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MAXEPA CAPSULES

Active substance(s): DOCOSAHEXAENOIC ACID / EICOSAPENTAENOIC ACID

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REGULATORY TEXT – COMBINED LABEL-LEAFLET
MAXEPA CAPSULES, PL 01932/0002
Top of Label
SEVEN SEAS
Maxepa Capsules
200 capsules
Front of Label (design panel)
SEVEN SEAS
Maxepa Capsules
Front of Label (design panel)
SEVEN SEAS
Maxepa Capsules
200 capsules
Front of Label (design panel)
SEVEN SEAS
Maxepa Capsules
Each 1 g capsule contains 170 mg Eicosapentaenoic Acid (EPA) and 115 mg Docosahexaenoic Acid
(DHA) for adult use only.
200 capsules
Front of Label (text panel)
Ingredients
Each 1g capsule of Maxepa contains the following active ingredients: Eicosapentaenoic
Acid (EPA) 170mg and Docosahexaenoic Acid (DHA) 115mg. Also contains Tocopheryl
Acetate (Vitamin E), Gelatin and Glycerin.
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

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








Suffer from non-insulin dependent 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 from 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 that can thin your blood (e.g. warfarin, aspirin, cephalosporin)
Are pregnant, trying to become pregnant or breast feeding

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.
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.

What Maxepa Capsules look like:
Colourless, oblong shaped soft gelatin capsules containing 1g of clear golden oil contained in a plastic
tub fitted with snap-on cap. Each tub contains 200 capsules. Check cap seal is not damaged before
first use.
Storage instructions: Keep out of the reach and sight of children
Store below 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 the carton.
Further information:
Product Licence Holder and Manufacturer: Seven Seas Ltd., Hedon Road, Hull, HU9 5NJ, United
Kingdom.
PL 01932/0002
This label was last revised: October 2013
Seven Seas and Maxepa are registered trade marks

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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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