Omacor

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Omacor

1000 mg, soft capsules

Omega-3 acid ethyl esters 90

Read the 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 those not listed in this leaflet, please inform 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 statements apply 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 rhythm 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 blood-thinning medicines.
Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.

Omacor with food and drink

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

Elderly patients

Caution should be exercised when using Omacor in patients over 70 years of age.

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 problems.
• Your doctor will decide how long you should take this medicine.

Dosage 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 effect of the medicine is not sufficient, 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, consult 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 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, acid 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 the exact 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 inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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.
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 packaging. The expiry date refers to the last day of the month.
Store in a temperature below 25°C, in the original packaging. 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 of Omacor is omega-3 ethyl esters.
1000 mg of omega-3 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-α-tocopherol (mixed with vegetable 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 in the form of transparent, soft capsules containing a light yellow oil.
The pack contains 28 capsules.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the 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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Romania, the country of export: 9639/2017/01
Parallel import authorization number: 301/24

Date of approval of the leaflet: 24.07.2024

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