PROSPECTO: INFORMATION FOR THE USER

Ácidos Omega 3 KERN PHARMA 1.000 mg soft capsules EFG

Esters of omega 3 fatty acids at 90%

Read this prospect carefully before starting to take this medication, because

it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

Omega 3 Kern Pharma belongs to a group of medications called “Other cholesterol and triglyceride reducers”.

This medication 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 medications may be necessary.

Do not take Ácidos Omega 3 Kern Pharma

• if you are allergic to the active ingredient or any of the other components of Ácidos Omega 3 Kern Pharma.

Warnings and precautions

Consult your doctor or pharmacist:

• If you are taking an anticoagulant (blood-thinning medication such as warfarin) and take the high dose of omega-3 fatty acids (4 capsules daily).
• If you are at risk of bleeding due to a severe injury 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 fatty acids (4 capsules daily), your doctor should perform regular blood tests to monitor liver function. There is no information on the use of omega-3 fatty acids in patients with liver dysfunction.
• Exercise caution in patients with kidney problems, as there is limited experience with the use of this product in such patients.
• If you have endogenous hypertriglyceridemia (elevated triglycerides due to another underlying disease, such as uncontrolled diabetes), as there is limited experience with the use of this medication in such conditions. Omega-3 fatty acids are not indicated for exogenous hypertriglyceridemia (elevated triglycerides due to inadequate diet).
• If you are allergic to fish.
• If you have or have had heart problems
• If you experience dizziness, fatigue, 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 fatty acids should not be administered to children.

Older adults

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

Use of Ácidos Omega 3 Kern Pharma with other medications

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

If you are taking anticoagulants (blood-thinning medications), such as warfarin, you may need additional blood tests and adjustments to your usual anticoagulant dose.

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

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

There is no information on the use of omega-3 fatty acids in pregnant women or on the elimination of omega-3 fatty acids in breast milk, so omega-3 fatty acids should not be used during pregnancy or lactation unless strictly necessary.

Driving and operating machinery

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

Follow these instructions unless your doctor has given you different instructions. In those cases, it is advisable to ask your doctor for written instructions and make sure you understand them well.

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

Do not forget to take your medication.

Omega 3 acids must be administered orally. Take the capsules with water. You can take the capsules during meals to help reduce gastrointestinal side effects.

Hipertrigliceridemia (High Triglyceride Levels in Blood)

The usual dose is 2 capsules per day. If you do not get the desired response, your doctor may increase the dose up to 4 capsules per day.

The long-term lipid-reducing effect (after more than a year) is unknown.

If you take more Ácidos Omega 3 Kern Pharma than you should

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

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Ácidos Omega 3 Kern Pharma

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

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

Like all medications, Ácidos Omega 3 Kern Pharma may produce adverse effects, although not all people will experience them.

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

Very frequent (affect more than 1 in 10 patients)

Frequent (affect between 1 and 10 in 100 patients)

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

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

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

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

Infrequent: abdominal pain and gastrointestinal disturbances, gastritis, dizziness, alteration of taste, allergic reactions.

Rare: headache, acne, itchy skin rash (hives or urticaria), elevated blood sugar, liver discomfort, gastrointestinal pain, undefined gastrointestinal disturbances.

Very rare: gastrointestinal bleeding, decreased blood pressure, nasal dryness, urticaria, changes in blood, moderate elevation of transaminases (blood tests related to the liver) in patients with elevated triglycerides (hypertriglyceridemia), elevated 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 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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 expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Omega 3 Acids Kern Pharma

• The active principles 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 components (excipients) are alpha-tocopherol, gelatin, glycerol (E-422), purified water, medium-chain triglycerides, and sunflower lecithin.

Appearance of the product and content of the packaging

Soft gelatin capsule of light yellow color.

Plastic containers with pressure cap containing 100 capsules.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa -Barcelona

Spain

Responsible for manufacturing

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

Last review date of this leaflet: December 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es