin, additional blood tests and changes in the dosage of blood-thinning medicines may be necessary.
The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Omacor with food and drink

The capsules should be taken during meals. This will help avoid stomach and gastrointestinal disorders.

Patients of advanced age

Caution should be exercised when using Omacor in people over 70 years old.

Children

Omacor should not be used in children.

Pregnancy and breastfeeding

Omacor should not be used during pregnancy and breastfeeding, unless the doctor decides that it is absolutely necessary.
Before using any medicine, the patient should consult a doctor or pharmacist.

Driving and operating machinery

It is unlikely that Omacor will affect the ability to drive or operate any tools or machines.

Omacor contains soybean oil

Omacor contains soybean oil. If the patient is allergic to peanuts or soy, they should not take Omacor.

3. How to take Omacor

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult a doctor or pharmacist.

• Swallow the capsules with water.
• The capsules can be taken during meals to avoid gastrointestinal disorders.
• The doctor will decide how long to take this medicine.

Dosage for high triglyceride levels in the blood (high fat levels in the blood or hypertriglyceridemia)

The usual dose is two capsules per day, as recommended by the doctor.
If the effect of the medicine is not sufficient, the doctor may increase the dose to four capsules per day.

Taking a higher dose of Omacor than recommended

Accidental overdose of the medicine should not cause concern, as it usually does not require special treatment. However, the patient should consult a doctor or pharmacist.

Missing a dose of Omacor

In case of missing a dose, the patient should take it as soon as possible, unless it is almost time for the next dose. In this case, the patient should take the next dose at the scheduled time. The patient should not take a double dose (twice the recommended dose) to make up for the missed dose.
In case of doubts about taking the medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Omacor can cause side effects, although not everybody gets them.
During treatment with Omacor, the following side effects may occur:

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

• irregular, rapid heart rhythm
• stomach problems such as bloating, pain, constipation, diarrhea, indigestion (dyspepsia), gas, belching, acid reflux, nausea, and vomiting

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

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

Rare side effects (may occur in up to 1 in 1000 people):

• allergic reactions
• itchy rash (hives)
• liver disorders with possible changes in laboratory test results

Other side effects that have occurred in a small number of people, but the exact frequency is unknown:

• itching

If any of the side effects worsen or if any side effects not listed in the leaflet occur, the patient should inform their doctor or pharmacist.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Omacor

The medicine should be stored out of 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 month stated.
Do not store above 25°C. Do not freeze.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Omacor contains

The active substance of Omacor is omega-3 ethyl esters 90.
1000 mg of omega-3 ethyl esters 90 contains 460 mg of ethyl ester of eicosapentaenoic acid (EPA) and 380 mg of ethyl ester of docosahexaenoic acid (DHA) (these substances are called omega-3 polyunsaturated fatty acids), and as an antioxidant 4 mg of all-rac-α-Tocopherol (mixed with vegetable oil, e.g., soybean oil).
The capsule shell: gelatin, glycerol, purified water, medium-chain triglycerides, lecithin (soy).

What Omacor looks like and what the packaging contains

Omacor is available in the form of transparent, soft capsules containing light yellow oil.
The packaging contains 28 or 100 soft capsules.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

BASF AS
P.O. Box 420
NO-1327 Lysaker
Norway

Manufacturer:

BASF AS
Framnesveien 41
NO-3222 Sandefjord
Norway
Pierre Fabre Médicament Production
Le Payrat
FR-46000 Cahors
France

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Spain, the country of export: 873141.1

• 873166.4

Parallel import authorization number: 437/22

Date of leaflet approval: 30.05.2025

[Information about the trademark]