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FORCINUIT 1000MG SOFT CAPSULES

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Forcinuit 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 need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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. This includes any possible side effects not
listed in this leaflet.

What is in this leaflet:
1. What Forcinuit is and what it is used for
2. What you need to know before you take Forcinuit
3. How to take Forcinuit
4. Possible side effects
5. How to store Forcinuit
6. Contents of the pack and other information

1

Forcinuit contains highly purified omega-3
polyunsaturated fatty acids.

Pregnancy and breast-feeding
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.

Forcinuit is used:
• alone or together with other medicines to treat
certain forms of increased triglycerides (fats) in the
blood after changes to the diet have not worked

Forcinuit contains soybean oil
Forcinuit contains soybean oil. If you are allergic to
peanut or soya, do not use this medicinal product.

What Forcinuit is and what it is used
for

Forcinuit belongs to a group of so called reducers of
cholesterol and triglycerides.

2

What you need to know before you
take Forcinuit

Do not take Forcinuit:
• if you are allergic to Omega-3-acid ethyl esters,
soya, peanuts or any of the other ingredients of this
medicine (listed in section 6)

Warnings and precautions
Talk to your doctor or pharmacist before using
Forcinuit.
For proper use of this product, it is necessary to
submit to regular medical supervision. Always take
this medicine exactly as described in this leaflet or
your doctor has told you.
Do not stop to continue the regular use of other
medicines.

Take special care with Forcinuit 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 Forcinuit may
have on your liver with blood tests.

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

Other medicines and Forcinuit
If you are using a medicine to stop blood clotting in
your arteries, such as warfarin, you may need extra
blood tests and your usual dose of your blood thinning
medicine may have to be changed.

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

3

How to take Forcinuit

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

• Swallow the capsules with a drink of water.
• You may take the capsules at meal times to help
reduce gastro-intestinal side effects.
• Your doctor will decide how long you should take
this medicine.

Dose to treat high blood triglyceride levels (high
levels of fat in the blood or hypertriglyceridaemia)
The usual dose is 2 capsules a day, as recommended
by a doctor. If the medicine is not working well enough
at this dose, your doctor may increase this to 4
capsules a day.

Use in elderly
Use Forcinuit with care if you are over 70 years.

Use in children
Children should not take this medicine.

If you take more of Forcinuit than you should
If you accidentally take more of this medicine than you
should, do not worry, as this is unlikely to need special
treatment.

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines.

Continued on the next page >>

Artwork Proof Box
A healthy decision
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom.
T: 01276 698020
F: 01276 698324
W: www.uk.sandoz.com
E: sandoz.artwork@me.com

Ref: Licence application - Day 210, National Phase
Proof no.
001.0

Date prepared:
04/07/2012

Prepared by:
DW

RA Approved?
Yes

Date approved:
04/07/2012

Approved by:
PR
Fonts:
Helvetica

Colours:
Black
Dimensions: 160 x 300 mm

PROPOSED
MOCK UP

Artwork/RA Checklist:
Product name
Strength/dosage

Font size: 8pt
Pack size
PL number
Storage

Warnings
Excipients
Braille

If you forget to take Forcinuit
If you miss a dose, take it when you remember unless
it is almost time for your next dose, in which case take
the next dose as usual. Do not take a double dose
(twice the dose recommended by your doctor) to
make up for a forgotten dose.
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. Side
effects can occur with the following frequencies:

Common, affects 1 to 10 per 100 users
• stomach problems and indigestion (dyspepsia)
• feeling sick (nausea)

Uncommon, affects 1 to 10 per 1,000 users
• abdominal and stomach pain
• allergic reactions
• dizziness
• problems with taste
• diarrhoea
• being sick (vomiting)
Rare, affects 1 to 10 per 10,000 users
• headache
• acne
• itchy rash (pruritus)
• high blood sugar levels
• liver problems

Very rare, affects fewer than 1 per 10,000 users
• blood in your stools
• low blood pressure
• dry nose
• raised red skin rash (hives or urticaria)
• changes in the results of certain blood tests

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

5

eicosapentaenoic acid (EPA) 460 mg (46%) and
docosahexaenoic acid (DHA) 380 mg (38%)
The other ingredients are:
Capsule fill:
alpha-tocopherol
soybean oil
sun flower oil

Capsule shell:
Glycerol
Gelatin
Medium-chain triglycerides
(3-sn-Phosphatidyl)choline

What Forcinuit looks like and contents of the pack
Oblong shaped, transparent, colourless capsule, soft,
filled with light yellowish oil.

OPA-Al-PVC/Al blister containing 28, 30, 56, 90, 100,
capsules.
HDPE bottle, closed with LDPE cap, containing 28,
30, 56, 90,100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
R.P. Scherer GmbH & Co. KG,
Gammelsbacher Straße 2,
69412 Eberbach,
Germany
or

Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana,
Slovenia
or

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany
or

How to store Forcinuit

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 (of the bottle and the blister) after
EXP.
The expiry date refers to the last day of that month.

S.C. Sandoz, S.R.L.,
Str. Livezeni nr. 7A, RO-540472 Targu-Mures,
Romania.

This leaflet was last revised in 07/2012 (to be
amended upon approval).

Blister
Store below 30°C. Store in the original packaging in
order to protect from moisture.
HDPE bottle
Store below 30°C. Keep the bottle tightly closed in
order to protect from moisture

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 Forcinuit contains
The active substances are omega -3-acid ethyl esters
90, 1000 mg, comprising 840 mg ethylesters of

SZ00000LT000

Artwork Proof Box
A healthy decision
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom.
T: 01276 698020
F: 01276 698324
W: www.uk.sandoz.com
E: sandoz.artwork@me.com

Ref: Licence application - Day 210, National Phase
Proof no.
001.0

Date prepared:
04/07/2012

Prepared by:
DW

RA Approved?
Yes

Date approved:
04/07/2012

Approved by:
PR
Fonts:
Helvetica

Colours:
Black
Dimensions: 160 x 300 mm

PROPOSED
MOCK UP

Artwork/RA Checklist:
Product name
Strength/dosage

Font size: 8pt
Pack size
PL number
Storage

Warnings
Excipients
Braille

+ Expand Transcript

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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