Package leaflet: Information for the user

AGEMO, 1000 mg soft capsules

Omega-3 ethyl esters 90
Equivalent medicine
Please read all of 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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What AGEMO is and what it is used for
What you need to know before taking AGEMO
How to take AGEMO
Possible side effects
How to store AGEMO
Contents of the pack and other information

1. What AGEMO is and what it is used for

AGEMO, 1000 mg soft capsules, contains highly purified omega-3 polyunsaturated fatty acids.
AGEMO, 1000 mg soft capsules belongs to a group of medicines called cholesterol and triglyceride-lowering agents.
AGEMO is used:
for the treatment of certain forms of elevated triglycerides (fats) in the blood, after dietary modification has not proven effective.

2. What you need to know before taking AGEMO

Do not take AGEMO 1000 mg soft capsules
if you are allergic (hypersensitive) to omega-3 ethyl esters 90 or to any of the other
excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking AGEMO 1000 mg soft capsules
if you are scheduled for or have recently undergone surgery;
if you have recently suffered trauma;
if you have kidney problems;
if you have uncontrolled diabetes;
if you have liver problems. Your doctor will monitor any potential effects of AGEMO 1000 mg soft
capsules on your liver through blood tests.

Other medicines and AGEMO 1000 mg soft capsules
If you are taking a medicine to prevent blood clots in the arteries, such as
warfarin, additional blood tests may be required and the usual dose of your anticoagulant
may need to be adjusted.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.

AGEMO 1000 mg soft capsules with food, drinks and alcohol
You may take the capsules with meals. This will help reduce the likelihood of gastrointestinal side effects.

Use in the elderly
Take AGEMO 1000 mg soft capsules with caution if you are over 70 years of age.

Children and adolescents
Children and adolescents should not take this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.

Driving and use of machines
It is unlikely that this medicine will affect your ability to drive or operate tools or machinery.

3. How to take AGEMO

Take AGEMO, 1000 mg soft capsules, exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Swallow the capsules with water.
You may take the capsules with food to help reduce gastrointestinal side effects.
Your doctor will determine how long you should take this medicine.

Dosage for treatment of high blood triglyceride levels (high blood fat levels or hypertriglyceridemia)
The recommended dose is 2 capsules daily, as prescribed by your doctor.
If the medicine is not sufficiently effective at this dose, your doctor may increase the dose up to 4 capsules daily.

If you take more AGEMO, 1000 mg soft capsules than you should
If you accidentally take more capsules than you should, do not worry, as it is unlikely that you will require specific treatment.

If you forget to take AGEMO, 1000 mg soft capsules
If you forget a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and take the next one at the usual time. Do not take a double dose (twice the prescribed dose) to make up for a forgotten dose.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

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 such as abdominal tightness and/or pain, constipation, diarrhoea, dyspepsia,
flatulence, burping, acid reflux, nausea or vomiting
Uncommon side effects (may affect up to 1 in 100 people):
high blood glucose levels
gout
dizziness
taste disturbances
headache
low blood pressure
nosebleeds
blood in the stool
skin rashes
Rare side effects (may affect up to 1 in 1,000 people):
allergic reactions
pruritic rash (skin eruption with redness, raised areas and itching)
liver problems with possible changes in certain blood test results (liver enzymes).
Side effects not known (frequency cannot be estimated from the available data):
itching
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: //www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AGEMO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, and blister.
The expiry date refers to the last day of that month.
Store AGEMO, 1000 mg soft capsules, below 30°C.
Do not freeze. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via 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 AGEMO, 1000 mg soft capsules contains
The active substances are omega-3 fatty acid ethyl esters.
Each soft capsule contains 1000 mg of omega-3 acid ethyl esters 90, consisting mainly of
840 mg of eicosapentaenoic acid (EPA) as ethyl ester (460 mg) and docosahexaenoic acid (DHA)
as ethyl ester (380 mg) (these substances are known as omega-3 polyunsaturated fatty acids), and contains as antioxidant 4 mg of the excipient d-alpha-tocopherol.
The other excipients are:
the capsule shell is composed of gelatin, glycerol and traces of medium-chain triglycerides.

Description of the appearance of AGEMO, 1000 mg soft capsules and package contents
AGEMO, 1000 mg soft capsules are transparent soft gelatin capsules containing pale yellow oil.
AGEMO, 1000 mg soft capsules are available in the following pack sizes:
Transparent PVC/Aclar®–aluminum blisters, available in packs of 20, 28, 30, 3x10, 60, 90, 9x10,
100 and 120 capsules.
HDPE containers with tamper-evident HDPE screw caps, available in packs of 20, 28,
30, 90, 98 and 100 capsules and in a hospital pack of 280 (10x28) capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
I. B. N. Savio S.r.l
Via del Mare, 36 Pomezia (RM)

Manufacturer:
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen (Hungary)
Merckle GmbH
Graf-Arco-Straße 3, 89079 Ulm (Germany)
Doppel Farmaceutici Srl, Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)

This patient information leaflet was last revised on: