Omacor

Package Leaflet: Information for the Patient

Omacor

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

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

• Keep this leaflet, 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. 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 any not listed in this leaflet, please 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. Contents of the pack 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 you are allergic to the active substance or any of the other ingredients of Omacor (see section 6: Contents of the pack and other information)

If any of the above applies to you, do not take the medicine and consult your doctor.

Warnings and precautions

Before taking Omacor, consult 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
• if you have or have had heart disorders
• if you experience 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

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 your blood-thinning medicines.
Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take.

Omacor with food and drink

Capsules should be taken with meals. This will help avoid stomach and gastrointestinal upset.

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 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 with meals to avoid gastrointestinal upset.
• 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 have the desired effect, 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, you should consult your doctor or pharmacist.

Missing a 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 during treatment with Omacor:

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

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

Uncommon side effects (may affect 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 affect up to 1 in 1,000 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 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, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this 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 carton and label.
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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Omacor contains

The active substance is omega-3 acid ethyl esters.
1000 mg of omega-3 acid 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 contents of the pack

Omacor is available as transparent, soft capsules containing a light yellow oil.
The pack contains 20, 28, or 100 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder:

BASF AS
Lilleakerveien 2B
NO-0283 Oslo
P.O. Box 420; NO-1327 Lysaker
Norway

Manufacturer:

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