Omacor

Patient Information Leaflet: Instructions for Use

Warning! Keep this leaflet. 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 the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents:

1. What Omacor is and what it is 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 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 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 should not take the medicine and must
contact their doctor.
Warnings and precautions
Before starting treatment with Omacor, consult a doctor or pharmacist:

• if the patient is planning or has recently undergone surgery,
• if the patient has recently suffered 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 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 medicines 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 should inform their doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Omacor with food and drink
The capsules should be taken during meals. This will help 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 while 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 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 should 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 during 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 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.

Accidental overdose of Omacor
An accidental overdose of this medicine should not 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
• headaches
• 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 patients, but with unknown frequency:

• 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 those not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can 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
Phone: +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 safety of the medicine.

5. How to store the medicine Omacor

Keep the medicine out of the sight and reach of
children.
Store below 25°C in the original packaging. Do not freeze.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Omacor contains
The active substance in this medicine 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).
Other components are:
Capsule core: 4 mg D-α-tocopherol as an antioxidant (mixed with a vegetable oil, e.g. soybean oil).
Capsule shell: gelatin, glycerol, purified water, fractionated coconut oil, lecithin (soy), isopropyl alcohol, anhydrous ethanol.

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

For further information, please contact the responsible party or the parallel importer.

Responsible party in Romania, country of export:
BASF AS
Lilleakerveien 2B
NO-0283 Oslo
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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Authorization number in Romania, country of export: 9639/2017/01
Parallel import authorization number: 298/22