TRISCUDIL

Package leaflet: Information for the patient

TRISCUDIL 1000 mg Soft capsules

Equivalent medicine
Active substance: omega-3 acid ethyl esters 90
Please read 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 other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 taking 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 TRISCUDIL is and what it is used for

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

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

2. What you should know before taking TRISCUDIL

Do not take TRISCUDIL

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking TRISCUDIL if:
you are scheduled for or have recently undergone surgery
you have recently experienced trauma
you have kidney problems
you suffer from uncontrolled diabetes
you have liver problems. Your doctor will prescribe blood tests to monitor any potential effects of
TRISCUDIL on liver function.
you are allergic to fish
If any of these situations apply to you, discuss them with your doctor or pharmacist before taking this
medicinal product.

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

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

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

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

Driving and operating machinery
No special precautions are required.

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

3. How to take TRISCUDIL

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is:
for high levels of fats in the blood: 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 during meals. This way,
you can avoid possible gastrointestinal side effects.
If you take more TRISCUDIL than you should
If you accidentally take more capsules than you should and experience side effects,
contact your doctor.
If you forget to take TRISCUDIL
Do not take a double dose if you have missed the previous dose. Instead, continue taking the
next 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 how to use 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
• diarrhoea
• vomiting

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

• headache
• acne
• high blood sugar levels
• liver problems

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

• blood in the faeces
• low blood pressure
• dry nose
• itchy skin rash (urticaria)
• altered blood test results

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

• itching

If you experience any side effect, including those not listed in this leaflet, consult 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 stated on the label and on the carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not freeze.

Duration 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 bottles: 20 days per bottle

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What TRISCUDIL contains
The active substances are ethyl esters90 of omega-3 acid.
Each soft capsule contains 1000 mg of ethyl esters90 of omega-3 acid, 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 core: alpha-tocopherol (Ph. Eur.).
• Capsule shell: gelatin, glycerol, purified water, medium-chain triglycerides, sunflower lecithin.

Description of the appearance of TRISCUDIL and packaging contents
Soft capsules: transparent, soft, oblong gelatin capsules containing pale yellow oil, packed in white HDPE bottles of 75 ml and 150 ml with sealed LDPE press caps, or in white HDPE bottles of 250 ml with white screw caps made of PE.
TRISCUDIL is available in the following pack sizes:
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 Authorization Holder
PIAM Farmaceutici S.p.A.
Via Fieschi, 8
16121 Genova
Italy
Batch Release Responsible Person
Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany
This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: omega-3 NTC 1000 mg Weichkapseln
Italy: TRISCUDIL
Spain: Ácidos omega 3 STADA, 1000 mg cápsulas blandas EFG