Trioreg

Patient Information Leaflet

TRIOREG 1000 mg soft capsules

Omega-3 acid ethyl esters 90
Generic medicine
Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What TRIOREG is and what it is used for

The active substances in TRIOREG are highly purified omega-3 fatty acid ethyl esters.
TRIOREG reduces certain blood fats (triglycerides).
TRIOREG is used to treat certain forms of elevated blood fats (endogenous hypertriglyceridemia) after dietary changes and other non-pharmacological measures alone (e.g. physical activity) have not produced results.

2. What you need to know before taking TRIOREG

Do not take TRIOREG

• if you are allergic to omega-3 fatty acids, soybean lecithin, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking TRIOREG

• if you have conditions that make you prone to bleeding
• if you are scheduled for or have recently undergone surgery
• if you have recently suffered a traumatic injury
• if you have kidney problems
• if you have uncontrolled diabetes
• if you have or have had liver problems. Your doctor will order blood tests to monitor any potential liver-related effects of TRIOREG, especially if you are taking high doses of TRIOREG
• if you are allergic to fish
• 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).

Children and adolescents

• Due to lack of data on efficacy and safety, the use of TRIOREG is not recommended in children and adolescents.

Elderly

• There is no available data on the use of TRIOREG in elderly patients over 70 years of age. Caution is advised when using TRIOREG in patients above 70 years of age.

Other medicines and TRIOREG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
If you are taking TRIOREG together with a medicine that inhibits blood coagulation (anticoagulant) or other medicines affecting blood clotting, an increased bleeding time may occur. Your doctor will monitor your treatment carefully and, if necessary, adjust the dose of TRIOREG or the other medicine.

Pregnancy, breastfeeding and fertility
Do not use TRIOREG if you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding.

Driving and using machines
No special precautions are required.

TRIOREG contains soybean lecithin
If you are allergic to peanuts or soy, do not take this medicine.

3. How to take TRIOREG

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is
1 capsule 1-3 times daily, depending on your doctor's prescription.
Contact your doctor or pharmacist if you feel that the effect of TRIOREG is too strong or
too weak.
Instructions for use

• Swallow the capsules with a glass of water.
• Take the medicine for the duration of treatment prescribed by your doctor.

Use in the paediatric population
No data are available on the use of TRIOREG 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 TRIOREG (see section “Warnings and precautions”).
If you take more TRIOREG than you should
If you accidentally take more medicine than you should, contact your doctor or pharmacist.
If you forget to take TRIOREG
Do not take a double dose to make up for the forgotten dose. Take the next dose as prescribed.
If you stop taking TRIOREG
Do not stop treatment without consulting your doctor.
If you have any questions about how to use 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.
The following side effects may occur with the use of this medicine.

Common (may affect up to 1 in 10 people)

• difficulty digesting (dyspepsia)
• nausea, stomach and/or intestinal disturbances
• rapid or irregular heartbeat

Uncommon (may affect up to 1 in 100 people)

• inflammation of the stomach and/or intestine (gastritis, gastroenteritis)
• abdominal pain and upper abdominal pain
• allergic reactions
• dizziness
• taste disturbances
• diarrhoea

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

• allergic reactions (hypersensitivity)
• headache
• acne
• itchy rash
• hyperglycaemia (high glucose levels)
• inflammation of the stomach and/or intestine (gastritis, gastroenteritis)
• altered liver function
• skin reactions
• inflammatory bowel disease
• stomach burning
• vertigo
• weakness
• abdominal pain

Very rare (may affect up to 1 in 10,000 people)

• presence of blood in the stool
• hypotension (low blood pressure)
• nasal dryness
• itchy skin rash (urticaria)
• changes in the results of certain blood tests

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

• itching

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 https://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 TRIOREG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
Store below 25 °C.
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 TRIOREG contains

• The active substances are omega-3 fatty acid ethyl esters 90, with a content of EPA and DHA of not less than 85%, and in a ratio of 0.9 - 1.5 between them. Each capsule contains 1000 mg of omega-3 fatty acid ethyl esters 90.
• The other components are: D,L-rac-α-Tocoferolo, succinylated gelatin, glycerol, medium-chain triglycerides, traces of soy lecithin.

Description of the appearance of TRIOREG and contents of the package
This medicine is presented as soft, oblong-shaped capsules of light yellow color, containing a yellowish oil with a characteristic fish odor.
The capsules are packed in aluminum/PVC/PE/PVDC blisters, each containing 10 capsules.
Pack sizes of 2 or 3 blisters.
Marketing Authorization Holder
Alfasigma S.p.A. – Via Ragazzi del ‘99, n. 5 - 40133 Bologna (BO)
Manufacturer
IBSA Farmaceutici Italia Srl, via Martiri di Cefalonia, 2, 26900 Lodi, Italy