TRECOR 1000 mg Soft Capsule

Зміст інструкції

1. TRECOR 1000 mg soft capsules
   1. What is TRECOR and what is it used for
   2. What you need to know before taking TRECOR
   3. How to take TRECOR
   4. Possible side effects
   5. How to store TRECOR
   6. Package Contents and Other Information

TRECOR 1000 mg soft capsules

Ethyl esters of polyunsaturated fatty acids
Generic medicine

Read 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 pass it on 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 TRECOR is and what it is used for
• 2. What you need to know before you take TRECOR
• 3. How to take TRECOR
• 4. Possible side effects
• 5. How to store TRECOR
• 6. Contents of the pack and other information

1. What is TRECOR and what is it used for

TRECOR contains as active ingredients ethyl esters of polyunsaturated fatty acids (derived from fish oil) at high concentration and purity, which reduce the level of certain fats in the blood (triglycerides) and have positive effects on the heart and blood vessels.
TRECOR is indicated:

• to reduce high levels of fats (triglycerides) in the blood, when diet and other non-pharmacological measures alone have not been sufficient. Treatment with TRECOR must always be associated with adequate dietary rules.

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 if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking TRECOR.
Tell your doctor before taking TRECOR:

• if you are allergic to fish, as the active ingredient of TRECOR is derived from fish oil;
• if you have liver problems. Your doctor will monitor your liver function during the

treatment, especially if you are using high doses of TRECOR;

• if you have bleeding disorders.

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

• medicines to thin the blood (anticoagulants) e.g. coumarin anticoagulants
• other medicines that affect blood clotting because an increase in bleeding time may occur.

Pregnancy and breastfeeding
Do not use TRECOR if you are pregnant or if you are breastfeeding.

Driving and using machines
TRECOR does not alter the ability to drive vehicles or use machines.

3. How to take TRECOR

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Take the TRECOR capsules whole with a little 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 a day, as prescribed by your doctor.

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

Use in elderly patients and patients with renal impairment
No dose adjustment is required in these patients.

Use in patients with hepatic impairment
The doctor will monitor your liver function during treatment, especially if you are using
high doses of TRECOR (see section “Warnings and precautions”).

If you take more TRECOR than you should
In case of accidental ingestion of an excessive dose of TRECOR, inform your doctor or pharmacist.

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

If you stop taking TRECOR
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people)

• stomach and/or intestinal discomfort

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

• difficulty digesting
• pain in the upper part of the 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 intestines (gastritis, gastroenteritis)
• abdominal pain
• heartburn
• alteration of liver function
• skin reactions
• weakness

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

• itching
• itchy skin rash (urticaria).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after Exp. The date
of expiry refers to the last day of that month.
Store at a temperature below 30 ° C. Store in the blister pack to protect from light.
Do not dispose of any medicine in 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 TRECOR contains

• The active ingredients 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 of not less than 85% and a ratio of 0.9 - 1.5 between them.
• The other components are alpha-tocopherol, succinate gelatin, glycerol, medium-chain triglycerides, purified water.

Description of the appearance of TRECOR and package contents
Soft, transparent, oblong capsules containing a clear oil, light yellow in color, with a
characteristic fishy odor.
Each package contains 20 or 30 soft capsules in a white-opaque heat-sealed blister made of PVC/PVDC-
AL.
Not all package sizes may be marketed.

Marketing Authorisation 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)