Omacor capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Eicosapentaenoic acid; Docosahexaenoic acid

Available from:

Viatris UK Healthcare 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: 5012781993452 5012781996781

Patient Information leaflet

8030092_d1
FRONT
PACKAGE LEAFLET:
INFORMATION FOR THE USER
1000 mg soft capsules
Omega-3-acid ethyl esters 90
Other medicines and Omacor
If you are using a medicine to stop blood clotting in
your arteries, such as warfarin you may need extra
blood tests and your usual dose of your blood
thinning medicine may have to be changed.
Please tell your doctor or pharmacist if you are
using, have recently used or might use any other
medicines including medicines obtained without
prescription.
Omacor with food and drink
You should take the capsules at meal times. This is
to help lower the chances of side effects that affect
the area in and around the stomach (the gastro-
intestinal area).
Elderly
Use Omacor with care if you are over 70 years.
Children
Children should not take this medicine.
Pregnancy and breast-feeding
You
should
not
take
this
medicine
if
you
are
pregnant or breast-feeding, unless your doctor
decides it is absolutely necessary.
Ask your doctor or pharmacist for advice before
using any medicine.
Driving and using machines
This medicine is not likely to affect you being able
to drive or use any tools or machines.
Omacor contains soya oil
Omacor contains soya oil. If you are allergic to
peanut or soya, do not use this medicinal product.
3. HOW TO TAKE OMACOR
Always take Omacor exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
•
Swallow the capsules with a drink of water.
•
You may take the capsules at meal times to help
reduce gastro-intestinal side effects.
•
Your doctor will decide how long you should
take this medicine.
Dose after a heart attack
The usual dose is one capsule a day.
Dose
to
treat
high
blood
triglyceride
levels
(high
levels
of
fat
in
the
blood
or
hypertriglyceridaemia)
The
usual
dose
is
2
capsules
a
day,
as
recommended by a doctor.
If the medicine is not working well enough at this
dose, your doctor may increase this to 4 capsules
a day.
If you take more Omacor than you should
If you accidentally take more of this medicine than
yo

Summary of Product characteristics

OBJECT 1
OMACOR
Summary of Product Characteristics Updated 12-Mar-2018 | Mylan
Products Limited
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
Post Myocardial Infarction
Adjuvant treatment in secondary prevention after myocardial
infarction, in addition to other standard
therapy (e.g. statins, antiplatelet medicinal products, betablockers,
ACE inhibitors).
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
Post Myocardial Infarction
One capsule daily.
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.
Omacor contains soya oil. If you are allergic to peanut or soya, do
not use this medicinal produc