TRIBOK

Patient Information Leaflet

TRIBOK 1000 mg soft capsules

ethyl esters of polyunsaturated fatty acids
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 they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What TRIBOK is and what it is used for
2. What you need to know before taking TRIBOK
3. How to take TRIBOK
4. Possible side effects
5. How to store TRIBOK
6. Package contents and other information

1. What TRIBOK is and what it is used for

TRIBOK contains as active substances ethyl esters of polyunsaturated fatty acids (derived from fish oil) with 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.
TRIBOK is indicated:

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

2. What you need to know before taking it

Do not take TRIBOK

• 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 TRIBOK.
Inform your doctor before taking TRIBOK:

• if you are allergic to fish, since the active substance in TRIBOK 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 TRIBOK;
• if you have conditions that cause you to bleed easily.

Other medicines and TRIBOK
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 affecting blood clotting, as this may result in an increased bleeding time.

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

3. How to take TRIBOK

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

Use in adults
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 TRIBOK 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 TRIBOK (see section “Warnings and precautions”).

If you take more TRIBOK than you should
In case of accidental overdose, inform your doctor or pharmacist immediately.

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

If you stop taking TRIBOK
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 everybody will experience them.

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

• Stomach and/or intestinal disturbances

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

• nausea
• difficulty digesting
• upper abdominal pain
• diarrhoea

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

• allergic reactions (hypersensitivity), allergy to 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, please inform your doctor or pharmacist.
You may also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TRIBOK

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.
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. Contents of the pack and other information

What TRIBOK contains
TRIBOK 1000 mg soft capsules

• 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 of 0.9 - 1.5 between them.
• The other components are D,L α-tocoferol, gelatin succinate, glycerol.

Description of the appearance of TRIBOK and contents of the pack
TRIBOK 1000 mg soft capsules
Oblong, transparent soft capsules.
Each pack contains 20 soft capsules in blisters.
Marketing Authorization Holder and Manufacturer
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Rome) – Italy
Manufacturer
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 129016 Cortemaggiore (Piacenza)