Omacor 1000 mg, capsules, soft

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

OMEGA, ACID ETHYL, ESTERS

Available from:

BASF AS P.O.Box 420, N-1327 Lysaker, Norway

ATC code:

C10AX06

INN (International Name):

OMEGA-3-ACID ETHYL ESTERS 90 1000 mg

Pharmaceutical form:

SOFT CAPSULE

Composition:

OMEGA-3-ACID ETHYL ESTERS 90 1000 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Authorised

Authorization date:

2006-02-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OMACOR 1000 MG SOFT CAPSULES
Omega-3-acid ethyl esters 90
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
•
If you get any side-effects, talk to your doctor. This includes any
possible side effects
not listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET:
1. WHAT OMACOR IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMACOR
3. HOW TO TAKE OMACOR
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE OMACOR
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT OMACOR IS AND WHAT IT IS USED FOR
Omacor contains highly purified omega-3 polyunsaturated fatty acids.
Omacor belongs to a group of so called reducers of cholesterol and
triglycerides.
_ _
Omacor is used:
• to treat certain forms of increased triglycerides (fats) in the
blood after changes to the diet
have not worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMACOR
DO NOT TAKE OMACOR:
•
If you are allergic (hypersensitive) to the active substances or any
of the other
ingredients of OMACOR (listed in Section 6: Contents of the pack and
other
information)
If any of the above applies to you, do not take this medicine, and
talk to your doctor.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING OMACOR.
•
if you are due to have or have had surgery recently
•
if you have had a trauma recently
•
if you have a kidney problem
•
if you have diabetes which is not controlled
•
if you have problems with your liver. Your doctor will monitor any
effects Omacor may
have on your liver with blood tests.
•
if you are allergic to fish
•
if you have, or have had, heart problems
•
if you develop light-headedness, asthenia (feeling

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Omacor 1000 mg, capsules, soft
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_ONE CAPSULE CONTAINS _
Omega-3-acid ethyl esters 90
..................................................................................
1000 mg
comprising 840 mg eicosapentaenoic acid (EPA) ethyl ester (460mg) and
docosahexaenoic
acid (DHA) ethyl ester (380mg), including also as antioxidant 4 mg
d-alpha-tocopherol
(mixed with a vegetable oil e.g. soya oil).
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, soft
Soft, oblong, transparent gelatin capsules containing 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:
- type IV in monotherapy,
- type IIb/III in combination with statins, when control of
triglycerides is insufficient.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Hypertriglyceridaemia
Initial treatment two capsules daily. If adequate response is not
obtained, the dose may be
increased to four capsules daily.
The capsules may be taken with food to avoid gastrointestinal
disturbances.
There is limited clinical data regarding the use of Omacor in elderly
patients over 70 years of
age and patients with renal impairment (see section 4.4).
There is no information regarding the use of Omacor in children and
adolescents or in
patients with hepatic impairment (see section 4.4).
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, to soya or to any of the
excipients listed in section
6.1._ _
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Omacor contains soya oil. If you are allergic to peanut or soya, do
not use this medicinal
product.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Systematic reviews and meta-analyses of randomized controlled clinical
trials highlighted a
dose-dependent increased risk of atrial fibrillation in patients with
established cardiovascular
diseases or ca