OMEKON 1000 mg Soft Capsule

Зміст інструкції

1. Omekon 1000 mg soft capsules
   1. What is Omekon and what is it used for
   2. What you need to know before taking Omekon
   3. How to take Omekon
   4. Possible side effects
   5. How to store Omekon
   6. Contents of the pack and other information

Omekon 1000 mg soft capsules

omega 3 ethyl esters 90
Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Omekon is and what it is used for
• 2. What you need to know before you take Omekon
• 3. How to take Omekon
• 4. Possible side effects
• 5. How to store Omekon
• 6. Contents of the pack and other information

1. What is Omekon and what is it used for

Omekon contains as active ingredients omega 3 ethyl esters 90 (derived from fish oil) at high
concentration and purity, which reduce the level of certain fats in the blood (triglycerides) and which have positive
effects at the level of the heart and blood vessels.
Omekon is indicated to reduce high levels of fats (triglycerides) in the blood, in cases where diet and other
non-pharmacological measures alone have not been sufficient. Treatment with Omekon must always be
associated with adequate dietary rules

2. What you need to know before taking Omekon

Do not take Omekon if:

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

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

• you are allergic to fish, as the active ingredient of Omekon is derived from fish oil;
• you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are using high doses of Omekon;
• you have bleeding disorders.

Other medicines and Omekon
Tell 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 because an increase in bleeding time may occur.

Pregnancy, breastfeeding and fertility
Do not use Omekon if you are pregnant or breastfeeding.

Driving and operating machinery
Omekon does not affect the ability to drive vehicles or operate machinery.

3. How to take Omekon

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
Take the Omekon capsules whole with a little water.

Use in adults
The recommended dose is 1 capsule of 1000 mg 1-3 times a day, as prescribed by your doctor.

Use in children
No data are available on the use of Omekon in the pediatric population in the authorized indications.
Use in elderly patients and in patients with impaired renal function
No dose adjustment is required in these patients.
Use in patients with impaired hepatic function
Your doctor will monitor your liver function during treatment, especially if you are using high
doses of Omekon (see section “Warnings and precautions”).

If you take more Omekon than you should
In case of accidental ingestion of an excessive dose of Omekon, inform your doctor or pharmacist.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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, indigestion (dyspepsia), diarrhoea, pain in the upper abdomen.

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

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

Other side effects that have been reported in a very small number of people, but whose exact
frequency is unknown (frequency cannot be estimated on the basis of the available data)

• Itching, itchy rash (urticaria).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 at a temperature below 30°C.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Omekon contains

• The active ingredient is made up of 90 ethyl ester omega-3 acids. Each soft capsule contains 1000 mg of 90 ethyl ester omega-3 acids, with an EPA and DHA content of not less than 85% and a ratio of 0.9 - 1.5. The active ingredient contains: mixed tocopherols and refined sunflower oil.
• The other components in the capsule shell are: gelatin succinate, 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 Authorisation Holder
Alikon S.r.l.
Via Dei Piatti, 3
20123 Milano
Italy

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