TRISCUDIL 1000 mg Soft Capsule

Зміст інструкції

1. TRISCUDIL 1000 mg Soft Capsules
   1. What is TRISCUDIL and what is it used for
   2. What you need to know before you take TRISCUDIL
   3. How to take TRISCUDIL
   4. POSSIBLE SIDE EFFECTS
   5. How to store TRISCUDIL
   6. PACKAGE CONTENTS AND OTHER INFORMATION

TRISCUDIL 1000 mg Soft Capsules

Equivalent Medicinal Product
Active ingredient: 90 ethyl esters of omega-3 acid

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 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, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. What is TRISCUDIL and what is it used for

The active ingredients of TRISCUDIL are the polyunsaturated omega-3 fatty acids eicosapentaenoic acid
(EPA) and docosahexaenoic acid (DHA). TRISCUDIL reduces certain types of fats in the blood (triglycerides).
TRISCUDIL is used:

• in the treatment of some forms of increased fat levels in the blood (endogenous hypertriglyceridemia) after dietary changes alone have not proven sufficient.

2. What you need to know before you take TRISCUDIL

Do not take TRISCUDIL

• if you are hypersensitive (allergic) to the active ingredient, to soy, to peanuts or to any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking TRISCUDIL if:
you are about to undergo or have recently undergone surgery
you have recently had a trauma
you have kidney problems
you suffer from uncontrolled diabetes
you have liver problems. The doctor will prescribe blood tests to monitor any effects of
TRISCUDIL on liver function.
you are allergic to fish
If any of these applies to you, talk to your doctor or pharmacist before taking this
medicine.

Children and adolescents
Due to the lack of data regarding efficacy and safety, children should not take TRISCUDIL.

Elderly
There is no data available regarding the use of TRISCUDIL in patients over 70 years of age.

Other medicines and TRISCUDIL
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those without a prescription.
TRISCUDIL can prolong bleeding time. If you are using TRISCUDIL together with a medicine
that blocks blood clotting (anticoagulant), the doctor will carefully monitor the treatment and
adjust the dose, if necessary.

Pregnancy and breastfeeding and fertility
If you are pregnant or breastfeeding, this medicine should only be taken if your doctor considers it absolutely
necessary.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No special precautions are necessary.

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

3. How to take TRISCUDIL

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:
for high blood lipid values, 2 soft capsules per day. If the response is insufficient, the dose may
be increased to 4 soft capsules per day.
If you feel that the effect of TRISCUDIL is too strong or too weak, consult your doctor or
pharmacist.
How to use:
The soft capsules must be swallowed with a sufficient amount of liquid at mealtimes. This will
help you avoid possible gastro-intestinal side effects.

If you take more TRISCUDIL than you should
If you accidentally take more tablets than you should and experience side effects,
consult your doctor.

If you forget to take TRISCUDIL
Do not take a double dose if you have forgotten the previous dose. Instead, continue to take the
following soft capsules as prescribed.

If you stop taking TRISCUDIL
Do not stop treatment without consulting your doctor. Talk to your doctor if you are not satisfied
with the effects of TRISCUDIL.
If you have any doubts 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 gets them.

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

• stomach problems and indigestion (dyspepsia)
• feeling unwell (nausea) Uncommon side effects (may affect up to 1 in 100 people)
• abdominal and stomach pain
• allergic reactions
• dizziness
• taste disturbances
• diarrhea
• vomiting Rare side effects (may affect up to 1 in 1,000 people):
• headache
• acne
• elevated blood sugar level
• liver problems

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

• blood in the stools
• low blood pressure
• dry nose
• itchy skin rash (urticaria)
• altered blood values

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

• itching

If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

5. How to store TRISCUDIL

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 label and on the packaging. The expiry date refers to the last day of that month.
Do not store at a temperature above 25° C.
Do not freeze.
Shelf life after first opening:
20 capsules -75ml: 20 days
28 capsules -75ml: 28 days
60 capsules -150ml: 105 days
98 capsules -250ml: 98 days
100 capsules-250ml: 100 days
20 capsules x 10 vials each vial 20 days
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 TRISCUDIL contains
The active ingredients are ethyl esters of omega-3 acids.
Each soft capsule contains 1000 mg of ethyl esters of omega-3 acids, consisting mainly of 840
mg of ethyl esters (460 mg) of eicosapentaenoic acid (EPA) and (380 mg) of docosahexaenoic acid
(DHA).
The excipients are:

• Capsule shell: alpha-tocopherol (Ph. Eur.).
• Capsule shell: gelatin, glycerol, purified water, medium-chain triglycerides, sunflower lecithin.

Description of the appearance of TRISCUDIL and contents of the pack
Soft capsules: transparent, soft, oblong gelatin capsules containing pale yellow oil,
packaged in white (HDPE) bottles of 75 ml and 150 ml with a pressure-sealed cap in LDPE or bottles
white (HDPE) of 250 ml with a white screw cap in PE.
TRISCUDIL is available in packs of
75 ml bottles
1 x 20 capsules
1 x 28 capsules
10 x 20 capsules (200 capsules)
150 ml bottles
1 x 60 capsules
250 ml bottles
1 x 98 capsules
1 x 100 capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder
PIAM Farmaceutici S.p.A.
Via Fieschi, 8
16121 Genoa
Italy

Release Batch Responsible
Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Germany: omega-3 NTC 1000 mg soft capsules
Italy: TRISCUDIL
Spain: Ácidos omega 3 STADA, 1000 mg soft gelatin capsules EFG