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)..

 

.3 Contraindications
 Hypersensitivity to the active substance, to soya or to any of the excipients listed in section 6.1.

Omacor contains soya-bean oil oil. If you are allergic to peanut or soya, do not use this medicinal product.

4.4 Special warnings and precautions for use

 Warnings

Omacor should be used with caution in patients with known sensitivity or allergy to fish.

Paediatric population
In the absence of efficacy and safety data, use of this medication in children is not recommended.

Clinical data regarding the use of Omacor in elderly patients over 70 years of age are limited.

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 for the surveillance usually required for patients of this type.
 
Make allowance for the increased bleeding time in patients at high risk of haemorrhage (because of severe trauma, surgery, etc).

In the absence of efficacy and safety data, use of this medication in children is not recommended.

During treatment with Omacor, there is a fall in thromboxane A2 production. No significant effect has been observed on the other coagulation factors. Some studies with omega-3-acids demonstrated a prolongation of bleeding time, but the bleeding time reported in these studies has not exceeded normal limits and did not produce clinically significant bleeding episodes.

Clinical data regarding the use of Omacor in elderly patients over 70 years of age are limited.

4.6 Fertility, pPregnancy and lactation
 Pregnancy
 There are no adequate data from the use of Omacor in pregnant women.
Studies in animals have not shown reproductive toxicity. The potential risk for humans is unknown and therefore Omacor should not be used during pregnancy unless clearly necessary.

Breastfeeding Lactation
There are no data on the excretion of Omacor in animal and human milk. Omacor should not be used during lactation.

Fertility
There are no adequate data on the effect of Omacor on fertility.

6. PHARMACEUTICAL PARTICULARS

6.1  List of excipients
 Capsule core :
 alpha-tocopherol

 

6.1        Nature and contents of container

            White high density polyethylene (HDPE) bottle

            -     1X20 capsules

-       1x28 capsules

-       1x30 capsules

-       1x60 capsules

-       1x100 capsules

-       10x28 capsules                                          

 

            Not all pack sizes may be marketed.

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 no information regarding the use of Omacor in children and adolescents, in elderly patients over 70 years of age, or in patients with hepatic impairment (see section 4.4), and only limited information regarding the use in patients with renal impairment

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).

 

 

4.4       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 for the surveillance usually required for patients of this type.

           

Make allowance for the increased bleeding time in patients at high risk of haemorrhage (because of severe trauma, surgery, etc).

 

In the absence of efficacy and safety data, use of this medication in children is not recommended.

 

During treatment with Omacor, there is a fall in thromboxane A2 production. No significant effect has been observed on the other coagulation factors. Some studies with omega-3-acids demonstrated a prolongation of bleeding time, but the bleeding time reported in these studies has not exceeded normal limits and did not produce clinically significant bleeding episodes.

Clinical data regarding the use of Omacor in elderly patients over 70 years of age are limited.

Only limited information regarding the use in patients with renal impairment is available.

 

In some patients a small but significant increase (within normal values) in ASAT and ALAT was reported, but there are no data indicating an increased risk for patients with hepatic impairment. ALAT and ASAT levels should be monitored in patients with any signs of liver damage (in particular with the high dosage, i.e. 4 capsules).

 

Omacor is not indicated in exogenous hypertriglyceridaemia (type 1 hyperchylomicronaemia). There is only limited experience in secondary endogenous hypertriglyceridaemia (especially uncontrolled diabetes).

           

There is no experience regarding hypertriglyceridaemia in combination with fibrates.

4.8        Undesirable Effects

 

The frequencies of adverse reactions are ranked according to the following : very common (> 1/10), common (> 1/100 to < 1/10); uncommon (>1/1000 to < 1/100); rare (>1/10000 to < 1/1000); very rare (< 1/10000)

Immune system disorders:

Rare: hypersensitivity

 

Metabolism and nutrition disorders:

Uncommon: hyperglycaemia, gout

 

Nervous system disorders:

Uncommon: dizziness, dysgeusia, headache

 

Vascular disorders:

Uncommon: hypotension

 

Respiratory thoracic and mediastinal disorders:

Uncommon: epistaxis

 

Gastrointestinal disorders:

Common: gastrointestinal disorders (including abdominal distension, abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, eructation, gastro-oesophageal reflux disease, nausea or vomiting)

Uncommon: gastrointestinal haemorrhage

 

Hepatobiliary disorders:

Rare: liver disorders (including transaminases increased, alanine aminotransferase increased and aspartate aminotransferase increased)

 

 

Skin and subcutaneous tissue disorders:

Uncommon: rash

Rare: urticaria

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance,
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie

- Section 2 - Administrative update
- Section 4.2 - Addition of adolescents to text
- Section 4.4 - Change to text regarding ASAT and ALAT, Addition of text regarding bleeding time
- Section 4.7 - Update of text regarding ability to drive & use machines
- Section 4.8 - Update of undesirable effects list
- Section 4.9 - Minor text revision
- Section 5.1 - Addition of pharmacotherapeutic group
- Section 5.3 - Update of text regarding pre-clinical safety data
- Section 6.1 - Update of excipient list
- Section 6.5 - Addition of description of bottle
- Section 6.6 - Addition of waste disposal information

Section 7. Marketing Authorisation Holder; Change of company name and address

Previous

1.         NAME OF THE MEDICINAL PRODUCT

Omacor, capsule, soft                 

 

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

22 July 2001

 

10.        DATE OF REVISION OF THE TEXT

January 2006

 

AMENDED

 

1.                   NAME OF THE MEDICINAL PRODUCT

Omacor 1000 mg Soft Capsules

 

7.                   DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

8 August 2003/22 July 2006

 

8.                   DATE OF REVISON OF THE TEXT

January 2007