Eskim

Package leaflet: Information for the patient

Eskim 500 mg soft capsules, 1000 mg soft capsules

ethyl esters of polyunsaturated fatty acids
Please read all of 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including 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 taking 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 Eskim is and what it is used for

Eskim contains highly concentrated and purified ethyl esters of polyunsaturated fatty acids (derived from fish oil) as active substances, which reduce the levels of certain fats in the blood (triglycerides) and have beneficial effects on the heart and blood vessels.
Eskim is indicated for the reduction of elevated levels of fats (triglycerides) in the blood, when diet and other non-pharmacological measures alone have not been sufficient. Treatment with Eskim should always be accompanied by appropriate dietary measures.

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.
Inform your doctor before taking Eskim:

• if you are allergic to fish, since the active substance in Eskim is derived from fish oil;
• if you have or have had heart problems;
• if you experience dizziness, weakness, 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 taking high doses of Eskim;
• if you have conditions that cause you to bleed easily.

Other medicines and Eskim
Tell 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 affecting blood clotting, as this may lead to an increased bleeding time.

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 sodium ethyl p-hydroxybenzoate and sodium propyl p-hydroxybenzoate
Eskim contains sodium ethyl p-hydroxybenzoate and sodium propyl p-hydroxybenzoate, 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 exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Take the Eskim 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.
For dose adjustment and maintenance therapy, your doctor may prescribe the 500 mg capsules.

Use in the paediatric population
There are no data available on the use of Eskim 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 Eskim (see section "Warnings and precautions").

If you take more Eskim than you should
In case of accidental overdose, inform your doctor or pharmacist.

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

If you stop taking Eskim
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• Stomach and/or intestinal disturbances
• Fast or irregular heartbeat

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

• Nausea
• Indigestion
• Pain in the upper abdomen
• Diarrhoea

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

• Allergic reactions (hypersensitivity), allergy to 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
• Skin rash with itching (urticaria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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 Eskim

Keep this medicine out of the sight and reach of children.
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 you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Eskim Contains
Eskim 500 mg soft capsules

• The active substances are ethyl esters of polyunsaturated fatty acids. Each soft capsule contains 500 mg of ethyl esters of polyunsaturated fatty acids, with a content of EPA and DHA not less than 85%, and a ratio between them of 0.9 - 1.5.
• The other components are D,L α-tocopherol, soybean oil, succinated gelatin, glycerol, ethyl p-hydroxybenzoate sodium, propyl p-hydroxybenzoate sodium.

Eskim 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 not less than 85%, and a ratio between them of 0.9 - 1.5.
• The other components are D,L α-tocopherol, soybean oil, succinated gelatin, glycerol, ethyl p-hydroxybenzoate sodium, propyl p-hydroxybenzoate sodium.

Description of the Appearance of Eskim and Contents of the Package
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.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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)