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PATIENT INFORMATION LEAFLET

Maxepa® Capsules

Please read this Patient Information Leaflet carefully before you start to take your medicine. This leaflet provides a summary of information about your medicine. Please ask your doctor or pharmacist (chemist) if you have any questions or are not sure about anything to do with this medicine. Keep this leaflet in a safe place, you may wish to refer to it later.

In this leaflet:

1.    What are Maxepa Capsules?

2.    Before you take Maxepa Capsules

3.    How to take Maxepa Capsules

4.    Side effects

5.    How to store Maxepa Capsules

6.    Further information

1.    WHAT ARE MAXEPA CAPSULES?

Maxepa Capsules belong to a group of fat lowering medicines. This medicine reduces the amount of fat (triglycerides) in the blood in those who have been told they may be at risk of heart disease and/or inflammation of the pancreas (pancreatitis).

DO NOT TAKE Maxepa Capsules if you:

•    Are allergic (hypersensitive) to any of the ingredients of Maxepa Capsules

•    Suffer from non-insulin dependent diabetes and have aspirin sensitive asthma

2.    BEFORE YOU TAKE MAXEPA CAPSULES

Before taking Maxepa Capsules tell your doctor or pharmacist if you:

•    Suffer from non-insulin dependant diabetes

•    Suffer with aspirin sensitive asthma (this is an allergy where taking aspirin or aspirin-like substances can bring on the symptoms of asthma)

•    Suffer with haemophilia (a disorder that affects blood clotting)

•    Suffer from liver problems

•    Are taking any medicines, including those you have bought without a prescription

•    Are taking any medicines than can thin your blood (e.g. warfarin, aspirin, cephalosporin)

•    Are pregnant, trying to become pregnant or breast feeding

3.    HOW TO TAKE MAXEPA CAPSULES

For adult use only.

For oral use.

Adults and the elderly

The usual dose is 5 capsules to be swallowed whole with water at meal times twice daily or as directed by your doctor. If you miss a dose, do not worry. Take the next dose at your usual time. Do not take this medicine twice to make up for a forgotten dose. Consult your doctor or pharmacist before you stop your treatment with this medicine. If you are unsure about how to take this medicine or you have any other questions talk to your doctor or pharmacist.

4.    SIDE EFFECTS

As with all medicines there may be some side effects with Maxepa Capsules, although not everyone will get them. Maxepa Capsules can sometimes cause nausea (feeling sick) vomiting (being sick), fishy after-taste, wind, skin reactions (e.g. acne, eczema) and a slight increase in liver enzymes if you have high levels of fat in your blood (hypertriglyceridaemia), diarrhoea or constipation If any side effect becomes serious or you notice any side effects not listed on this label, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, 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.

5.    HOW TO STORE MAXEPA CAPSULES Keep out of the sight and reach of children.

Do not store above 25°C. Do not refrigerate. Keep Maxepa Capsules in the original container in order to protect from light and moisture.

Do not use after the expiry date shown on carton.

6. FURTHER INFORMATION What Maxepa Capsules look like

Clear, oblong soft gelatin capsules containing clear, golden oil. Capsules are contained in a plastic tub fitted with a snap-on cap. Each plastic container holds 200 capsules. Check cap seal is not damaged before first use.

Ingredients

Each capsule contains 170mg of eicosapentaenoic acid and 115mg of docosahexaenoic acid as the active ingredients.

Excipients: Tocopheryl Acetate, Gelatin, Glycerol and citric acid.

Manufactured by:

Seven Seas Ltd, Hedon Road, Hull, HU9 5NJ, UK

Procured from within the EU and repackaged by:

Amimed Direct Ltd, Hendon, London, nW9 6AQ.

Product licence holder:

Sam Pharma Ltd, Unit 20, Garrick industrial estate, Irving way, Hendon, London, NW9 6Aq.

PL: 33902/0169

MAXEPA® is a registered trademark of Merck Consumer Healthcare Limited.

Leaflet revision date: 13/12/2013

S0169-200-GR-PI L-13.12.2013