ACIDOS OMEGA 3 TARBIS 1000 mg SOFT GEL CAPSULES

Introduction

Omega 3 Tarbis 1,000 mg soft capsules EFG

Ethyl esters of omega-3 fatty acids 90

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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 leaflet. See section 4.

Contents of the leaflet:

1. What is Omega 3 Tarbis and what is it used for
2. What you need to know before taking Omega 3 Tarbis
3. How to take Omega 3 Tarbis
4. Possible side effects
5. Storage of Omega 3 Tarbis
6. Package contents and additional information

1. What is Omega 3 Tarbis and what is it used for

Omega 3 Tarbis contains highly purified polyunsaturated omega-3 fatty acids. Omega 3 Tarbis belongs to the group of medications called "cholesterol and triglyceride reducers".

Omega 3 Tarbis is used:

• to treat certain forms of elevated triglyceride levels (fats) in the blood, when dietary changes do not work.

2. What you need to know before taking Omega 3 Tarbis

Do not take Omega 3 Tarbis:

• If you are allergic (hypersensitive) to ethyl esters of omega-3 fatty acids 90 or to any of the other components of this medication (listed in section 6).
• If you meet any of the above points, do not take this medication and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Omega 3 Tarbis, if:

• you are going to undergo or have recently undergone surgery
• you have recently suffered a trauma
• you have kidney problems
• you have diabetes and it is not controlled
• you have liver problems. Your doctor will perform blood tests to monitor the effects that Omega 3 Tarbis may have on the liver.
• if you are allergic to fish
• if you have or have had heart problems
• if you experience dizziness, asthenia (feeling of weakness), palpitations, or difficulty breathing, as they 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

This medication is not suitable for the pediatric population.

Elderly

If you are over 70 years old, use Omega 3 Tarbis with caution.

Using Omega 3 Tarbis with other medications

Inform 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 will need to have additional blood tests and it may be necessary to modify your usual dose of anticoagulants.

Using Omega 3 Tarbis with food and beverages

You should take the capsules with meals. This is to help reduce the possibility of gastrointestinal side effects (gastrointestinal region).

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.

Driving and using machines

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

Omega 3 Tarbis contains soybean oil

Omega 3 Tarbis may contain soybean oil. Do not use this medication if you are allergic to peanuts or soy.

3. How to take Omega 3 Tarbis

Follow your doctor's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again.

• Swallow the capsules with a glass of water.
• It is recommended to take the capsules with meals to help 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 usual dose is 2 capsules per day, as recommended by your doctor. If this dose does not work as expected, your doctor may increase it to 4 capsules per day.

If you take more Omega 3 Tarbis than you should

If you accidentally take more medication than you should, do not worry, as you will likely not need any special treatment. However, you should contact your doctor or pharmacist for additional advice.

If you forget to take Omega 3 Tarbis

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 to make up for the forgotten dose (double the dose recommended by your doctor).

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

4. Possible side effects

Like all medications, Omega 3 Tarbis 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.
• Irregular and rapid heart rhythm

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

• elevated blood sugar levels
• gout
• feeling of dizziness
• taste disturbances
• headache
• low blood pressure
• nosebleeds
• blood in the stool
• rash

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

• allergic reactions
• itchy rash (hives or urticaria)
• liver disorders with possible changes in some blood test results

Frequency not known (cannot be estimated from available data):

• Itching

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System (www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Omega 3 Tarbis

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

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

Do not store Omega 3 Tarbis at a temperature above 25°C. Do not freeze.

Omega 3 Tarbis should be used within 100 days of opening the bottle.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Contents of Omega 3 Tarbis

The active ingredients are ethyl esters of omega-3 fatty acids 90, 1000 mg, comprising 840 mg of ethyl esters, of which 460 mg correspond to eicosapentaenoic acid (EPA) and 380 mg to docosahexaenoic acid (DHA).

• The capsule core contains:

alpha-tocopherol (may contain vegetable oils such as soybean oil).

• The capsule shell contains: gelatin, glycerol, purified water, medium-chain triglycerides, and lecithin (sunflower).

Appearance of Omega 3 Tarbis and package contents

The Omega 3 Tarbis capsules are transparent soft gelatin capsules containing oil with a light yellow color.

Omega 3 Tarbis is available in the following package sizes:

• 1 x 20 soft capsules
• 1 x 28 soft capsules
• 1 x 30 soft capsules
• 1 x 60 soft capsules
• 1 x 100 soft capsules
• 10 x 28 soft capsules

Not all package sizes may be marketed.

Marketing authorization holder

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

VIANEX S.A. – Plant A

12km National Road Athens Lamia,

Metamorfossi, 144 51,

GRECIA

Alternative site:

ONE-PHARMA, S.A.

60th km National Road Athens-Lamia

320 09 Schimatari, Viotia

GRECIA

Date of the last revision of this leaflet: February 2024

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