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

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 Forcinuit contains highly purified omega-3    planning to have a baby, ask your doctor or

polyunsaturated fatty acids.    pharmacist for advice before taking this medicine.

What Forcinuit is and what it is used for

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

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

Driving and using machines

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

Forcinuit contains soybean oil

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

What you need to know before you take Forcinuit

3 How to 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.

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

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.

Continued on the next page >>

Sandoz Ltd,

Frimley Business Park, Frimley, Camberley, Surrey, GU 16 7SR, United Kingdom.

T: 01276 698020 F: 01276 698324 W: www.uk.sandoz.com E: sandoz.artwork@me.com

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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 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. 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.

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 StraGe 2,

69412 Eberbach,

Germany

or

Lek Pharmaceuticals d.d.,

Verovskova 57, 1526 Ljubljana,

Slovenia

or

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,39179 Barleben,

Germany

or

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).

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

Sandoz Ltd,

Frimley Business Park, Frimley, Camberley, Surrey, GU 16 7SR, United Kingdom.

T: 01276 698020 F: 01276 698324 W: www.uk.sandoz.com E: sandoz.artwork@me.com

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