OMEGA 1000 mg Soft Capsule

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

OMEGA 3 SPA Società Prodotti Antibiotici 1000 mg soft capsules

ethyl esters of polyunsaturated fatty acids
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 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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is OMEGA 3 SPA Società Prodotti Antibiotici and what is it for

OMEGA 3 SPA Società Prodotti Antibiotici contains as active ingredients ethyl esters of polyunsaturated fatty acids
(derived from fish oil) with high concentration and purity, which reduce the level of certain
fats in the blood (triglycerides) and which have positive effects on the heart and blood vessels.
OMEGA 3 SPA Società Prodotti Antibiotici 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 OMEGA 3 SPA Società Prodotti Antibiotici must always be associated with adequate
dietary rules.

2. What you need to know before taking OMEGA 3 SPA Società Prodotti Antibiotici

Do not take OMEGA 3 SPA Società Prodotti Antibiotici

• 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”)
• This medicine contains soya. If you are allergic to peanuts or soya, do not use this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking OMEGA 3 SPA Società Prodotti Antibiotici.
Tell your doctor before taking OMEGA 3 SPA Società Prodotti Antibiotici:

• if you are allergic to fish, as the active ingredient of OMEGA 3 SPA Società Prodotti Antibiotici 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 OMEGA 3 SPA Società Prodotti Antibiotici;
• if you have bleeding disorders.

Other medicines and OMEGA 3 SPA Società Prodotti Antibiotici
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 OMEGA 3 SPA Società Prodotti Antibiotici if you are pregnant or breastfeeding.

Driving and using machines
OMEGA 3 SPA Società Prodotti Antibiotici does not affect the ability to drive or operate machinery.

OMEGA 3 SPA Società Prodotti Antibiotici contains ethyl p-hydroxybenzoate sodium and propyl p-
hydroxybenzoate sodium
OMEGA 3 SPA Società Prodotti Antibiotici contains ethyl p-hydroxybenzoate sodium and propyl p-hydroxybenzoate
sodium, which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per soft capsule, i.e. essentially ‘sodium-free’.

3. How to take OMEGA 3 SPA Società Prodotti Antibiotici

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
Take the capsules of OMEGA 3 SPA Società Prodotti Antibiotici whole with a little water.

Use in adults
The recommended dose is 1 capsule 1-3 times a day, as prescribed by your doctor.

Use in the paediatric population
No data are available on the use of OMEGA 3 SPA Società Prodotti Antibiotici 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 OMEGA 3 SPA Società Prodotti Antibiotici (see section “Warnings and precautions”).

If you take more OMEGA 3 SPA Società Prodotti Antibiotici than you should
In case of accidental ingestion of an excessive dose of OMEGA 3 SPA Società Prodotti Antibiotici,
inform your doctor or pharmacist.

If you forget to take OMEGA 3 SPA Società Prodotti Antibiotici
Do not take a double dose to make up for a missed dose.

If you stop taking OMEGA 3 SPA Società Prodotti Antibiotici
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.
manifest.

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
• pain in the upper part of the abdomen
• diarrhea

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
• alteration of 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
https://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 OMEGA 3 SPA Società Prodotti Antibiotici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging after Scad. 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 eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What OMEGA 3 SPA Società Prodotti Antibiotici contains

• The active ingredients are ethyl esters of polyunsaturated fatty acids. Each soft capsule contains 1000 mg of ethyl esters of polyunsaturated fatty acids, with a content of EPA and DHA not less than 85% and a ratio between them of 0.9 - 1.5.
• The other components are D,L α-tocopherol in soybean oil, gelatin succinate, glycerol, ethyl p-hydroxybenzoate sodium, propyl p-hydroxybenzoate sodium.

Description of the appearance of OMEGA 3 SPA Società Prodotti Antibiotici and contents of the pack
Soft, transparent, oblong capsules.
Each pack contains 20 or 30 soft capsules in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
SPA Società Prodotti Antibiotici S.p.A.
Via Biella, 8
20143 Milano

Manufacturer
DOPPEL FARMACEUTICI S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (Piacenza)