Patient Information Leaflet

TRECOR 1000 mg soft capsules

Ethyl esters of polyunsaturated fatty acids
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because 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 may 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:

What TRECOR is and what it is used for
What you need to know before taking TRECOR
How to take TRECOR
Possible side effects
How to store TRECOR
Contents of the pack and other information

1. What TRECOR is and what it is used for

TRECOR contains, as active substances, highly concentrated and purified ethyl esters of polyunsaturated fatty acids (derived from fish oil), which reduce the levels of certain fats in the blood (triglycerides) and have beneficial effects on the heart and blood vessels.
TRECOR is indicated:

to reduce elevated levels of fats (triglycerides) in the blood, when diet and other non-pharmacological measures alone have not been sufficient. Treatment with TRECOR should always be accompanied by appropriate dietary measures.

2. What you need to know before taking TRECOR

Do not take TRECOR

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 TRECOR.
Inform your doctor before taking TRECOR:

if you are allergic to fish, as the active substance in TRECOR 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 TRECOR;
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 TRECOR
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 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 TRECOR if you are pregnant or breastfeeding.
Driving and using machines
TRECOR does not affect the ability to drive vehicles or operate machinery.

3. How to take TRECOR

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Swallow the TRECOR capsules whole with some water.

Use in adults
For the reduction of elevated blood fat levels (triglycerides).
The recommended dose is 1 capsule of 1000 mg 1-3 times daily, according to your doctor's prescription.

Use in the paediatric population
No data are available on the use of TRECOR in the paediatric population for the approved indications.

Use in elderly patients and 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 TRECOR (see section “Warnings and precautions”).

If you take more TRECOR than you should
If you accidentally take too much TRECOR, inform your doctor or pharmacist.

If you forget to take TRECOR
Do not take a double dose to make up for the forgotten dose.

If you stop taking TRECOR
If you have any questions about the use of 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
Diarrhoea

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
Changes in 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 may 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 TRECOR

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 pack to protect from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What TRECOR 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 an EPA and DHA content not less than 85%, and a ratio between them of 0.9 - 1.5.
The other components are alpha-tocopherol, gelatin, glycerol, medium-chain triglycerides, purified water.

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

Marketing Authorization Holder
Epifarma 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 (Milano)