Package Leaflet: Information for the User

Omacor 1000 mg Soft Capsules

Esters of Omega-3 Fatty Acids 90

Read this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you onlyonlyand should not be given to others, even if they have the same symptomsas you, as it may harm them.

• If you experience any side effects,consult your doctor or pharmacist, evenifthey are not listed in this leaflet. See section 4.

1. What Omacor is and what it is used for

2. What you need to know before you start taking Omacor

3. How to take Omacor

4. Possible side effects

5. Storage of Omacor

6. Contents of the pack and additional information

OMACOR contains highly purified omega-3 polyunsaturated fatty acids.

OMACOR belongs to a group of medications called “Other cholesterol and triglyceride reducers”.

OMACOR is indicated:

• for the treatment of some cases of high levels of triglycerides (fats) in the blood when dietary changes have not been effective.

Do not take Omacor

• if you are allergic (hypersensitive) to the active ingredientor to any of the other components ofOmacor(listed in section 6: Contents of the pack and other information).

In any of the above situations, do not take this medicine and inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omacor:

• if you are about to undergo or have recently undergone surgery
• if you have recently suffered a trauma
• if you have kidney problems
• if you have uncontrolled diabetes
• if you have liver problems. Your doctor will monitor the possible effects of Omacor on the liver through blood tests
• if you are allergic to fish
• if you have or have had heart problems
• if you experience dizziness, fatigue, palpitations, or difficulty breathing, as these may be symptoms of an irregular and often very fast heart rhythm (atrial fibrillation)

Use of Omacor with other medicines

If you are taking medicines to prevent the formation of blood clots in the arteries, such as warfarin, you may need additional blood tests and an adjustment to your usual dose of blood-thinning medication.

Inform your doctor or pharmacist if you are using, have recently used, or may need to use other medicines, including those purchased without a prescription.

Taking Omacor with food and drinks

You should take the capsules with meals. This helps to reduce the likelihood of adverse effects in the internal area of the stomach and around it (gastrointestinal area).

Older adults

If you are over 70 years old, use Omacor with caution.

Children

Children should not take this medicine.

Pregnancy and breastfeeding

Omacor should not be used during pregnancy or breastfeeding, unless your doctor considers it absolutely necessary.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

It is unlikely that this medicine will affect your ability to drive and use machinery.

Omacor contains soybean oil.Do not use this medicine if you are allergic to peanuts or soy..

Follow exactly the administration instructions for Omacor as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

• Take the capsules with water.
• You can take the capsules during meals to help reduce gastrointestinal side effects.
• Your doctor will tell you the duration of treatment.

Dosage for treating high levels of triglycerides in the blood (high levels of fat in the blood or hypertriglyceridemia)

The usual dose is 2 capsules per day, as recommended by your doctor.

If the medication does not work adequately at this dose, your doctor may increase the dose up to 4 capsules per day.

If you take more Omacor than you should

If you have accidentally taken more Omacor than you should, do not worry, as it is unlikely that you will need special treatment. However, you should contact your doctor or pharmacist for additional advice.

If you forgot to take Omacor

If you forgot to take a dose, take it as soon as you remember, except if it is almost time to take the next dose, in which case it is better to wait for the next dose. Do not take a double dose (two times the dose recommended by your doctor) to make up for the missed doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Omacor may produce adverse effects, although not all people will experience them. The following possible adverse effects may be produced by the medication:

Frequent (may affect up to1 in 10 people):

• Irregular and rapid heart rhythm

):

• Stomach problems such as bloating, pain, constipation, diarrhea, indigestion (dyspepsia), gas, belching, acid reflux, dizziness, and vomiting

Possible (may affect up to1 in 100 people)):

• High blood sugar levels
• Gout
• Dizziness
• Altered taste
• Headache
• Low blood pressure
• Nosebleed
• Blood in the stool
• Rash

Rare (may affect up to1 in 1000 people):

• Allergic reactions
• Rash with itching(hives or urticaria)
• Liver disorders with possible changes in some blood test results

Other adverse effects have occurred in a very small number of people, but their exact frequency is unknown.

• Itching

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use (www.notificaram.es). By reporting adverse effects, you can contribute to providing more information about the safety of this medication

• Keepthis medicationout of the sight and reach of children.
• Do not use Omacor after the expiration date that appears on the box and on the label. The expiration date is the last day of the month indicated.
• Do not store above 25°C. Do not freeze.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. By doing so, you will help protect the environment.

Composition of Omacor

The active principles are ethyl esters of omega-3 fatty acids,

1000 mg of ethyl esters of omega-3 fatty acids 90 including 460 mg of ethyl esters of eicosapentaenoic acid (EPA), 380 mg of ethyl esters of docosahexaenoic acid (DHA) (these substances are called polyunsaturated omega-3 fatty acids) and including 4 mg of d-alpha-tocopherol (mixed with vegetable oil, e.g. soybean oil) as an antioxidant.

The capsule coating is composed of gelatin, glycerol, medium-chain triglycerides, soy lecithin, and purified water.

Appearance of the product and contents of the packaging

Omacor capsules are soft, transparent gelatin capsules containing a clear yellow oil.

Omacor is available in the following presentations:

- 1 x 20 capsules

- 1 x 28 capsules

- 1 x 30 capsules

- 1 x 60 capsules

- 1 x 100 capsules

- 10 x 28 capsules

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

The marketing authorization holder of Omacor is:

BASF AS

PO Box 420

NO-1327 Lysaker

Norway

Responsible manufacturer

BASF AS

Framnesveien 41

NO-3222 Sandefjord

Norway

or

Pierre Fabre Médicament Production

Le Payrat

FR- 46000 Cahors

France

Last review date of this leaflet: January 2024