Omacor

Patient Information Leaflet

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Omacor
1000 mg, soft capsules
Omega-3 acidorum esteri ethylici 90
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Omacor is and what it is used for
2. What you need to know 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 Omacor is and what it is used for

Omacor contains highly purified polyunsaturated omega-3 fatty acids.
Omacor belongs to a group of medicines that lower blood cholesterol and triglyceride levels.
Omacor is used:

• in the treatment of certain types of disorders characterized by elevated levels of triglycerides (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 to any of the other ingredients of Omacor (see section 6: Contents of the pack and other information)

If any of the above apply, the patient should not take the medicine and must
contact a doctor.
Warnings and precautions
Before starting treatment with Omacor, consult a doctor or pharmacist:

• if the patient is scheduled for or has recently undergone surgical procedures
• if the patient has recently suffered an injury
• if the patient has impaired kidney function
• if the patient has uncontrolled diabetes
• if the patient has impaired liver function. 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 previously 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 with other medicines
When taking medications that prevent blood clotting in arteries,
such as warfarin, additional blood tests may be required and the dose of anticoagulant medicines may need to be adjusted.
The patient must inform the doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines planned for use.
Omacor with food and drink
Capsules should be taken during meals. This will help prevent gastrointestinal discomfort.
Elderly patients
Caution is advised when administering Omacor to patients over 70 years of age.
Children
Omacor must not be used in children.
Pregnancy and breastfeeding
Omacor should not be used during pregnancy or breastfeeding, unless the doctor decides it is absolutely necessary.
Consult a doctor or pharmacist before taking any medicine.
Driving and using machines
It is unlikely that Omacor affects the ability to drive or operate tools or machinery.
Omacor contains soya oil
Omacor contains soya oil. If the patient is allergic to peanuts or soya, Omacor must not be used.

3. How to take Omacor

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

• Swallow the capsules with water.
• The capsules may be taken with meals to avoid gastrointestinal discomfort.
• Your doctor will decide how long you should continue taking this medicine.

Dosage for high blood triglyceride levels (high blood fat levels or hypertriglyceridemia)
The usual dose is two capsules per day, as prescribed by your doctor.
If the effect of the medicine is insufficient, your doctor may increase the dose to four capsules per day.

Accidentally taking more Omacor than prescribed
Accidental overdose of this medicine should not cause concern, as it usually does not require specific treatment. However, you should consult your doctor or pharmacist.

If you forget to take Omacor
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and take the next dose at the scheduled time. Do not take a double dose (twice the prescribed amount) to make up for a missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur during treatment with Omacor:
Common adverse reactions (may occur in up to 1 in 10 people):

• irregular, rapid heartbeat
• stomach problems such as bloating, pain, constipation, diarrhoea, indigestion (dyspepsia), gas, belching, gastric reflux, nausea and vomiting

Uncommon adverse reactions (may occur in up to 1 in 100 people):

• high blood sugar levels
• gout
• dizziness
• taste disturbances
• headache
• low blood pressure
• nosebleeds
• presence of blood in stool
• rash

Rare adverse reactions (may occur in up to 1 in 1000 people):

• hypersensitivity reactions
• itchy rash (urticaria)
• liver disorders with possible changes in laboratory test results

Other adverse reactions which occurred in a small number of people, but their exact frequency is unknown:

• itching

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reactions, including those not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Omacor

Keep this medicine out of 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 stated month.
Store below 25 °C, in the original packaging. Do not freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps 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 90 omega-3 acid ethyl esters contains 460 mg of eicosapentaenoic acid ethyl ester (EPA) and 380 mg of docosahexaenoic acid ethyl ester (DHA) (these substances are known as omega-3 polyunsaturated fatty acids), and as an antioxidant, 4 mg of D-ɑ-tocopherol (mixed with plant oil, e.g. soybean oil).
Capsule shell: gelatin, glycerol, purified water, lecithin (soy), fractionated coconut oil, isopropyl alcohol, anhydrous ethanol.

What Omacor looks like and contents of the pack
Omacor is available as transparent soft capsules containing a pale yellow oil.
The pack contains 28 capsules.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Romania, country of export:
BASF AS
Lilleakerveien 2B
0283 Oslo
Norway

Manufacturer:
BASF AS
Framnesveien 41
3222 Sandefjord
Norway
PIERRE FABRE MÉDICAMENT PRODUCTION
Le Payrat
46000 Cahors
France

Parallel importer:
TDF SA
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing authorisation number in Romania, country of export: 9639/2017/01
Parallel import authorisation number: 301/24