Omega-3 Zentiva

Package leaflet: Information for the patient

OMEGA 3 ZENTIVA 1000 mg soft capsules

Ethyl esters of polyunsaturated fatty acids
Equivalent medicine
Please read 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What OMEGA 3 ZENTIVA is and what it is used for

OMEGA 3 ZENTIVA contains, as active substances, ethyl esters of polyunsaturated fatty acids (derived from fish oil) in high concentration and purity, which reduce the levels of certain fats in the blood (triglycerides) and have beneficial effects on the heart and blood vessels.
OMEGA 3 ZENTIVA is indicated:

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

2. What you need to know before taking OMEGA 3 ZENTIVA

Do not take OMEGA 3 ZENTIVA

• 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 ZENTIVA.
Inform your doctor before taking OMEGA 3 ZENTIVA:

• if you are allergic to fish, as the active substance in OMEGA 3 ZENTIVA is derived from fish oil;
• if you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are taking high doses of OMEGA 3 ZENTIVA;
• if you have conditions that make you prone to bleeding.

Talk to your doctor or pharmacist if:

• 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 heart rhythm (atrial fibrillation).

Other medicines and OMEGA 3 ZENTIVA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Inform your doctor if you are being treated with:

• medicines used 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 and breastfeeding
Do not use OMEGA 3 ZENTIVA if you are pregnant or breastfeeding.
Driving and using machines
OMEGA 3 ZENTIVA does not affect the ability to drive or operate machinery.

3. How to take OMEGA 3 ZENTIVA

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

Use in adults
For reduction of elevated levels of fats (triglycerides) in the blood.
The recommended dose is 1 capsule of 1000 mg 1–3 times daily, according to your doctor's prescription.

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

If you take more OMEGA 3 ZENTIVA than you should
If you accidentally take an excessive dose of OMEGA 3 ZENTIVA, inform your doctor or pharmacist.

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

If you stop taking OMEGA 3 ZENTIVA
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, irregular heartbeat

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

• Nausea
• Difficulty digesting
• Pain in the upper abdomen
• Diarrhoea

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

• Allergic reactions (hypersensitivity), allergy to components
• Dizziness
• Inflammation of the stomach and/or intestine (gastritis, gastroenteritis)
• Abdominal pain
• Stomach burning
• Changes in 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 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 ZENTIVA

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 after Exp. The expiry date refers to the last day of that month.
Store below 30 °C. Keep in the blister pack to protect from light.
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 ZENTIVA 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 of not less than 85%, and a ratio between them of 0.9 – 1.5.
• The other components are alpha-tocopherol, gelatin, glycerol, medium-chain triglycerides, purified water.

Description of the appearance of OMEGA 3 ZENTIVA and package contents
Soft, transparent, oval capsules containing a clear, light yellow oil with a characteristic fish odor.
Each pack contains 20 or 30 soft capsules in thermoformed opaque-white blister packs made of PVC/PVDC-AL.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l. - Via P. Paleocapa, 7 – 20121 Milan

Manufacturer
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (Piacenza)
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto de’ Stampi, Rozzano (MI)