Omacor Capsules

Omacor is a capsule-based medication that belongs to a class of drugs designed to lower cholesterol and triglycerides.

It is particularly recommended for the treatment of certain forms of hypertriglyceridemia (excessive levels of fat in the blood) when a regular, appropriate diet has proven insufficient. This treatment must be combined with a suitable diet and may or may not be combined with other therapies.

Composition of Omacor Pierre Fabre Capsules

The active ingredients in Omacor capsules are omega-3 acid ethyl esters 90, known as polyunsaturated fatty acids of the Omega-3 series, at a dose of 1000 mg per softgel capsule, including:

eicosapentaenoic acid (EPA in ethyl ester form: 460 mg)
docosahexaenoic acid (DHA in ethyl ester form: 380 mg)

For a total dose of 840 mg of DHA + EPA

The capsules also include alpha tocopherol (blended with soybean oil) at a dose of 4 mg as an antioxidant.

The excipients are gelatin, glycerol, purified water, medium-chain triglycerides, and lecithin (soy).

Excipients with known effects are soybean oil, glycerol, and soy lecithin.

Dosage of Omacor Omega 3 1000 mg

You must strictly follow the dosage prescribed by your doctor.

For high blood triglyceride levels, the usual recommended dosage is 2 capsules per day. This dosage may exceptionally be increased to 4 capsules per day, if your doctor deems it necessary.

The capsules should be swallowed with a large glass of water and at mealtimes to reduce the risk of digestive problems.
If you accidentally take more of this medicine (overdose), consult your doctor or pharmacist for advice.
If you miss a dose, take it as soon as you remember, unless it is almost time for the next dose, in which case, take the next dose at the scheduled time (do not double the dose to make up for the missed one).

Duration of treatment with Omacor capsules

The duration of treatment with Omacor capsules is determined by the doctor.

Contraindications to the use of Omacor cholesterol triglycerides

Omacor has contraindications. It should not be used in cases of allergy/hypersensitivity to the active ingredient, peanuts or soy, fish, or any of the other ingredients it contains.

Precautions for use with Omacor

Omacor is a medication that should be used with caution in certain situations. Indeed, its use is not recommended for children.
It should be used with caution in people over 70 years of age.

Caution should be exercised with Omacor capsules in various situations: if you are about to undergo surgery or have recently undergone surgery, if you have recently had an injury, if you have kidney problems, if you have uncontrolled diabetes, or if you have liver problems.

If any of these apply to you, consult your doctor or pharmacist before using this medicine.

Omacor and anticoagulant medications

Tell your doctor or pharmacist about any other medication you are currently or recently taking.
If you are taking a medication to stop blood clots from forming in the arteries, such as warfarin, additional blood tests may be necessary and the usual anticoagulant dose may need to be adjusted due to the moderate increase in bleeding time (with the high dose of 4 softgels).

Omacor and heart disease

Patients with cardiovascular disease or cardiovascular risk factors who are taking Omega-3 ethyl esters have an increased risk of atrial fibrillation. If you experience symptoms of fibrillation such as palpitations, severe fatigue, shortness of breath, or dizziness, consult a doctor. In case of atrial fibrillation, treatment must be permanently discontinued.

Omacor, pregnancy and breastfeeding

Omacor capsules are not recommended during pregnancy and breastfeeding, unless your doctor deems it absolutely necessary.

Side effects of Omacor soft capsules

Omacor soft capsules may cause adverse effects. They may include:

Digestive problems such as nausea, vomiting, abdominal pain, a feeling of fullness, belching, heartburn, constipation, diarrhea, bloating, and gas;
Heart problems manifested by irregular and rapid heartbeat and a drop in blood pressure;
Nosebleeds, stool bleeding;
Dizziness, headache;
Skin rash, itching;
Loss of taste;
Gout;
Increased blood sugar levels;
Liver problems with changes in liver enzymes;
Allergic reactions

For further information, refer to the package leaflet. It should be read carefully before using Omacor capsules.

Packaging: Bottle of 28 softgel capsules

Pierre Fabre Laboratory also offers Percutaféine 5% gel to reduce excess fat.








LEAFLET
ANSM - Updated on: 01/03/2024
Name of the medicinal product
OMACOR 1000 mg, soft capsule
Omega-3 acid ethyl esters 90
Box
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
You must always take this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ask your pharmacist for advice or information.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to your doctor if you do not feel better or if you feel worse.
What is in this leaflet? 1. What is OMACOR 1000 mg soft capsule and what is it used for?
2. What you need to know before taking OMACOR 1000 mg soft capsule?
3. How to take OMACOR 1000 mg soft capsule?
4. Possible side effects?
5. How to store OMACOR 1000 mg soft capsule?
6. Contents of the pack and other information.
1. WHAT IS OMACOR 1000 mg soft capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic group - ATC code: C10AX06.
OMACOR contains purified polyunsaturated fatty acids of the Omega-3 series.
OMACOR belongs to a class of drugs known to lower cholesterol and triglycerides. This medication is used:
· in the treatment of certain forms of hypertriglyceridemia (excessive amounts of fat in the blood) when a suitable and consistent diet has proven insufficient.
2. WHAT YOU NEED TO KNOW BEFORE TAKING OMACOR 1000 mg, soft capsule?
Never take OMACOR 1000 mg, soft capsule:
· If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine, listed in section 6.
If any of these conditions apply to you, do not take this medicine and talk to your doctor. Warnings and Precautions
Talk to your doctor or pharmacist before taking OMACOR 1000 mg soft capsules:
· if you are due to have surgery or have recently had surgery,
· if you have recently had an injury,
· if you have kidney problems,
· if you have uncontrolled diabetes,
· if you have liver problems. Your doctor will perform blood tests to monitor the effects of this medicine on your liver.
· if you are allergic to fish.
· if you have or have had heart problems,
· if during treatment you experience dizziness (lightheadedness), extreme tiredness (asthenia), heart palpitations, or shortness of breath; these may be symptoms of atrial or atrial fibrillation (an irregular and often very rapid heartbeat).

Use in the Elderly
Use OMACOR with caution if you are over 70 years of age.
Use in children
The use of OMACOR is not recommended in children.
Other medicines and OMACOR 1000 mg soft capsules
If you are taking a medicine to stop blood clots from forming in your arteries, such as warfarin, you may need to have additional blood tests and adjust your usual dose of anticoagulant.
If you are taking or have recently taken any other medicine, including medicines obtained without a prescription, talk to your doctor or pharmacist.
OMACOR 1000 mg soft capsules with food and drink
It is recommended to take the capsules with meals to reduce the risk of digestive upset (gastrointestinal side effects).
Pregnancy and breastfeeding
It is not recommended to take this medicine during pregnancy and breastfeeding, unless your doctor considers it absolutely necessary.
Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines
This medicine is unlikely to affect your driving or the use of tools and machines.
OMACOR 1000 mg soft capsules contain soybean oil.
If you are allergic to peanuts or soybeans, do not use this medicine.
3. HOW TO TAKE OMACOR 1000 mg soft capsules?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
Swallow the capsules with a glass of water.
It is recommended to take the capsules with meals to reduce the risk of digestive problems.
Your doctor will decide how long you should take the medicine.
Dose to treat high blood triglyceride levels (excessive amounts of fat in the blood or hypertriglyceridemia):
The usual dose recommended by a doctor is 2 capsules per day. If the medicine is not working well enough, your doctor may increase the dose to 4 capsules per day.
If you take more OMACOR 1000 mg soft capsules than you should:
If you accidentally take more of this medicine than you should, don't worry as it is unlikely to require any special treatment.
However, you should consult your doctor or pharmacist for advice.
If you forget to take OMACOR 1000 mg soft capsules:
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 usual time.
Do not take a double dose (twice the dose recommended by your doctor) to make up for a forgotten dose.
If you stop taking OMACOR 1000 mg soft capsules:
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Common side effects (affects less than 1 in 10 people)
· irregular and rapid heartbeat (atrial or atrial fibrillation)
· digestive disturbances including abdominal distension, abdominal pain, constipation, diarrhea, intestinal gas, stomach disturbances with a feeling of fullness (dyspepsia), belching, heartburn (gastroesophageal reflux disease), nausea and vomiting
Uncommon side effects (affects less than 1 in 100 people)
· high blood sugar
· gout
· dizziness
· loss or change in sense of taste
· headache
· low blood pressure
· nosebleed
· blood in your stool
· rash
Rare side effects (affects less than 1 in 1,000 people)
· allergic reactions
· itchy rash (hives)
· liver problems, with possible changes in the results of certain tests of blood (liver enzymes)
Other side effects have occurred in a very small number of people, but their exact frequency is unknown.
· itching
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr/
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE OMACOR 1000 mg, soft capsule?
Keep this medicine out of the sight and reach of children.
Do not use OMACOR after the expiry date shown on the carton and bottle. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What OMACOR 1000 mg softgel capsules contain
· The active ingredients are:
Omega-3 Acid Ethyl Esters 90 ........................................................................ 1000 mg
Containing 840 mg of eicosapentaenoic acid (EPA, as ethyl ester: 460 mg) and docosahexaenoic acid (DHA, as ethyl ester: 380 mg)
Per softgel capsule. The active ingredients are called "omega-3 polyunsaturated fatty acids."
· Other ingredients are:
Alpha-tocopherol (antioxidant that can be mixed with soybean oil).
Capsule shell: gelatin, glycerol, purified water, medium-chain triglycerides, lecithin (soy).
What OMACOR 1000 mg softgel capsule looks like and contents of the outer packaging
This medicine comes in the form of oblong, transparent gelatin softgel capsules containing a pale yellow oil.
Boxes of 20, 28, 30, 60, 10 x 28, or 100 softgel capsules.
Not all pack sizes may be marketed. Marketing Authorization Holder
BASF AS
PO BOX 420
1327 LYSAKER
NORWAY
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
Parc Industriel de la Chartreuse
81100 CASTRES
Manufacturer
BASF AS
FRAMNESVEIEN 41
3222 SANDEFJORD
NORWAY
or
PIERRE FABRE MEDICAMENT PRODUCTION
LE PAYRAT
46000 CAHORS
FRANCE
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names: In accordance with current regulations. [To be completed later by the holder]
This leaflet was last revised:
[To be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM (France) website.