Omacor

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Omacor

1000 mg, soft capsules
Omega-3 acid ethyl esters 90

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their 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, pharmacist, or nurse. 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. Package contents 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 the patient is allergic to the active substance or any of the other ingredients of Omacor (see section 6: Package contents and other information).

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

Warnings and precautions

Before starting to take Omacor, the patient should consult their 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.
• if the patient is allergic to fish,
• if the patient has or has had heart disorders,
• if the patient experiences dizziness, weakness, palpitations, or shortness of breath, as these may be symptoms of irregular and very rapid heart rhythm (atrial fibrillation).

Omacor and other medicines

In case of taking medicines that prevent blood clots in arteries, such as warfarin, additional blood tests and dose adjustment 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

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

Elderly patients

Caution should be exercised when using Omacor in patients 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 it is absolutely necessary.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

It is unlikely that Omacor will affect the ability to drive or operate machinery.

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 exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

• Swallow the capsules with water.
• Capsules can be taken during meals to avoid gastrointestinal disorders.
• The doctor will decide how long the patient should 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 prescribed by the doctor.
If the effect of the medicine is not sufficient, the doctor may increase the dose to four capsules per day.

Overdose of Omacor

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

Missed dose of Omacor

In case of a missed 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 dose prescribed by the doctor) to make up for the missed dose.
In case of doubts about taking the medicine, the patient should consult their 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 the patient experiences any side effects not listed in the leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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
tel.: + 48 (22) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Omacor

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C, in the original packaging. Do not freeze.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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. Package contents 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).
The other ingredients are:
Core of the capsule: 4 mg of D-α-tocopherol as an antioxidant (mixed with vegetable oil, e.g., soybean oil).
Capsule shell: gelatin, glycerol, purified water, fractionated coconut oil, lecithin (soy), isopropyl alcohol, anhydrous ethanol.

What Omacor looks like and what the package contains

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

Marketing authorization holder in Romania, the country of export:

BASF AS
Lilleakerveien 2B
NO-0283 Oslo
Norway

Manufacturer:

BASF AS
Framnesveien 41
NO-3222 Sandefjord
Norway
PIERRE FABRE MÉDICAMENT PRODUCTION
Le Payrat, 46000 Cahors, France

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export: 9639/2017/01

Parallel import authorization number: 298/22

Date of leaflet approval: 16.05.2025

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