Label: Information for the User

Omega-3 Strides 1000 mg Softgels EFG

90% Ethyl Esters of Omega-3 Fatty Acids

Read this label carefully before starting to take this medication, as it contains important information for you.

− Keep this label, as you may need to refer to it again.

− If you have any questions, consult your doctor or pharmacist.

− This medication has been prescribed only to you, 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 any adverse effects, consult your doctor or pharmacist, even if they do not appear in this label. See section 4.

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

2. What you need to know before starting to take Omega-3 Strides

3. How to take Omega-3 Strides

4. Possible adverse effects

5. Storage of Omega-3 Strides

6. Contents of the package and additional information

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

Omega-3 fatty acid esters are used:

To treat certain forms of elevated triglycerides (fats) in the blood when dietary changes have not been effective.

Do not take Ácidos Omega-3 Strides:

- if you are allergic to 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 Ácidos Omega-3 Strides if:

- You are about to undergo or have recently undergone surgery.

- You have recently experienced a trauma.

- You have kidney problems.

- You have diabetes that is not controlled.

- You have liver problems. Your doctor will perform blood tests to monitor

the effects this medication may have on the liver.

- you are allergic to fish.

• You have or have had heart problems
• You experience dizziness, fatigue, palpitations, or difficulty breathing, which may be symptoms of an irregular and often very 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

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

Geriatric population

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

Use of Ácidos Omega-3 Strides with other medications

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

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

Use of Ácidos Omega-3 Strides with food

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

Pregnancy and lactation

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

You should not take this medication during pregnancy or lactation, unless your doctor decides it is absolutely necessary.

Driving and operating machinery

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

Ácidos Omega-3 Strides contains lecithin (soya)

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 your baby has been given other medications containing propylene glycol or alcohol

Follow exactly the administration instructions for this medication as indicated by your doctor.

Consult your doctor or pharmacist again if you are unsure.

Swallow the capsules with the help of a glass of water.

Take the capsules with meals to reduce gastrointestinal side effects.

Gastrointestinal side effects.

Your doctor will decide the time period for which you should take this medication.

Dosage for treating elevated triglyceride levels(high concentration of fats 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 Ácidos Omega-3 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 Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Ácidos Omega-3 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 (two times the dose recommended by your doctor) to make up for the missed doses.

If you interrupt treatment with Ácidos Omega-3 Strides

Do not stop treatment with Ácidos Omega-3 Strides without consulting your doctor first. If you consider that the effects of the ethyl esters of omega-3 acid are not desired, consult your doctor.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them. The following adverse effects may appear with this medication:

Adverse EffectsFrequent(may affect up to 1 in 10 people):

- Stomach problems, such as bloating, pain, constipation, diarrhea,

indigestion (dyspepsia), gas, belching, acid reflux, sensation of nausea (nausea) and

vomiting (dizziness)

• Irregular and rapid heart rhythm

Adverse EffectsInfrequent(may affect up to 1 in 100 people):

- Elevated blood sugar concentrations

- Gout

- Dizziness

- Taste alterations

- Headache

- Low blood pressure

- Nasal bleeding

- Blood in the stool

- Hives

Adverse EffectsRare(may affect up to 1 in 1,000 people):

- Allergic reactions

- Skin hives with redness and inflammation (hives or urticaria)

- Liver disorders, accompanied by variations in certain blood test results

Others adverse effects have occurred in a very small number of patients and their exact frequency is unknown:

- Itching

- Rash with itching (rash or urticaria).

Reporting Adverse Effects

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

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

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

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

Medications should not be thrown into the drains or trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy or any other medication waste collection system. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Omega-3 Acids Strides

- The active principles 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 (840 mg) of 465 mg of ethyl ester of eicosapentaenoic acid (EPA) and 375 mg of ethyl ester of docosahexaenoic acid (DHA).

- The other components are: α-tocopherol, gelatin, glycerol,

medium-chain triglycerides, and dye (dye composition: bleached and deparaffined shellac resin, isopropyl alcohol, propylene glycol, titanium dioxide, sodium lauryl sulfate, Twin 80.Appearance of the product and contents of the packaging

Omega-3 Strides are soft gelatin capsules, oval and transparent, containing a clear yellow oily liquid and bearing the inscription «740».

Omega-3 Strides is available in the following packaging sizes:

- High-density polyethylene (HDPE) white and opaque packaging, with a white HDPE screw cap sealed by induction. Each bottle contains 20, 28, 100, or 120

capsules.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Strides Pharma (Cyprus) Ltd,

Themistokli, 3,

Julia House, 1066,

Nicosia, Cyprus

Responsible for Manufacturing

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, Edificio 1, Oficina 1, 28290, Las Rozas (Spain)

This medicinal product is authorized in the member states of the European Economic Area with the following names:

SpainOmega-3 Strides 1000 mg soft gelatin capsules EFG

ItalyOmega 3 Strides Arcolab International

FranceEsters éthyliques d’acides Oméga-3 Strides 1 g soft capsule

Last review date of this leaflet:01/2024.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/