Omega 3-acid-ethyl esters 1000mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Eicosapentaenoic acid; Docosahexaenoic acid

Available from:

Glenmark Pharmaceuticals Europe Ltd

ATC code:

C10AX06

INN (International Name):

Eicosapentaenoic acid; Docosahexaenoic acid

Dosage:

460mg ; 380mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5060204162343 5060204162350

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Omega 3-acid-ethyl esters 1000mg Soft Capsules
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Omega 3-acid-ethyl esters 1000mg Soft Capsules is and what it is
used for
2.
What you need to know before you take Omega 3-acid-ethyl esters 1000mg
Soft Capsules
3.
How to take Omega 3-acid-ethyl esters 1000mg Soft Capsules
4.
Possible side effects
5.
How to store Omega 3-acid-ethyl esters 1000mg Soft Capsules
6.
Contents of the pack and other information
1. WHAT OMEGA 3-ACID-ETHYL ESTERS 1000MG SOFT CAPSULES IS AND WHAT IT
IS USED FOR
Omega 3-acid-ethyl esters 1000mg Soft Capsules contains highly
purified omega-3 polyunsaturated fatty
acids. Omega 3-acid-ethyl esters 1000mg Soft Capsules belongs to a
group of so-called reducers of
cholesterol and triglycerides.
Omega 3-acid-ethyl esters 1000mg Soft Capsules 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 OMEGA 3-ACID-ETHYL ESTERS
1000MG SOFT CAPSULES
DO NOT TAKE OMEGA 3-ACID-ETHYL ESTERS 1000MG SOFT CAPSULES

If you are allergic (hypersensitive) to Omega 3-acid-ethyl esters or
any of the other ingredients of
this medicine (listed in Section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Omega 3-acid-ethyl
esters 1000mg Soft Capsules

If you are due to have or have had surgery recently

If you have had a trauma recently

If you have a kidney problem
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Omega 3-acid-ethyl esters 1000mg soft capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 1000 mg Omega-3-Acid Ethyl Esters 90, comprising
principally
840 mg ethylesters of eicosapentaenoic acid (EPA) (465 mg) and
docosahexaenoic
acid (DHA) (375 mg).
Excipient with known effect: Lecithin (soya)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, soft.
Soft, oblong, transparent gelatin capsule containing pale yellow
coloured oily liquid
imprinted with ‘740’.
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,
-
typeIIb/III in combination with statins, when control of triglycerides
is
insufficient.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults _
_ _
Hypertriglyceridae
mia
Initial treatment is 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.
_Special populations _
_ _
There is limited clinical data regarding the use of Omega 3-acid-ethyl
esters Strides
1000mg soft capsules in older people over 70 years of age and patients
with renal
impairment (see section 4.4).
There is no information regarding the use of Omega 3-acid-ethyl esters
Strides 1000mg
soft capsules in children and adolescents or in patients with hepatic
impairment (see
section 4.4).
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, to soya, peanut or to any of
the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Warnings
Because of the moderate increase in bleeding time (with the high
dosage, i.e. 4 capsules
per day), patients receiving anticoagulant therapy must be monitored
and the dosage of
anticoagulant adjusted if necessary (see section 4.5 Interaction with
other Medicinal