ESAPENT 1 Г Софт капсула

Содержание инструкции

1. Esapent 1000 mg soft capsules
   1. What is Esapent and what is it used for
   2. What you need to know before taking Esapent
   3. How to take Esapent
   4. Possible side effects
   5. How to store Esapent
   6. Contents of the pack and other information

Esapent 1000 mg soft capsules

ethyl esters of polyunsaturated fatty acids

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Esapent is and what it is used for
• 2. What you need to know before you take Esapent
• 3. How to take Esapent
• 4. Possible side effects
• 5. How to store Esapent
• 6. Contents of the pack and other information

1. What is Esapent and what is it used for

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

• to reduce high levels of fats (triglycerides) in the blood, in cases where diet and other non-pharmacological measures alone have not been sufficient. Treatment with Esapent must always be associated with adequate dietary rules.

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 use this medicine.

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

• if you are allergic to fish, as the active ingredient of Esapent is derived from fish oil;
• if you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are using high doses of Esapent;
• if you have bleeding disorders.

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

• medicines to thin the blood (anticoagulants) e.g. coumarin anticoagulants
• other medicines that affect blood clotting because an increase in bleeding time may occur.

Pregnancy and breastfeeding
Do not use Esapent if you are pregnant or breastfeeding.

Driving and operating machinery
Esapent does not affect the ability to drive or operate machinery.

Esapent contains ethyl p-oxybenzoate sodium and propyl p-oxybenzoate sodium
Esapent contains ethyl p-oxybenzoate sodium and propyl p-oxybenzoate sodium, which may cause
allergic reactions (including delayed reactions).
Esapent contains less than 1mmol (23mg) of sodium per soft capsule, i.e. it is essentially ‘sodium-free’.

3. How to take Esapent

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
Take the Esapent capsules whole with a little water.

Use in adults
The recommended dose is 1 capsule of 1000 mg 1-3 times a day, as prescribed by your doctor.

Use in the paediatric population
No data are available on the use of Esapent in the paediatric population in the authorised indications.

Use in elderly patients and in patients with impaired renal function
No dose adjustment is required in these patients.

Use in patients with impaired hepatic function
Your doctor will monitor your liver function during treatment, especially if you are using
high doses of Esapent (see section “Warnings and precautions”).

If you take more Esapent than you should
In case of accidental ingestion of an excessive dose of Esapent, inform your doctor or pharmacist.

If you forget to take Esapent
Do not take a double dose to make up for a missed dose.

If you stop taking Esapent
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

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

• stomach and/or intestinal disorders

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

• nausea
• difficulty digesting
• pain in the upper part of the abdomen
• diarrhoea

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

• allergic reactions (hypersensitivity), allergy to the components
• dizziness
• inflammation of the stomach and/or intestines (gastritis, gastroenteritis)
• abdominal pain
• heartburn
• alteration of 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 rash (urticaria).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through 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 package of medicine to the pharmacist if you notice that the capsules
are reddish-brown in color. This discoloration may be due to oxidation phenomena of the fish
oil.
Do not use this medicine after the expiry date which is reported on the package after Expiry. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Esapent contains
Esapent 1000 mg soft capsules

• The active ingredients are ethyl esters of polyunsaturated fatty acids. Each soft capsule contains 1000 mg of ethyl esters of polyunsaturated fatty acids, with an EPA and DHA content of not less than 85% and a ratio between them of 0.9 - 1.5.
• The other ingredients are D,Lα-tocopherol, soybean oil, succinate 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
Soft, transparent, oblong capsules.
Each pack contains 20 soft capsules in blisters.
Not all pack sizes may be marketed.

Marketing authorisation 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)