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 or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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. 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 high triglyceride levels (fats) in the blood, when dietary changes have been insufficient.

2. Important information before taking Omacor

When not to take Omacor:

• if you are 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 you, do not take the medicine and consult your doctor.

Warnings and precautions

Before taking Omacor, discuss it with your doctor or pharmacist:

• if you are scheduled for or have recently undergone surgery,
• if you have recently suffered an injury,
• if you have kidney problems,
• if you have uncontrolled diabetes,
• if you have liver function impairment. Your doctor should monitor the effect of Omacor on liver function by ordering blood tests,
• if you are allergic to fish.

Omacor and other medicines

If you are taking medicines that prevent blood clots in arteries, such as warfarin, you may need to have additional blood tests and adjust the dose of blood-thinning medicines.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Omacor with food and drink

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

Elderly patients

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 your doctor decides it is absolutely necessary.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

It is unlikely that Omacor will affect your ability to drive or use machines.

Omacor contains soybean oil

Omacor contains soybean oil. If you are allergic to peanuts or soy, do not take Omacor.

3. How to take Omacor

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• Swallow the capsules with water.
• Capsules can be taken during meals to avoid gastrointestinal problems.
• Your doctor will decide how long you should take this medicine.

Dosing 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 your doctor.
If the medicine does not work well enough, your doctor may increase the dose to four capsules per day.

Overdose of Omacor

Accidental overdose is unlikely to cause concern, as it usually does not require special treatment. However, consult your doctor or pharmacist.

Missed dose of Omacor

If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In this case, take the next dose at the scheduled time. Do not take a double dose (twice the dose recommended by your doctor) to make up for the missed dose.
If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Omacor can cause side effects, although not everybody gets them.
The following side effects may occur when taking Omacor:

Common side effects (occurring in 1 to 10 patients out of 100):

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

Uncommon side effects (occurring in 1 to 10 patients out of 1000):

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

Rare side effects (occurring in 1 to 10 patients out of 10,000):

• 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 whose frequency is unknown

• itching.

If any of the side effects get worse or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store 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 month.
Do not store above 25°C. Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your 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), and as an antioxidant 4 mg of D-alpha-tocopherol (mixed with vegetable oil, e.g., soybean oil).
Capsule shell: gelatin, glycerol, purified water, medium-chain triglycerides, lecithin (soy).

What Omacor looks like and what the package contains

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

Marketing authorization holder in Greece, the country of export:

BGP PRODUCTS LTD
Ag. Dimitriou 63
174 56 Alimos
Greece

Manufacturer:

Pronova BioPharma Norge AS
Lilleakerveien 2 C
0238 Oslo
Norway
Pierre Fabre Medicament Production
Le Payrat
46000 Cahors
France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Greece, the country of export:3196/13-01-2009
Parallel import authorization number:242/13
Date of leaflet approval: 27.04.2023
[Information about the trademark]