Omega-3 Mylan

Patient Information Leaflet

Omega 3 Mylan 1000 mg soft capsules

omega-3 ethyl esters 90
Equivalent medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Omega 3 Mylan is and what it is used for
2. What you need to know before taking Omega 3 Mylan
3. How to take Omega 3 Mylan
4. Possible side effects
5. How to store Omega 3 Mylan
6. Package contents and other information

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

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

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

Do not take Omega 3 Mylan 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);
• you are allergic to peanuts or soy, as this medicine may contain traces of these;
• you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

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

• you are allergic to fish, as the active substance in Omega 3 Mylan 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 Mylan;
• you have bleeding disorders;
• you have or have had heart problems;
• you experience dizziness, weakness, palpitations, or shortness of breath, as these may be symptoms of an irregular and often very rapid heartbeat (atrial fibrillation).

Other medicines and Omega 3 Mylan
Inform 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, as this may lead to an increased bleeding time.

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

3. How to take Omega 3 Mylan

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Take the Omega 3 Mylan capsules whole, with a little water.

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

Use in children
There are no data available on the use of Omega 3 Mylan 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 Mylan (see section "Warnings and precautions").

If you take more Omega 3 Mylan than you should
In case of accidental overdose, inform your doctor or pharmacist.

If you forget to take Omega 3 Mylan
Do not take a double dose to make up for the forgotten dose.

If you stop taking Omega 3 Mylan
If you have any questions 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 everyone experiences them.
Common side effects (may affect up to 1 in 10 people)

• Stomach and/or intestinal disorders;
• fast or irregular heartbeat.

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

• Nausea, difficulty digesting (dyspepsia), diarrhoea, upper abdominal pain.

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 whose exact frequency is unknown
(frequency cannot be estimated from the available data)

• Itching, skin rash with itching (urticaria).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult 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 Mylan

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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Omega 3 Mylan 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 of not less than 85%, and a ratio between them 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 soy lecithin (E322) and medium-chain saturated triglycerides.

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

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

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