Omacor

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

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Preparatomtale Preparatomtale (SPC)
27-04-2024

Aktiv ingrediens:

Omega-3-acid ethyl esters 90

Tilgjengelig fra:

Abbott Australasia Pty Ltd

Klasse:

Medicine Registered

Informasjon til brukeren

                                OMACOR
®
 CAPSULES
 
_Omega-3-acid ethyl esters 90 (includes EPA & DHA)_
CONSUMER MEDICINE INFORMATION (CMI)
   
 
 
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Omacor.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Omacor
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT OMACOR IS USED
FOR
Omacor reduces the risk of
experiencing another heart attack in
people who have already had a heart
attack.
Omacor is also used, along with a
low - fat and low - cholesterol diet, to
lower very high triglycerides (fats) in
blood. High levels of triglycerides
may increase your risk of developing
coronary heart disease. In most
people there are no symptoms of high
triglycerides. Your doctor can
measure your triglyceride levels with
a simple blood test.
_HOW OMACOR WORKS_
Omacor contains highly purified
omega-3 polyunsaturated fatty acids.
These fatty acids are natural
substances that your body needs in
sufficient amounts to provide energy.
However as the body cannot make
enough on its own, the balance needs
to be obtained in the diet. Omega-3
fatty acids are found naturally in
some oily marine fish.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY OMACOR HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
There is no evidence that this
medicine is addictive.
Omacor is only available with a
doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE OMACOR IF YOU ARE
ALLERGIC TO IT OR TO ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
•
Symptoms of an allergic reaction
may include skin rash, itching,
difficulty breathing or swelling of
the face.
DO NOT TAKE IT IF THE PACKAGING IS
TORN OR SHOWS SIGNS OF TAMPERIN
                                
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Preparatomtale

                                Omacor PI 
Version 1 
Page 1  
 
PRODUCT INFORMATION 
OMACOR
®
  
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Eicosapentaenoic acid (EPA) ethyl ester.  
Docosahexaenoic acid (DHA) ethyl ester. 
CHEMICAL STRUCTURE 
Eicosapentaenoic acid (EPA) ethyl ester 
 
 
 
 
 
 
Molecular Formula: C
22
H
34
O
2
 
Molecular Weight: 330.51 
 
Docosahexaenoic acid (DHA) ethyl ester. 
 
 
 
Molecular formula: C
24
H
36
O
2
 
Molecular Weight: 356.55 
CAS NUMBER 
Eicosapentaenoic acid (EPA) ethyl ester: 86227-47-6 
Docosahexaenoic acid (DHA) ethyl ester: 81926-94-5 
DESCRIPTION 
Each capsule is comprised of 840  mg  of the omega-3-acid
esters; eicosapentaenoic acid (EPA) 
ethyl ester 46% and docosahexaenoic acid
(DHA) ethyl esters 38%. Omega-3 acid ethyl esters are 
obtained by the transesterification of the body oil of fat fish
species. 
The empirical formula of EPA is C
22
H
34
O
2
.  MW: 330.51. It is a pale yellow liquid. Very soluble in 
methanol, ethanol, acetone and heptane. Practically insoluble in
water. Slight smell. 
The empirical formula for DHA is C
24
H
36
O
2
. MW: 356.55. It is a pale yellow liquid. Very soluble in 
ethanol, acetone, heptane, and freely  soluble in
methanol.  Practically insoluble in water.  Slight 
smell. 
The capsules also
contain d-alpha-tocopherol: 4 mg (antioxidant), gelatin,
glycerol, purified water, 
medium chain triglycerides and lecithin (soya). 
Omacor
®
 capsules are gluten-free. 
Omacor PI 
Version 1 
Page 2  
 
PHARMACOLOGY 
PHARMACODYNAMICS 
The omega-3  series polyunsaturated
fatty acids  (OFA),  eicosapentaenoic acid (EPA) and 
docosahexaenoic acid (DHA) are
essential fatty acids. They are essential nutrients that cannot be 
synthesised by the human body in sufficient amounts and have to be
obtained in the diet. Like all 
fatty acids, omega-3 fatty acids are used to provide energy and
are sto
                                
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