Omega 3 PensA

Package leaflet: Information for the patient

OMEGA 3 PENSA 1000 mg soft capsules

Ethyl esters of polyunsaturated fatty acids
Equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What OMEGA 3 PENSA is and what it is used for
2. What you need to know before taking OMEGA 3 PENSA
3. How to take OMEGA 3 PENSA
4. Possible side effects
5. How to store OMEGA 3 PENSA
6. Contents of the pack and other information

1. What OMEGA 3 PENSA is and what it is used for

OMEGA 3 PENSA contains, as active substances, ethyl esters of polyunsaturated fatty acids (derived from fish oil) of high concentration and purity, which reduce the levels of certain fats in the blood (triglycerides) and have beneficial effects on the heart and blood vessels.
OMEGA 3 PENSA is indicated:

• for reducing elevated levels of fats (triglycerides) in the blood, when diet and other non-pharmacological measures alone have not been sufficient. Treatment with OMEGA 3 PENSA should always be accompanied by appropriate dietary measures.

2. What you need to know before taking OMEGA 3 PENSA

Do not take OMEGA 3 PENSA

• if you are allergic to ethyl esters of polyunsaturated fatty acids (derived from fish oil) or to any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking OMEGA 3 PENSA.
Inform your doctor before taking OMEGA 3 PENSA:

• if you are allergic to fish, since the active substance in OMEGA 3 PENSA is derived from fish oil;
• if you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are taking high doses of OMEGA 3 PENSA;
• if you have conditions that cause you to bleed easily;
• if you have or have had heart problems;
• if you experience dizziness, weakness, palpitations, or shortness of breath, as these may be symptoms of an irregular and often very rapid heart rhythm (atrial fibrillation).

Other medicines and OMEGA 3 PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are being treated with:

• medicines used to thin the blood (anticoagulants), e.g. coumarin anticoagulants;
• other medicines that affect blood clotting, as this may lead to an increased bleeding time.

Pregnancy and breastfeeding
Do not use OMEGA 3 PENSA if you are pregnant or breastfeeding.
Driving and using machines
OMEGA 3 PENSA does not affect the ability to drive or operate machinery.

3. How to take OMEGA 3 PENSA

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Take OMEGA 3 PENSA capsules whole with some water.
Use in adults
For the reduction of elevated levels of fats (triglycerides) in the blood.
The recommended dose is 1 capsule of 1000 mg 1-3 times daily, according to your doctor's prescription.
Use in the paediatric population
There are no data available on the use of OMEGA 3 PENSA in the paediatric population for the approved indications.
Use in elderly patients and in patients with impaired kidney function
No dose adjustment is required in these patients.
Use in patients with impaired liver function
Your doctor will monitor your liver function during treatment, especially if you are taking high doses of OMEGA 3 PENSA (see section “Warnings and precautions”).
If you take more OMEGA 3 PENSA than you should
If you accidentally take too much OMEGA 3 PENSA, inform your doctor or pharmacist.
If you forget to take OMEGA 3 PENSA
Do not take a double dose to make up for the forgotten dose.
If you stop taking OMEGA 3 PENSA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Common side effects (may affect up to 1 in 10 people)

• Stomach and/or intestinal disturbances
• Fast, irregular heartbeat

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

• Nausea
• Difficulty digesting
• Pain in the upper abdomen
• Diarrhea

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

• Allergic reactions (hypersensitivity), allergy to the components
• Dizziness
• Inflammation of the stomach and/or intestine (gastritis, gastroenteritis)
• Abdominal pain
• Stomach burning
• Alteration of liver function
• Skin reactions
• Weakness

Other side effects that have occurred in a very small number of people, but whose exact frequency is unknown

• Itching
• Itchy skin rash (urticaria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OMEGA 3 PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Store below 30 °C. Keep in the blister to protect from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What OMEGA 3 PENSA contains

• The active substances are ethyl esters of polyunsaturated fatty acids. Each soft capsule contains 1000 mg of ethyl esters of polyunsaturated fatty acids, with a content of EPA and DHA not less than 85%, and in a ratio to each other of 0.9 - 1.5.
• The other components are alpha-tocopherol, gelatin, glycerol, medium-chain triglycerides, purified water.

Description of the appearance of OMEGA 3 PENSA and package contents
Soft, transparent, oblong capsules containing a clear, light yellow oil with a characteristic fishy odor.
Each package contains 20 or 30 soft capsules in white-opaque thermoformed blisters in PVC/PVDC-AL.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
FG S.r.l.
Via San Rocco, 6
85033 Episcopia (PZ)

Manufacturer

• Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (Piacenza)
• Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto de’ Stampi - Rozzano (Milan)