Omacor 1000 mg soft capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Omacor 1000 mg soft capsules
Omega-3 fatty acid ethyl esters 90
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
-
Keep this leaflet, as you may need to read it again.
-
If you have any questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
-
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Omacor is and what it is used for
- What you need to 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 polyunsaturated fatty acids.
Omacor belongs to a group of medicines called "Other cholesterol- and triglyceride-lowering agents."
Omacor is indicated:
- for the treatment of certain cases of high levels of triglycerides (fats) in the blood when dietary changes have not been effective.
2. BEFORE TAKING OMACOR
Do not take Omacor
- if you are allergic (hypersensitive) to the active substance or to any of the other components of Omacor (listed in section 6: Contents of the pack and other information).
In any of the above situations, do not take this medicine and inform your doctor.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Omacor:
- if you are scheduled for or have recently undergone surgery
- if you have recently suffered any trauma
- if you have kidney problems
- if you have uncontrolled diabetes
- if you have liver problems. Your doctor will monitor possible effects of Omacor on the liver through blood tests
- if you are allergic to fish
- if you have or have had heart problems
- if you experience dizziness, weakness, palpitations, or difficulty breathing, as these may be symptoms of an irregular and often very rapid heart rhythm (atrial fibrillation)
Use of Omacor with other medicines
If you are taking medications to prevent blood clots in the arteries, such as warfarin, you may require additional blood tests and an adjustment of your usual anticoagulant dose.
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.
Taking Omacor with food and drink
You should take the capsules with meals. This helps reduce the likelihood of adverse effects in the internal area of the stomach and surrounding gastrointestinal area.
Elderly
If you are over 70 years old, use Omacor with caution.
Children:
Children must not take this medicine.
Pregnancy and breastfeeding
Omacor must not be used during pregnancy or breastfeeding unless your doctor considers it absolutely necessary.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.
Omacor contains soybean oil. Do not use this medicine if you are allergic to peanuts or soy.
3. HOW TO TAKE OMACOR
Follow exactly the administration instructions for Omacor provided by your physician. Consult your doctor or pharmacist if you have any doubts.
- Take the capsules with water.
- You may take the capsules with meals to help reduce gastrointestinal effects.
- Your doctor will determine the duration of treatment.
Dosage for treating high blood triglyceride levels (high blood fat levels or hypertriglyceridemia)
The usual dose is 2 capsules per day, as recommended by your doctor.
If the medicine is not working adequately at this dose, your doctor may increase the dose up to 4 capsules per day.
If you take more Omacor than you should
If you have accidentally taken more Omacor than you should, there is generally no need for concern, as it is unlikely that special treatment will be required. However, you should contact your doctor or pharmacist for further advice.
If you forget to take Omacor
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose, in which case it is better to wait and take the next dose at the usual time. Do not take a double dose (twice the dose recommended by your doctor) to make up for a missed dose.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Omacor can cause adverse effects, although not everyone will experience them. The possible adverse effects of this medicine are listed below:
Frequent (may affect up to 1 in 10 people):
-
irregular and rapid heart rate
-
stomach problems such as abdominal distension, pain, constipation, diarrhoea, indigestion (dyspepsia), gas, belching, acid reflux, feeling sick (nausea), and vomiting
Uncommon (may affect up to 1 in 100 people):
- increased blood sugar levels
- gout
- dizziness
- altered taste
- headache
- low blood pressure
- nosebleeds
- blood in the stools
- rash
Rare (may affect up to 1 in 1,000 people):
- allergic reactions
- itchy rash (hives or urticaria)
- liver disorders with possible changes in the results of certain blood tests
Other adverse effects have been reported in a very small number of people, but their exact frequency is unknown.
- itching
Reporting of adverse effects
If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of OMACOR
- Keep this medicine out of the sight and reach of children.
- Do not use Omacor after the expiry date stated on the carton and label. The expiry date refers to the last day of the month indicated.
- Do not store above 25°C. Do not freeze.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Omacor
The active substances are omega-3 fatty acid ethyl esters,
1000 mg of omega-3 fatty acid ethyl esters 90 containing 460 mg of eicosapentaenoic acid ethyl ester (EPA), 380 mg of docosahexaenoic acid ethyl ester (DHA) (these substances are known as omega-3 polyunsaturated fatty acids), and including 4 mg of d-alpha-tocopherol (mixed with vegetable oil, e.g. soybean oil) as antioxidant.
The capsule shell is composed of gelatin, glycerol, medium-chain triglycerides, lecithin (soy), and purified water.
Appearance of the product and contents of the pack
Omacor capsules are soft gelatin capsules, transparent, containing a light yellow oil.
Omacor is available in the following pack sizes:
- 1 x 20 capsules
- 1 x 28 capsules
- 1 x 30 capsules
- 1 x 60 capsules
- 1 x 100 capsules
- 10 x 28 capsules
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
The Marketing Authorization Holder of Omacor is:
BASF AS
PO Box 420
NO-1327 Lysaker
Norway
Manufacturer
BASF AS
Framnesveien 41
NO-3222 Sandefjord
Norway
or
Pierre Fabre Médicament Production
Le Payrat
FR-46000 Cahors
France
Date of the most recent revision of this leaflet: January 2024