PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

NEBBARO 1000 MG SOFT CAPSULES

Omega-3-acid ethyl esters 90

Read all of this leaflet carefully before you start

taking this medicine because it contains

important information for you.

•    Keep this leaflet. You may want to read it again.

•    If you have any further questions, ask your doctor or pharmacist or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side-effects talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Nebbaro is and what it is used for

2.    What you need to know before you take Nebbaro

3.    How to take Nebbaro

4.    Possible side effects

5.    How to store Nebbaro

6.    Contents of the pack and other information

1. What Nebbaro is and what it is used for

The active ingredients of Nebbaro are the poly unsaturated omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Nebbaro reduces certain blood fats (triglycerides).

Nebbaro is used:

•    together with other medicines for treatment after a heart attack.

•    to treat certain forms of increased fats in the blood (endogenous hypertriglyceridemia) after changes to the diet alone have not worked.

If any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Children and adolescents

Because there are no data on the efficacy and safety, children should not take Nebbaro .

Elderly Persons

There are no data on the use of Nebbaro in elderly patients above 70 years of age.

Other medicines and Nebbaro

Please tell your doctor or pharmacist if you are using or have recently used other medicines including medicines obtained without prescription.

Nebbaro may increase the bleeding time. If you are using Nebbaro together with a medicine which stops blood clotting (anticoagulants), your doctor will closely supervise your treatment, and adjust the dose if required.

Pregnancy and breast-feeding and fertility

You should not take this medicine if you are pregnant or breast-feeding, unless your doctor decides it is absolutely necessary.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No special precautions are necessary.

Nebbaro 1000 mg soft capsules contain soya oil. If you are allergic to peanut or soya, do not take this medicine.

3. How to take Nebbaro

2. What you need to know before you take Nebbaro

Nebbaro must not be taken if:

•    you are allergic to the active ingredient, soya, peanut or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist or nurse before

taking Nebbaro if:

•    you are due to have or have had surgery recently

•    you have had a trauma recently

•    you have a kidney problem

•    you have diabetes which is not controlled

•    you have problems with your liver. Your doctor will monitor any effects of Nebbaro which may have influence on your liver with blood tests.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

After heart attack:

The recommended dose is 1 soft capsule per day

For elevated blood fat values 2 soft capsules per day. In the case of insufficient effect, the dose can be increased to 4 soft capsules per day.

Please talk to your doctor or pharmacist if you have the impression that the effect of Nebbaro is too strong or too weak.

How to use:

The soft capsules should be swallowed together with a sufficient amount of fluid at meal times. This way, you can avoid possible gastro-intestinal side effects.

If you take more Nebbaro than you should

If you accidentally take more of this medicinal product than you should and you are experiencing negative effects, please contact your doctor.

If you forget to take Nebbaro

Do not take a double dose if you have forgotten the previous dose. Instead, take the next soft capsules as prescribed.

If you discontinue using Nebbaro

Do not stop the treatment without consulting your doctor. Talk to your doctor if you are not satisfied with the effects of Nebbaro.

If you have further questions concerning the use of the medicine, ask your doctor or your pharmacist.

Storage conditions:

Do not store above 25°C.

Do not freeze.

Shelf life after first opening:

28 caps = 28 days 100 caps = 100 days

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment

4. Possible side effects

6. Contents of the pack and other information

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 problems and indigestion (dyspepsia)

•    feeling sick (nausea)

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

•    abdominal and stomach pain

•    allergic reactions

•    dizziness

•    taste impairment

•    diarrhoea

•    vomiting

Rare side effects (may affect up to 1 in

1.000    people):

•    headache

•    acne

•    pruritic (itchy) rash

•    raised blood sugar

•    liver problems

Very rare side effects (may affect up to 1 in

10.000    people):

•    blood in your faeces

•    low blood pressure

•    dry nose

•    urticaria (hives)

•    changes in the results of certain blood tests

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nebbaro

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is printed on the label and carton. The expiry date refers to the last day of the month.

What Nebbaro 1000 mg soft capsules contain

The active substance is omega-3-acid ethyl esters 90.

Each soft capsule contains 1000 mg of omega-3-acid ethyl esters 90, comprising principally 840 mg ethyl esters of eicosapentaenoic acid (EPA) (460 mg) and docosahexaenoic acid (DHA) ethyl ester (380 mg).

The further components are:

•    Capsule filling: alpha-tocopherol (Ph. Eur.)

•    Capsule shell: gelatin, glycerol, purified water, medium chain triglycerides, sunflower lecithin.

What Nebbaro 1000 mg soft capsules look like and contents of the pack

Soft capsule: soft, transparent oblong gelatin capsules, containing a pale yellow oil packed in white (HDPE) bottles of 75 ml and 150 ml with a LDPE push-fit tamper-evident cap or white (HDPE) bottles of 250 ml with a PE white flip-top cap.

Nebbaro is available in packs of 75 ml bottles 1 x 20 capsules 1 x 28 capsules 1 x 30 capsules

10 bottles x 20 capsules (200 capsules)

150 ml bottles 1 x 60 capsules

250 ml bottles 1 x 98 capsules 1 x 100 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Zentiva,

One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Manufacturer: One Pharma S.A., 60^th km National Road Athens-Lamia, 320 09 Schimatari, Viota, Greece

This leaflet was last revised in July 2013