ACIDOS OMEGA 3 KERN PHARMA 1000 mg SOFT GEL CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omega 3 KERN PHARMA 1,000 mg soft capsules EFG

Ethyl esters of omega 3 fatty acids at 90%

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What Omega 3 Kern Pharma is and what it is used for

Omega 3 Kern Pharma belongs to a group of medicines called "Other agents reducing cholesterol and triglycerides".

This medicine is indicated for the treatment of high levels of triglycerides (fats present in our body, whose excess is harmful to health) when dietary changes have been insufficient. In certain cases, it will be necessary to combine it with other medications.

2. What you need to know before you take Omega 3 Kern Pharma

Do not take Omega 3 Kern Pharma

• if you are allergic to the active substance or to any of the other ingredients of Omega 3 Kern Pharma.

Warnings and precautions

Consult your doctor or pharmacist:

• If you are taking anticoagulant medication (medicines to thin the blood, such as warfarin) and you take the high dose of omega 3 (4 capsules daily).
• If you have a risk of bleeding due to severe trauma or surgery.
• If you are pregnant or breastfeeding.
• If you have liver disease, and in particular, if you take the high dose of omega 3 (4 capsules daily), your doctor should perform periodic blood tests to monitor liver function. There is no information on the use of omega 3 in patients with liver dysfunction.
• Be cautious in patients with kidney problems, as there is limited experience with the use of this product in this type of patient.
• If you have secondary endogenous hypertriglyceridemia (increase in triglycerides due to another disease you have, such as uncontrolled diabetes), as there is limited experience with the use of this medication in this type of disease. Omega 3 is not indicated in exogenous hypertriglyceridemia (increase in triglycerides due to an inadequate diet).
• If you are allergic to fish.
• If you have or have had heart problems.
• If you experience dizziness, asthenia, palpitations, or difficulty breathing, as these may be symptoms of an irregular and often rapid heart rhythm (atrial fibrillation).

Children and adolescents

Omega 3 should not be administered to children.

Elderly patients

There is no information on the use of omega 3 in patients over 70 years old.

Use of Omega 3 Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

If you are taking anticoagulants (medicines to thin the blood), such as warfarin, you may need additional blood tests and an adjustment of your usual anticoagulant dose.

There is no experience with the combination of omega 3 with fibrates in the treatment of hypertriglyceridemia.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

There are no data on the use of omega 3 in pregnant women or on the elimination of omega 3 in breast milk, so omega 3 should not be used during pregnancy or breastfeeding unless it is strictly necessary.

Driving and using machines

No effects have been observed on the ability to drive and use machinery.

3. How to take Omega 3 Kern Pharma

Follow these instructions unless your doctor has given you other different instructions. In those cases, it is advisable to ask the doctor for the instructions in writing and make sure you have understood them well.

Your doctor will indicate the duration of treatment with omega 3. Do not stop treatment before consulting your doctor.

Do not forget to take your medication.

Omega 3 should be taken orally. Take the capsules with water. You can take the capsules during meals to help reduce gastrointestinal effects.

Hypertriglyceridemia (high levels of triglycerides in the blood)

The usual dose is 2 capsules per day. If an adequate response is not obtained, your doctor may increase the dose to 4 capsules per day.

The long-term lipid-lowering effect (after more than one year) is unknown.

If you take more Omega 3 Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

It is recommended to take the package and the leaflet of the medication to the healthcare professional.

If you forget to take Omega 3 Kern Pharma

In case of forgetting a dose, take the medication as soon as possible, continuing with the treatment as prescribed. However, when the next dose is near, it is best not to take the forgotten dose and wait for the next one. Do not take a double dose to make up for the forgotten doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Omega 3 Kern Pharma can cause side effects, although not everybody gets them.

The frequencies of side effects have been listed below according to the following definitions:

Very common (affect more than 1 in 10 patients)

Common (affect between 1 and 10 in 100 patients)

Uncommon (affect between 1 and 10 in 1,000 patients)

Rare (affect between 1 and 10 in 10,000 patients)

Very rare (affect less than 1 in 10,000 patients)

Common: indigestion and nausea, irregular and rapid heart rhythm.

Uncommon: abdominal pain and gastrointestinal disorders, gastritis, dizziness, alteration of taste, allergic reactions.

Rare: headache, acne, itching eruption (hives or urticaria), increase in blood sugar, liver discomfort, gastrointestinal pain, poorly defined disorders.

Very rare: gastrointestinal bleeding, decrease in blood pressure, nasal dryness, urticaria, changes in blood, moderate elevation of transaminases (liver-related blood tests) in patients with increased triglycerides (hypertriglyceridemia), increase in white blood cell count and LDH.

Other side effects have occurred in a very small number of people, but their exact frequency is unknown: itching.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Omega 3 Kern Pharma

Keep out of sight and reach of children.

Do not store above 25°C. Do not refrigerate or freeze.

Do not use Omega 3 Kern Pharma after the expiry date stated on the package after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omega 3 Kern Pharma

• The active ingredients are ethyl esters of omega 3 fatty acids at 90% [ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)]. Each soft capsule contains 1,000 mg of ethyl esters of omega 3 fatty acids at 90%, equivalent to 840 mg of eicosapentaenoic acid (460 mg) and docosahexaenoic acid (380 mg).
• The other ingredients (excipients) are alpha-tocopherol, gelatin, glycerol (E-422), purified water, medium-chain triglycerides, and sunflower lecithin.

Appearance and packaging of the product

Light yellow soft gelatin capsule.

Plastic containers with a pressure cap containing 100 capsules.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

VIANEX S.A. – Plant A

12km National Road Athens Lamia,

Metamorfossi, 144 51,

GREECE

or

ONE PHARMA S.A

60th Km N.N.R Athinon-Lamias

32009 Sximatari, Greece

Date of the last revision of this leaflet: December 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es