ESKIM 1000 mg Soft Capsule

Содержание инструкции

1. Eskim 500 mg soft capsules, 1000 mg soft capsules
   1. What is Eskim and what is it for
   2. What you need to know before taking Eskim
   3. How to take Eskim
   4. Possible side effects
   5. How to store Eskim
   6. Contents of the pack and other information

Eskim 500 mg soft capsules, 1000 mg soft capsules

ethyl esters of polyunsaturated fatty acids

Read this leaflet carefully before you start to take 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 they have the same symptoms as you, as it may 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 Eskim is and what it is used for
• 2. What you need to know before you take Eskim
• 3. How to take Eskim
• 4. Possible side effects
• 5. How to store Eskim
• 6. Contents of the pack and other information

1. What is Eskim and what is it for

Eskim contains as active ingredients ethyl esters of polyunsaturated fatty acids (derived from fish oil) at a
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.
Eskim 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 Eskim must always be
associated with adequate dietary rules.

2. What you need to know before taking Eskim

Do not take Eskim

• 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 Eskim.
Tell your doctor before taking Eskim:

• if you are allergic to fish; as the active ingredient of Eskim is derived from fish oil;
• if you have, or have had, heart problems;
• if you experience dizziness, asthenia, palpitations or shortness of breath, as these may be symptoms of an irregular and often very rapid heartbeat (atrial fibrillation).
• if you have liver problems. Your doctor will monitor your liver function during treatment, especially if you are using high doses of Eskim;
• if you have bleeding disorders.

Other medicines and Eskim
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 Eskim if you are pregnant or breastfeeding.

Driving and using machines
Eskim does not affect the ability to drive or operate machinery.

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

3. How to take Eskim

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
Take the Eskim 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.
For dose adjustment and maintenance therapy, your doctor may prescribe the capsules of
500 mg.

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

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

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

If you take more Eskim than you should
If you accidentally ingest an excessive dose of Eskim, inform your doctor or pharmacist.

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

If you stop taking Eskim
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
• fast, irregular heartbeat.

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

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

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
• 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 not known

• itching
• itchy skin 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 Eskim

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 pack after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Eskim contains
Eskim 500 mg soft capsules

• The active ingredients are ethyl esters of polyunsaturated fatty acids. Each soft capsule contains 500 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,L α-tocopherol, soybean oil, succinate gelatin, glycerol, ethyl p-hydroxybenzoate sodium, propyl p-hydroxybenzoate sodium.

Eskim 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,L α-tocopherol, soybean oil, succinate gelatin, glycerol, ethyl p-hydroxybenzoate sodium, propyl p-hydroxybenzoate sodium.

Description of the appearance of Eskim and contents of the pack
Eskim 500 mg soft capsules
Soft, transparent, oval capsules.
Each pack contains 30 soft capsules in blisters.
Eskim 1000 mg soft capsules
Soft, transparent, oblong capsules.
Each pack contains 20 or 30 soft capsules in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
Catalent Italy S.p.A. - Via Nettunense km 20,100 - 04011 Aprilia (LT)
Doppel Farmaceutici S.r.l.- Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)