Omega-3 fatty acids Kern Pharma 1.000 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

OMEGA 3 FATTY ACIDS KERN PHARMA 1,000 mg soft capsules EFG

Ethyl esters of omega-3 fatty acids 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.
• 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 yours, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Omega 3 Fatty Acids KERN PHARMA is and what it is used for
2. What you need to know before taking Omega 3 Fatty Acids KERN PHARMA
3. How to take Omega 3 Fatty Acids KERN PHARMA
4. Possible side effects
5. How to store Omega 3 Fatty Acids KERN PHARMA
6. Contents of the pack and other information

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

Ácidos Omega 3 Kern Pharma belongs to a group of medicines called "Other cholesterol- and triglyceride-lowering agents".

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, combination with other medicines may be necessary.

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

Do not take Omega 3 Acids Kern Pharma

• if you are allergic to the active substance or to any of the other components of Omega 3 Acids 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 are taking the high dose of omega 3 fatty acids (4 capsules daily).
• If you are at 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 are taking the high dose of omega 3 fatty acids (4 capsules daily), your doctor should perform periodic blood tests to monitor liver function. There is no information available on the use of omega 3 fatty acids in patients with hepatic dysfunction.
• Exercise caution in patients with kidney problems, as experience with the use of this product in such patients is limited.
• If you have secondary endogenous hypertriglyceridemia (elevated triglycerides due to another condition you may have, such as uncontrolled diabetes), as experience with the use of this medicine in this type of disease is limited. Omega 3 Acids is not indicated for exogenous hypertriglyceridemia (elevated 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 very rapid heart rhythm (atrial fibrillation).

Children and adolescents

Omega 3 Acids must not be administered to children.

Elderly patients

There is no information available on the use of omega 3 fatty acids in patients over 70 years of age.

Use of Omega 3 Acids Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

There are no data on the use of omega 3 fatty acids in pregnant women or on the excretion of omega 3 fatty acids in breast milk. Therefore, omega 3 fatty acids must not be used during pregnancy or breastfeeding unless strictly necessary.

Driving and operating machinery

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

3. How to take Omega 3 Fatty Acids Kern Pharma

Follow these instructions unless your doctor has given you different ones. In such cases, it is advisable to request written instructions from your doctor and make sure you have fully understood them.

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

Do not forget to take your medicine.

Omega 3 Fatty Acids must be administered orally. Take the capsules with water. You may take the capsules during meals to help reduce gastrointestinal effects.

Hypertriglyceridemia (high blood triglyceride levels)

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

The long-term lipid-lowering effect (beyond one year) is unknown.

If you take more Omega 3 Fatty Acids Kern Pharma than you should

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

It is recommended to bring the medicine package and leaflet to the healthcare professional.

If you forget to take Omega 3 Fatty Acids Kern Pharma

If you miss a dose, take the medicine as soon as possible and continue treatment as prescribed. However, if it is almost time for the next dose, it is better not to take the missed dose and wait for the next one. Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, Ácidos Omega 3 Kern Pharma can produce adverse effects, although not everyone experiences them.

The frequencies of adverse effects are listed below according to the following definitions:

Very common (affects more than 1 in every 10 patients)

Common (affects between 1 and 10 in every 100 patients)

Uncommon (affects between 1 and 10 in every 1,000 patients)

Rare (affects between 1 and 10 in every 10,000 patients)

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

Common: indigestion and nausea, irregular and rapid heartbeat.

Uncommon: abdominal pain, gastrointestinal disorders, gastritis, dizziness, taste disturbances, allergic reactions.

Rare: headache, acne, itchy rash (hives or urticaria), increased blood sugar, liver discomfort, gastrointestinal pain, poorly defined disorders.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omega 3 Acids Kern Pharma

Keep out of the sight and reach of children.

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

Do not use Omega 3 Acids Kern Pharma after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Omega 3 Acids Kern Pharma

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

Appearance of the product and contents of the container

Light yellow soft gelatin capsule.

Plastic containers with pressurized 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 most recent review of this leaflet: December 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es