Omega 3 Strides 1000 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omega-3 Acids Strides 1000 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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

1. What Omega-3 Acids Strides is and what it is 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. How to store Omega-3 Acids Strides
6. Contents of the pack and other information

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

This medicine contains highly purified omega-3 polyunsaturated fatty acids. The omega-3 fatty acid ethyl esters belong to a group of medicines called "lipid-lowering agents" (cholesterol and triglyceride reducing agents).

Omega-3 fatty acid ethyl esters are used:

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

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

Do not take Omega-3 Acids Strides:

• if you are allergic to omega-3 fatty acid ethyl esters,

or to any of the other components of this medicine (listed in section

6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Omega-3 Acids Strides if:

• You are scheduled for or have recently undergone surgery.
• You have recently suffered trauma.
• You have kidney problems.
• You have uncontrolled diabetes.
• You have liver problems. Your doctor will perform blood tests to monitor the effects this medicine may have on your 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 very rapid heartbeat (atrial fibrillation).

If any of the above apply to you, consult your doctor or pharmacist before taking this medicine.

Children and adolescents

Due to lack of data on efficacy and safety, children and adolescents should not take this medicine.

Elderly population

Data on the use of omega-3 fatty acid ethyl esters in elderly patients over 70 years of age are limited; therefore, caution should be exercised when using this medicine in this patient population.

Taking Omega-3 Acids Strides with other medicines

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

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

Taking Omega-3 Acids Strides with food

You should take the capsules with meals in order to reduce the likelihood of gastrointestinal side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not take this medicine during pregnancy or breastfeeding unless your doctor decides it is absolutely necessary.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or operate tools or machinery.

Omega-3 Acids Strides contains lecithin (soy)

This medicine 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 medicines containing propylene glycol or alcohol.

3. How to take Omega-3 Acids Strides

Follow exactly the instructions for use of this medicine as given by your doctor.

If in doubt, 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 medicine.

Dose for treating high triglyceride levels (elevated fat levels in the blood or hypertriglyceridemia)

The recommended dose is 2 capsules daily.

If this dose does not produce the desired effect, your doctor may increase it to 4 capsules daily.

If you take more Omega-3 Acids Strides than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine 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 take your next dose as normal. Do not take a double dose (twice the dose recommended by your doctor) to make up for a missed dose.

If you stop taking Omega-3 Acids Strides

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following are the adverse effects that may occur with this medicine:

Frequent adverse effects (may affect up to 1 in 10 people):

• stomach problems, such as bloating, pain, constipation, diarrhoea,
  indigestion (dyspepsia), gas, belching, acid reflux, feeling sick (nausea), and
  dizziness (vomiting)
• Irregular and rapid heartbeat

Uncommon adverse effects (may affect up to 1 in 100 people):

• high blood sugar levels
• gout
• dizziness
• taste disturbances
• headache
• low blood pressure
• nosebleeds
• blood in the stools
• rash

Rare adverse effects (may affect up to 1 in 1,000 people):

• allergic reactions
• skin rash with redness and swelling (hives or urticaria)
• liver disorders, accompanied by changes in certain blood test results

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

• Itching
• itchy rash (wheals or urticaria)

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 via the Spanish Pharmacovigilance System for Human Medicines: 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 Strides

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

Do not use this medicine after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a pharmacy’s SIGRE collection point or any other medicine waste collection system. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Omega-3 Acids Strides

• The active substances are 90% omega-3 fatty acid ethyl esters. Each
  capsule contains 1000 mg of 90% omega-3 fatty acid ethyl esters,
  mainly composed (840 mg) of 465 mg of ethyl eicosapentanoate (EPA) and 375 mg of ethyl docosahexaenoate (DHA).

• The other components are: α-tocopherol, gelatin, glycerol,
  medium-chain triglycerides, and dye (composition
  of the dye: bleached and deparaffinized gum lac resin, isopropyl alcohol, propylene glycol, titanium dioxide, sodium lauryl sulfate, Tween 80).

Nature of the product and contents of the container

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

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

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

Only certain pack 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, Edificio 1, Oficina 1, 28290, Las Rozas (Spain)

This medicinal product 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 capsule molle

Date of the latest revision of this leaflet: 01/2024.

The 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) http://www.aemps.gob.es/