NOTICE
ANSM - Updated: 15/07/2015
Name of the drug
OMACOR 1000 mg soft capsule
Ethyl esters 90 of Omega-3 acids
framed
Read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have further questions, if you are not sure, ask your doctor or pharmacist for more information.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, talk to your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Summary notice
In this leaflet :
1. WHAT OMACOR 1000 mg soft capsule AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE OMACOR 1000 mg,
soft capsule?
3. HOW TO TAKE OMACOR 1000 mg, soft capsule?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE OMACOR 1000 mg, soft capsule?
6. ADDITIONAL INFORMATION
1. WHAT OMACOR 1000 mg soft capsule AND WHAT IT IS USED FOR
Pharmacotherapeutic class
OMACOR contains purified polyunsaturated fatty acids from the Omega-3 series.
Therapeutic indications
OMACOR belongs to a class of drugs called cholesterol lowering 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 dietary regime adapted and diligent was found to be insufficient.
2. BEFORE YOU TAKE OMACOR 1000 mg soft capsule?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not 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 (see section "Important information about selected OMACOR components " and section 6 "Additional information" ).
If you are affected by any of these situations, do not take this medicine and talk to your doctor.
Precautions for use; special warnings
Take special care with OMACOR 1000 mg soft capsule:
· if you have to undergo surgery or if you have had one recently,
· if you have had a recent 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 have any of these conditions, talk to your doctor or pharmacist before taking this medicine.
Use in the elderly
Use OMACOR with caution if you are over 70 years old.
Use in children
The use of OMACOR is not recommended for children.
Interactions with other drugs
Taking or using other medicines
If you take a medicine to stop blood clot formation in your arteries, such as warfarin, it may be necessary to perform additional blood tests and adjust your usual dose of anticoagulant.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
Interactions with food and drinks
Food and drinks
It is recommended to take the capsules during meals to reduce the risk of digestive disorders (gastrointestinal side effects).
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
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.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
This medication is unlikely to affect your driving or the use of tools and machinery.
List of excipients with known effect
Important information about some of the ingredients of OMACOR 1000 mg soft capsule
OMACOR soft capsule may contain soybean oil. If you are allergic to peanut or soy, do not use this medicine.
3. HOW TO TAKE OMACOR 1000 mg, soft capsule?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Always take the dose recommended by your doctor. If in doubt, consult your doctor or pharmacist.
· 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 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.
Symptoms and instructions in case of overdose
If you take more OMACOR 1000 mg, 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.
However, you should consult your doctor or pharmacist for advice.
Instructions for omitting one or more doses
If you forget to take OMACOR 1000 mg, 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 (twice the dose recommended by your doctor) 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 or pharmacist for more information.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, OMACOR 1000 mg soft capsule 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
· dizziness
· loss or change 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 rash pink or red 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 OMACOR 1000 mg, soft capsule?
Keep out of sight and reach of children.
Expiration date
Do not use OMACOR after the expiry date which is stated on the carton and vial. The expiry date refers to the last day of this month.
Storage conditions
Store at a temperature not exceeding 25 ° C. Do not freeze.
If necessary, warn against some visible signs of deterioration
Medications should not be thrown away to the sewer or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does OMACOR 1000 mg, soft capsule contain?
The active substances are :
Ethyl esters 90 of Omega-3 acids ......................................... .................................................. 1,000 mg
Comprising 840 mg of eicosapentaenoic acid (EPA, in the form of ethyl ester: 460 mg) and docosahexaenoic acid (DHA, in the form of ethyl ester: 380 mg).
For a soft capsule.
The active substances are called "polyunsaturated fatty acids of the Omega-3 series".
The other components are :
Alpha-tocopherol (antioxidant that can be mixed with soybean oil),
Soft capsule shell : gelatin, glycerol, purified water, medium chain triglycerides, lecithin (soy).
Pharmaceutical form and content
What is OMACOR 1000 mg soft capsule and contents of the pack?
This medicine comes in the form of an oblong, transparent gelatin soft capsule containing a pale yellow oil.
Box of 20, 28, 30, 60, 10 x 28 or 100 soft capsules.
Not all presentations may be marketed.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
PRONOVA BIOPHARMA NORGE AS
PO BOX 420
1327 LYSAKER
NORWAY
exploiting
PIERRE FABRE MEDICAMENT
45 place abel gance
92100 BOULOGNE
Maker
PRONOVA BIOPHARMA NORGE AS
lilleakerveien 2 c
0283 oslo
NORWAY
or
PIERRE FABRE MEDICAMENT PRODUCTION
45, PLACE ABEL GANCE
92100 BOULOGNE
Names of the drug in the member states of the European Economic Area
This medicine is authorized in the member states of the European Economic Area under the following names:
In accordance with the regulations.
Date of approval of the notice
The last date this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the Ansm (France) website.
Information reserved for health professionals
Not applicable.
Other
Not applicable.