OLEVIA 1000 mg Soft Capsule

Зміст інструкції

1. OLEVIA 1000 mg soft capsules
   1. What is OLEVIA and what is it used for
   2. What you need to know before you take OLEVIA
   3. How to take OLEVIA
   4. Possible side effects
   5. How to store OLEVIA
   6. Package Contents and Other Information

OLEVIA 1000 mg soft capsules

Omega-3 ethyl esters 90
Generic medicine
Read this leaflet carefully before you start 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 OLEVIA is and what it is used for
• 2. What you need to know before you take OLEVIA
• 3. How to take OLEVIA
• 4. Possible side effects
• 5. How to store OLEVIA
• 6. Contents of the pack and other information

1. What is OLEVIA and what is it used for

The active ingredients of OLEVIA are highly purified omega-3 polyunsaturated fatty acid ethyl esters.
OLEVIA reduces certain fats in the blood (triglycerides).
OLEVIA is used for the treatment of certain forms of increased fats in the blood
(endogenous hypertriglyceridemia) after a change in diet and other non-
pharmacological measures alone (for example physical activity) have not produced results.

2. What you need to know before you take OLEVIA

Do not take OLEVIA

• if you are allergic to omega-3 fatty acids, soy 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 OLEVIA

• if you are about to undergo or have recently undergone surgery
• if you have recently suffered a traumatic injury
• if you have a kidney problem
• if you suffer from uncontrolled diabetes
• if you have or have had liver problems. Your doctor will prescribe blood tests to monitor any effects on the liver from OLEVIA
• if you are allergic to fish.

Children and adolescents

• In the absence of data on efficacy and safety, the use of OLEVIA is not indicated in children and adolescents. Elderly
• There are no data on the use of OLEVIA in elderly patients over 70 years of age. Caution should be exercised when using OLEVIA over the age of 70.

Other medicines and OLEVIA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
If you are taking OLEVIA in combination with a medicine that counteracts blood clotting
(anticoagulant), an increase in bleeding time may occur. Your doctor will carefully monitor
your treatment and, if necessary, adjust the dosage of OLEVIA or the other
medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.

Driving and operating machinery
No special precautions are necessary.

OLEVIA contains soy lecithin
If you are allergic to peanuts or soy, do not take this medicine.

3. How to take OLEVIA

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 capsule 1-3 times a day depending on your doctor's prescription
Contact your doctor or pharmacist if you feel that the effect of OLEVIA is too strong or
too weak.

Instructions for use

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

If you take more OLEVIA than you should
If you accidentally take a higher amount of medicine than necessary and experience
negative effects, contact your doctor.

If you forget to take OLEVIA
Do not take a double dose to make up for a missed dose. Take the next
capsule as prescribed.

If you stop taking OLEVIA
Do not stop the treatment without consulting your doctor.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of this medicine, the following side effects may occur.

Common (may affect up to 1 in 10 people)

• stomach discomfort and indigestion (dyspepsia)
• nausea

Uncommon (may affect up to 1 in 100 people):

• stomach ache and abdominal pain
• allergic reactions
• dizziness
• taste alterations
• diarrhoea
• vomiting

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

• headache
• acne
• itchy rash
• hyperglycaemia (high glucose)
• liver problems

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

• presence of blood in the stools
• arterial hypotension (low blood pressure)
• nasal dryness
• itchy skin rash (urticaria)
• alterations in the values of some blood tests

Other side effectsthat have occurred in a very small number of people, but whose
frequency is unknown:

• itching

Reporting of side effects

If you get any side effects, even those not listed in this leaflet, please tell

your doctor or pharmacist. You can also report side effects directly through the

national reporting system at the address “http://www.agenziafarmaco.gov.it/content/come-

segnalare-una-sospetta-reazione-avversa”.

By reporting side effects you can help to provide more information on the safety of

this medicine.

5. How to store OLEVIA

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 visible signs of deterioration.
Store at a temperature below 25 °C.
Do not dispose of any medicine in 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 OLEVIA contains

• The active ingredients are omega-3 fatty acid ethyl esters 90 with an EPA and DHA content of not less than 85% and a ratio between them of 0.9 - 1.5. Each capsule contains 1000 mg of omega-3 fatty acid ethyl esters 90.
• The other ingredients are: D,L-rac-α-Tocopherol, succinylated gelatin, glycerol, medium-chain triglycerides, traces of soybean lecithin.

Description of the appearance of OLEVIA and package contents
This medicine is presented as oblong-shaped soft capsules of light yellow color containing
a yellowish oil with a characteristic fishy odor.
The capsules are packaged in aluminum/PVC/PE/PVDC blisters of 10 capsules each.
Packs of 2 or 3 blisters.

Marketing Authorisation Holder and Manufacturer
IBSA Farmaceutici Italia Srl, via Martiri di Cefalonia, 2, 26900 Lodi, Italy