OMACOR (omega-3-acid ethyl esters 90) 1000 mg soft capsule bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

omega-3-acid ethyl esters 90, Quantity: 1000 mg

Tilgjengelig fra:

Viatris Pty Ltd

INN (International Name):

omega-3-acid ethyl esters 90

Legemiddelform:

Capsule, soft

Sammensetning:

Excipient Ingredients: purified water; Gelatin; glycerol; d-alpha-tocopherol

Administreringsrute:

Oral

Enheter i pakken:

100, 28

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Hypertriglyceridaemia: Endogenous hypertriglyceridaemia as a supplement to diet when dietary measures alone are insufficient to produce an adequate response. Treatment is indicated for the following types of dyslipidaemia (Fredrickson classification) only: -Type IV & V as monotherapy and with close monitoring of LDL-C levels. - Type IIb as add-on therapy to statins, when control of triglycerides with statins has been shown to be insufficient. Patients with higher baseline levels of triglycerides are more likely to exhibit a better response to Omacor. Omacor is not indicated in exogenous hypertriglyceridaemia (Type 1 hyperchylomicronaemia). There are insufficient data to support the use in patients with secondary endogenous hypertriglyceridaemia including patients with diabetes mellitus.

Produkt oppsummering:

Visual Identification: Transparent, oblong (size 20) soft gelatin capsule, light yellow oil fill.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2010-08-05

Informasjon til brukeren

OMACOR
®
O
M
A
C
O
R
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING OMACOR?
OMACOR contains the active ingredient Omega-3-acid ethyl esters 90
(includes EPA & DHA). OMACOR is used, along with a low
fat and low-cholesterol diet, to lower very high triglycerides (fats)
in blood.
For more information, see Section 1. Why am I using OMACOR? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE OMACOR?
Do not use if you have ever had an allergic reaction to OMACOR or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
OMACOR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with OMACOR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE OMACOR?
•
Your doctor will decide what dose you will receive.
•
The dose to lower triglyceride levels is 4 capsules daily.
More instructions can be found in Section 4. How do I use OMACOR? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OMACOR?
THINGS YOU
SHOULD DO
•
Have your blood triglyceride level checked regularly when your doctor
says to make sure OMACOR is
working.
•
Tell your doctor if you become pregnant while you are taking OMACOR.
•
Tell your doctor and pharmacist if you start or stop any new medicine
THINGS YOU
SHOULD NOT DO
•
Do not give OMACOR to anyone else even if they have the same condition
as you.
•
Do not use OMACOR to treat any other complaints unless your doctor
tells you to.
LOOKING AFTER
YOUR MEDICINE
•
Keep OMACOR in a cool dry place where the temperature stays below
30°C. Do not refrigerate. Do not
freeze.
•
Do not store it in the bathroom, near a sink, on

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION
OMACOR
®
_Omega-3-acid ethyl esters _
1
NAME OF THE MEDICINE
omega-3-acid ethyl esters 90
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule is comprised of about 900 mg of the omega-3-acid ethyl
esters; the main components are
eicosapentaenoic acid (EPA) ethyl ester of about 460mg and
docosahexaenoic acid (DHA) ethyl esters of
about 380mg. Omega-3 acid ethyl esters are obtained by the
transesterification of the body oil of fat fish
species.
Excipient with known effect: soya bean products and trace amounts of
sulfites and fish products. OMACOR
capsules are gluten-free.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Capsule appearance: Soft, oblong, transparent capsule containing 1000
mg pale yellow oil.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertriglyceridaemia: Endogenous hypertriglyceridaemia as a
supplement to diet when dietary measures
alone are insufficient to produce an adequate response. Treatment is
indicated for the following types of
dyslipidaemia (Fredrickson classification) only:
•
Type IV & V as monotherapy and with close monitoring of LDL-C levels.
•
Type IIb as add-on therapy to statins, when control of triglycerides
with statins has been shown to be
insufficient.
Patients with higher baseline levels of triglycerides are more likely
to exhibit a better response to OMACOR.
OMACOR is not indicated in exogenous hypertriglyceridaemia (Type 1
hyperchylomicronaemia). There are
insufficient data to support the use in patients with secondary
endogenous hypertriglyceridaemia including
patients with diabetes mellitus).
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS:
Hypertriglyceridaemia: Four capsules per day taken with a glass of
water.
OMACOR must be taken with food to avoid gastrointestinal disturbances.
OMACOR has been given in clinical trials in doses of up to 8 g per day
and has been found to be well tolerated.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, to peanut, to soya
(including so