NOTICE
ANSM - Updated: 07/11/2017
Name of the drug
ETHYL ESTERS OF ACIDS OMEGA 3 EG LABO TIP 1 g soft capsule
Ethyl esters of 90% Omega-3 acids
framed
Read this leaflet carefully before this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse
Do not let this medicine within the reach of children.
What does this booklet contain ?
1. What is ETHYLIC ACID ESTERS OMEGA 3 EG LABO TIP 1 g soft capsule and in what cases is it used?
2. What you need to know before taking ETHYLIC ACID ESTERS OMEGA 3 EG LABO TIP 1 g soft capsule?
3. How to take ESTERS ETHYLIC ACIDS OMEGA 3 EG LABO TIP 1 g soft capsule?
4. What are the possible side effects?
5. How to store ETHYLIC ACID ESTERS OMEGA 3 EG LABO TIP 1 g soft capsule?
6. Contents of the package and other information.
1. WHAT ETHYL ESTERS OF ACIDS OMEGA 3 EG LABO TIP 1 g soft capsule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Omega-3 triglycerides including other esters and acids and hypotriglyceridemic agents, ATC code: C10AX06
OMEGA-3 EG LABO BOARD ETHYL ESTERS contains purified polyunsaturated fatty acids from the Omega-3 series.
ETHYL ESTERS OF ACIDS OMEGA-3 EG LABO BOARD belongs to a class of drugs known to lower cholesterol and triglycerides.
This medicine is used:
· as a complementary treatment following a heart attack (myocardial infarction), in combination with other medications;
· in the treatment of certain forms of hypertriglyceridemia (excessive amount of fats in the blood) when a diet adapted and diligent diet proved insufficient.
2. WHAT YOU SHOULD KNOW BEFORE TAKING ETHYLIC ESTERS FROM OMEGA 3 EG LABO BOARD ACIDS 1 g soft capsule?
Do not take ESTERS ETHYLIC ACIDS OMEGA 3 EG LABO TIP 1 g soft capsule:
· if you are allergic (hypersensitive) to the active substance or peanut or soy because of the presence of soybean oil or any of the other ingredients of this medicinal product mentioned in Item 6.
If you are affected by any of these situations, do not take this medicine and talk to your doctor.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking OMEGA 3 EG LABO BOARD ETHYLIC ESTERS 1 g soft capsule .
· if you have to undergo surgery or have had one recently;
· if you have had a recent injury
· if you have problems with your kidneys
· 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 have any of these conditions, talk to your doctor or pharmacist before taking this medicine.
Use in the elderly
Use ESTERS ETHYLIC ACIDS OMEGA 3 EG LABO TIP with caution if you are over 70 years old.
children
The use of ETHYLIC ACID ESTERS OMEGA-3 EG LABO CONSEIL is not recommended in children.
Other medicines and ETHYLIC ACID ESTERS OMEGA 3 EG LABO BOARD 1 g soft capsule
If you take a medicine to stop blood clot formation without your arteries, such as warfarin, it may be necessary to perform additional blood tests and adjust your usual dose of anti-coagulant.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
ETHYL ESTERS OF ACIDS OMEGA 3 EG LABO TIP 1 g soft capsule with food, drinks and alcohol
It is recommended to take the capsules during meals to reduce the risk of digestive disorders (gastrointestinal side effects).
Pregnancy and breast feeding
It is not recommended to take this medicine during pregnancy and lactation unless your doctor deems it absolutely necessary.
Ask your doctor or pharmacist for advice before taking any medicine. .
Driving and using machines
This medication is unlikely to affect your driving or the use of tools and machinery.
ETHYLIC ESTERS OF OMEGA ACIDS 3 EG LABO BOARD 1 g soft capsule contains soybean oil
If you are allergic to peanut or soy, do not use this medicine.
3. HOW TO TAKE ESTERS ETHYLIC ACIDS OMEGA 3 EG LABO TIP 1 g soft capsule?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
· Swallow the capsules with a glass of water;
· it is recommended to take the capsules during meals to reduce the risk of digestive disorders;
· your doctor will decide on the duration of the treatment.
Dose to take for after a heart attack:
The usual dose is 1 capsule daily.
Dose to treat blood levels of high triglycerides (excessive amount of fat in the blood or hypertriglyceridemia):
The usual dose recommended by a doctor is 2 capsules a day. If the medicine does not work enough, your doctor may increase the dose to 4 capsules a day.
IF YOU HAVE TAKEN MORE ETHYLIC ACID ESTERS OMEGA 3 EG LABO BOARD 1 g soft capsule than you should:
If you accidentally take more of this medicine than you should, do not worry because it is unlikely that this will require special treatment.
Immediately consult your doctor or pharmacist.
If you forget to take ETHYLIC ACID ESTERS OMEGA 3 EG LABO TIP 1 g soft capsule:
If you forget to take a dose, take it as soon as you remember, unless it is almost time to take the next dose. In this case, take the next dose at the usual time.
Do not take a double dose to make up for the dose you forgot to take.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse for more information.
If you stop taking ETHYLIC ACID ESTERS OMEGA 3 EG LABO TIP 1 g soft capsule:
Not applicable.
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 (occurring in less than 1 patient in 10)
· digestive disorders including abdominal distension, abdominal pain, constipation, diarrhea, intestinal gas, digestive disorders of the stomach with feeling of overflow (dyspepsia), belching, heartburn (gastro-oesophageal reflux) nausea and vomiting.
Uncommon side effects (occurring in less than 1 in 100 patients)
· high blood sugar level ;
· drop;
· vertigo;
· loss or modification of taste;
· headache ;
· low blood pressure;
· nosebleed ;
· blood in your stool;
· rash.
Rare side effects (occurring in less than 1 in 1000 patients)
· allergic reactions;
· transient pink or red rash with burning sensation (hives);
· liver disorders, with possible changes in the results of some blood tests (liver enzymes).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned 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: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE ESTERS ETHYLIC ACIDS OMEGA 3 EG LABO TIP 1 g soft capsule?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer carton and vial. The expiry date refers to the last day of this month.
After first opening of the bottle: 100 days
Store at a temperature not exceeding 25 ° C. Do not refrigerate or freeze.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What's in ETHYLIC ACID ESTERS OMEGA 3 EG LABO BOARD 1 g soft capsule
· The active substances are:
90% omega-3 fatty acid ethyl esters ...................................... ............................ 1,000 mg
of which mainly 840 mg of ethyl esters:
Elcosapentanoic acid (EPA) ............................................. ............................................... 460 mg
Docosahexaenoic acid (DHA) ............................................. ............................................... 380 mg
For a soft capsule.
· The other components are:
Content of the soft capsule : Alpha-tocopherol (antioxidant that can be mixed with soybean oil).
Soft capsule shell : Gelatin, glycerol, purified water, medium chain triglycerides, sunflower lecithin.
What is ESTERS ETHYLIC ACIDS OMEGA 3 EG LABO TIP 1 g soft capsule and contents of the pack
This medicine is in the form of a soft capsule.
Bottle of 20, 28, 30, 60, 100 or 10x28 soft capsules.
Not all presentations may be marketed.
Marketing Authorization Holder
EG LAB - LABORATORIES EUROGENERICS
THE QUINTET - BUILDING A
12 DANJOU STREET
925175 BOULOGNE-BILLANCOURT CEDEX
LA FRANCE
Operator of the marketing authorization
EG LAB - LABORATORIES EUROGENERICS
THE QUINTET - BUILDING A
12 DANJOU STREET
925175 BOULOGNE-BILLANCOURT CEDEX
LA FRANCE
Maker
ONE PHARMA INDUSTRIAL PHARMACEUTICAL COMPANY
60TH KM NNR ATHINON-LAMIAS
320 09 SXIMATARI, VOIOTIAS
GREECE
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
Other
Not applicable.