Omega 3 Bouty

Patient Information Leaflet

OMEGA 3 BOUTY 1000 mg soft capsules

Omega-3 ethyl esters 90
Generic medicine
Please read this leaflet carefully before you start 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

The active substances in OMEGA 3 BOUTY are highly purified omega-3 fatty acid ethyl esters.
OMEGA 3 BOUTY reduces certain blood fats (triglycerides).
OMEGA 3 BOUTY is used to treat certain forms of elevated blood fats (endogenous hypertriglyceridemia) when dietary changes and other non-pharmacological measures alone (such as physical activity) have not been effective.

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

Do not take OMEGA 3 BOUTY

• if you are allergic to omega-3 fatty acids, soybean lecithin, peanuts, or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking OMEGA 3 BOUTY

• if you are scheduled for, or have recently undergone, surgery
• if you have recently suffered a traumatic injury
• if you have a kidney problem
• if you have uncontrolled diabetes
• if you have or have had liver problems. Your doctor will order blood tests to monitor any potential liver-related effects of OMEGA 3 BOUTY
• 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)
• if you are allergic to fish.

Children and adolescents

• Due to lack of data on efficacy and safety, the use of OMEGA 3 BOUTY is not recommended in children and adolescents. Elderly
• There are no data available on the use of OMEGA 3 BOUTY in elderly patients over 70 years of age. Caution should be exercised when using OMEGA 3 BOUTY in patients over 70.

Other medicines and OMEGA 3 BOUTY
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
If you are taking OMEGA 3 BOUTY together with a medicine that reduces blood clotting (anticoagulant), an increased bleeding time may occur. Your doctor will monitor your treatment closely and, if necessary, adjust the dose of OMEGA 3 BOUTY or the other medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Driving and using machines
No special precautions are required.
OMEGA 3 BOUTY contains soybean lecithin
If you are allergic to peanuts or soy, do not take this medicine.

3. How to take OMEGA 3 BOUTY

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 capsule 1-3 times daily, depending on your doctor's prescription.
If you feel that the effect of OMEGA 3 BOUTY is too strong or too weak, talk to your doctor or pharmacist.

Instructions for use

• Swallow the capsules with a glass of water.
• Take the medicine for the duration of treatment prescribed by your doctor.

Use in pediatric population
There are no data available on the use of OLEVIA in the pediatric 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 OLEVIA (see section “Warnings and precautions”).

If you take more OMEGA 3 BOUTY than you should
If you accidentally take more medicine than you should and experience any adverse effects, contact your doctor.

If you forget to take OMEGA 3 BOUTY
Do not take a double dose to make up for the forgotten dose. Take the next capsules as prescribed.

If you stop taking OMEGA 3 BOUTY
Do not stop treatment without consulting your doctor.

If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur with the use of this medicine.

Common (may affect up to 1 in 10 people)

• Stomach disturbances and indigestion/digestive difficulties (dyspepsia)
• Nausea
• Rapid or irregular heartbeat

Uncommon (may affect up to 1 in 100 people)

• Stomach ache, abdominal pain and upper abdominal pain
• Stomach and/or intestinal disorders
• Allergic reactions
• Dizziness
• Taste disturbances
• Diarrhoea
• Vomiting

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

• Headache
• Acne
• Itchy rash
• Hyperglycaemia (high glucose levels)
• Changes in liver function
• Skin reactions
• Intestinal inflammation
• Stomach burning
• Vertigo
• Weakness

Very rare (may affect up to 1 in 10,000 people)

• Blood in the stools
• Hypotension (low blood pressure)
• Dry nose
• Itchy skin rash (urticaria)
• Changes in the results of certain blood tests

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: “http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa”.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OMEGA 3 BOUTY

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the
last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
Store below 25 °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. Pack contents and other information

What OMEGA 3 BOUTY contains

• The active substances are omega-3 fatty 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. Each capsule contains 1000 mg of omega-3 fatty acid ethyl esters 90.
• The other components are: D,L-rac-α-Tocoferolo, succinylated gelatin, glycerol, medium-chain triglycerides, traces of soy lecithin.

Description of the appearance of OMEGA 3 BOUTY and pack contents
This medicine comes as soft, oblong, light yellow capsules containing a yellowish oil with a characteristic fishy odour.
The capsules are packed in aluminium/PVC/PE/PVDC blisters, each containing 10 capsules.
Pack sizes of 2 or 3 blisters.
Marketing Authorization Holder
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2-26900 Lodi
Tel. 03716171 Fax. 0371617244
Manufacturer
IBSA Farmaceutici Italia Srl, via Martiri di Cefalonia, 2, 26900 Lodi, Italia