Patient Information Leaflet

Omekon 1000 mg soft capsules

omega-3 ethyl esters 90
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Omekon is and what it is used for
What you need to know before taking Omekon
How to take Omekon
Possible side effects
How to store Omekon
Contents of the pack and other information

1. What Omekon is and what it is used for

Omekon contains as active substances highly concentrated and purified ethyl esters of omega-3 fatty acids 90 (derived from fish oil), which reduce the levels of certain fats in the blood (triglycerides) and have beneficial effects on the heart and blood vessels.
Omekon is indicated to reduce high levels of fats (triglycerides) in the blood when diet and other non-pharmacological measures alone have not been sufficient. Treatment with Omekon must always be accompanied by appropriate dietary measures.

2. What you need to know before taking Omekon

Do not take Omekon if:

you are allergic to the active substance (derived from fish oil) or to any of the other ingredients of this medicine (listed in section 6);
you are allergic to peanuts and soybeans, as this medicine may contain traces thereof;
you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Omekon.
Inform your doctor before taking Omekon if:

you are allergic to fish, since the active ingredient in Omekon is derived from fish oil;
you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are taking high doses of Omekon;
you have conditions that make you bleed easily.

Other medicines and Omekon
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Tell your doctor if you are being treated with:

medicines to thin the blood (anticoagulants), e.g. coumarin anticoagulants;
other medicines that affect blood clotting, as this may lead to an increased bleeding time.

Pregnancy, breastfeeding and fertility
Do not use Omekon if you are pregnant or breastfeeding.
Driving and using machines
Omekon does not affect the ability to drive or use machinery.

3. How to take Omekon

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
Swallow the Omekon capsules whole with some water.

Use in adults
The recommended dose is 1 capsule of 1000 mg 1-3 times daily, according to your doctor's prescription.

Use in children
There are no data available on the use of Omekon in the paediatric population for the authorised indications.

Use in elderly patients and patients with impaired kidney function
No dose adjustment is required in these patients.

Use in patients with impaired liver function
Your doctor will monitor your liver function during treatment, especially if you are taking high doses of Omekon (see section “Warnings and precautions”).

If you take more Omekon than you should
In case of accidental overdose, inform your doctor or pharmacist.

If you forget to take Omekon
Do not take a double dose to make up for the missed dose.

If you stop taking Omekon
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Common side effects (may affect up to 1 in 10 people)

Stomach and/or intestinal disorders.

Uncommon side effects (may affect up to 1 in 100 people)

Nausea, difficulty digesting (dyspepsia), diarrhoea, pain in the upper part of the abdomen.

Rare side effects (may affect up to 1 in 1,000 people)

Allergic reactions (hypersensitivity);
dizziness;
inflammation of the stomach and/or intestine (gastritis, inflammatory bowel disease, and gastroenteritis), abdominal pain, stomach burning (pyrosis);
alteration of normal liver function;
skin reactions;
weakness (asthenia).

Other side effects that have occurred in a very low number of people, but for which the exact frequency is unknown (frequency cannot be estimated from the available data)

Itching, skin rash with itching (urticaria).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omekon

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the pack after “Exp”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Omekon contains

The active substance is omega-3 acid ethyl esters 90. Each soft capsule contains 1000 mg of omega-3 acid ethyl esters 90, with a content of EPA and DHA not less than 85%, and in a ratio to each other of 0.9 - 1.5. The active substance contains: mixed tocopherols and refined sunflower oil.
The other components in the capsule shell are: succinated gelatin, glycerol, and possible traces of soy lecithin (E322) and medium-chain saturated triglycerides.

Description of the appearance of Omekon and contents of the pack
Each pack contains 20 or 30 soft capsules in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Alikon S.r.l.
Via Dei Piatti, 3
20123 Milan
Italy

Manufacturer
Catalent Italy S.p.A.
Via Nettunense km 20,100
04011 Aprilia (Latina)
Italy