TRIOREG 1000 mg Soft Capsule

Зміст інструкції

1. TRIOREG 1000 mg soft capsules
   1. What is TRIOREG and what is it used for
   2. What you need to know before you take TRIOREG
   3. How to take TRIOREG
   4. Possible side effects
   5. How to store TRIOREG
   6. Contents of the pack and other information

TRIOREG 1000 mg soft capsules

Ethyl ester omega-3 acids 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 others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even 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 you take 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 is TRIOREG and what is it used for

The active ingredients of TRIOREG are highly purified omega-3 polyunsaturated fatty acid ethyl esters.
TRIOREG reduces certain fats in the blood (triglycerides).
TRIOREG is used
for the treatment of certain forms of increased fats in the blood (endogenous hypertriglyceridemia) after
dietary changes alone and other non-pharmacological measures (for example physical
activity) have not produced results.

2. What you need to know before you take TRIOREG

Do not take TRIOREG

• if you are allergic to omega-3 fatty acids, soy lecithin, peanuts 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 are going to have or have recently had surgery
• if you have recently suffered a traumatic injury
• if you have a kidney problem
• if you suffer from uncontrolled diabetes
• if you have or have had liver problems. Your doctor will prescribe blood tests to monitor any effects on the liver from TRIOREG
• if you are allergic to fish.

Children and adolescents

• In the absence of data on efficacy and safety, the use of TRIOREG is not indicated in children and adolescents.

Elderly

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

Other medicines and TRIOREG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
If you are taking TRIOREG in combination with a medicine that counteracts blood clotting
(anticoagulant), an increase in bleeding time may occur. The doctor will carefully monitor your treatment and, if necessary, adjust the dose of TRIOREG or the other medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor for advice before taking this medicine.

Driving and operating machinery
No special precautions are necessary.

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

3. How to take TRIOREG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is
1 capsule 1-3 times a day depending on your doctor's prescription.
If you feel that the effect of TRIOREG is too strong or
too weak, contact your doctor or pharmacist.

Instructions for use

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

If you take more TRIOREG than you should
If you accidentally take a higher amount of medicine than necessary and experience adverse
effects, contact your doctor.

If you forget to take TRIOREG
Do not take a double dose to make up for a missed dose. Take the next capsules
as prescribed.

If you stop taking TRIOREG
Do not stop the treatment without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor.

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)

• stomach discomfort and indigestion (dyspepsia)
• nausea

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

• stomach pain and abdominal pain
• allergic reactions
• dizziness
• taste alterations
• diarrhoea
• vomiting

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

• headache
• acne
• itchy rash
• hyperglycaemia (high glucose)
• liver problems

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

• presence of blood in the stools
• arterial hypotension (low blood pressure)
• nasal dryness
• itchy skin rash (urticaria)
• changes in the values of some blood tests

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

• itching

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

athttps://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting

side effects you can help to 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 visible signs of deterioration.
Store at a temperature below 25 °C.
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. Contents of the pack and other information

What TRIOREG contains

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

Description of the appearance of TRIOREG and contents of the pack
This medicine is presented as oblong soft capsules of light yellow color containing a
yellowish oil with a characteristic fishy odor.
The capsules are packaged in aluminum/PVC/PE/PVDC blisters of 10 capsules each.
Packs of 2 or 3 blisters.

Marketing Authorisation 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, Italia