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NEBBARO 1000MG SOFT CAPSULES

Active substance(s): OMEGA-3-ACID ETHYL ESTERS

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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. See section 4.
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



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 people
There are no data on the use of Nebbaro in elderly
patients above 70 years of age.
Other medicines and Nebbaro
Tell your doctor or pharmacist if you are using, have
recently used or might use any 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, 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.
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.

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Driving and using machines
This medicine is not likely to affect you being able
to drive or use any tools or machines.

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.

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

2. What you need to know before you take Nebbaro
Do not take Nebbaro if:
• you are allergic to omega-3-acid ethyl esters 90,
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.

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

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3. How to take Nebbaro
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

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 take:
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.

Zentiva Regulatory
Approved: Yes
No
Date:
Signature:

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Zentiva - Head of Regulatory
Approved: Yes
No
N/A
Date:
Signature:
Other - as required
Approved: Yes
No
Date:
Signature:

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If you forget to take Nebbaro
Do not take a double dose to make up for a forgotten
dose. Instead, take the next soft capsules as
prescribed.
If you stop taking 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 any further questions on the use of this
medicine, ask 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 problems such as feeling bloated
(abdominal distension), pain, constipation,
diarrhoea, indigestion (dyspepsia), wind, belching
(eructation), acid reflux, feeling sick (nausea) and
being sick (vomiting).
Uncommon side effects (may affect up to
1 in 100 people):
• raised blood sugar
• gout
• dizziness
• taste impairment
• headache
• low blood pressure
• nose bleed
• blood in your faeces
• rash
Rare side effects (may affect up to 1 in
1,000 people):
• allergic reactions
• itchy, lumpy rash
• liver problems with possible 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.

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
6. Contents of the pack and other information
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.

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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 with a LDPE push-fit
tamper-evident cap or white (HDPE) bottles of
250 ml with a PE white flip-top cap.

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Nebbaro is available in packs of
75 ml bottles
1 x 28 capsules
250 ml bottles
1 x 100 capsules
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder: Zentiva,
One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturer: One Pharma S.A., 60th km National
Road Athens-Lamia, 320 09 Schimatari, Viota,
Greece
This leaflet was last revised in September 2014

Zentiva Regulatory
Approved: Yes
No
Date:
Signature:

N/A

Zentiva - Head of Regulatory
Approved: Yes
No
N/A
Date:
Signature:

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 stated on the label and carton. The expiry date
refers to the last day of the month.

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Other - as required
Approved: Yes
No
Date:
Signature:

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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