Package leaflet: Information for the patient

Esapent 1000 mg soft capsules

ethyl esters of polyunsaturated fatty acids
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Esapent is and what it is used for
What you need to know before taking Esapent
How to take Esapent
Possible side effects
How to store Esapent
Contents of the pack and other information

1. What Esapent is and what it is used for

Esapent contains, as active substances, ethyl esters of polyunsaturated fatty acids (derived from fish oil)
with high concentration and purity, which reduce the levels of certain fats in the blood (triglycerides) and have beneficial effects on the heart and blood vessels.
Esapent is indicated:

for reducing elevated levels of fats (triglycerides) in the blood, when diet and other non-pharmacological measures alone have not been sufficient. Treatment with Esapent must always be accompanied by appropriate dietary measures.

2. What you need to know before taking Esapent

Do not take Esapent

if you are allergic to ethyl esters of polyunsaturated fatty acids (derived from fish oil) or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
This medicine contains soya. If you are allergic to peanuts or soya, do not take this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Esapent.
Inform your doctor before taking Esapent:

if you are allergic to fish, as the active substance in Esapent is derived from fish oil;
if you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are taking high doses of Esapent;
if you have conditions that make you prone to bleeding.

Other medicines and Esapent
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Inform your doctor if you are being treated with:

medicines to thin the blood (anticoagulants), e.g. coumarin anticoagulants;
other medicines that affect blood clotting, as this may lead to an increased bleeding time.

Pregnancy and breastfeeding
Do not use Esapent if you are pregnant or breastfeeding.
Driving and using machines
Esapent does not affect the ability to drive or operate machinery.
Esapent contains sodium ethyl p-hydroxybenzoate and sodium propyl p-hydroxybenzoate
Esapent contains sodium ethyl p-hydroxybenzoate and sodium propyl p-hydroxybenzoate, which may cause
allergic reactions (including delayed reactions).
Esapent contains less than 1 mmol (23 mg) of sodium per soft capsule, i.e. it is essentially ‘sodium-free’.

3. How to take Esapent

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Swallow the Esapent capsules whole with some water.
Use in adults
The recommended dose is 1 capsule of 1000 mg 1-3 times daily, according to your doctor's prescription.
Use in the paediatric population
There are no data available on the use of Esapent in the paediatric population for the authorised indications.
Use in elderly patients and patients with impaired kidney function
No dose adjustment is required in these patients.
Use in patients with impaired liver function
Your doctor will monitor your liver function during treatment, especially if you are taking
high doses of Esapent (see section “Warnings and precautions”).
If you take more Esapent than you should
In case of accidental overdose, inform your doctor or pharmacist.
If you forget to take Esapent
Do not take a double dose to make up for the missed dose.
If you stop taking Esapent
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Common side effects (may affect up to 1 in 10 people)

Stomach and/or intestinal disturbances

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

Nausea
Difficulty digesting
Upper abdominal pain
Diarrhoea

Rare side effects (may affect up to 1 in 1,000 people)

Allergic reactions (hypersensitivity), allergy to the ingredients
Dizziness
Inflammation of the stomach and/or intestine (gastritis, gastroenteritis)
Abdominal pain
Heartburn
Changes in liver function
Skin reactions
Weakness

Other side effects that have occurred in a very small number of people, but whose exact frequency is unknown:

Itching
Itchy skin rash (urticaria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Esapent

Keep this medicine out of the sight and reach of children.
Do not use this medicine and return the medicine package to the pharmacist if you notice that the capsules
are reddish-brown in colour. This discolouration may be due to oxidation of the fish oil.
Do not use this medicine after the expiry date stated on the packaging after Exp.. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Esapent contains
Esapent 1000 mg soft capsules

The active substances are ethyl esters of polyunsaturated fatty acids. Each soft capsule contains 1000 mg of ethyl esters of polyunsaturated fatty acids, with a content of EPA and DHA of not less than 85%, and a ratio between them of 0.9 - 1.5.
The other components are D,Lα-tocopherol, soybean oil, succinated gelatin, glycerol, ethyl p-hydroxybenzoate sodium, propyl p-hydroxybenzoate sodium.

Description of the appearance of Esapent and contents of the pack
Esapent 1000 mg soft capsules
Transparent, elongated soft capsules.
Each pack contains 20 soft capsules in blisters.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina

Manufacturer
Pfizer Italia S.r.l.
Località Marino del Tronto
63100 Ascoli Piceno (AP)