Trimega 1000 mg Capsules

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Omega-3-acid ethyl esters 90

Disponibil de la:

Clonmel Healthcare Ltd

Codul ATC:

C10AX; C10AX06

INN (nume internaţional):

Omega-3-acid ethyl esters 90

Dozare:

1000 milligram(s)

Forma farmaceutică:

Capsule, soft

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

Other lipid modifying agents; omega-3-triglycerides incl. other esters and acids

Statutul autorizaţiei:

Marketed

Data de autorizare:

2012-08-17

Prospect

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIMEGA 1000MG 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 want 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 Trimega is and what it is used for
2.
What you need to know before you take Trimega
3.
How to take Trimega
4.
Possible side effects
5.
How to store Trimega
6.
Contents of the pack and other information
1.
WHAT TRIMEGA IS AND WHAT IT IS USED FOR
Trimega contains highly purified omega-3 polyunsaturated fatty acids.
Trimega belongs to a group of
so called reducers of cholesterol and triglycerides.
Trimega is used:
•
To treat certain forms of increased triglycerides (fats0 in the blood
after changes to the diet
have not worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIMEGA
DO NOT TAKE TRIMEGA:
If you are allergic to Omega-3-Acid Ethyl Esters 90 (the main
ingredient) or any of the other
ingredients of this medicine (listed in section 6)
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 Trimega if: you
are due to have or have had surgery recently
you have had a trauma recently you
have a kidney problem
you have diabetes which is not controlled
you have problems with your liver. Your doctor will monitor any
effects Omega-3-Acid Ethyl
Esters 90 may have on your liver with blood tests.
•
you are allergic to fish.
•
you have, or have had, heart problems
•
you develop light-headedness, asthenia (feeling of weakness),
palpitations or shortne

Caracteristicilor produsului

Health Products Regulatory Authority
31 January 2024
CRN00F25D
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trimega 1000 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 1000 mg Omega-3-acid ethyl esters 90, comprising
840 mg eicosapentaenoic acid (EPA) ethyl ester (460
mg) and docosahexaenoic acid (DHA) ethyl ester (380mg).
Excipient with known effect: contains soya oil
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft.
Slightly yellow soft capsules, 23.8 mm x 9.5 mm
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.
Method of administration
The capsules may be taken with food to avoid gastrointestinal
disturbances.
There is limited clinical data regarding the use of Omega-3-acid ethyl
esters 90 in elderly patients over 70 years of age and in
patients with renal impairment (see section4.4).
There is no information regarding the use of Omega-3-acid ethyl esters
90 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.
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), patients receiving anticoagulant
therapy must be monitored and the dosage of anticoagulant adjusted if
necessary (see section 4.5 Interaction with other
Medicinal Products and other forms of Interaction). Use of this
medication does not eliminate the need