OMACOR 1000 mg SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the User

Omacor 1000 mg Soft Capsules

Ethyl esters of omega-3 fatty acids 90

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not pass it on to others, as it may harm them, even if their symptoms are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Omacor and what is it used for
2. What you need to know before taking Omacor
3. How to take Omacor
4. Possible side effects
5. Storage of Omacor
6. Contents of the pack and further 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 called “Other agents reducing cholesterol and triglycerides”.

Omacor is indicated:

• for the treatment of certain cases of high triglyceride levels (fats) in the blood when dietary changes have not worked.

2. BEFORE TAKING OMACOR

Do not take Omacor

• if you are allergic (hypersensitive) to the active substance or any of the other ingredients of Omacor (listed in section 6: Contents of the pack and further 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 going to undergo or have recently undergone surgery
• if you have recently suffered any 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, weakness, palpitations, or difficulty breathing, as these may be symptoms of an irregular and often very fast heart rhythm (atrial fibrillation)

Using Omacor with other medicines

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

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines, including those obtained without a prescription.

Taking Omacor with food and drinks

You should take the capsules during meals. This helps reduce the likelihood of side effects in the stomach and surrounding area (gastrointestinal area).

Elderly

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 using machines

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

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

3. HOW TO TAKE OMACOR

Follow exactly the administration instructions of Omacor 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 effects.
• Your doctor will indicate the duration of the treatment.

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

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

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

If you take more Omacor than you should

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

If you forget to take Omacor

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose, in which case you should wait until the next dose. Do not take a double dose (twice the dose recommended by your doctor) to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, Omacor can cause side effects, although not everybody gets them. The following are possible side effects that may occur with this medicine:

Common (may affect up to 1 in 10 people):

• irregular and fast heart rhythm

):

• stomach problems such as abdominal distension, pain, constipation, diarrhea, indigestion (dyspepsia), gas, belching, acid reflux, feeling of nausea, and vomiting

Uncommon (may affect up to 1 in 100 people):

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

Rare (may affect up to 1 in 1000 people):

• allergic reactions
• itchy rash (hives or urticaria)
• liver disorders with possible changes in some blood test results

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

• itching

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website (www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of OMACOR

• Keep this medicine out of the sight and reach of children.
• Do not use Omacor after the expiry date stated on the carton and label. The expiry date is 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. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Omacor

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

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

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

Appearance and packaging of the product

Omacor capsules are soft gelatin capsules, transparent, containing a light 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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

The marketing authorisation holder for Omacor is:

BASF AS

PO Box 420

NO-1327 Lysaker

Norway

Manufacturer

BASF AS

Framnesveien 41

NO-3222 Sandefjord

Norway

or

Pierre Fabre Médicament Production

Le Payrat

FR- 46000 Cahors

France

Date of last revision of this leaflet: January 2024