Omega 3 Eg

Patient Information Leaflet

Omega 3 EG 1000 mg soft capsules

ethyl esters of polyunsaturated fatty acids
Equivalent medicine
Please read all of 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Omega 3 EG is and what it is used for

Omega 3 EG contains as active ingredients ethyl esters of highly concentrated and purified polyunsaturated fatty acids (derived from fish oil), which reduce the levels of certain fats in the blood (triglycerides) and have beneficial effects on the heart and blood vessels.
Omega 3 EG is indicated:

• for reducing elevated levels of fats (triglycerides) in the blood, when diet and other non-pharmacological measures alone have not been sufficient. Treatment with Omega 3 EG must always be accompanied by appropriate dietary measures.

2. What you need to know before taking Omega 3 EG

Do not take Omega 3 EG

• 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”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Omega 3 EG.
Inform your doctor before taking Omega 3 EG:

• if you are allergic to fish, as the active substance in Omega 3 EG is derived from fish oil;
• if you have liver problems. During treatment, especially if you are taking high doses of Omega 3 EG, your doctor will prescribe blood tests to monitor liver function;
• if you have blood clotting disorders or are being treated with anticoagulants (medicines that prevent blood clots). Your doctor will prescribe certain tests during treatment; see “Other medicines and Omega 3 EG”;
• if you have or have had heart problems;
• if you experience dizziness, weakness, palpitations, or shortness of breath, as these may be symptoms of an irregular and often very rapid heart rhythm (atrial fibrillation).

Other medicines and Omega 3 EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor if you are taking anticoagulants (medicines that delay blood clotting, e.g. coumarin anticoagulants) or other medicines affecting blood clotting, as prolonged bleeding time may occur.

Pregnancy and breastfeeding
Do not use Omega 3 EG if you are pregnant or breastfeeding.

Driving and using machines
Omega 3 EG does not affect the ability to drive or operate machinery.

3. How to take Omega 3 EG

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
Adults
The recommended dose is 1 capsule of 1000 mg 1-3 times daily, according to the doctor's prescription.
Children and adolescents
No data are available on the use of Omega 3 EG in the paediatric population for the approved indications.
Elderly and patients with impaired renal function
No dose adjustment is required in these patients.
Patients with impaired liver function
Your doctor will monitor your liver function during treatment, especially if you are taking high doses of Omega 3 EG (see "Warnings and precautions").
Method of administration
For oral use.
Omega 3 EG capsules should be swallowed whole with water.
It is preferable to take the capsules with food to reduce the risk of gastrointestinal disturbances.
If you take more Omega 3 EG than you should
Cases of overdose have not been reported. If you take more than the prescribed dose, consult your doctor.
If you forget to take Omega 3 EG
Do not take a double dose to make up for the forgotten dose.
If you stop taking Omega 3 EG
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 and/or intestinal disorders: abdominal distension, constipation, flatulence (excessive gas production in the intestine), eructation, acid reflux, and vomiting;
• Fast or irregular heartbeat.

Uncommon side effects (may affect up to 1 in 100 people)

• Nausea;
• Dyspepsia (indigestion);
• Upper abdominal pain;
• Diarrhea;
• Gastrointestinal hemorrhage (bleeding from the stomach or intestine);
• Hyperglycemia (increased blood sugar concentration);
• Gout;
• Dizziness;
• Dysgeusia (altered taste);
• Headache;
• Hypotension (low blood pressure);
• Epistaxis (nosebleed);
• Skin rash.

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

• Hypersensitivity (allergy), allergic reactions to the components;
• Vertigo (sensation of body or surrounding environment movement);
• Gastritis (inflammation of the stomach);
• Inflammatory bowel disease;
• Gastroenteritis (inflammation of the stomach and intestine);
• Abdominal pain;
• Pyrosis (heartburn);
• Liver function abnormalities, including increased transaminases (liver enzymes indicating liver function, measured in blood);
• Skin reactions;
• Asthenia (weakness).

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

• Itching;
• Urticaria (skin irritation).

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 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 EG

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 packaging and on the blister after Exp.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine 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 Omega 3 EG contains

• The active substances 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 in a ratio to each other of 0.9 - 1.5.
• The other components are D,L α-tocoferol, gelatin, glycerol.

Description of the appearance of Omega 3 EG and contents of the package
Soft, elastic, transparent, oblong gelatin capsules containing a clear, light yellow oil with a characteristic fish odor.
Each package contains 20 or 30 soft capsules in blisters.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milano
Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe, 1 29016 Cortemaggiore (Piacenza)
Vamfarma S.r.l., Via Kennedy, 5 - 26833 Comazzo (Lodi)
Doppel Farmaceutici S.r.l., Via Volturno 48, Quinto De’ Stampi - 20089 Rozzano (MI)