Consumer medicine information

Omacor capsules

Eicosapentaenoic acid ethyl ester; Docosahexaenoic acid ethyl ester

BRAND INFORMATION

Brand name

Omacor

Active ingredient

Eicosapentaenoic acid ethyl ester; Docosahexaenoic acid ethyl ester

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Omacor capsules.

What is in this leaflet

This leaflet answers some common questions about Omacor.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Omacor against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Omacor is used for

Omacor is used, along with a low-fat and low-cholesterol diet, to lower very high triglycerides (fats) in blood. High levels of triglycerides may increase your risk of developing coronary heart disease. In most people there are no symptoms of high triglycerides. Your doctor can measure your triglyceride levels with a simple blood test.

How Omacor works

Omacor contains highly purified omega-3 polyunsaturated fatty acids. These fatty acids are natural substances found in the body oil of fat fish species that your body needs in sufficient amounts to provide energy. However, as the body cannot make enough on its own, the balance needs to be obtained in the diet.

Ask your doctor if you have any questions about why Omacor has been prescribed for you. Your doctor may have prescribed it for another reason.

There is no evidence that this medicine is addictive.

Omacor is only available with a doctor's prescription.

Before you take it

When you must not take it

Do not take Omacor if you are allergic to it or to any of the ingredients listed at the end of this leaflet.

Do not take Omacor if you are allergic to peanut or soya (including soya milk or soya beans).

  • Symptoms of an allergic reaction may include skin rash, itching, difficulty breathing or swelling of the face.

Do not take it if the packaging is torn or shows signs of tampering.

Do not take it after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work as well.

If you are not sure whether you should start taking Omacor, talk to your doctor.

Do not give Omacor to a child under 18 years. The safety and effectiveness of this medicine in children have not been established.

Before you start to take it

Tell your doctor if:

  1. you have any allergies or sensitivity to any other medicines or any other substances, such as foods, preservatives or dyes.
  2. you are pregnant or intend to become pregnant.
It is not known if Omacor can harm your unborn baby.
  1. you are breast-feeding or intend to breast-feed.
It is not known whether Omacor passes into breast milk.
  1. you have, or have had, any other medical conditions, including:
  • liver problems
  • a history of bleeding disorders
  • diabetes
  • are over 70 years of age

If you have not told your doctor about any of the above, tell them before you take any Omacor.

Taking other medicines

Tell your doctor if you are taking any other medicines or remedies, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may be affected by Omacor, or they may affect how well Omacor works. These include medicines used to prevent clotting, such as aspirin and warfarin.

If you are taking these medicines, you may need additional blood tests, and the dose may need to be changed.

Please talk with your doctor or pharmacist for further information.

How to take it

Follow your doctor's instructions about how and when to take this medicine. These directions may differ from the information contained in this leaflet.

How much to take

Take Omacor only when prescribed by your doctor.

Follow the directions your doctor has given you on how many capsules to take each day. These will be printed on the pharmacy label on the container.

The dose to lower triglyceride levels is 4 capsules daily.

How to take it

Swallow the capsules whole with a glass of water.

Omacor capsules must be taken with a meal. Taking your capsules with meals helps to avoid any stomach upset.

Take Omacor at about the same time each day. Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take the capsules.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

Omacor helps to lower very high triglyceride (fat) levels in your blood. It does not cure your condition. Therefore, you need to take it for as long as directed by your doctor if you wish to keep those levels down. You may need to take this medicine for the rest of your life. If you stop taking Omacor your triglyceride levels may rise again,

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering to take your capsules, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Australian Poisons Information Centre (telephone 13 11 26), or go to the Accident and Emergency department at your nearest hospital if you think you or anyone else may have taken too much Omacor.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers for these handy.

While you are taking it

Things you must do

Have your blood triglyceride level checked regularly when your doctor says to make sure Omacor is working.

Tell your doctor if you become pregnant while you are taking Omacor.

Tell your doctor and pharmacist if you start or stop any new medicine.

Things you must not do

Do not give Omacor to anyone else even if they have the same condition as you.

Do not use Omacor to treat any other complaints unless your doctor tells you to.

Things that may help your condition

People who have high triglyceride (fat) levels in their blood have an increased chance of developing coronary heart disease. Other factors which may contribute to this condition include high blood pressure, cigarette smoking, diabetes, excessive weight and a family history of coronary heart disease.

Some self-help measures suggested below may help lower your high triglyceride levels.

Talk to your doctor, pharmacist or dietitian about them:

  • a low-fat and low-cholesterol diet
  • losing weight, if you are overweight
  • making physical exercise, such as walking, a part of your routine
  • stopping smoking.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking Omacor.

All medicines can have side effects. Sometimes they are serious, but most of the time they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor if you notice any of the following and they worry you:

  • belching or flatulence
  • nausea or vomiting
  • taste disturbance
  • gastrointestinal discomfort or pain.
  • diarrhoea or constipation

These are mild side effects of the medicine, and usually short-lived.

Stop taking Omacor and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you experience any of the following:

  • swelling of the face, or tongue
  • shortness of breath
  • skin rash.

These are very serious side effects. They may need urgent medical attention. These side effects are rare.

Other side effects not listed above may also occur in some people.

Ask your doctor or pharmacist to answer any questions you may have.

After taking it

Storage

Keep your capsules in the bottle until it is time to take them. If you take the capsules out of the bottle they may not keep well.

Keep Omacor in a cool dry place where the temperature stays below 30°C. Do not refrigerate. Do not freeze.

Do not store it or any other medicine in the bathroom, near a sink or on a window sill.

Do not leave it in the car. Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is good place to store medicines.

Disposal

If your doctor tells you to stop taking Omacor or the capsules have passed their expiry date, return any unused medicine to your pharmacist.

Product description

What it looks like

Soft, oblong, transparent gelatin capsules containing pale yellow oil.

Ingredients

Active ingredient:

Each Omacor capsule contains about 900 mg Omega-3-acid ethyl esters 90 including:

Eicosapentaenoic Acid (EPA) about 460mg

Docosahexaenoic Acid (DHA) about 380 mg

Inactive ingredients:

Each capsule also contains:

  • gelatin
  • glycerol
  • purified water
  • medium chain triglycerides
  • d-alpha-Tocopherol
  • lecithin (soya)

Omacor does not contain gluten, lactose monohydrate, sucrose, tartrazine or any other azo dyes.

It may contain traces of soya (lecithin), sulfites and fish products.

Manufacturer/Sponsor

Omacor capsules are made in Europe and supplied in Australia by:

Mylan Health Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 314 527

This leaflet was updated in Feb 2020.

Australian Registration Number:
AUST R 155717

Published by MIMS April 2020

BRAND INFORMATION

Brand name

Omacor

Active ingredient

Eicosapentaenoic acid ethyl ester; Docosahexaenoic acid ethyl ester

Schedule

S4

 

1 Name of Medicine

Eicosapentaenoic acid (EPA) ethyl ester, docosahexaenoic acid (DHA) ethyl ester.

6.7 Physicochemical Properties

Chemical structure.

Eicosapentaenoic acid (EPA) ethyl ester.
Molecular Formula: C22H34O2.
Molecular Weight: 330.51.
Docosahexaenoic acid (DHA) ethyl ester.
Molecular formula: C24H36O2.
Molecular Weight: 356.55.

CAS number.

Eicosapentaenoic acid (EPA) ethyl ester: 86227-47-6.
Docosahexaenoic acid (DHA) ethyl ester: 81926-94-5.

2 Qualitative and Quantitative Composition

Each capsule is comprised of about 900 mg of the omega-3-acid ethyl esters; the main components are eicosapentaenoic acid (EPA) ethyl ester of about 460 mg and docosahexaenoic acid (DHA) ethyl esters of about 380 mg. Omega-3-acid ethyl esters are obtained by the transesterification of the body oil of fat fish species.

Excipient with known effect.

The capsules also contain lecithin (soya) and trace amounts of sulfites and fish products. Omacor capsules are gluten-free.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

The empirical formula of EPA is C22H34O2. MW: 330.51. It is a pale yellow liquid. Very soluble in methanol, ethanol, acetone and heptane. Practically insoluble in water. Slight smell.
The empirical formula for DHA is C24H36O2. MW: 356.55. It is a pale yellow liquid. Very soluble in ethanol, acetone, heptane, and freely soluble in methanol. Practically insoluble in water. Slight smell.
Capsule appearance: Soft, oblong, transparent capsule containing 1000 mg pale yellow oil.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The omega-3 series polyunsaturated fatty acids (OFA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are essential fatty acids. They are essential nutrients that cannot be synthesised by the human body in sufficient amounts and have to be obtained in the diet. Like all fatty acids, omega-3 fatty acids are used to provide energy and are stored in adipose tissue; small amounts are incorporated into cell membranes as well.
Omacor is active on the plasma lipids by lowering triglyceride levels as a result of a fall in VLDL (very low density lipoprotein), and the substance is also active on haemostasis and blood pressure.
The mechanism of action of Omacor in lowering plasma triglycerides (TG) is not completely understood. Potential mechanisms of action include inhibition of acyl CoA: 1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal β-oxidation of fatty acids in the liver and decreased lipogenesis in the liver. Omacor may reduce the synthesis of TG in the liver because EPA and DHA are poor substrates for the enzymes responsible for TG synthesis, and EPA and DHA inhibit esterification of other fatty acids.
Omacor increases low density lipoproteins (LDL) cholesterol in some patients with hypertriglyceridaemia. A small rise in high density lipoproteins (HDL) cholesterol has also been observed however it is significantly smaller than seen after fibrates, and is not consistent across this population subset.
There is no strong evidence that lowering the triglycerides reduces the risk of ischaemic heart disease.
During treatment with Omacor a decrease in thromboxane A2 production has been observed and a slight increase in bleeding time (particularly with the higher doses, 4 g per day). No significant effect has been observed on the other coagulation factors (see Section 4.4 Special Warnings and Precautions for Use).
Omacor has been shown to cause a significant reduction in blood pressure.

Clinical trials.

Hypertriglyceridaemia.

There have been eight double blind, parallel group, placebo controlled studies in hypertriglyceridaemia, using Omacor 4 g per day. These eight studies are the pivotal studies. These studies included seven individual studies and one part of a study that evaluated Omacor 2 g, 4 g, 8 g, and placebo treatment arms.
The duration of the eight pivotal studies was short-term (maximum 12 weeks).
Numerous studies in patients with hypertriglyceridemia have been conducted with Omacor, with variable designs: double blind studies, placebo controlled studies, randomised studies, open studies and long-term studies (up to 24 months). Omacor at doses of 4 g per day consistently and significantly reduced triglycerides levels compared to placebo. The studies have shown that the reductions were maintained for up to 24 months after treatment. See Table 2.
Table 3 summarises the median percent changes in lipid parameters from baseline in the overall population, and in patients with types IIb, IV and V dyslipidaemia.
The documented number of patients enrolled in clinical trials with type III dyslipidaemia is very limited, and no studies were designed to especially investigate the effect of Omacor in these patients. Type III dyslipidaemic patients are homozygotes for ApoE, and genotyping of patients was only performed in one study (K85-95011). More type III dyslipidaemic patients may have been therefore enrolled in clinical studies without being verified as such. There is no reason to believe that type III dyslipidaemic patients do not respond to Omacor.
One of the pivotal clinical trials in patients with type IV and V dyslipidaemia (K85-95009 study) demonstrated a mean LDL-C increase of 42.6% with Omacor 4 g/day. 67% of the patients in the study experienced increases in LDL-C, and the increases observed were in the range of 6%-110%. However, mean LDL-C concentrations at the end of the study were still only equal to 2.69 mmol/L (104 mg/dL). For the majority of these patients (40 of 42 with no history of coronary disease) this is still below their target LDL-C levels.
In clinical trials on patients with type IIb dyslipidaemia mean LDL-C is unchanged or slightly increased (maximum 8.6%) with Omacor treatment. In studies with concomitant treatment of Omacor and a statin no significant increase in LDL-C has been observed with Omacor.
The cholesterol enrichment of LDL particles appears to happen in conjunction with a marked reduction in VLDL-C. Studies also demonstrate a shift from small, dense LDL particles to larger, more buoyant LDL particles, indicating a shift towards less atherogenic lipoprotein particles.
Consistent with the overall population (see Table 4 hereafter), subjects in each baseline triglycerides level category in the Omacor 4 g treatment group had significantly larger mean absolute and relative changes in triglycerides levels compared with those in the placebo treatment group.
For the subjects who received Omacor 4 g per day, those with higher baseline levels (TG = 500-749 mg/dL and ≥ 750 mg/dL [5.65-8.46 mmol/L, and ≥ 8.47 mmol/L]) had greater reductions in triglycerides levels, and therefore were more likely to exhibit a better response to Omacor.
A number of studies have been conducted to evaluate the effect of concomitant use of Omacor with widely used statins (simvastatin, atorvastatin). The studies have been carried out in patients with elevated serum triglycerides receiving statin therapy. The results of the studies demonstrate that the combined treatment increases the efficacy in lowering triglycerides. In these studies, little or no effect on LDL-C has been observed and no significant safety issues have been raised.

5.2 Pharmacokinetic Properties

Absorption.

The absorption of Omacor has been determined by measuring the increase of EPA and DHA in plasma or serum phospholipids after dosing. The levels of EPA and DHA do increase on ingestion of Omacor, although in a less than dose-proportional manner.
After absorption, OFA are metabolised by multiple pathways that are not highly predictable. Animal pharmacokinetic studies have shown that there is no systemic exposure of the ethyl esters. Due to this complicated process, it is not possible to conduct standard bioavailability studies, and consequently, to measure meaningful values for Cmax, Tmax, AUC, etc. for Omacor.
Concomitant ingestion of another unsaturated fatty acid, olive oil, did not affect absorption of omega-3 fatty acids from Omacor.

Distribution.

The concentration of omega-3 fatty acids, EPA and DHA, in the plasma phospholipids corresponds to the EPA and DHA incorporated into the cell membranes.
Significant, dose-dependent increases in serum phospholipid EPA content were seen, while increases in DHA incorporation were less marked and not dose dependent. Uptake of EPA and DHA into plasma/serum phospholipids in subjects treated with Omacor was also independent of gender, age, and hypertensive status.

Metabolism and excretion.

The hydrolysis of omega-3 ethyl esters by esterases in the intestine is complete and rapid. During and after absorption there are three main pathways for the metabolism of the omega-3 fatty acids:
The fatty acids are first transported to the liver where they are incorporated into various categories of lipoproteins and then channelled to the peripheral lipids stores.
The cell membrane phospholipids are replaced by lipoprotein phospholipids and the fatty acids can then act as precursors for various eicosanoids.
The majority is oxidised to meet energy requirements.

5.3 Preclinical Safety Data

Genotoxicity.

There was no clear evidence of a genotoxic effect of Omacor from the genotoxicity studies conducted (Ames test in Salmonella typhimurium, gene mutation at the HGPRT locus in Chinese hamster V79 cells, chromosome aberration study in cultured human lymphocytes and in vivo mouse micronucleus test).

Carcinogenicity.

There was no evidence of a carcinogenic effect of Omacor from the carcinogenicity studies in rats and mice at oral doses of up to 2,000 mg/kg/day (35 times the human dose of 4 g/day on a mg/kg basis).

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. Treatment is indicated for the following types of dyslipidaemia (Fredrickson classification) only:
type IV and V as monotherapy and with close monitoring of LDL-C levels;
type IIb as add-on therapy to statins, when control of triglycerides with statins has been shown to be insufficient.
Patients with higher baseline levels of triglycerides are more likely to exhibit a better response to Omacor. Omacor is not indicated in exogenous hypertriglyceridaemia (type 1 hyperchylomicronaemia). There are insufficient data to support the use in patients with secondary endogenous hypertriglyceridaemia including patients with diabetes mellitus.

4.3 Contraindications

Hypersensitivity to the active substance, to peanut, to soya (including soya milk, soya beans) or to any of the excipients.

4.4 Special Warnings and Precautions for Use

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 studies have not been done to thoroughly examine the combined effect of Omacor and concomitant anticoagulants. Patients receiving treatment with Omacor and an anticoagulant or other drug affecting coagulation (e.g. aspirin, warfarin, and coumarin) should be monitored periodically, and the dosage of anticoagulant therapy adjusted if necessary (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
It is recommended that routine monitoring of the entire lipid profile is undertaken.
As a possible rise in LDL-C has been shown in some studies with intake of Omacor 4 g/day (see Section 5.1 Pharmacodynamic Properties), LDL-C should therefore be monitored on a regular basis, especially in patients with type IV and V dyslipidaemia.
Omacor is not recommended as monotherapy in type IIb dyslipidaemia. Statins are to be used as first line treatment with Omacor indicated as add-on therapy when control of the triglyceride levels is required.
Omacor should be used with caution in patients with known sensitivity or allergy to fish.

Use in hepatic impairment.

In some patients a small but significant increase (within normal values) in ASAT and ALAT have been reported (see Section 4.8 Adverse Effects (Undesirable Effects)). ALAT and ASAT levels should be monitored in patients with hepatic impairment, in particular with the higher dosage of 4 capsules.

Use in the elderly.

There is no information regarding the use of Omacor in elderly patients over 70 years of age.

Paediatric use.

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

Effects on laboratory tests.

See Section 4.8 Adverse Effects (Undesirable Effects).

4.5 Interactions with Other Medicines and Other Forms of Interactions

Drugs affecting coagulation.

Increased bleeding time has been seen when Omacor is given in conjunction with NSAIDs, aspirin and warfarin, but without haemorrhagic complications (see Section 4.4 Special Warnings and Precautions for Use). Patients should be informed about potential increased bleeding time.
When used with warfarin and coumarin, the prothrombin time/international normalised ratio (PT/INR) must be monitored during combination treatment with Omacor among patients receiving blood-thinning therapy, and when treatment with Omacor is discontinued.

Statins.

Omacor 4 g has been administered with simvastatin 80 mg under fasting conditions to 24 healthy volunteers in a two 14-days period drug-drug interaction study. Results of this study demonstrated that at steady-state, the coadministration of Omacor capsules with simvastatin did not appear to affect the pharmacokinetics of simvastatin tablets. The combination appeared to be well tolerated.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No adverse effects on fertility were observed in a rat fertility study at oral doses of up to 2,000 mg/kg/day (35 times the human dose of 4 g/day on a mg/kg basis).
(Category B1)
There are no adequate data from the use of Omacor in pregnant women. The potential risk for humans is unknown. Therefore Omacor should not be used during pregnancy unless clearly necessary.
In female rats given oral gavage doses of up to 2,000 mg/kg/day (35 times the human dose of 4 g/day on a mg/kg basis) beginning two weeks prior to mating and continuing during gestation and lactation, no adverse effects were observed). In pregnant rats given oral gavage doses of up to 6,000 mg/kg/day (105 times the human dose of 4 g/day on a mg/kg basis) over gestation days 6 to 15, no adverse effects were observed. In pregnant rats given oral gavage doses of up to 2,000 mg/kg/day (35 times the human dose of 4 g/day on a mg/kg basis), from gestation day 14 to the end of lactation, no adverse effects were observed.
In rabbits given oral gavage doses over gestation days 7 to 19, no adverse effects were observed at 375 mg/kg/day (ca. 7 times the human dose of 4 g/day on a mg/kg basis), but reduced foetal weights were observed at ≥ 750 mg/kg/day (ca. 13 times the human dose of 4 g/day on a mg/kg basis) and increased postimplantation loss was observed at 1500 mg/kg/day (ca. 26 times the human dose of 4 g/day on a mg/kg basis). Doses of ≥ 750 mg/kg/day were maternotoxic. Overall there is no preclinical evidence for a potential risk in pregnant humans.
There are no data on the excretion of Omacor components in human milk. Because many drugs are excreted in human milk, caution should be exercised when Omacor is administered to a woman who is breastfeeding.

4.8 Adverse Effects (Undesirable Effects)

Hypertriglyceridaemia.

In all subjects (655) treated with Omacor for hypertriglyceridaemia, the following results were seen:
adverse events (AEs) occurred in approximately 30% of subjects;
only 11 specific AEs occurred at a rate greater than 1%;
the most common treatment emergent AEs were eructation (4.4%) and taste perversion (4.1%);
treatment emergent serious adverse events occurred in 2.4% of subjects;
four subjects (0.6%) died.
The 8 pivotal trials showed similar safety profiles.
The only potentially drug related laboratory abnormality was mild elevation in alanine aminotransferase (ALT) levels, without concurrent elevation in aspartate aminotransferase (AST) levels.
A slight, but significant, prolongation of bleeding time has been observed without any reports of bleeding problems during clinical trials with Omacor alone.
Table 1 summarises the treatment emergent adverse events experienced by subjects from the 8 double blind, parallel group, placebo controlled studies in hypertriglyceridaemia, using Omacor 4 g per day (see Section 5.1 Pharmacodynamic Properties).

Adverse events according to system organ class.

The following list presents the frequencies of study related adverse events, observed both in postmyocardial infarction and in hypertriglyceridaemia.
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 (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000).

Immune system disorders.

Uncommon: 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. Very rare: nasal dryness.

Gastrointestinal disorders.

Common: gastrointestinal disorders (including abdominal pain, dyspepsia, gastroesophageal reflux disease, eructation, nausea or vomiting, abdominal distension, flatulence, diarrhoea or constipation). Uncommon: gastrointestinal haemorrhage.

Hepatobiliary disorders.

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

Skin and subcutaneous tissue disorders.

Uncommon: rash. Rare: urticaria, acne.

Investigations.

Very rare: white blood cell count increased, blood lactate dehydrogenase increased.
The following adverse events have been reported spontaneously during postmarketing use of Omacor (frequency unknown).

Blood and lymphatic system disorders.

Haemorrhagic diathesis.

Skin and subcutaneous tissue disorders.

Pruritus

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at http://www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Adults.

Hypertriglyceridaemia.

Four capsules per day taken with a glass of water.
Omacor must be taken with food to avoid gastrointestinal disturbances.
Omacor has been given in clinical trials in doses of up to 8 g per day and has been found to be well tolerated.

4.7 Effects on Ability to Drive and Use Machines

The effects of Omacor on a person's ability to drive and use machines were not assessed as part of its registration. Nevertheless, Omacor is expected to have no or negligible influence on the ability to drive and use machines.

4.9 Overdose

There are no special recommendations for overdosage with Omacor. Treatment should be symptomatic.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

The capsules also contain d-alpha-Tocopherol: 4 mg (antioxidant), gelatin, glycerol, purified water, medium chain triglycerides and lecithin (soya). Omacor capsules are gluten-free.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.
Protect from light.
Do not refrigerate.
Do not freeze.

6.5 Nature and Contents of Container

Omacor capsules are packed in white tamper-evident high density polyethylene (HDPE) bottles with desiccant closed with an inner seal and a screw cap.
Pack size: 28 or 100* capsules. AUST R 155717.
*Not currently marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes