Patient Information Leaflet

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

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Omacor is and what it is used for
Important information before taking Omacor
How to take Omacor
Possible side effects
How to store Omacor
Contents of the pack and other information

1. What Omacor is and what it is 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:

in the treatment of certain types of disorders characterized by elevated levels of triglycerides (fats) in the blood, when dietary changes alone 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 must not take the medicine and should
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 surgery,
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 an irregular and very rapid heart rhythm (atrial fibrillation).

Omacor and other medicines
If the patient is taking medicines that prevent blood clots in arteries,
such as warfarin, additional blood tests may be required and the dose of anticoagulant medicines may need to be adjusted.
The patient should inform the doctor or pharmacist about all medicines currently used, recently taken, or planned to be taken.
Omacor with food and drink
Capsules should be taken during meals. This will help prevent gastrointestinal discomfort.
Elderly patients
Caution should be exercised when using Omacor in patients over 70 years of age.
Children
Omacor must not be used in children.
Pregnancy and breastfeeding
Omacor should not be used during pregnancy and breastfeeding unless the doctor decides it is absolutely necessary.
Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
It is unlikely that Omacor will affect 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 take this medicine.

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

Accidental overdose of Omacor
An accidental overdose of this medicine is unlikely to cause concern, as it usually does not require specific treatment. However, you should seek advice from 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 one at the regular 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
gastrointestinal 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 reported in a small number of people, but exact frequency 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 any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables further information on the safety of this medicine to be collected.

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.
Do not store above 25°C. Do not freeze.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 90.
1000 mg of omega-3 acid ethyl esters 90 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 α-tocopherol (mixed with a 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 pale yellow oil.
The pack contains 28 capsules.

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

Marketing authorisation holder in Spain, country of export:
BASF AS
P.O. Box 420
NO-1327 Lysaker
Norway

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

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in Spain, country of export: 873141.1
Parallel import authorisation number: 415/19