Omacor
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
Warning! Keep the 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 following instructions carefully before using this medicine, as they contain
important information for the patient.
- Keep this leaflet for future reference.
- 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 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
- What you should know 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 fatty acid ethyl esters.
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 not been sufficient.
2. Information before taking Omacor
When not to take Omacor:
- if the patient is allergic to the active substance or any of the other ingredients of this medicine, Omacor (see section 6: Contents of the pack and other information).
If any of the above apply, do not take the medicine and contact your doctor.
Warnings and precautions
Before starting Omacor, consult your doctor or pharmacist:
- if you are scheduled for, or have recently undergone, a surgical procedure
- if you have recently suffered an injury
- if you have impaired kidney function
- if you have uncontrolled diabetes
- if you have impaired liver function. 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 disorders in the past
- if you experience dizziness, weakness, palpitations or shortness of breath, as these may be symptoms of an irregular and very rapid heart rhythm (atrial fibrillation)
Omacor with other medicines
If you are taking medicines that prevent blood clots in arteries, such as warfarin, additional blood tests and dose adjustments of anticoagulant medicines may be required.
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
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 your doctor decides it is absolutely necessary.
Consult your 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 you are allergic to peanuts or soya, do not take Omacor.
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 food 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 prescribed by your doctor.
If the treatment effect is insufficient, your doctor may increase the dose to four capsules daily.
Accidentally taking more Omacor than prescribed
Accidental overdose should not cause concern, as it usually does not require special 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 effects
Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The following adverse effects may occur during treatment with Omacor:
Common adverse effects (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 effects (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 effects (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 effects which occurred in a small number of people, but their exact frequency is unknown:
- itching
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any adverse effects, including those not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 effects helps to provide more information on the safety of this medicine.
5. How to store Omacor
Keep this 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 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 in Omacor is omega-3 acid ethyl esters 90.
1000 mg of omega-3 acid 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 known as omega-3 polyunsaturated fatty acids), and as an antioxidant, 4 mg of all-rac-α-Tocopherol (mixed with 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.
Packaging contains 28 or 100 soft capsules.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland
Marketing Authorization Number in Spain, country of export: 873141.1
873166.4
Parallel Import Authorization Number: 437/22