AGEMO 1000 mg Soft Capsule

Зміст інструкції

1. What is AGEMO and what is it used for
2. What you need to know before you take AGEMO
3. How to take AGEMO
4. Possible side effects
5. How to store AGEMO
6. Package Contents and Other Information

AGEMO, 1000 mg soft capsules
Ethyl ester omega-3 acids 90
Generic medicine

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, pharmacist or nurse.
• 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is AGEMO and what is it 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
reducers.
AGEMO is used:
for the treatment of certain forms of increased triglycerides (fats) in the blood, after
dietary changes have not proven effective.

2. What you need to know before you take AGEMO

Do not take AGEMO, 1000 mg soft capsules
if you are allergic (hypersensitive) to Ethyl 90 omega-3 esters or any of the other
ingredients 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 about to undergo or have recently undergone surgery;
if you have recently suffered a trauma;
if you have kidney problems;
if you suffer from uncontrolled diabetes;
if you have liver problems. The doctor will check any effect that AGEMO 1000 mg capsules
soft capsules may have on your liver through blood tests.

Other medicines and AGEMO, 1000 mg soft capsules
If you are taking a medicine to block the formation of blood clots in the arteries, such as
warfarin, further blood tests may be necessary and the usual dose of the anticoagulant
you are taking may need to be adjusted.
Tell 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 can take the capsules during meals. This will help reduce the possibility of
undesirable effects on the stomach and surrounding area (the gastrointestinal tract).

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
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, following the instructions of your doctor or pharmacist exactly as given. If you have any doubts, ask your doctor or pharmacist.
Swallow the capsules with water.
You can take the capsules during meals to help reduce undesirable gastrointestinal effects.
Your doctor will determine the duration of your treatment with this medicine.
Dose for the treatment of high triglyceride levels in the blood (high levels of fats in the blood or
hypertriglyceridemia)
The recommended dose is 2 capsules per day, 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 per day.

If you take more AGEMO, 1000 mg soft capsules than you should
If you accidentally take more capsules of this medicine than you should, do not worry,
as it is unlikely that you will need any particular 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 the next dose; in this case, take the next dose as usual. Do not take a double dose
(twice the dose prescribed by your doctor) to make up for the forgotten dose.
If you have any doubts about the use of this medicine, ask 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 tension and/or abdominal pain, constipation, diarrhoea, dyspepsia,
flatulence, belching, acid reflux, nausea or vomiting
Uncommon side effects (may affect up to 1 in 100 people):
elevated blood glucose levels
gout
dizziness
taste alterations
headache low blood pressure
nosebleeds
blood in the stools
skin rashes
Rare side effects (may affect up to 1 in 1000 people):
allergic reactions
pruritic (a skin rash with raised, red and itchy areas)
liver problems with possible alterations in the results of certain blood tests (liver
enzymes).
Side effects with unknown frequency (frequency cannot be estimated from available data):
itching

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the package, bottle and
blister. The expiry date refers to the last day of that month.
Store AGEMO, 1000 mg soft capsules at a temperature below 30°C.
Do not freeze. Store in the original package to protect the medicine from moisture.
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 AGEMO, 1000 mg soft capsules contain
The active ingredients are omega-3 ethyl esters.
Each soft capsule contains 1000 mg of omega-3 ethyl esters 90, which include
mainly 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 an antioxidant 4 mg of the excipient d-alpha-tocopherol.
The other excipients are:
the soft capsule shell is formed by 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 soft gelatin capsules, transparent, containing oil of a pale yellow color.
AGEMO, 1000 mg soft capsules is available in the following packs:
Transparent PVC/Aclar®–aluminium blisters, available in packs of 20, 28, 30, 3x10, 60, 90, 9x10,
100 and 120 capsules.
HDPE containers with tamper-evident HDPE screw cap, available in packs of 20, 28,
30, 90, 98 and 100 capsules and in hospital pack of 280 (10x28) capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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)