Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg, zachte capsules 460 mg/380 mg

Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg contains highly purified omega-3 polyunsaturated fatty acids.

Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg belongs to a group of so called reducers of cholesterol and triglycerides.

Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg is used:

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

Do not take Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg:

• 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 Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg.

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 Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg 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 Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg 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 Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg

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.

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.

Driving and using machines

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

Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg contains soybean oil

Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg contains soybean oil. If you are allergic to peanut or soya, do not use this medicinal product.

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 after a heart attack

The usual dose is one capsule a day.

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 Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg with care if you are over 70 years.

Use in children

Children should not take this medicine.

If you take more of Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg 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.

If you forget to take Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg

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.

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.

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.

What Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg contains

The active substances are omega -3-acid ethyl esters 90, 1000 mg, comprising 840 mg ethylesters of 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 Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg looks like and contents of the pack

Oblong shaped, transparent, colourless capsule, soft, filled with light yellowish oil.

NL/H/2265/001/DC

OPA-Al-PVC/Al blister containing 20, 20x1, 28, 28x1, 100 and 300 capsules HDPE bottle, closed with LDPE cap, containing 20, 28, 100 and 300 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz B.V., Veluwezoom 22, Almere

Correspondentie: Postbus 10332, 1301 AH Almere

Manufacturers

R.P. Scherer GmbH & Co. KG

Gammelsbacher Straße 2

69412 Eberbach

Duitsland

Lek Pharmaceuticals d.d.

Verovškova 57, 1526 Ljubljana

Slovenië

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, 39179 Barleben

Duitsland

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A, RO-540472 Targu-Mures

Roemenië

Lek S.A.

Ul. Domanieuwska 50C

02-672 Warschau

Polen

MA-number:

RVG 109421

This medicinal product is authorised in the Member States of the EEA under the following names:

Nederland	Omega-3 vetzuren ethylesters 90 Sandoz 1000 mg, zachte
	capsules 460 mg/380 mg
Duitsland	Omega-3-HEXAL 1000 mg Weichkapseln
Italië	Omega 3 Sandoz

This leaflet was last revised in augustus 2012