ACIDOS OMEGA 3 STRIDES 1000 MG SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the User

Omega-3 Acids Strides 1000 mg Soft Capsules EFG

Ethyl esters of omega-3 fatty acids at 90%

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others

even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Omega-3 Acids Strides and what is it used for
2. What you need to know before taking Omega-3 Acids Strides
3. How to take Omega-3 Acids Strides
4. Possible side effects
5. Storage of Omega-3 Acids Strides
6. Package Contents and Additional Information

1. What is Omega-3 Acids Strides and what is it used for

This medication contains highly purified polyunsaturated omega-3 fatty acids. The ethyl esters of omega-3 fatty acids belong to the group of medications called "cholesterol and triglyceride reducers".

The ethyl esters of omega-3 fatty acids are used:

To treat certain forms of elevated triglyceride levels (fats) in the blood when dietary changes have not worked.

2. What you need to know before taking Omega-3 Acids Strides

Do not take Omega-3 Acids Strides:

• if you are allergic to the ethyl esters of omega-3 fatty acids,

or to any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Omega-3 Acids Strides if:

• You are going to undergo or have recently undergone surgery.
• You have recently suffered a trauma.
• You have kidney problems.
• You have uncontrolled diabetes.
• You have liver problems. Your doctor will perform blood tests to monitor the effects of this medication on the liver.

-you are allergic to fish.

• you have or have had heart problems
• you experience dizziness, weakness, palpitations, or difficulty breathing, as these may be symptoms of an irregular and often rapid heart rhythm (atrial fibrillation).

If you meet any of the above points, consult your doctor or pharmacist before taking this medication.

Children and Adolescents

As there are no data on the efficacy and safety, children and adolescents should not take this medication.

Elderly Population

Data on the use of ethyl esters of omega-3 fatty acids in patients over 70 years of age are limited, so caution should be exercised when using this medication in this patient population.

Using Omega-3 Acids Strides with Other Medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

If you are using any medication to prevent blood clots in the arteries (such as warfarin), you may need additional blood tests and your usual dose of anticoagulants may need to be adjusted.

Using Omega-3 Acids Strides with Food

You should take the capsules with meals to reduce the possibility of gastrointestinal side effects.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take this medication during pregnancy or breastfeeding, unless your doctor decides it is absolutely necessary.

Driving and Using Machines

It is unlikely that this medication will affect your ability to drive or use tools or machinery.

Omega-3 Acids Strides contains Soybean Lecithin

This medication contains 1.38 mg of propylene glycol in each capsule.

If your baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications that contain propylene glycol or alcohol.

3. How to Take Omega-3 Acids Strides

Follow your doctor's instructions for taking this medication exactly.

If you are unsure, consult your doctor or pharmacist again.

• Swallow the capsules with a glass of water.
• Take the capsules with meals to reduce gastrointestinal side effects.

Your doctor will decide how long you should take this medication.

Dose for Treating High Triglyceride Levels(elevated fat levels in the blood or hypertriglyceridemia)

The recommended dose is 2 capsules per day.

If this dose does not work as expected, your doctor may increase it to 4 capsules per day.

If You Take More Omega-3 Acids Strides Than You Should

If you accidentally take more medication than you should, do not worry, as it is unlikely that you will need special treatment. However, you should consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If You Forget to Take Omega-3 Acids Strides

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose, in which case you should take the next dose as usual. Do not take a double dose (twice the dose recommended by your doctor) to make up for missed doses.

If You Stop Taking Omega-3 Acids Strides

Do not stop taking Omega-3 Acids Strides without consulting your doctor first. If you think the effects of the ethyl esters of omega-3 fatty acids are not what you expected, consult your doctor.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them. The following side effects may occur with this medication:

Common Side Effects(may affect up to 1 in 10 people):

• stomach problems, such as abdominal distension, pain, constipation, diarrhea, indigestion (dyspepsia), gas, belching, acid reflux, feeling of dizziness (nausea) and vomiting

Uncommon Side Effects(may affect up to 1 in 100 people):

• irregular and rapid heart rhythm

Rare Side Effects(may affect up to 1 in 1,000 people):

• allergic reactions
• skin rash with redness and inflammation (hives or urticaria)
• liver disorders, accompanied by changes in the results of certain blood tests

Other side effects have occurred in a very small number of patients, and their frequency is unknown:

• itching
• itchy rash (hives or urticaria)

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Omega-3 Acids Strides

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the box and label after CAD. The expiration date is the last day of the month indicated.

Store below 30°C. The validity period after the first opening of the HDPE container is 120 days.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in your pharmacy or any other medication waste collection system. If you have any questions, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Omega-3 Acids Strides

• The active ingredients are ethyl esters of omega-3 fatty acids at 90%. Each capsule contains 1000 mg of ethyl esters of omega-3 fatty acids at 90%, mainly composed of 465 mg of ethyl ester of eicosapentaenoic acid (EPA) and 375 mg of ethyl ester of docosahexaenoic acid (DHA).

The other ingredients are: α-tocopherol, gelatin, glycerol, medium-chain triglycerides, and dye (dye composition: bleached and dewaxed lacquer resin, isopropyl alcohol, propylene glycol, titanium dioxide, sodium lauryl sulfate, twin 80.

Appearance of the Product and Package Contents

Omega-3 Acids Strides are soft gelatin capsules, oval and transparent, containing a light yellow oily liquid and marked with "740".

Omega-3 Acids Strides is available in the following package sizes:

• High-density polyethylene (HDPE) container, white and opaque, with a white HDPE screw cap and induction seal. Each bottle contains 20, 28, 100, or 120 capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder

Strides Pharma (Cyprus) Ltd,

Themistokli, 3,

Julia House, 1066,

Nicosia, Cyprus

Manufacturer

STRIDES PHARMA UK LTD

Unit 4, Metro Centre, Tolpits Lane,

Watford, Hertfordshire, WD18 9SS,

United Kingdom

Local Representative

Ababor Pharmaceuticals S.L

Calle Chile 4, Edifico 1, Oficina 1, 28290, Las Rozas (Spain)

This medication is authorized in the Member States of the European Economic Area under the following names:

Spain: Omega-3 Acids Strides 1000 mg Soft Capsules EFG

Italy: Omega 3 Strides Arcolab International

France: Esters éthyliques d’acides Oméga-3 Strides 1 g Soft Capsules

Date of the Last Revision of this Package Leaflet:01/2024.

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