Package leaflet: Information for the patient

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 the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

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 give it to others. This medicine may harm others, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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 polyunsaturated omega-3 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 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 this medicine and must
contact their doctor.
Warnings and precautions
Before starting Omacor, consult a doctor or pharmacist:

if the patient is scheduled for or has recently undergone surgery,
if the patient has recently sustained an injury,
in case of impaired kidney function,
in case of uncontrolled diabetes,
in case of 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 problems,
if the patient experiences dizziness, weakness, palpitations, or shortness of breath, as these may be symptoms of an irregular and very rapid heartbeat (atrial fibrillation).

Omacor with other medicines
When taking medications 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 their doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines they plan to take.
Omacor with food and drink
Capsules should be taken during meals. This helps prevent gastrointestinal discomfort.
Elderly patients
Caution should be exercised when administering Omacor to patients over 70 years of age.
Children
Omacor should 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.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
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 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.
Missed 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 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 everyone 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 1,000 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 for which the 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 any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of 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 provide more information on the safety 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.
Do not store above 25°C. 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. These measures will help protect the environment.

6. Contents of the package and other information

What Omacor contains
The active substance is omega-3 acid ethyl esters.
1000 mg omega-3 acid ethyl esters 90 contains 460 mg eicosapentaenoic acid ethyl ester (EPA) and 380 mg docosahexaenoic acid ethyl ester (DHA)
(these substances are known as omega-3 polyunsaturated fatty acids).
Other components are:
Core: 4 mg all-rac-α-Tocopherol as antioxidant (mixed with a vegetable oil such as 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.
Pack sizes: 28 or 100 soft capsules.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Spain, the 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
46000 Cahors
France

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Spanish Marketing Authorisation numbers (country of export): 873141.1
873166.4
Parallel Import Licence number: 179/15