OMEGANA contains highly purified omega-3 polyunsaturated fatty acids. OMEGANA belongs to a group of so-called reducers of cholesterol and triglycerides.

OMEGANA is used:

• together with other medicines for treatment after a heart attack.
• to treat certain forms of increased triglycerides (fats) in the blood after changes to the diet have not worked.

Do not take OMEGANA:

If you are allergic (hypersensitive) to Omega-3-Acid Ethyl Esters 90 or any of the other ingredients of this medicine (listed in section 6). If any of the above applies to you, do not take this medicine, and talk to your doctor.

Take special care with OMEGANA:

Talk to your doctor or pharmacist before taking OMEGANA 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 OMEGANA may have on your liver with blood tests
• you are allergic to fish.

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

Children

Children should not take this medicine.

Elderly

Use OMEGANA with care if you are over 70 years.

Taking other medicines and OMEGANA

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

 Taking OMEGANA with food and drink

You should take the capsules at mealtimes. This is to help lower the chances of side effects that affect the area in and around the stomach (the gastro-intestinal area).

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, 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 your being able to drive or use any tools or machines.

OMEGANA contains soya bean oil.

OMEGANA may contain soya-bean oil. If you are allergic to peanuts or soya, do not use this 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 mealtimes to help reduce gastrointestinal side effects.
• Your doctor will decide how long you should take this medicine.

Dose after a heart attack

The recommended dose is one capsule a day.

Dose to treat high blood triglyceride levels (high levels of fat in the blood or hypertriglyceridemia)

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.

If you take more of OMEGANA 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. However, you should contact your doctor or pharmacist for further advice.

If you forget to take OMEGANA

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. The following are side effects that may happen with this medicine:

Common side effects (may affect up to 1 in 10 people):

stomach problems like abdominal distension, pain, constipation, diarrhea, indigestion (dyspepsia), gas, belching (eructation), acid reflux, feeling sick (nausea), and being sick (vomiting)

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

• high blood sugar levels
• gout
• dizziness
• problems with taste
• headache
• low blood pressure
• nose bleed
• blood in your stools
• rash

Rare side effects (may affect up to 1 in 1000 people):

• allergic reactions
•  itchy rash (hives or urticaria)
• liver disorders, with possible changes in the results of certain blood tests

Not known (frequency cannot be estimated from the available data):

• Itching

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, health care provider, or pharmacist.

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 carton and the label after EXP. The expiry date refers to the last day of the month.

Do not store OMEGANA above 25°C. Do not freeze.

OMEGANA 1000 mg Soft Gel Capsules should be used within 100 days of opening the bottle.

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.