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OMACOR Omega3 28 Capsules
Over-the-counter medication

OMACOR Omega3 28 Capsules

€16.04 EXCL. VAT €17.64 INCL. VAT
In stock
Reference : 3400935702586
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OMACOR 28 Capsules Omega3 in our bio pharmacy

OMACOR Omega3 28 Capsules

Omega-3 ethyl esters

Description of OMACOR Omega3 28 Capsules

OMACOR soft capsule is indicated in the following situations:

  • post-myocardial infarction : adjuvant treatment for secondary prevention of myocardial infarction, in combination with reference treatments (including statins, antiplatelet agents, beta-blockers and angiotensin converting enzyme inhibitors);
  • endogenous hypertriglyceridemia , in addition to a regimen whose prescription alone has proved insufficient to provide an adequate response: type IV as monotherapy, type IIb / III in combination with statins, when triglyceride control is insufficient.

Directions for use and dosage

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 with meals in order to reduce the risk of digestive disorders.
  • Your doctor will decide the duration of treatment.

Dose to take after a heart attack:
The usual dose is 1 capsule per day.

Dose to take to treat high triglycerides in the blood (excessive amount of fat in the blood or hypertriglyceridemia):
The usual dose recommended by a doctor is 2 capsules per day. If the medicine does not work enough, your doctor may increase the dose to 4 capsules per day.

Composition of OMACOR Omega3 28 Capsules

OMACOR contains purified polyunsaturated fatty acids from the Omega-3 series.

Active ingredients : Ethyl esters of Omega 3 acids, Including ethyl esters of Eicosapentaenoic acid, Docosahexaenoic acid
Excipients : Soft capsule content: Alpha-tocopherol (E307), Soft capsule shell: Gelatin, Glycerol (E422), Purified water, Triglycerides, Lecithin (E322)

Precautions for use

This medication is NOT SUBJECT TO MEDICAL PRESCRIPTION

Presentation of OMACOR Omega3 28 Capsules

Box of 28 capsules

Our advice from pharmacy experts

OMACOR, soft capsule belongs to a class of drugs known to lower cholesterol and triglycerides.

This medication is used:

  • as additional treatment following a heart attack (myocardial infarction), in combination with other drugs.
  • in the treatment of certain forms of hypertriglyceridemia (excessive quantity of fats in the blood) when an adapted and assiduous diet plan has been found to be insufficient.

Cholesterol and triglycerides: what's the difference ?

  • Cholesterol comes from a third of dietary fat, the rest being produced directly by the liver. It enters the composition of cell membranes. It is also involved in the production of steroid hormones produced by the adrenal and genital glands.
  • Triglycerides result from the transformation by the liver of sugars and alcohol which we sometimes tend to abuse. Stored in fat cells, triglycerides provide us with energy when we need to support a prolonged effort or fight against the cold.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

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.

VIDAL OF THE FAMILY

OMACOR

hypolipémiant

Omega-3 acids

. Presentations . Composition . Indications . Attention . Drug interactions . Pregnancy and breastfeeding . Instructions for use and dosage . Tips . Side effects . Lexicon

PRESENTATIONS (summary)

OMACOR: soft capsule; box of 28.
Not refunded - Free price -

Pierre Fabre Laboratory Drug

COMPOSITION (summary)
p capsule
Ethyl esters of 90% omega-3 acids 1000 mg
Of which elcosapentaenoic acid (EPA) 460 mg
of which docosahexaenoic acid (DHA) 380 mg
Soya oil +

INDICATIONS (summary)
This medicine contains essential fatty acids that have the property to lower the level of triglycerides in the blood. It also slightly decreases the ability of the blood to clot.
It is used in the treatment of persistent excesses of triglycerides despite an adapted and diligent diet, and in addition to the reference treatments, in the prevention of recurrence of myocardial infarction .
ATTENTION (summary)
Precautions are necessary in case of serious haemorrhage (surgical intervention, trauma ...). Caution is also recommended in patients with renal impairment and those over 70 years of age (limited clinical data).
Blood tests ( transaminase assays) will be prescribed regularly in patients with liver disorders.
DRUG INTERACTIONS (summary)
Tell your doctor or pharmacist if you are taking oral anticoagulants .
PREGNANCY and BREASTFEEDING (summary)
The effect of this medicine during pregnancy or breastfeeding is poorly known: only your doctor can evaluate the possible risk of its use in your case.
DIRECTIONS AND DOSAGE (summary)
The capsules should be swallowed during meals, to avoid digestive disorders.

Usual dosage:

TIPS (summary)
The diet remains essential for the duration of the treatment.
A diet low in animal fat is not easy to follow: mistakes are common. Ask your doctor, pharmacist or nutrition professional for advice.
ADVERSE POSSIBLE EFFECTS (summary)
Frequent: constipation, diarrhea, abdominal pain, difficult digestion, flatulence, discharge, heartburn, nausea or vomiting.
Uncommon: nosebleeds, headache, dizziness, hypotension, taste disturbances, gout, hyperglycemia , gastrointestinal bleeding, rash.
Rarely: urticaria, elevation of transaminases .


LEXICON (summary)


anticoagulant
A drug that prevents blood from clotting and prevents clots from forming in the blood vessels.
Anticoagulants are used to treat or prevent phlebitis, pulmonary embolism, certain infarcts. They also help prevent clots in the heart during rhythm disorders such as atrial fibrillation or in case of artificial heart valve.
There are two main types of anticoagulants:
  • oral anticoagulants, which block the action of vitamin K (antivitamin K, or AVK) and whose effectiveness is controlled by a blood test: the INR (formerly TP);
  • injectable anticoagulants, derived from heparin, the effectiveness of which can be controlled by the blood determination of the anti-Xa activity, the Howell's Time (TH) or the Kaolin Cephalin Time (TCK) according to the products used. Regular dosing of blood platelets is necessary throughout the duration of use of a heparin derivative.


hemorrhage
Loss of blood from an artery or vein. Hemorrhage can be external, but also internal and go unnoticed.


hyperglycemia
Abnormal elevation of blood sugar (blood sugar).


myocardial infarction
Destruction of part of the heart muscle (myocardium), deprived of blood by obstruction of its arteries.


renal failure
Inability of the kidneys to eliminate waste or drug substances. Advanced renal failure does not necessarily result in a decrease in the amount of urine eliminated. Only a blood test and the determination of creatinine can reveal this disease.


transaminases
Enzymes dosed in the blood, the rate of which rises during certain hepatitis. They appear in blood tests under the name of SGOT and SGPT or ASAT and ALAT.


triglycerides
Fats circulating in the blood. They come mainly from the assimilation of fats, sugars and alcohol.

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