Leaflet: information for the user

Omegaflex peri Emulsion for infusion

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What isOmegaflexperiand what it is used for

2. What you need to know before you start usingOmegaflexperi

3. How to useOmegaflexperi

4. Possible side effects

5. Storage ofOmegaflexperi

6. Contents of the pack and additional information

Omegaflexperi contains liquids and substances called amino acids, electrolytes, and fatty acids that are essential for the growth or recovery of the organism. It also contains calories in the form of carbohydrates and fats.

Omegaflexperi is administered to adults,adolescents, and children over two years old..

Omegaflexperi is administered when there is an inability to ingest food normally.There are many situations in which this can occur, such as, for example, in the recovery phases of surgical interventions, traumas, or burns, or when there is an inability to absorb food in the stomach and intestine.

No use Omegaflex peri

?if you are allergic to any of the active ingredients, egg, peanut, soy, fish, or any other component of this medication (listed in section6).

?This medication should not be administered to newborns, infants, and children under two years of age.

Also, do not useOmegaflexperi if you have any of the following conditions:

?potentially life-threatening blood circulation problems, such as those that may occur in cases of collapse or shock

?heart failure or stroke

?severe blood clotting disorder, risk of bleeding (severe coagulopathy, bleeding diathesis)

?blockage of blood vessels by blood clots or fat (embolism)

?severe liver failure

?altered bile flow (intrahepatic cholestasis)

?severe kidney failure, where dialysis equipment is not available

?imbalance of body salts

?fluid deficiency or excess in your body

?fluid in your lungs (pulmonary edema)

?severe heart failure

?certain metabolic disorders, such as:

–excessive lipids (fats) in the blood

–congenital disorders of amino acid metabolism

–abnormally high blood sugar levels that require more than 6 units of insulin per hour to control

–metabolic disorders that may occur after surgical interventions or trauma

–unknown origin coma

–insufficient oxygen supply to tissues

–abnormally high levels of acids in the blood

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to useOmegaflexperi.

Inform your doctor if:

?You have heart, liver, or kidney problems

?You present certain types of metabolic disorders, such as diabetes, abnormal levels of fats in the blood, and disorders in the body's composition of fluids and salts or acid-base balance.

You will be closely monitored to detect the first signs of an allergic reaction (such as fever, chills, skin rash, or shortness of breath) when receiving this medication.

You will undergo additional control and tests, such as various blood sample examinations, to ensure that your body adequately assimilates the administered foods.

The healthcare staff will also take measures to ensure that your body's fluid and electrolyte needs are met.In addition toOmegaflexperi, you may receive additional nutrients (food) to fully meet your needs.

Children

This medication should not be administered to newborns, infants, and children under two years of age.

Use of Omegaflex peri with other medications

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

Omegaflexperi may interact with some medications. Inform your doctor, pharmacist, or nurse if you are taking or receiving any of the following medications:

?insulin

?heparin

?medications that prevent unwanted blood clotting, such as warfarin or other coumarin derivatives

?diuretics (medications that promote urine flow)

?medications to treat high blood pressure or heart problems (ACE inhibitors and angiotensin II receptor antagonists)

?medications used in organ transplantation, such as cyclosporine and tacrolimus

?corticosteroids (medications used to treat inflammation)

?hormonal preparations that affect your fluid balance (adrenocorticotropic hormone [ACTH])

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.If you are pregnant, you will receive this medication only if your doctor or pharmacist considers it absolutely necessary for your recovery. There are no available data on the use ofOmegaflexperi in pregnant women.

It is not recommended to breastfeed in mothers treated with parenteral nutrition.

Driving and operating machinery

This medication is usually administered to patients who are bedridden, e.g., in a hospital or clinic, which excludes the possibility of driving or operating machinery. However, the medication itself does not affect the ability to drive or operate machinery.

Omegaflexperi contains sodium

This medication contains 0.931mg of sodium (main component of table salt/for cooking) per ml. This is equivalent to 0.047% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need one or more daily bags for a prolonged period, especially if you have been recommended a low-sodium diet.

This medication is administered through intravenous infusion (drop by drop), that is, through a small tube into a vein. This medication may be administered through one of its small veins (peripheral) orthrough one of its large veins (central).The recommended duration for the infusion of a parenteral nutrition bag is a maximum of 24hours.

Your doctor or pharmacist will decide what amountof this medication you need and for how long.

Use in children

This medication should not be administered to newborns, infants, and children under two years old.

Your doctor will decide what amount of this medication your child needs and for how long your child will require treatment with this medication.

If you use more Omegaflex than you should

If you have received too much of this medication, you may experience the so-called “overload syndrome” and the following symptoms:

?excess fluids and electrolyte imbalances

?fluid in your lungs (pulmonary edema)

?loss of amino acids through urine and imbalances in amino acid levels

?vomiting, nausea

?chills

?high blood sugar levels

?glucose in urine

?dehydration

?blood that is much more concentrated than normal (hyperosmolality)

?altered or loss of consciousness due to extremely high blood sugar levels

?enlargement of the liver(hepatomegaly) with or without jaundice

?enlargementof the spleen (splenomegaly)

?deposition of fat in internal organs

?abnormal values in liver function tests

?reduction in red blood cell count (anemia)

?reduction in white blood cell count (leukopenia)

?reduction in platelet count (thrombocytopenia)

?increase in immature red blood cells (reticulocytosis)

?breakdown of blood cells (hemolysis)

?bleeding or tendency to bleed

?alterations in blood coagulation (such as changes in bleeding time, coagulation time, prothrombin time, etc.)

?fever

?high levels of fats in the blood

?loss of consciousness

Ifany of the following symptoms occur, the infusion should be stopped immediately

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects may be serious. If you experience any of the following side effects, inform your doctor immediately, who will stop administering this medicine:

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

?allergic reactions such as, for example, skin reactions, shortness of breath, swelling of the lips, mouth, and throat, difficulty breathing

Other side effects include:

Frequent (may affect up to 1 in 10 people):

?irritation or inflammation of the veins (phlebitis, thrombophlebitis)

Poorly frequent (may affect up to 1 in 100 people):

?nausea, vomiting, loss of appetite

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

?increased tendency of blood coagulation

?blue discoloration of the skin

?shortness of breath

?headache

?flushing

?redness of the skin (erythema)

?sweating

?chills

?feeling of cold

?high body temperature

?drowsiness

?chest, back, bone, or lumbar region pain

?decrease or increase in blood pressure

Very rare (may affect up to 1 in 10,000 people):

?abnormally high levelsofsugar or fat in the blood

?high levels of acidic substances in your blood

?an excess of lipids may cause the overload syndrome; for more information, consult the heading, “If you use moreOmegaflexthan you should” in section3. Symptoms usually disappear when infusion is interrupted.

Frequency not known (cannot be estimated from available data):

?decreasein white blood cell count (leucopenia)

?decrease in platelet count (thrombocytopenia)

?bile flow alterations (cholestasis)

Reporting side effects

If you experience any type of side effect, consult yourdoctor, pharmacist, or nurse,even if it is a possible side effect that does not appear in this prospectus.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use. Website:www.notificaRAM.es

Keep this medication out of the sight and reach of children.

Do not store at a temperature above25°C.

Do not freeze.Discard the bag if it has been accidentally frozen.

Store the bag in the outer packaging to protect it from light.

Do not use this medication after the expiration date shown on the label. The expiration date is the last day of the month indicated.

Composition ofOmegaflex peri

The active ingredients of the ready-to-use mixture are:

The other components are citric acid monohydrate (for