TRIBOK 1000 mg Miękka Kapsułka

Treść ulotki

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

TRIBOK 1000 mg soft capsules

ethyl esters of polyunsaturated fatty acids

Read this leaflet carefully before taking this medicine as 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 may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take TRIBOK
• 3. How to take TRIBOK
• 4. Possible side effects
• 5. How to store TRIBOK
• 6. Contents of the pack and other information

1. What is TRIBOK and what is it used for

TRIBOK 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 which have
positive effects at the level of the heart and blood vessels.
TRIBOK is indicated:

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

2. What you need to know before you take

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.
Tell your doctor before taking TRIBOK:

• if you are allergic to fish; as the active ingredient of TRIBOK is derived from fish oil;
• if you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are using high doses of TRIBOK;
• if you have bleeding disorders.

Other medicines and TRIBOK
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 TRIBOK if you are pregnant or breastfeeding.

Driving and using machines
TRIBOK does not impair the ability to drive vehicles or use machines.

3. How to take TRIBOK

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
Take the TRIBOK capsules whole with a little water.

Use in adults
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 TRIBOK 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
Your doctor will monitor your liver function during treatment, especially if you are using high doses of TRIBOK (see section “Warnings and precautions”).

If you take more TRIBOK than you should
If you accidentally ingest an excessive dose of TRIBOK, inform your doctor or pharmacist.

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

If you stop taking TRIBOK
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
• upper abdominal pain
• 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
• alterations 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 effects, including those not listed in this leaflet, please inform your doctor
or pharmacist. You can also report side effects directly through the national reporting system at
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 which is stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
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 TRIBOK contains
TRIBOK 1000 mg soft capsules

• 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.
• The other ingredients are D,L α-tocopherol, succinate gelatin, glycerol.

Description of the appearance of TRIBOK and contents of the pack
TRIBOK 1000 mg soft capsules
Soft, transparent, oblong capsules.
Each pack contains 20 soft capsules in blisters.

Marketing Authorisation Holder and Manufacturer
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Roma) – Italy

Manufacturer
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 129016 Cortemaggiore (Piacenza)