Patient Information Leaflet

Omega 3 Teva Italia 1000 mg soft capsules

omega-3 ethyl esters 90
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 may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Omega 3 Teva Italia is and what it is used for
What you need to know before taking Omega 3 Teva Italia
How to take Omega 3 Teva Italia
Possible side effects
How to store Omega 3 Teva Italia
Contents of the pack and other information

1. What Omega 3 Teva Italia is and what it is used for

Omega 3 Teva Italia contains as active substances highly concentrated and purified omega-3 fatty acid ethyl esters 90 (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 Teva Italia is indicated for the reduction of elevated levels of fats (triglycerides) in the blood, when diet and other non-pharmacological measures alone have not been sufficient. Treatment with Omega 3 Teva Italia must always be accompanied by appropriate dietary measures.

2. What you need to know before taking Omega 3 Teva Italia

Do not take Omega 3 Teva Italia:

if you are allergic to the active substance (derived from fish oil) or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to peanuts and soy, because this medicine may contain traces of them;
if you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

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

you are allergic to fish, as the active substance in Omega 3 Teva Italia is derived from fish oil;
you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are taking high doses of Omega 3 Teva Italia;
you have conditions that make you bleed easily;
you have or have had heart problems;
you experience dizziness, asthenia, 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 Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Inform your doctor if you are being treated with:

medicines to thin the blood (anticoagulants), e.g. coumarin anticoagulants;
other medicines that affect blood clotting, as this may lead to an increased bleeding time.

Pregnancy, breastfeeding and fertility
Do not use Omega 3 Teva Italia if you are pregnant or breastfeeding.
Driving and using machines
Omega 3 Teva Italia does not affect the ability to drive or operate machinery.

3. How to take Omega 3 Teva Italia

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Take the Omega 3 Teva Italia capsules whole, with a little water.

Use in adults
The recommended dose is 1 capsule of 1000 mg 1-3 times daily, according to your doctor's prescription.

Use in children
There are no data available on the use of Omega 3 Teva Italia in the paediatric population for the approved indications.

Use in elderly patients and patients with impaired kidney function
No dose adjustment is required in these patients.

Use in patients with impaired liver function
Your doctor will monitor your liver function during treatment, especially if you are taking high doses of Omega 3 Teva Italia (see section “Warnings and precautions”).

If you take more Omega 3 Teva Italia than you should
If you accidentally take too much Omega 3 Teva Italia, inform your doctor or pharmacist.

If you forget to take Omega 3 Teva Italia
Do not take a double dose to make up for the missed dose.

If you stop taking Omega 3 Teva Italia
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 and/or intestinal disorders;
fast, irregular heartbeat.

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

Nausea, difficulty digesting (dyspepsia), diarrhoea, pain in the upper abdomen;
increased blood glucose levels (hyperglycaemia).

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

Allergic reactions (hypersensitivity);
dizziness;
inflammation of the stomach and/or intestine (gastritis, inflammatory bowel disease, and gastroenteritis), abdominal pain, stomach burning (pyrosis);
alteration of normal liver function;
skin reactions;
weakness (asthenia).

Other side effects that have occurred in a very small number of people, but for which the exact
frequency is unknown (frequency cannot be estimated from the available data)

Itching, skin rash with itching (urticaria).

Reporting of side effects
If you get any side effects, including ones 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 Teva Italia

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
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. Contents of the pack and other information

What Omega 3 Teva Italia contains

The active substance is omega-3 acid ethyl esters 90. Each soft capsule contains 1000 mg of omega-3 acid ethyl esters 90, with a content of EPA and DHA not less than 85%, and in a ratio to each other of 0.9 - 1.5. The active substance contains: mixed tocopherols and refined sunflower oil.
The other components in the capsule shell are: gelatin, glycerol, and possible traces of soya lecithin (E322) and medium-chain saturated triglycerides.

Description of the appearance of Omega 3 Teva Italia and contents of the pack
Each pack contains 20 or 30 soft capsules in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg, 5
2031 GA - Haarlem
The Netherlands

Manufacturer
Catalent Italy S.p.A.
Via Nettunense km 20,100
04011 Aprilia (Latina)
Italy