OMEGA 3 MYLAN 1000 MG Kapsułka miękka

Treść ulotki

1. Omega 3 Mylan 1000 mg soft capsules
   1. What is Omega 3 Mylan and what is it 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. Contents of the pack and other information

Omega 3 Mylan 1000 mg soft capsules

omega-3 fatty acid ethyl esters 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take Omega 3 Mylan
• 3. How to take Omega 3 Mylan
• 4. Possible side effects
• 5. How to store Omega 3 Mylan
• 6. Contents of the pack and other information

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

Omega 3 Mylan contains as active ingredients omega-3 ethyl esters 90 (derived from fish oil) at
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 Mylan 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 Mylan
must always be associated with adequate dietary rules

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

Do not take Omega 3 Mylan if:

• you are allergic to the active ingredient (derived from fish oil) or to any of the other ingredients of this medicine (listed in section 6);
• you are allergic to peanuts and soy, as this medicine may contain traces of them;
• 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.
Tell your doctor before taking Omega 3 Mylan if:

• you are allergic to fish, as the active ingredient of 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 using high doses of Omega 3 Mylan;
• you have bleeding disorders;
• 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 heartbeat (atrial fibrillation).

Other medicines and Omega 3 Mylan
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, breastfeeding and fertility
Do not use Omega 3 Mylan if you are pregnant or breastfeeding.

Driving and operating machinery
Omega 3 Mylan does not impair the ability to drive or operate machinery.

3. How to take Omega 3 Mylan

Take this medicine following the instructions of your doctor exactly. 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 1-3 times a day, as prescribed by your doctor.

Use in children
No data are available on the use of Omega 3 Mylan in the pediatric population for the authorized
indications.
Use in elderly patients and patients with impaired renal function
No dose adjustment is required in these patients.
Use in patients with impaired hepatic function
Your doctor will monitor your liver function during treatment, especially if you are using 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 ingestion of an excessive dose of Omega 3 Mylan, inform your doctor or pharmacist.

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

If you stop taking Omega 3 Mylan
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;
• fast, irregular heartbeat.

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

• Nausea, indigestion (dyspepsia), diarrhea, pain in the upper part of the abdomen.

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

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

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

• Itching, itchy rash (urticaria).

Reporting of side effects
If you get any side effects, talk to 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 Mylan

Keep this medicine out of the sight and reach of children.
Store at a temperature below 30°C.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Omega 3 Mylan contains

• The active ingredient is made up of 90% ethyl ester omega-3 acids. Each soft capsule contains 1000 mg of 90% ethyl ester omega-3 acids, with an EPA and DHA content of not less than 85% and a ratio of 0.9 - 1.5 between them. The active ingredient contains: mixed tocopherols and refined sunflower oil.
• The other components in the capsule shell are: gelatin, glycerol and possible traces of soybean 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 Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Italy

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